ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained

[Bran]

ISO clause 5.3 states:

Top management shall assign the responsibility and authority for:
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Currently to show what we're doing for this clause, I have a list of Accountable positions listed in the quality manual. My interpretation of "changes to the QMS" up to this point (also given the context of cl. 5.3) has been surrounding system-level changes such as changing the adding/removing a process on the QMS process map, or maybe some other scenarios that would go through Management Review (or a similar -type) review/approval process.

I have an auditor who is interpreting "changes to the QMS" to mean creating or updating all QMS documentation, including things like production SOPs, Forms, or even maintenance SOPs. His argument then flowed to stating that document change approvers need to be reviewing documents to make sure QMS integrity is maintained with every document change.

This is a big ask for us. Internally we've got ~9,000 controlled documents and maybe 100-150 document approvers. Document approvers in almost all cases are not ISO or IATF quality-trained folks, but rather subject matter experts for their respective processes/departments. We are a bulk material supplier, so process-level SOPs generally do not contain specific ISO/IATF/customer requirements, but rather the specific work orders for each lot of material have those details. Long story short, it is in no way feasible to have quality (3 people) review all the document changes.

I'm curious how other folks are interpreting this requirement and how you would handle this scenario.

 

[Big Jim]

I view it as all, but it doesn't need to be a big cumbersome deal. Be aware that there iss no record keeping attached here so that the organization doesn't need a record of the review performed.

Top management needs to make sure that those that make such changes understand the need to stay on course with the standard.

You can make this as easy as you want or as difficult as you want as long as you can explain yourselves.

 

[Funboi]

Its a non-sense issue. Maintaining integrity means ensuring control over changes. An organization doesn’t stop doing things one way on Friday @ 5.00pm and at 8.00am on Monday, do things differently. There has to be a plan, a transition period etc and documents updated. That‘s maintaining intergrity

 

[Tagin]

TS9002:2016 states this:

For ISO 9001:2015, 5.3, bullets a) to e), responsibilities and authorities should be assigned for the following:
e) maintaining the integrity of the quality management system when changes are made such as the implementation of a new enterprise resource planning (ERP) system, the decision to outsource the design and development process, growth due to new market opportunities, restructuring the organization, a merger or an acquisition; this responsibility is typically assigned to the person(s) who is(are) responsible for ensuring that the overall quality management system is maintained and who has(have) the ability to ensure that changes are not planned without considering their potential impact.

The auditor has no justification for their ridiculous assertions.

 

[Bran]

I view it as all, but it doesn't need to be a big cumbersome deal. Be aware that there is
no record keeping attached here so that the organization doesn't need a record of the review performed. Top management needs to make sure that those that make such changes understand the need to stay on course with the standard.

I did actually catch that there is no retention requirement. I had written in my notes "There is no requirement stating that we need to show evidence that integrity is being maintained. If an auditor wants to go down this road they need to find evidence that integrity is not being maintained".

TS9002:2016 reference

The auditor has no justification for their ridiculous assertions.

This is exactly what I was hoping for. Thank you!