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<dc:creator>$exy Mistakes</dc:creator>
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<title><![CDATA[ISO Consultant]]></title>
<link>http://iso90012008consultant.wordpress.com/2012/06/02/iso-consultant/</link>
<pubDate>Sat, 02 Jun 2012 09:26:45 +0000</pubDate>
<dc:creator>Master Group</dc:creator>
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<description><![CDATA[We provide the servicesISO, ISO 9001, ISO9001, ISO Consultant, ISO Consultancy, ISO Certification, I]]></description>
<content:encoded><![CDATA[<div id="attachment_9" class="wp-caption alignnone" style="width: 529px"><a href="http://iso90012008consultant.files.wordpress.com/2012/06/iso-029.jpg"><img class="size-full wp-image-9" title="ISO-029" src="http://iso90012008consultant.files.wordpress.com/2012/06/iso-029.jpg" alt="We provide the services  ISO, ISO 9001, ISO9001, ISO Consultant, ISO Consultancy, ISO Certification, ISO 9001 Consultancy, ISO 9001 Consultant, ISO9001 2008, ISO 9001 2008, ISO 9001:2008, ISO 9001 2008 Consultant, ISO 9001 2008 Consultancy, ISO  9001:2008 Consultants, ISO 9001:2008 Consultancy. ISO/TS, ISO/TS 16949, ISO/TS 16949:2009, TS 16949, TS16949, TS Consultant, TS 16949 Consultant, TS 16949 Consultancy, ISO/TS 16949 Consultant, ISO/TS 16949 Consultancy, ISO/TS 16949:2009 Consultant. QMS, QMS Consultant, QMS Implementation, Quality System. ISO 14001, ISO 14001 Consultants, ISO 14001 Consultancy, ISO 14001 Certification. SA , SA 8000, SA 8000 Consultant, SA Consultancy Service. OHSAS, OHSAS Consultants, HACCP, HACCP Consultant, CE Mark. Consultancy for  Improvement, Improvement Process, Productivity, Waste Management, Energy Saving, Workplace Cooperation, Cleaner Production, Quality Circle, VAVE etc Trainings on APQP, PAP, PPAP, FMEA, MSA, SPC, 5S, 5-S, Problem Solving, Time Management, short term courses for Engineers providing class room, laboratory and industrial education " width="519" height="389" /></a><p class="wp-caption-text">We provide the services<br />ISO, ISO 9001, ISO9001, ISO Consultant, ISO Consultancy, ISO Certification, ISO 9001 Consultancy, ISO 9001 Consultant, ISO9001 2008, ISO 9001 2008, ISO 9001:2008, ISO 9001 2008 Consultant, ISO 9001 2008 Consultancy, ISO 9001:2008 Consultants, ISO 9001:2008 Consultancy.<br />ISO/TS, ISO/TS 16949, ISO/TS 16949:2009, TS 16949, TS16949, TS Consultant, TS 16949 Consultant, TS 16949 Consultancy, ISO/TS 16949 Consultant, ISO/TS 16949 Consultancy, ISO/TS 16949:2009 Consultant.<br />QMS, QMS Consultant, QMS Implementation, Quality System.<br />ISO 14001, ISO 14001 Consultants, ISO 14001 Consultancy, ISO 14001 Certification.<br />SA , SA 8000, SA 8000 Consultant, SA Consultancy Service.<br />OHSAS, OHSAS Consultants, HACCP, HACCP Consultant, CE Mark.<br />Consultancy for<br />Improvement, Improvement Process, Productivity, Waste Management, Energy Saving, Workplace Cooperation, Cleaner Production, Quality Circle, VAVE etc<br />Trainings on<br />APQP, PAP, PPAP, FMEA, MSA, SPC, 5S, 5-S, Problem Solving, Time Management, short term courses for Engineers providing class room, laboratory and industrial education</p></div>
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<li>  CE Mark</li>
<li>  Process Improvement</li>
<li>  Value Analysis, Value Engineering (VAVE)</li>
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<p>Consultancy and Training for ISO 9001, ISO/TS 16949, ISO14000, SA 8000, OHSAS, HACCP, CE Mark etc.</p>
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<p>short term courses for Engineers providing class room, laboratory and industrial education</p>
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<p>The International Organization for Standardization , widelyknownas ISO,isaninternationalstandardsettingbodycomposed of representatives from various national standardsorganizations.FoundedonFebruary23,1947,theorganization promulgates worldwide proprietary,industrial,andcommercial standards.Ithasitsheadquartersin Geneva,Switzerland.1 Name and abbreviation2 History3 Financing4 InternationalStandardsandotherpublications5 Standardization process6 ISO document copyright7 Members8 ProductsnamedafterISO9 ISO/IJointTechnical Committee 110 Criticism<br />
The three official languages of the ISO are English, French, and Russian.[3] The organization&#8217;s logos in two of its official languages, English and French, include the word ISO, and it is usually referred to by this short-form name. The organization says that ISO is not anacronym or initialism for the organization&#8217;s full name in either official language; rather, recognizing that its initials would be different in different languages, it adopted ISO, based on the Greek word isos (ἴσος, meaning equal), as the universal short form of its name.[4]However, one of the founding delegates, Willy Kuert, recollected the original naming question with the comment: &#8220;I recently read that the name ISO was chosen because &#8216;iso&#8217; is a Greek term meaning &#8216;equal&#8217;. There was no mention of that in London!&#8221;History<br />
Memory plaque of founding ISA in PragueThe organization today known as ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA) This organization focused heavily on mechanical engineering. It was disbanded in 1942 during the Second World War but was re-organized under the current name, ISO, in 1946ISO is a voluntary organization whose members are recognized authorities on standards, each one representing one country. The bulk of the work of ISO is done by the 2700 technical committees, subcommittees, and working groups. Each committee and subcommittee is headed by a Secretariat from one of the member organizations<br />
Financing<br />
ISO is funded by a combination of: Organizations that manage the specific projects or loan experts to participate in the technical work.Subscriptions from member bodies (&#8220;the national body most representative of standardization in its country&#8221;These subscriptions are in proportion to each country&#8217;s gross national product and trade figures.<br />
International Standards and other publications<br />
ISO&#8217;s main products are international standards. ISO also publishes technical reports, technical specifications, publicly available specifications, technical corrigenda, and guides. International standards are designated with the format ISO[/IEC] [/ASTM] [IS]] Title, where nnnnn is the number of the standard, p is an optional part number, yyyy is the year published, and Title describes the subject. IEC for International Electrotechnical Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). ASTM (American Society for Testing and Materials) is used for standards developed in cooperation with ASTM International. The date and IS are not used for an incomplete or unpublished standard and may under some circumstances be left off the title of a published work.Technical reports are issued when a technical committee or subcommittee has collected data of a different kind from that normally published as an International Standard.[10] such as references and explanations. The naming conventions for these are the same as for standards, except TR prepended instead of IS in the report&#8217;s name. Examples:ISO/IEC TR 17799:2000 Code of Practice for Information Security ManagementISO/TR 19033:2000 Technical product documentation — Metadata for construction documentationTechnical specifications can be produced when &#8220;the subject in question is still under development or where for any other reason there is the future but not immediate possibility of an agreement to publish an International Standard&#8221;. Publicly Available Specifications may be &#8220;an intermediate specification, published prior to the development of a full International Standard, or, in IEC may be a &#8216;dual logo&#8217; publication published in collaboration with an external organization&#8221;.[10] Both are named by convention similar to Technical Reports, for example:ISO/TS 16952-1:2006 Technical product documentation — Reference designation system — Part 1: General application rulesISO/PAS 11154:2006 Road vehicles — Roof load carriersISO sometimes issues technical corrigenda. Corrigenda (plural of corrigendum) are amendments to existing standards because of minor technical flaws, usability improvements, or limited applicability extensions. Generally, these are issued with the expectation that the affected standard will be updated or withdrawn at its next scheduled review. ISO Guides are meta-standards covering &#8220;matters related to international standardization&#8221; They are named in the format &#8220;ISO[/IEC] Guide N:yyyy: Title&#8221;, for exampleISO/IEC Guide 2:2004 Standardization and related activities — General vocabularyISO/IEC Guide 65:1996 General requirements for bodies operating product certification<br />
Standardization process<br />
A standard published by ISO/IEC is the last stage of a long process that commonly starts with the proposal of new work within a committee. Here are some abbreviations used for marking a standard with its status: PWI &#8211; Preliminary Work ItemNP or NWIP &#8211; New Proposal / New Work Item Proposal (e.g., ISO/IEC NP 23007)AWI &#8211; Approved new Work Item (e.g., ISO/IEC AWI 15444-14)WD &#8211; Working Draft (e.g., ISO/IEC WD 27032)CD &#8211; Committee Draft (e.g., ISO/IEC CD 23000-5)FCD &#8211; Final Committee Draft (e.g., ISO/IEC FCD 23000-12)DIS &#8211; Draft International Standard (e.g., ISO/IEC DIS 14297)FDIS &#8211; Final Draft International Standard (e.g., ISO/IEC FDIS 27003)PRF &#8211; Proof of a new International Standard (e.g., ISO/IEC PRF 18018)IS &#8211; International Standard (e.g., ISO/IEC 13818-1:2007)Abbreviations used for amendmentsNP Amd &#8211; New Proposal Amendment (e.g., ISO/IEC 15444-2:2004/NP Amd 3)AWI Amd &#8211; Approved new Work Item Amendment (e.g., ISO/IEC 14492:2001/AWI Amd 4)WD Amd &#8211; Working Draft Amendment (e.g., ISO 11092:1993/WD Amd 1)CD Amd / PDAmd &#8211; Committee Draft Amendment / Proposed Draft Amendment (e.g., ISO/IEC 13818-1:2007/CD Amd 6)FPDAmd / DAM (DAmd) &#8211; Final Proposed Draft Amendment / Draft Amendment (e.g., ISO/IEC 14496-14:2003/FPDAmd 1)FDAM (FDAmd) &#8211; Final Draft Amendment (e.g., ISO/IEC 13818-1:2007/FDAmd 4)PRF Amd &#8211; (e.g., ISO 12639:2004/PRF Amd 1)Amd &#8211; Amendment (e.g., ISO/IEC 13818-1:2007/Amd 1:2007Other abbreviations: TR &#8211; Technical Report (e.g., ISO/IEC TR 19791:2006)DTR &#8211; Draft Technical Report (e.g., ISO/IEC DTR 19791)TS &#8211; Technical Specification (e.g., ISO/TS 16949:2009)DTS &#8211; Draft Technical Specification (e.g., ISO/DTS 11602-1PAS &#8211; Publicly Available SpecificationTTA &#8211; Technology Trends Assessment (e.g., ISO/TTA 1:1994)IWA &#8211; International Workshop Agreement (e.g., IWA 1:2005)Cor &#8211; Technical Corrigendum (e.g., ISO/IEC 13818-1:2007/Cor 1:2008)Guide &#8211; a guidance to technical committees for the preparation of standardsInternational Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps: Stage 1: Proposal stageStage 2: Preparatory stageStage 3: Committee stageStage 4: Enquiry stageStage 5: Approval stageStage 6: Publication stageThe TC/SC may set up working groups (WG) of experts for the preparation of a Working Drafts. Subcommittees may have several working groups, which can have several Sub Groups (SG).