Tags » Quality Systems

5 Factors Quality Systems Fail

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PQ Systems lists 5 factors why quality systems fail that will likely lead to recalls.

  1. Following the old rule, “it ain’t broken, why fix it.” It happens when an organization has already a pattern of producing only good products over time, thus tends to overlook excess.
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Schools Can Teach Quality to Business

After two decades of experience in implementing and auditing Quality Management Systems (QMS) in organizations, I have come to the conclusion that QMS are best implemented, continuously improved and audited at schools more than in structured businesses. 1,249 more words

Quality Systems

A New Approach to Quality Part 2 of 2

In part 1 of 2, we discussed about the former approach of quality based on statistical and a posteriori correction of issues. In this second part, we will discuss a new approach that bring a beneficiary extension of the notion of quality to Product Safety. 498 more words

Product Safety

A New Approach to Quality: part 1 of 2 : ISO 9001 alone is no longer the solution

Quality perception has changed in the eyes of the customers and this is now obliging the producers to change their approach to quality.
A more global vision of Quality… 494 more words

Product Safety

Quality and Diversity, Especially Women in Tech

The newly launched R Consortium has announced its inaugural Board members, and not one of them is a woman. (Even more unfortunately, I don’t think any of them are active R users; although I’m sure he’s used it, the new President’s bio establishes him as a SAS and S-PLUS user.) 854 more words


12 months of ISO 270001:2013 and 9001:2008 certification

It’s been a busy year since we secured our ISO 27001:2013 and ISO 9001:2008 certification, but having just passed our first surveillance visit with flying colours, we know our systems are all as they should be – good news for us and all our clients. 366 more words

Quality System Maturity Model for Medical Devices

Assessing quality system maturity models that could help medical device companies drive quality beyond compliance

Posted by George Serafin, National Managing Director, Life Sciences & Healthcare on July 28, 2015. 753 more words

Deloitte Center For Regulatory Strategies