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 for the auditees, and nuisance work for auditors.  This is one of the most important…

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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 areas to be monitored, then shifts back to describing types and methods of monitoring performance. …

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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 place.  I’ve seen companies write documentation and do internal audits and have records and forms…

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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 organization shall ensure that outputs that do not conform to their requirements are identified and…

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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 the manufacture or creation of the product/service.  And it is very typical for there to…

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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 confusion.  Changes which have not been adequately reviewed and vetted may be implemented and result…

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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 many other clauses, there is also the very welcome addition of beginning with the determination…

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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 outputs during production and service provision, to the extent necessary to ensure conformity to requirements.” …

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