[22]It is possible to omit certain stages, if there is a document with a certain degree of maturity at the start of a standardization project &#8211; for example a standard developed by another organization. ISO/IEC Directives allow also the so-called &#8220;Fast-track procedure&#8221;. In this procedure a document is submitted directly for approval as a draft International Standard (DIS) to the ISO member bodies or as a final draft International Standard (FDIS) if the document was developed by an international standardizing body recognized by the ISO Council. The first step &#8211; a proposal of work (New Proposal) is approved at the relevant subcommittee or technical committee (e.g., SC29 and JTC1 respectively in the case of Moving Picture Experts Group &#8211; ISO/IEC JTC1/SC29/WG11). A working group (WG) of experts is set up by the TC/SC for the preparation of a Working Draft. When the scope of a new work is sufficiently clarified, some of the working groups (e.g., MPEG) usually make open request for proposals &#8211; known as &#8220;Call for proposals&#8221;. The first document that is produced for example for audio and video coding standards is called a Verification Model (VM) (previously also called a Simulation and Test Model). When a sufficient confidence in the stability of the standard under development is reached, a Working Draft (WD) is produced. This is in the form of a standard but is kept internal to working group for revision. When a Working Draft is sufficiently solid and the working group is satisfied that it has developed the best technical solution to the problem being addressed, it becomes Committee Draft (CD). If it is required, it is then sent to the P-members of the TC/SC (National Bodies) for ballot.The CD becomes Final Committee Draft (FCD) if the number of positive votes is above the quorum. Successive committee drafts may be considered until consensus is reached on the technical content. When it is reached, the text is finalized for submission as a draft International Standard (DIS). The text is then submitted to National Bodies for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. ISO will then hold a ballot with National Bodies where no technical changes are allowed (yes/no ballot), within a period of two months. It is approved as an International Standard (IS) if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. After approval, only minor editorial changes are introduced into the final text. The final text is sent to the ISO Central Secretariat, which publishes it as the International Standard<br />
ISO document ISO documents are copyrighted and ISO charges for copies of most. ISO does not, however, charge for most draft copies of documents in electronic format. Although useful, care must be taken using these drafts as there is the possibility of substantial change before it becomes finalized as a standard. Some standards by ISO and its official U.S. representative (and theInternational Electrotechnical Commission&#8217;s via the U.S. National Committee) are made freely available.ISO has 162 national members,[2] out of the 205 total countries in the world.ISO has three membership categories:Member bodies are national bodies considered the most representative standards body in each country. These are the only members of ISO that have voting rights.Correspondent members are countries that do not have their own standards organization. These members are informed about ISO&#8217;s work, but do not participate in standards promulgation.Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standardsParticipating members are called &#8220;P&#8221; members, as opposed to observing members, who are called &#8220;O&#8221; members.<br />
Products named after ISO<br />
The fact that many of the ISO-created standards are ubiquitous has led, on occasion, to common use of &#8220;ISO&#8221; to describe the actual product that conforms to a standard. Some examples of this are:Many CD images end in the file extension &#8220;ISO&#8221; to signify that they are using the ISO 9660standard file system as opposed to another file system &#8211; hence CD images are commonly referred to as &#8220;ISOs&#8221;. Virtually all computers with CD-ROM drives can read CDs that use this standard. Some DVD-ROMs also use ISO 9660 file systems.Photographic film&#8217;s sensitivity to light, its &#8220;film speed&#8221;, is described by ISO 6, ISO 2240 and ISO 5800. Hence, the film&#8217;s speed is often referred to as its &#8220;ISO number&#8221;.Often, the flash hot shoe found on cameras is called &#8220;ISO shoe&#8221;, as it was originally defined in ISO 518.<br />
ISO/IEC Joint Technical Committee 1<br />
Main article: ISO/IEC JTC1To deal with the consequences of substantial overlap in areas of standardization and work related to information technology, ISO and IEC formed a Joint Technical Committee known as the ISO/IEC JTC1. It was the first such joint committee. The second joint committee was created in 2009 &#8211; Joint Project Committee &#8211; Energy efficiency and renewable energy sources &#8211; Common terminology (ISO/IEC/JTC 2) With the exception of a small number of isolated standards ISO standards are normally not available free of charge, but for a purchase fee which has been seen by some as too expensive for small open source projects. The ISO/IEC JTC1 fast-track procedures (&#8220;Fast-track&#8221; as used by OOXML and &#8220;PAS&#8221; as used by OpenDocument) have garnered criticism in relation to the standardization of Office Open XML (ISO/IEC 29500). Martin Bryan, outgoing Convenor of ISO/IEC JTC1/SC34 WG1, is quoted as saying:I would recommend my successor that it is perhaps time to pass WG1’s outstanding standards over to OASIS, where they can get approval in less than a year and then do a PAS submission to ISO, which will get a lot more attention and be approved much faster than standards currently can be within WG1.The disparity of rules for PAS, Fast-Track and ISO committee generated standards is fast making ISO a laughing stock in IT circles. The days of open standards development are fast disappearing. Instead we are getting &#8216;standardization by corporation&#8217;. Computer security entrepreneur and Ubuntu investor, Mark Shuttleworth, commented on the Standardization of Office Open XML process by sayingI think it de-values the confidence people have in the standards setting process,and Shuttleworth alleged that ISO did not carry out its responsibility. He also noted that Microsoft had intensely lobbied many countries that traditionally had not participated in ISO and stacked technical committees with Microsoft employees, solution providers and resellers sympathetic to Office Open XML.When you have a process built on trust and when that trust is abused, ISO should halt the process &#8230; ISO is an engineering old boys club and these things are boring so you have to have a lot of passion … then suddenly you have an investment of a lot of money and lobbying and you get artificial results. The process is not set up to deal with intensive corporate lobbying and so you end up with something being a standard that is not clear. American National Standards Institute (ANSI)Deutsches Institut für Normung, German Institute for Standardization (DIN)British Standards Institution (BSI)Countries in International Organization for StandardizationCanadian Standards AssociationEuropean Committee for Standardization (CEN)Commonwealth of Independent States (CIS) set of standards (GOST)International Classification for StandardsInternational Electrotechnical Commission (IEC) and ISO/IEC standardsInternational healthcare accreditationInternational Telecommunication Union (ITU)Institute of Environmental Sciences and Technology (IEST)ISO A4ISO country codeList of International Organization for Standardization standards<br />
ISO divisions<br />
ISO/TC 37<br />
ISO/TC 68<br />
TC 46/SC 9<br />
ISO/TC 211<br />
ISO/TC 215<br />
ISO/TC 223<br />
Standardization<br />
Standards Australia<br />
Standards organization<br />
Terminology planning policy<br />
The International Customer Service Institute (TICSI)<br />
AP Stylebook (Associated Press Style)<br />
Interface 2010 (Interface Marketing Supplier Integration Institute)<br />
ISO 9000 is a family of standards related to quality management systems, outlines the requirements needed to ensure organizations meet the needs of its customers while striving to meet their expectationsThe standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systemsincluding the eight management principles) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.[<br />
Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwid are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Despite widespread use, however, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.<br />
Reasons for use<br />
The ISO family of standards is the only international standard that addresses systemic change. The global adoption of ISO 9001 may be attributable to a number of factors. A number of major purchasers require their suppliers to hold ISO 9001 certification. In addition to several stakeholders’ benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business. Corbett et al showed that certified organizations achieved superior return on assets compared to otherwise similar organizations without certification. Heras et al found similarly superior performance and demonstrated that this was statistically significant and not a function of organization size. Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the US motor carrier industry. Sharma identified similar improvements in operating performance and linked this to superior financial performance. Chow-Chua et alshowed better overall financial performance was achieved for companies in Denmark. Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 systemWhile the connection between superior financial performance and ISO 9001 may be seen from the examples cited, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al (2005) may suggest it. Other writers, such as Heras et al (2002), have suggested that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.The mechanism for improving results has also been the subject of much research. Lo et al (2007) identified operational improvements (cycle time reduction, inventory reductions, etc.) as following from certification. Internal process improvements in organizations lead to externally observable improvements. The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.<br />
