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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 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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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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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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8.4.2 Type and extent of control of external provision Last week, we reviewed 8.4.1 where the requirements of how the standard applies.  This week, we begin to peel back the layers, so to speak, about what must actually be done to be compliant. Before we get down to business, I’d like to point out the…

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8.4.1 Control of externally provided products and services Make it or buy it?  That is the question. Organizations with a focus on core competencies often choose to outsource rather than try to do themselves those things that fall outside of their “wheelhouse”.  When making this choice, the organization is relying on an outside provider to provide…

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8.3.6 Design and development changes One thing is for certain, change happens! This week, we’ll look at the final section of 8.3 Design and development of products and services.  8.3.6 Design and development changes.  Along with a very specific and disciplined list of required inputs, controls and outputs, we must always consider the importance of…

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8.3.4 Design and development controls Hello Readers!  It’s been a very busy summer and last week, an on site client project consumed the week before I knew it had gotten away from me!  So, this week, we have a double edition, talking about 2 sections, “8.3.4 Design and development controls” and “8.3.5 Design and development…

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