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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 the manufacture or creation of the product/service. And it is very typical for there to…
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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 confusion. Changes which have not been adequately reviewed and vetted may be implemented and result…
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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 many other clauses, there is also the very welcome addition of beginning with the determination…
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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 outputs during production and service provision, to the extent necessary to ensure conformity to requirements.” …
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ISO9001:2015 52-Wk Challenge (Wk 39) 8.5.3 Property belonging to customers or external providers
8.5.3 Property belonging to customers or external providers This week, we’ll discuss some of the situations when organizations along the whole supply chain cooperate in order to produce a product or service. As important as defining requirements prior to entering into a contractual agreement, it is also important to clearly define responsibilities where materials or…
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ISO9001:2015 52-Wk Challenge (Wk 38) 8.5.2 Identification and traceability
8.5.2 Identification and traceability This week we are transitioning from the draft version to the new final publication of ISO9001:2015. Please download your copy today! ID and traceability is a very basic but very critical requirement. There are only 3 sentences, but they are important and broadly sweeping (depending on the organization and nature of the…
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ISO9001:2015 52-Wk Challenge (Wk 37) 8.5 8.5.1 Control of production and service provision
8.5.1 Control of production and service provision Hello everyone! The great news this week is that we get to open a new chapter in the standard. We switch gears from external to internal. Previously we discussed the controls necessary to ensure any external providers do not impact our ability to provide consistent delivery of a…
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ISO9001:2015 52-Wk Challenge (Wk 36) 8.4.3 Information for external providers
8.4.3 Information for external providers Readers, I appreciate your patience as we work carefully through this section. It is one of the most detailed, which is a plus because it is clearly defined so it can be easily understood. However, the section is wordy and can be somewhat redundant. I’m happy to continue, though, because…
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