Background<br />
ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. However, its history can be traced back some twenty years before that, to the publication of the Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979 before being submitted to ISO.BSI has been certifying organizations for their quality management systems since 1978. Its first certification (FM 00001) is still extant and held by Tarmac, a successor to the original company which held this certificate. Today BSI claims to certify organizations at nearly 70,000 sites globally.[ The development of the ISO 9000 series is shown in the diagram to the right.<br />
ISO 9001ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach, which do not contain specific requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows:Pages v to vii: Section 0 IntroPages 1 to 14: RequirementsSection 1: ScopeSection 2: Normative ReferenceSection 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)Section 4: Quality Management SystemSection 5: Management ResponsibilitySection 6: Resource ManagementSection 7: Product RealizationSection 8: Measurement, analysis and improvemenIn effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standardsPage 23: BibliographThe standard specifies six compulsory documents:Control of Documents (4.2.3)Control of Records (4.2.4)Internal Audits (8.2.2)Control of Nonconforming Product / Service (8.3)Corrective Action (8.5.2)Preventive Action (8.5.3In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above documents).<br />
Summary of ISO 9001:2008<br />
The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.The business makes decisions about the quality system based on recorded data.The quality system is regularly audited and evaluated for conformance and effectiveness.Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.The business determines customer requirements.The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.The business has documented procedures for dealing with actual and potential nonconformances (problems involving suppliers, customers, or internal problems).The business:makes sure no one uses a bad product,determines what to do with a bad product,deals with the root cause of problems, andkeeps records to use as a tool to improve the system.<br />
Certification<br />
ISO does not itself certify organizations. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as 'ISO 9000' certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008. Many countries have formedaccreditation bodies to authorize ("accredit") the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021 while accreditation bodies operate under ISO/IEC 17011. An organization applying for ISO 9000 certification is audited based on an extensive sample of its sites, functions, products, services and processes. A list of problems ("action requests" or "non-compliance") is first made known to management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management in the form of corrective action reports showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate. The certificate is limited by a certain scope (e.g. production of golf balls) and names the locations covered.An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO certification contrasts with measurement-based quality systems such as the Capability Maturity Model.<br />
Evolution of ISO 9000 standards<br />
1987 version ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent. 1994 versionISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system2000 versionISO 9001:2000 combined the three standards—9001, 9002, and 9003—into one, called 9001. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard. 2008 versionISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.<br />
AuditingTwo types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to; to find out where it can improve; and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":Tell me what you do (describe the business process)Show me where it says that (reference the procedure manuals)Prove that this is what happened (exhibit evidence in documented records)The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote compliance by focusing on risk, status, and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus:Under the 1994 version, the question was broad: "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the questions are more specific: "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?"<br />
Industry-specific interpretationsThe ISO 9001 standard is generalized and abstract; its parts must be carefully interpreted to maksense within a particular organization. Developing software is not like making cheeseor offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 systems.Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt &#38; Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100C.PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 5.0; unlike ISO 9001 or other sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2000.ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to computer software.ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex<br />
EffectivenessThe debate on the effectiveness of ISO 9000 commonly centers on the following questions:Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important; in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994).Does it help to implement an ISO 9001:2000-compliant quality management system?Does it help to obtain ISO 9001:2000 certification?Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:Commitment of senior management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.How well the ISO system integrates into current business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.How well the ISO system focuses on improving the customer experience. The broadest definition of quality is "Whatever the customer perceives good quality to be." This means that a company doesn't necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements in the customer's experience.How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit. When management doesn't understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand.AdvantagesIt is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Implementing ISO often gives the following advantages:Creates a more efficient, effective operationIncreases customer satisfaction and retentionReduces auditsEnhances marketingImproves employee motivation, awareness, and moralePromotes international tradeIncreases profitReduces waste and increases productivity.common tool for standardisation.<br />
Criticisms of ISO<br />
A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for registration. Dalgleish cites the "inordinate and often unnecessary paperwork burden" of ISO, and says that "quality managers feel that ISO's overhead and paperwork are excessive and extremely inefficient." According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed." Wilson suggests that ISO standards "... elevate inspection of the correct procedures over broader aspects of quality," and therefore, "the workplace becomes oppressive and quality is not improved. According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards.&#8221; ] Paraphrased, Wade&#8217;s argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality&#8221;If you just want the certificate on the wall, chances are you will create a paper system that doesn&#8217;t have much to do with the way you actually run your business,&#8221; said ISO&#8217;s Roger Frost Certification by an independent auditor is often seen as the problem area, and according to Barnes, &#8220;has become a vehicle to increase consulting services. Dalglesh argues that while &#8220;quality has a positive effect on return on investment, market share, sales growth, better sales margins and competitive advantage,&#8221; that &#8220;taking a quality approach is unrelated to ISO 9000 registration.&#8221; In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. Abrahamson argues that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad. FAQs on ISO 9001:2008This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support the publication of ISO 9001:2008 and the revision of ISO 9004. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world.The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards.For the latest version of the FAQs, reference should be made to the open access web site at 1. What is ISO?The International Organization for Standardization (ISO) was established in 1947 and is (currently) an association of 163 members, which each represent their own country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards. Besides the National Standards Bodies, ISO permits other international organizations that develop standards to participate in its work, by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also include requirements on the presentation of standards.2. Who are the National Standards Bodies, and who represents my country at ISO?Please see the relevant page on ISO Online that gives details, including contact information, of the National Standards Bodies. What are the ISO 9000 standards ?The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis.(It should be noted that many of the International Standards in the ISO 9000 family are numbered in the ISO 10000 ranThe purpose of this ISO 9001 training -Book document is to provide a clear and in-depth understanding of the intent and implication of each clause and sub-clause of the ISO 9001:2008 standard. While not intended to serve as an implementation guide, this document should provide sufficient insight for a quality practitioner to develop and implement an effective ISO 9001 based quality management system (QMS).</p>
<p>This document can be used by:<br />
Beginners &#8211; to understand and apply ISO 9001 requirements.<br />
QMS managers &#8211; to develop a more effective QMS for their organization. QMS auditors &#8211; to conduct more effective QMS audits.Top management &#8211; to gain an understanding of ISO 9001 as a business tool.<br />
