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…
Blog Archives
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,…
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…
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,…
ISO9001:2015 52-Wk Challenge (Wk 35) 8.4.2 Type and extent of control of external provision
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…
ISO9001:2015 52-Wk Challenge (Wk 34) 8.4, 8.4.1 Control of externally provided products and services
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…
ISO9001:2015 52-Wk Challenge (Wk 33) 8.3.6 Design and development changes
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…
8.3.4 ISO9001:2015 52-Wk Challenge (Wk 32 & 33 Double Edition) 8.3.4 Design and development controls and 8.3.5 Design and development outputs
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…
ISO9001:2015 52-Wk Challenge (Wk 31) 8.3.3 Design and development inputs
8.3.3 Design and development inputs Ah yes, and now we get to the section so many companies previously chose to “exclude” from their quality management systems. This is some tough content and these are some tough requirements to meet. Many…
ISO9001:2015 52-Wk Challenge (Wk 30) 8.3.2 Design and development planning
8.3.2 Design and development planning When tackling this clause, it is important to clearly identify how and where it is applicable within your organization to avoid confusion. For example, last week we discussed how many organizations do not actually do…
