Blog Archives

ISO9001:2015 52-Wk Challenge (Wk 51 & 52) FINAL EDITION 10 Improvement

Well, this is it, folks! Thank you to everyone for your participation for the past 52 weeks.  Your comments have been thought provoking and helpful to many.  And with so many companies beginning to seriously consider their strategy for conversion to ISO9001:2015,

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ISO9001:2015 52-Wk Challenge (Wk 49 & 50) 9.3 Management review

9.3 Management Review This week’s topic is near and dear to my heart.  Every business I’ve worked with has underutilized this tool.  Many companies do it simply to meet the requirement, and do not fully embrace the idea that this

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ISO9001:2015 52-Wk Challenge (Wk 47 & 48) 9.2 (9.2.1 & 9.2.2) Internal audit

9.2 Internal audit (9.2.1, 9.2.2) This week is a double feature to include the entire 9.2 Internal audit clause.  Internal audits are one of the most underutilized tools in management systems.  The whole notion of internal audits can invoke fear

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ISO9001:2015 52-Wk Challenge (Wk 46) 9.1.2 Customer satisfaction, 9.1.3 Analysis and evaluation

9.1.2 Customer satisfaction Let me start this week’s discussion with the observation that this section is awkwardly constructed (in my opinion).  The section introduces itself as being about performance monitoring, then shifts gears and pulls out one of the specific

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ISO9001:2015 52-Wk Challenge (Wk 45) 9 Performance evaluation

9 Performance evaluation 9.1.1 General We are starting to enter the place where organizations can lose their way and ultimately miss out on the intended value-add they’re looking for when they decide to pursue certification to ISO9001 in the first

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ISO9001:2015 52-Wk Challenge (Wk 44) 8.7 Control of nonconforming outputs

8.7 Control of nonconforming outputs This week’s topic is one that is very clearly defined and universally applicable.  There is very little subjectivity in the requirements and they are listed in a logical and easy to understand way. “8.7.1 The

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ISO9001:2015 52-Wk Challenge (Wk 43) 8.6 Release of products and services

8.6 Release of products and services This week’s topic, “release of products and services” is a nuts and bolts component of most quality systems.  As products and services are manufactured or created, there are typically repetitive steps used to fulfill

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ISO9001:2015 52-Wk Challenge (Wk 42) 8.5.6 Control of changes

8.5.6 Control of changes This clause is critical and essential and, excluding the clear definition of requirements in the first place, the biggest risk, in my opinion to the stability of the QMS.  Changes which are not clearly communicated create

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ISO9001:2015 52-Wk Challenge (Wk 41) 8.5.5 Post-delivery activities

8.5.5 Post-delivery activities This requirement is not new, but it is a little different.  Whereas previously, the requirements were sprinkled in other clauses and pretty unclear, they are now more cohesively defined and placed as one coherent thought. As with

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ISO9001;2015 52-Wk Challenge (Wk 40) 8.5.4 Preservation

8.5.4 Preservation Why don’t we just put our feet up this week?  We’re not even going to break a sweat.  Not only is the section easy, but there isn’t much in the way of changes. “The organization shall preserve the

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