Consultants &#8211; to provide value-added service to their clients.</p>
<p>The ISO 9001:2008 standard is shown in the beige box and below each section, clause or sub-clause of the standard, I provide &#8220;key points and tips&#8221; to help you better understand the specific concepts, principles and requirements. You will find important explanatory points and tips being repeated or further elaborated in different parts of the standard. Whenever I make reference to ‘you’ or ‘your’ QMS, I mean your organization’s or facility’s quality management system.</p>
<p>In going through the explanatory points and tips, I request that you read each paragraph carefully and sometimes twice to fully grasp the additional interpretation or insight it may convey. By doing so, you might be able to save much time, effort and money in understanding and implementing these requirements or help make your QMS more effective and get the most of this ISO 9001 trainingISO 9001 Training Key Explanation Points and Tips:<br />
The first four clauses (clause 0. Introduction to &#8211; clause 3. Terms and Definitions) do not provide any requirements for a QMS. They provide background information as to the purpose; concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. These clauses will all be explained in more detail as we go through each section.<br />
The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. The following is a summary explanation of these 5 major clauses or elements of the ISO 9001:20000 standard. Each major clause has several sub-clauses. Collectively, these 5 clauses set out the requirements for your QMS.<br />
Clause 4 &#8211; Quality Management System &#8211; sets requirements to identify, plan, document, operate and control QMS processes and to continually improve QMS effectiveness.<br />
Clause 5 &#8211; Management Responsibility &#8211; sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS.<br />
Clause 6 &#8211; Resource Management &#8211; sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements.<br />
Clause 7 &#8211; Product Realization &#8211; sets requirements to plan, operate and control the specific QMS processes thatdetermine, design, produce and deliver an organization’s product and services.Clause 8-Measurement, Analysis and Improvement &#8211; sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.<br />
The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually improving QMS effectiveness.<br />
To help you get the most out this e-Book, you might find it useful to follow key themes that the ISO 9001 standard has emphasized. These include:All QMS processes must be planned, implemented, measured and improvedISO 9001 requirements focus on controlling QMS processes, not product.QMS controls must emphasize prevention of nonconformities rather than detection.<br />
QMS processes must be customer focused. Process personnel must be aware of and<br />
strive to meet internal and external customer requirements.You must continually improve the effectiveness of your QMS.<br />
1.1 Quality Managment Principles<br />
0.2 Process Approach<br />
0.2 Types Of Business Processes<br />
0.2 Process Characteristics<br />
0.2 Process Plan &#8211; Do &#8211; Check &#8211; Act<br />
0.3 Relationship With ISO 9004<br />
0.4 Compatibility With Other Management Systems<br />
1.1 ISO 9001 QMS Scope<br />
1.2, &#8211; 3 QMS Application<br />
4.1 QMS General Requirements<br />
4.1 QMS General Requirements &#8211; Continued<br />
4.2.1 Documentation Requirements<br />
4.2.2 Quality Manual<br />
4.2.3 Control of Documents<br />
4.2.3 Control of Documents -Continued<br />
4.2.4 Control of Records<br />
5.1 Management Commitment<br />
5.2 Customer Focus<br />
5.3 Quality Policy<br />
5.4.1 Quality Objectives<br />
5.4.2 Quality Management System Planning<br />
5.5.1 Responsibility and Authority<br />
5.5.2 Management Representative<br />
5.5.3 Internal Communication<br />
5.6 Management Review<br />
6.1 Provision of Resources<br />
6.2 Human Resources<br />
6.3-4 Infrastructure and Work Environment<br />
7.1 Planning of Product Realization<br />
7.1 Planning of Product Realization &#8211; 2<br />
7.2 Customer-Related Processes<br />
7.2 Customer-Related Processes &#8211; Cont&#8217;d<br />
7.3.1 Design and Development Planning<br />
7.3.2 Design and Development Inputs<br />
7.3.3 Design and Development Outputs<br />
7.3.5-7 Verification, Validation &#38; Changes<br />
7.4 Purchasing Process<br />
7.4.2-3 Purchasing Information &#38; Verification of Purchased Product<br />
7.5.1 Control of Production and Service Provision<br />
7.5.2 Production Process Validation<br />
7.5.3 Identification and Traceability<br />
7.5.4-5 Customer Property and Preservation of Product<br />
7.6 Control of Monitoring and Measuring Equipment<br />
7.6 Control of Monitoring and Measuring Equipment 2<br />
8.1 Measurement, Analysis and Improvement &#8211; General<br />
8.2.1 Customer Satisfaction<br />
8.2.2 Internal Audit<br />
8.2.3 Monitoring and Measurement of Processes<br />
8.2.4 Monitoring and Measurement of Product<br />
8.3 Control of Nonconforming Product<br />
8.4 Analysis of Data<br />
8.5.1 Continual Improvement<br />
8.5.2 Corrective Action<br />
8.5.3 Preventive Action<br />
Understanding The ISO/TS 16949:2002 StandardParticular requirements for applying ISO 9001:2000 to automotive production and relevant service part organizationsThe intent of this document is to provide a clear and in-depth understanding of the intent and implication of each clause and sub-clause of the TS 16949:2002 standard. While not intended to serve as an implementation guide, this document should provide sufficient insight for a quality practitioner to develop and implement an effective TS 16949 based quality management system (QMS). This document may be used by: Beginners &#8211; to understand and apply TS 16949 requirements. QMS managers – to develop a more effective QMS for their organization. QMS auditors – to conduct more effective QMS audits. Top management – to gain an understanding of TS 16949 as a business tool. Consultants – to provide value-added service to their clients.The specific requirements of the TS 16949:2002 standard is shown in shaded text Within this shaded background, the ISO 9001 foundational requirements are shown in regular print and the TS 19649 additions are shown initalics. The wording of the ISO/TS 16949 requirements are laid out in paraphrased but precise form, following the exact clause by clause numbering. Where ISO/TS 16949 has used the word “shall”, it indicates a mandatory requirement. The word ‘should’ indicates a recommendation and Certification Bodies (Registrars) lean towards interpreting ‘should’ as a ‘shall’ in most cases. Notes to paragraphs are for guidance in understanding or clarifying the associated requirement. However, if the note includes the word ‘should’, then you would be wise to implement the guidance or recommendation in the note. Wherever possible, I have stated the clauses in the active tense instead of the sometimes difficult to understand passive tense used in the standard. Below each section, clause or sub-clause of the standard, I provide key explanation points and tips to help you better understand the requirement and any underlying intent, concepts and principles. The key point or phrase in each explanatory paragraph is bolded for easy reference to the sub-clause being explained. You will find important explanatory points and tips being repeated or further elaborated in different parts of the standard. Whenever I make reference to ‘yoor ‘your’ QMS, I mean your organization’s quality management system.<br />
In going through the explanatory points and tips, I request that you read each paragraph carefully and sometimes twice to fully grasp the additional interpretation or insight it may convey. By doing so, you might be able to save much time, effort and money in understanding and implementing these requirements or help make your QMS more effective.</p>
<p>Preface &#8211; TS16949<br />
◦ Introduction<br />
◦ Major Clauses<br />
◦ Process Approach -1<br />
◦ Process Approach-2<br />
◦ Plan/Do/Check/Act<br />
◦ Cont Improve Model<br />
◦ Compatibility<br />
◦ TS 16949 Scope<br />
◦ Application<br />
◦ Normative References<br />
◦ Terms And Definitions<br />
◦ 4.1 General Reqmts<br />
◦ 4.2.1 Documentation Reqmts<br />
◦ 4.2.2 Quality Manual<br />
◦ 4.2.3 Document Control<br />
◦ 4.2.4 Control Of Records<br />
◦ 5.1 Mgmt Commitment<br />
◦ 5.2 Customer Focus<br />
◦ 5.3 Quality Policy<br />
◦ 5.4.1 Quality Objectives<br />
◦ 5.4.2 QMS Planning<br />
◦ 5.5.1 Quality Responsibility<br />
◦ 5.5.2 Mgmtt Rep<br />
◦ 5.5.3 Internal Communications<br />
◦ 5.6 Mgmt Review<br />
◦ 6.1 Resource Provision<br />
◦ 6.2 Human Resources<br />
◦ 6.3 Infrastructure<br />
◦ 7.1 Planning Product Realization<br />
◦ 7.2 Customer Processes<br />
◦ 7.3.1 D &#38; D Planning<br />
◦ 7.3.2 D &#38; D Inputs<br />
◦ 7.3.2 D &#38; D Outputs<br />
◦ 7.3.4 To 7.3.6 &#8211; Review, Verification And Validation<br />
◦ 7.3.6.2 Prototypes-PPAP-Changes<br />
◦ 7.4.1 Supplier Mgmt<br />
◦ 7.4.2 Purchasing Information And Supplier Performance Monitoring<br />
◦ 7.5.1 Production Control-1<br />
◦ 7.5.1 Production Control-2<br />
◦ 7.5.2 Production Process Validation<br />
◦ 7.5.3 to 7.5.5 Identification&#8211;Customer Property, etc<br />
◦ 7.6 Monitoring And Measuring Devices<br />
◦ 8.1 Measurement, Analysis &#38; Improvement<br />
◦ 8.2.1 Customer Satisfaction<br />
◦ 8.2.2 Internal Audits<br />
◦ 8.2.3 Monitoring Processes<br />
◦ 8.2.4 Product Monitoring And Measurement<br />
◦ 8.3 Control Of NC Product<br />
◦ 8.4 Analysis Of Data<br />
◦ 8.5.1 Continual Improvement<br />
◦ 8.5.2 Corrective Action<br />
◦ 8.5.3 Preventive Action<br />
◦ TS 16949 Annex A &#8211; Control Plan<br />
ISO 9001 Consulting<br />
ISO 9001 Training<br />
ISO 9001 Auditing<br />
ISO 9001 Requirements<br />
ISO 9001 Resources</p>
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<p>The International Organization for Standardization , widelyknownas ISO,isaninternationalstandardsettingbodycomposed of representatives from various national standardsorganizations.FoundedonFebruary23,1947,theorganization promulgates worldwide proprietary,industrial,andcommercial standards.Ithasitsheadquartersin Geneva,Switzerland.1 Name and abbreviation2 History3 Financing4 InternationalStandardsandotherpublications5 Standardization process6 ISO document copyright7 Members8 ProductsnamedafterISO9 ISO/IJointTechnical Committee 110 Criticism<br />
