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 ...

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.  Previous...

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 ...

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, abou...

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 t...

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 de...

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,...

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 ...

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 wee...

8.3 Design and development of products and services

I’d like to start this week’s discussion with a big thank you to one of my readers who brought to my attention a mistake I made last week.  Somehow...