The three official languages of the ISO are English, French, and Russian.[3] The organization&#8217;s logos in two of its official languages, English and French, include the word ISO, and it is usually referred to by this short-form name. The organization says that ISO is not anacronym or initialism for the organization&#8217;s full name in either official language; rather, recognizing that its initials would be different in different languages, it adopted ISO, based on the Greek word isos (ἴσος, meaning equal), as the universal short form of its name.[4]However, one of the founding delegates, Willy Kuert, recollected the original naming question with the comment: &#8220;I recently read that the name ISO was chosen because &#8216;iso&#8217; is a Greek term meaning &#8216;equal&#8217;. There was no mention of that in London!&#8221;History<br />
Memory plaque of founding ISA in PragueThe organization today known as ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA) This organization focused heavily on mechanical engineering. It was disbanded in 1942 during the Second World War but was re-organized under the current name, ISO, in 1946ISO is a voluntary organization whose members are recognized authorities on standards, each one representing one country. The bulk of the work of ISO is done by the 2700 technical committees, subcommittees, and working groups. Each committee and subcommittee is headed by a Secretariat from one of the member organizations<br />
Financing<br />
ISO is funded by a combination of: Organizations that manage the specific projects or loan experts to participate in the technical work.Subscriptions from member bodies (&#8220;the national body most representative of standardization in its country&#8221;These subscriptions are in proportion to each country&#8217;s gross national product and trade figures.<br />
International Standards and other publications<br />
ISO&#8217;s main products are international standards. ISO also publishes technical reports, technical specifications, publicly available specifications, technical corrigenda, and guides. International standards are designated with the format ISO[/IEC] [/ASTM] [IS]] Title, where nnnnn is the number of the standard, p is an optional part number, yyyy is the year published, and Title describes the subject. IEC for International Electrotechnical Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). ASTM (American Society for Testing and Materials) is used for standards developed in cooperation with ASTM International. The date and IS are not used for an incomplete or unpublished standard and may under some circumstances be left off the title of a published work.Technical reports are issued when a technical committee or subcommittee has collected data of a different kind from that normally published as an International Standard.[10] such as references and explanations. The naming conventions for these are the same as for standards, except TR prepended instead of IS in the report&#8217;s name. Examples:ISO/IEC TR 17799:2000 Code of Practice for Information Security ManagementISO/TR 19033:2000 Technical product documentation — Metadata for construction documentationTechnical specifications can be produced when &#8220;the subject in question is still under development or where for any other reason there is the future but not immediate possibility of an agreement to publish an International Standard&#8221;. Publicly Available Specifications may be &#8220;an intermediate specification, published prior to the development of a full International Standard, or, in IEC may be a &#8216;dual logo&#8217; publication published in collaboration with an external organization&#8221;.[10] Both are named by convention similar to Technical Reports, for example:ISO/TS 16952-1:2006 Technical product documentation — Reference designation system — Part 1: General application rulesISO/PAS 11154:2006 Road vehicles — Roof load carriersISO sometimes issues technical corrigenda. Corrigenda (plural of corrigendum) are amendments to existing standards because of minor technical flaws, usability improvements, or limited applicability extensions. Generally, these are issued with the expectation that the affected standard will be updated or withdrawn at its next scheduled review. ISO Guides are meta-standards covering &#8220;matters related to international standardization&#8221; They are named in the format &#8220;ISO[/IEC] Guide N:yyyy: Title&#8221;, for exampleISO/IEC Guide 2:2004 Standardization and related activities — General vocabularyISO/IEC Guide 65:1996 General requirements for bodies operating product certification<br />
Standardization process<br />
A standard published by ISO/IEC is the last stage of a long process that commonly starts with the proposal of new work within a committee. Here are some abbreviations used for marking a standard with its status: PWI &#8211; Preliminary Work ItemNP or NWIP &#8211; New Proposal / New Work Item Proposal (e.g., ISO/IEC NP 23007)AWI &#8211; Approved new Work Item (e.g., ISO/IEC AWI 15444-14)WD &#8211; Working Draft (e.g., ISO/IEC WD 27032)CD &#8211; Committee Draft (e.g., ISO/IEC CD 23000-5)FCD &#8211; Final Committee Draft (e.g., ISO/IEC FCD 23000-12)DIS &#8211; Draft International Standard (e.g., ISO/IEC DIS 14297)FDIS &#8211; Final Draft International Standard (e.g., ISO/IEC FDIS 27003)PRF &#8211; Proof of a new International Standard (e.g., ISO/IEC PRF 18018)IS &#8211; International Standard (e.g., ISO/IEC 13818-1:2007)Abbreviations used for amendmentsNP Amd &#8211; New Proposal Amendment (e.g., ISO/IEC 15444-2:2004/NP Amd 3)AWI Amd &#8211; Approved new Work Item Amendment (e.g., ISO/IEC 14492:2001/AWI Amd 4)WD Amd &#8211; Working Draft Amendment (e.g., ISO 11092:1993/WD Amd 1)CD Amd / PDAmd &#8211; Committee Draft Amendment / Proposed Draft Amendment (e.g., ISO/IEC 13818-1:2007/CD Amd 6)FPDAmd / DAM (DAmd) &#8211; Final Proposed Draft Amendment / Draft Amendment (e.g., ISO/IEC 14496-14:2003/FPDAmd 1)FDAM (FDAmd) &#8211; Final Draft Amendment (e.g., ISO/IEC 13818-1:2007/FDAmd 4)PRF Amd &#8211; (e.g., ISO 12639:2004/PRF Amd 1)Amd &#8211; Amendment (e.g., ISO/IEC 13818-1:2007/Amd 1:2007Other abbreviations: TR &#8211; Technical Report (e.g., ISO/IEC TR 19791:2006)DTR &#8211; Draft Technical Report (e.g., ISO/IEC DTR 19791)TS &#8211; Technical Specification (e.g., ISO/TS 16949:2009)DTS &#8211; Draft Technical Specification (e.g., ISO/DTS 11602-1PAS &#8211; Publicly Available SpecificationTTA &#8211; Technology Trends Assessment (e.g., ISO/TTA 1:1994)IWA &#8211; International Workshop Agreement (e.g., IWA 1:2005)Cor &#8211; Technical Corrigendum (e.g., ISO/IEC 13818-1:2007/Cor 1:2008)Guide &#8211; a guidance to technical committees for the preparation of standardsInternational Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps: Stage 1: Proposal stageStage 2: Preparatory stageStage 3: Committee stageStage 4: Enquiry stageStage 5: Approval stageStage 6: Publication stageThe TC/SC may set up working groups (WG) of experts for the preparation of a Working Drafts. Subcommittees may have several working groups, which can have several Sub Groups (SG).[22]It is possible to omit certain stages, if there is a document with a certain degree of maturity at the start of a standardization project &#8211; for example a standard developed by another organization. ISO/IEC Directives allow also the so-called &#8220;Fast-track procedure&#8221;. In this procedure a document is submitted directly for approval as a draft International Standard (DIS) to the ISO member bodies or as a final draft International Standard (FDIS) if the document was developed by an international standardizing body recognized by the ISO Council. The first step &#8211; a proposal of work (New Proposal) is approved at the relevant subcommittee or technical committee (e.g., SC29 and JTC1 respectively in the case of Moving Picture Experts Group &#8211; ISO/IEC JTC1/SC29/WG11). A working group (WG) of experts is set up by the TC/SC for the preparation of a Working Draft. When the scope of a new work is sufficiently clarified, some of the working groups (e.g., MPEG) usually make open request for proposals &#8211; known as &#8220;Call for proposals&#8221;. The first document that is produced for example for audio and video coding standards is called a Verification Model (VM) (previously also called a Simulation and Test Model). When a sufficient confidence in the stability of the standard under development is reached, a Working Draft (WD) is produced. This is in the form of a standard but is kept internal to working group for revision. When a Working Draft is sufficiently solid and the working group is satisfied that it has developed the best technical solution to the problem being addressed, it becomes Committee Draft (CD). If it is required, it is then sent to the P-members of the TC/SC (National Bodies) for ballot.The CD becomes Final Committee Draft (FCD) if the number of positive votes is above the quorum. Successive committee drafts may be considered until consensus is reached on the technical content. When it is reached, the text is finalized for submission as a draft International Standard (DIS). The text is then submitted to National Bodies for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. ISO will then hold a ballot with National Bodies where no technical changes are allowed (yes/no ballot), within a period of two months. It is approved as an International Standard (IS) if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. After approval, only minor editorial changes are introduced into the final text. The final text is sent to the ISO Central Secretariat, which publishes it as the International Standard<br />
ISO document ISO documents are copyrighted and ISO charges for copies of most. ISO does not, however, charge for most draft copies of documents in electronic format. Although useful, care must be taken using these drafts as there is the possibility of substantial change before it becomes finalized as a standard. Some standards by ISO and its official U.S. representative (and theInternational Electrotechnical Commission&#8217;s via the U.S. National Committee) are made freely available.ISO has 162 national members,[2] out of the 205 total countries in the world.ISO has three membership categories:Member bodies are national bodies considered the most representative standards body in each country. These are the only members of ISO that have voting rights.Correspondent members are countries that do not have their own standards organization. These members are informed about ISO&#8217;s work, but do not participate in standards promulgation.Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standardsParticipating members are called &#8220;P&#8221; members, as opposed to observing members, who are called &#8220;O&#8221; members.<br />
Products named after ISO<br />
The fact that many of the ISO-created standards are ubiquitous has led, on occasion, to common use of &#8220;ISO&#8221; to describe the actual product that conforms to a standard. Some examples of this are:Many CD images end in the file extension &#8220;ISO&#8221; to signify that they are using the ISO 9660standard file system as opposed to another file system &#8211; hence CD images are commonly referred to as &#8220;ISOs&#8221;. Virtually all computers with CD-ROM drives can read CDs that use this standard. Some DVD-ROMs also use ISO 9660 file systems.Photographic film&#8217;s sensitivity to light, its &#8220;film speed&#8221;, is described by ISO 6, ISO 2240 and ISO 5800. Hence, the film&#8217;s speed is often referred to as its &#8220;ISO number&#8221;.Often, the flash hot shoe found on cameras is called &#8220;ISO shoe&#8221;, as it was originally defined in ISO 518.<br />
ISO/IEC Joint Technical Committee 1<br />
Main article: ISO/IEC JTC1To deal with the consequences of substantial overlap in areas of standardization and work related to information technology, ISO and IEC formed a Joint Technical Committee known as the ISO/IEC JTC1. It was the first such joint committee. The second joint committee was created in 2009 &#8211; Joint Project Committee &#8211; Energy efficiency and renewable energy sources &#8211; Common terminology (ISO/IEC/JTC 2) With the exception of a small number of isolated standards ISO standards are normally not available free of charge, but for a purchase fee which has been seen by some as too expensive for small open source projects. The ISO/IEC JTC1 fast-track procedures (&#8220;Fast-track&#8221; as used by OOXML and &#8220;PAS&#8221; as used by OpenDocument) have garnered criticism in relation to the standardization of Office Open XML (ISO/IEC 29500). Martin Bryan, outgoing Convenor of ISO/IEC JTC1/SC34 WG1, is quoted as saying:I would recommend my successor that it is perhaps time to pass WG1’s outstanding standards over to OASIS, where they can get approval in less than a year and then do a PAS submission to ISO, which will get a lot more attention and be approved much faster than standards currently can be within WG1.The disparity of rules for PAS, Fast-Track and ISO committee generated standards is fast making ISO a laughing stock in IT circles. The days of open standards development are fast disappearing. Instead we are getting &#8216;standardization by corporation&#8217;. Computer security entrepreneur and Ubuntu investor, Mark Shuttleworth, commented on the Standardization of Office Open XML process by sayingI think it de-values the confidence people have in the standards setting process,and Shuttleworth alleged that ISO did not carry out its responsibility. He also noted that Microsoft had intensely lobbied many countries that traditionally had not participated in ISO and stacked technical committees with Microsoft employees, solution providers and resellers sympathetic to Office Open XML.When you have a process built on trust and when that trust is abused, ISO should halt the process &#8230; ISO is an engineering old boys club and these things are boring so you have to have a lot of passion … then suddenly you have an investment of a lot of money and lobbying and you get artificial results. The process is not set up to deal with intensive corporate lobbying and so you end up with something being a standard that is not clear. American National Standards Institute (ANSI)Deutsches Institut für Normung, German Institute for Standardization (DIN)British Standards Institution (BSI)Countries in International Organization for StandardizationCanadian Standards AssociationEuropean Committee for Standardization (CEN)Commonwealth of Independent States (CIS) set of standards (GOST)International Classification for StandardsInternational Electrotechnical Commission (IEC) and ISO/IEC standardsInternational healthcare accreditationInternational Telecommunication Union (ITU)Institute of Environmental Sciences and Technology (IEST)ISO A4ISO country codeList of International Organization for Standardization standards<br />
ISO divisions<br />
ISO/TC 37<br />
ISO/TC 68<br />
TC 46/SC 9<br />
ISO/TC 211<br />
ISO/TC 215<br />
ISO/TC 223<br />
Standardization<br />
Standards Australia<br />
Standards organization<br />
Terminology planning policy<br />
The International Customer Service Institute (TICSI)<br />
AP Stylebook (Associated Press Style)<br />
Interface 2010 (Interface Marketing Supplier Integration Institute)<br />
ISO 9000 is a family of standards related to quality management systems, outlines the requirements needed to ensure organizations meet the needs of its customers while striving to meet their expectationsThe standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systemsincluding the eight management principles) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.[<br />
Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwid are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Despite widespread use, however, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.<br />
Reasons for use<br />
The ISO family of standards is the only international standard that addresses systemic change. The global adoption of ISO 9001 may be attributable to a number of factors. A number of major purchasers require their suppliers to hold ISO 9001 certification. In addition to several stakeholders’ benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business. Corbett et al showed that certified organizations achieved superior return on assets compared to otherwise similar organizations without certification. Heras et al found similarly superior performance and demonstrated that this was statistically significant and not a function of organization size. Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the US motor carrier industry. Sharma identified similar improvements in operating performance and linked this to superior financial performance. Chow-Chua et alshowed better overall financial performance was achieved for companies in Denmark. Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 systemWhile the connection between superior financial performance and ISO 9001 may be seen from the examples cited, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al (2005) may suggest it. Other writers, such as Heras et al (2002), have suggested that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.The mechanism for improving results has also been the subject of much research. Lo et al (2007) identified operational improvements (cycle time reduction, inventory reductions, etc.) as following from certification. Internal process improvements in organizations lead to externally observable improvements. The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.<br />
Background<br />
ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. However, its history can be traced back some twenty years before that, to the publication of the Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979 before being submitted to ISO.BSI has been certifying organizations for their quality management systems since 1978. Its first certification (FM 00001) is still extant and held by Tarmac, a successor to the original company which held this certificate. Today BSI claims to certify organizations at nearly 70,000 sites globally.[ The development of the ISO 9000 series is shown in the diagram to the right.<br />
ISO 9001ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach, which do not contain specific requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows:Pages v to vii: Section 0 IntroPages 1 to 14: RequirementsSection 1: ScopeSection 2: Normative ReferenceSection 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)Section 4: Quality Management SystemSection 5: Management ResponsibilitySection 6: Resource ManagementSection 7: Product RealizationSection 8: Measurement, analysis and improvemenIn effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standardsPage 23: BibliographThe standard specifies six compulsory documents:Control of Documents (4.2.3)Control of Records (4.2.4)Internal Audits (8.2.2)Control of Nonconforming Product / Service (8.3)Corrective Action (8.5.2)Preventive Action (8.5.3In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above documents).<br />
Summary of ISO 9001:2008<br />
The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.The business makes decisions about the quality system based on recorded data.The quality system is regularly audited and evaluated for conformance and effectiveness.Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.The business determines customer requirements.The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.The business has documented procedures for dealing with actual and potential nonconformances (problems involving suppliers, customers, or internal problems).The business:makes sure no one uses a bad product,determines what to do with a bad product,deals with the root cause of problems, andkeeps records to use as a tool to improve the system.<br />
Certification<br />
ISO does not itself certify organizations. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as 'ISO 9000' certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008. Many countries have formedaccreditation bodies to authorize ("accredit") the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021 while accreditation bodies operate under ISO/IEC 17011. An organization applying for ISO 9000 certification is audited based on an extensive sample of its sites, functions, products, services and processes. A list of problems ("action requests" or "non-compliance") is first made known to management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management in the form of corrective action reports showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate. The certificate is limited by a certain scope (e.g. production of golf balls) and names the locations covered.An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO certification contrasts with measurement-based quality systems such as the Capability Maturity Model.<br />
Evolution of ISO 9000 standards<br />
1987 version ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent. 1994 versionISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system2000 versionISO 9001:2000 combined the three standards—9001, 9002, and 9003—into one, called 9001. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard. 2008 versionISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.<br />
AuditingTwo types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to; to find out where it can improve; and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":Tell me what you do (describe the business process)Show me where it says that (reference the procedure manuals)Prove that this is what happened (exhibit evidence in documented records)The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote compliance by focusing on risk, status, and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus:Under the 1994 version, the question was broad: "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the questions are more specific: "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?"<br />
Industry-specific interpretationsThe ISO 9001 standard is generalized and abstract; its parts must be carefully interpreted to maksense within a particular organization. Developing software is not like making cheeseor offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 systems.Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt &#38; Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100C.PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 5.0; unlike ISO 9001 or other sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2000.ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to computer software.ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex<br />
EffectivenessThe debate on the effectiveness of ISO 9000 commonly centers on the following questions:Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important; in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994).Does it help to implement an ISO 9001:2000-compliant quality management system?Does it help to obtain ISO 9001:2000 certification?Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:Commitment of senior management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.How well the ISO system integrates into current business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.How well the ISO system focuses on improving the customer experience. The broadest definition of quality is "Whatever the customer perceives good quality to be." This means that a company doesn't necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements in the customer's experience.How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit. When management doesn't understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand.AdvantagesIt is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Implementing ISO often gives the following advantages:Creates a more efficient, effective operationIncreases customer satisfaction and retentionReduces auditsEnhances marketingImproves employee motivation, awareness, and moralePromotes international tradeIncreases profitReduces waste and increases productivity.common tool for standardisation.<br />
Criticisms of ISO<br />
A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for registration. Dalgleish cites the "inordinate and often unnecessary paperwork burden" of ISO, and says that "quality managers feel that ISO's overhead and paperwork are excessive and extremely inefficient." According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed." Wilson suggests that ISO standards "... elevate inspection of the correct procedures over broader aspects of quality," and therefore, "the workplace becomes oppressive and quality is not improved. According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards.&#8221; ] Paraphrased, Wade&#8217;s argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality&#8221;If you just want the certificate on the wall, chances are you will create a paper system that doesn&#8217;t have much to do with the way you actually run your business,&#8221; said ISO&#8217;s Roger Frost Certification by an independent auditor is often seen as the problem area, and according to Barnes, &#8220;has become a vehicle to increase consulting services. Dalglesh argues that while &#8220;quality has a positive effect on return on investment, market share, sales growth, better sales margins and competitive advantage,&#8221; that &#8220;taking a quality approach is unrelated to ISO 9000 registration.&#8221; In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. Abrahamson argues that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad. FAQs on ISO 9001:2008This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support the publication of ISO 9001:2008 and the revision of ISO 9004. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world.The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards.For the latest version of the FAQs, reference should be made to the open access web site at 1. What is ISO?The International Organization for Standardization (ISO) was established in 1947 and is (currently) an association of 163 members, which each represent their own country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards. Besides the National Standards Bodies, ISO permits other international organizations that develop standards to participate in its work, by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also include requirements on the presentation of standards.2. Who are the National Standards Bodies, and who represents my country at ISO?Please see the relevant page on ISO Online that gives details, including contact information, of the National Standards Bodies. What are the ISO 9000 standards ?The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis.(It should be noted that many of the International Standards in the ISO 9000 family are numbered in the ISO 10000 ranThe purpose of this ISO 9001 training -Book document is to provide a clear and in-depth understanding of the intent and implication of each clause and sub-clause of the ISO 9001:2008 standard. While not intended to serve as an implementation guide, this document should provide sufficient insight for a quality practitioner to develop and implement an effective ISO 9001 based quality management system (QMS).</p>
<p>This document can be used by:<br />
Beginners &#8211; to understand and apply ISO 9001 requirements.<br />
QMS managers &#8211; to develop a more effective QMS for their organization. QMS auditors &#8211; to conduct more effective QMS audits.Top management &#8211; to gain an understanding of ISO 9001 as a business tool.<br />
Consultants &#8211; to provide value-added service to their clients.</p>
<p>The ISO 9001:2008 standard is shown in the beige box and below each section, clause or sub-clause of the standard, I provide &#8220;key points and tips&#8221; to help you better understand the specific concepts, principles and requirements. You will find important explanatory points and tips being repeated or further elaborated in different parts of the standard. Whenever I make reference to ‘you’ or ‘your’ QMS, I mean your organization’s or facility’s quality management system.</p>
<p>In going through the explanatory points and tips, I request that you read each paragraph carefully and sometimes twice to fully grasp the additional interpretation or insight it may convey. By doing so, you might be able to save much time, effort and money in understanding and implementing these requirements or help make your QMS more effective and get the most of this ISO 9001 trainingISO 9001 Training Key Explanation Points and Tips:<br />
The first four clauses (clause 0. Introduction to &#8211; clause 3. Terms and Definitions) do not provide any requirements for a QMS. They provide background information as to the purpose; concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. These clauses will all be explained in more detail as we go through each section.<br />
The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. The following is a summary explanation of these 5 major clauses or elements of the ISO 9001:20000 standard. Each major clause has several sub-clauses. Collectively, these 5 clauses set out the requirements for your QMS.<br />
Clause 4 &#8211; Quality Management System &#8211; sets requirements to identify, plan, document, operate and control QMS processes and to continually improve QMS effectiveness.<br />
Clause 5 &#8211; Management Responsibility &#8211; sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS.<br />
Clause 6 &#8211; Resource Management &#8211; sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements.<br />
Clause 7 &#8211; Product Realization &#8211; sets requirements to plan, operate and control the specific QMS processes thatdetermine, design, produce and deliver an organization’s product and services.Clause 8-Measurement, Analysis and Improvement &#8211; sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.<br />
The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually improving QMS effectiveness.<br />
To help you get the most out this e-Book, you might find it useful to follow key themes that the ISO 9001 standard has emphasized. These include:All QMS processes must be planned, implemented, measured and improvedISO 9001 requirements focus on controlling QMS processes, not product.QMS controls must emphasize prevention of nonconformities rather than detection.<br />
QMS processes must be customer focused. Process personnel must be aware of and<br />
strive to meet internal and external customer requirements.You must continually improve the effectiveness of your QMS.<br />
1.1 Quality Managment Principles<br />
0.2 Process Approach<br />
0.2 Types Of Business Processes<br />
0.2 Process Characteristics<br />
0.2 Process Plan &#8211; Do &#8211; Check &#8211; Act<br />
0.3 Relationship With ISO 9004<br />
0.4 Compatibility With Other Management Systems<br />
1.1 ISO 9001 QMS Scope<br />
1.2, &#8211; 3 QMS Application<br />
4.1 QMS General Requirements<br />
4.1 QMS General Requirements &#8211; Continued<br />
4.2.1 Documentation Requirements<br />
4.2.2 Quality Manual<br />
4.2.3 Control of Documents<br />
4.2.3 Control of Documents -Continued<br />
4.2.4 Control of Records<br />
5.1 Management Commitment<br />
5.2 Customer Focus<br />
5.3 Quality Policy<br />
5.4.1 Quality Objectives<br />
5.4.2 Quality Management System Planning<br />
5.5.1 Responsibility and Authority<br />
5.5.2 Management Representative<br />
5.5.3 Internal Communication<br />
5.6 Management Review<br />
6.1 Provision of Resources<br />
6.2 Human Resources<br />
6.3-4 Infrastructure and Work Environment<br />
7.1 Planning of Product Realization<br />
7.1 Planning of Product Realization &#8211; 2<br />
7.2 Customer-Related Processes<br />
7.2 Customer-Related Processes &#8211; Cont&#8217;d<br />
7.3.1 Design and Development Planning<br />
7.3.2 Design and Development Inputs<br />
7.3.3 Design and Development Outputs<br />
7.3.5-7 Verification, Validation &#38; Changes<br />
7.4 Purchasing Process<br />
7.4.2-3 Purchasing Information &#38; Verification of Purchased Product<br />
7.5.1 Control of Production and Service Provision<br />
7.5.2 Production Process Validation<br />
7.5.3 Identification and Traceability<br />
7.5.4-5 Customer Property and Preservation of Product<br />
7.6 Control of Monitoring and Measuring Equipment<br />
7.6 Control of Monitoring and Measuring Equipment 2<br />
8.1 Measurement, Analysis and Improvement &#8211; General<br />
8.2.1 Customer Satisfaction<br />
8.2.2 Internal Audit<br />
8.2.3 Monitoring and Measurement of Processes<br />
8.2.4 Monitoring and Measurement of Product<br />
8.3 Control of Nonconforming Product<br />
8.4 Analysis of Data<br />
8.5.1 Continual Improvement<br />
8.5.2 Corrective Action<br />
8.5.3 Preventive Action<br />
Understanding The ISO/TS 16949:2002 StandardParticular requirements for applying ISO 9001:2000 to automotive production and relevant service part organizationsThe intent of this document is to provide a clear and in-depth understanding of the intent and implication of each clause and sub-clause of the TS 16949:2002 standard. While not intended to serve as an implementation guide, this document should provide sufficient insight for a quality practitioner to develop and implement an effective TS 16949 based quality management system (QMS). This document may be used by: Beginners &#8211; to understand and apply TS 16949 requirements. QMS managers – to develop a more effective QMS for their organization. QMS auditors – to conduct more effective QMS audits. Top management – to gain an understanding of TS 16949 as a business tool. Consultants – to provide value-added service to their clients.The specific requirements of the TS 16949:2002 standard is shown in shaded text Within this shaded background, the ISO 9001 foundational requirements are shown in regular print and the TS 19649 additions are shown initalics. The wording of the ISO/TS 16949 requirements are laid out in paraphrased but precise form, following the exact clause by clause numbering. Where ISO/TS 16949 has used the word “shall”, it indicates a mandatory requirement. The word ‘should’ indicates a recommendation and Certification Bodies (Registrars) lean towards interpreting ‘should’ as a ‘shall’ in most cases. Notes to paragraphs are for guidance in understanding or clarifying the associated requirement. However, if the note includes the word ‘should’, then you would be wise to implement the guidance or recommendation in the note. Wherever possible, I have stated the clauses in the active tense instead of the sometimes difficult to understand passive tense used in the standard. Below each section, clause or sub-clause of the standard, I provide key explanation points and tips to help you better understand the requirement and any underlying intent, concepts and principles. The key point or phrase in each explanatory paragraph is bolded for easy reference to the sub-clause being explained. You will find important explanatory points and tips being repeated or further elaborated in different parts of the standard. Whenever I make reference to ‘yoor ‘your’ QMS, I mean your organization’s quality management system.<br />
In going through the explanatory points and tips, I request that you read each paragraph carefully and sometimes twice to fully grasp the additional interpretation or insight it may convey. By doing so, you might be able to save much time, effort and money in understanding and implementing these requirements or help make your QMS more effective.</p>
<p>Preface &#8211; TS16949<br />
◦ Introduction<br />
◦ Major Clauses<br />
◦ Process Approach -1<br />
◦ Process Approach-2<br />
◦ Plan/Do/Check/Act<br />
◦ Cont Improve Model<br />
◦ Compatibility<br />
◦ TS 16949 Scope<br />
◦ Application<br />
◦ Normative References<br />
◦ Terms And Definitions<br />
◦ 4.1 General Reqmts<br />
◦ 4.2.1 Documentation Reqmts<br />
◦ 4.2.2 Quality Manual<br />
◦ 4.2.3 Document Control<br />
◦ 4.2.4 Control Of Records<br />
◦ 5.1 Mgmt Commitment<br />
◦ 5.2 Customer Focus<br />
◦ 5.3 Quality Policy<br />
◦ 5.4.1 Quality Objectives<br />
◦ 5.4.2 QMS Planning<br />
◦ 5.5.1 Quality Responsibility<br />
◦ 5.5.2 Mgmtt Rep<br />
◦ 5.5.3 Internal Communications<br />
◦ 5.6 Mgmt Review<br />
◦ 6.1 Resource Provision<br />
◦ 6.2 Human Resources<br />
◦ 6.3 Infrastructure<br />
◦ 7.1 Planning Product Realization<br />
◦ 7.2 Customer Processes<br />
◦ 7.3.1 D &#38; D Planning<br />
◦ 7.3.2 D &#38; D Inputs<br />
◦ 7.3.2 D &#38; D Outputs<br />
◦ 7.3.4 To 7.3.6 &#8211; Review, Verification And Validation<br />
◦ 7.3.6.2 Prototypes-PPAP-Changes<br />
◦ 7.4.1 Supplier Mgmt<br />
◦ 7.4.2 Purchasing Information And Supplier Performance Monitoring<br />
◦ 7.5.1 Production Control-1<br />
◦ 7.5.1 Production Control-2<br />
◦ 7.5.2 Production Process Validation<br />
◦ 7.5.3 to 7.5.5 Identification&#8211;Customer Property, etc<br />
◦ 7.6 Monitoring And Measuring Devices<br />
◦ 8.1 Measurement, Analysis &#38; Improvement<br />
◦ 8.2.1 Customer Satisfaction<br />
◦ 8.2.2 Internal Audits<br />
◦ 8.2.3 Monitoring Processes<br />
◦ 8.2.4 Product Monitoring And Measurement<br />
◦ 8.3 Control Of NC Product<br />
◦ 8.4 Analysis Of Data<br />
◦ 8.5.1 Continual Improvement<br />
◦ 8.5.2 Corrective Action<br />
◦ 8.5.3 Preventive Action<br />
◦ TS 16949 Annex A &#8211; Control Plan<br />
ISO 9001 Consulting<br />
ISO 9001 Training<br />
ISO 9001 Auditing<br />
ISO 9001 Requirements<br />
ISO 9001 Resources</p>
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<dc:creator>$exy Mistakes</dc:creator>
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<dc:creator>$exy Mistakes</dc:creator>
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<dc:creator>don'tcomplicate</dc:creator>
<guid>http://mygreenbandana.wordpress.com/2012/06/02/was-that-sarcasm/</guid>
<description><![CDATA[As I told you in my last post ,I&#8217;ve got a friend  who sometimes starts to behave like Sheldon ]]></description>
<content:encoded><![CDATA[<p>As I told you in my last post ,I&#8217;ve got a friend  who sometimes starts to behave like Sheldon ( from <a href="http://en.wikipedia.org/wiki/The_Big_Bang_Theory" target="_blank">The Big Bang Theory</a>) .For those of you , who have neither seen The Big Bang Theory nor have read my <a href="http://mygreenbandana.wordpress.com/2012/05/25/stupid-questions-deserve-sarcastic-answers/" target="_blank">last post</a>-seriously people !what do you do in your free time ?Okay , a short briefing for you-</p>
<p>Sheldon is actually  a character in The Big Bang Theory and the thing is that he doesn&#8217;t get sarcasm , like he keeps on asking -&#8221;Was that sarcasm ?&#8221;.</p>
<p>I am fine with that ,but sometimes ,he(my friend) doesn&#8217;t know where to stop.So, the other day , he asked me a silly question as usual and I responded sarcastically as usual-</p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/1.png"><img class="alignnone size-full wp-image-257" title="1" src="http://mygreenbandana.files.wordpress.com/2012/06/1.png" alt="" width="497" height="320" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/2.png"><img class="alignnone size-full wp-image-258" title="2" src="http://mygreenbandana.files.wordpress.com/2012/06/2.png" alt="" width="497" height="320" /></a></p>
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<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/4.png"><img class="alignnone size-full wp-image-260" title="4" src="http://mygreenbandana.files.wordpress.com/2012/06/4.png" alt="" width="497" height="320" /></a></p>
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<p>Normally,it should just end here,but no,he just doesn&#8217;t let it go!</p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/6.png"><img class="alignnone size-full wp-image-262" title="6" src="http://mygreenbandana.files.wordpress.com/2012/06/6.png" alt="" width="497" height="316" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/7.png"><img class="alignnone size-full wp-image-263" title="7" src="http://mygreenbandana.files.wordpress.com/2012/06/7.png" alt="" width="497" height="316" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/8.png"><img class="alignnone size-full wp-image-264" title="8" src="http://mygreenbandana.files.wordpress.com/2012/06/8.png" alt="" width="497" height="297" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/9.png"><img class="alignnone size-full wp-image-265" title="9" src="http://mygreenbandana.files.wordpress.com/2012/06/9.png" alt="" width="497" height="297" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/10.png"><img class="alignnone size-full wp-image-266" title="10" src="http://mygreenbandana.files.wordpress.com/2012/06/10.png" alt="" width="497" height="297" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/11.png"><img class="alignnone size-full wp-image-267" title="11" src="http://mygreenbandana.files.wordpress.com/2012/06/11.png" alt="" width="497" height="297" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/12.png"><img class="alignnone size-full wp-image-268" title="12" src="http://mygreenbandana.files.wordpress.com/2012/06/12.png" alt="" width="497" height="280" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/13.png"><img class="alignnone size-full wp-image-269" title="13" src="http://mygreenbandana.files.wordpress.com/2012/06/13.png" alt="" width="497" height="280" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/14.png"><img class="alignnone size-full wp-image-270" title="14" src="http://mygreenbandana.files.wordpress.com/2012/06/14.png" alt="" width="497" height="280" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/15.png"><img class="alignnone size-full wp-image-271" title="15" src="http://mygreenbandana.files.wordpress.com/2012/06/15.png" alt="" width="497" height="280" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/16.png"><img class="alignnone size-full wp-image-272" title="16" src="http://mygreenbandana.files.wordpress.com/2012/06/16.png" alt="" width="497" height="280" /></a></p>
<p><a href="http://mygreenbandana.files.wordpress.com/2012/06/17.png"><img class="alignnone size-full wp-image-273" title="17" src="http://mygreenbandana.files.wordpress.com/2012/06/17.png" alt="" width="497" height="297" /></a></p>
<p>P.S. -This post is in no way a confession of a crime and my friend is alive and well-he may not be , in the near future(as soon as i get that AK-47 smuggled in) but, yeah, he is right now.</p>
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<pubDate>Sat, 02 Jun 2012 09:10:33 +0000</pubDate>
<dc:creator>$exy Mistakes</dc:creator>
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