ISO 9001 Document Control Requirements - Design and Development Department Checklists

We are implementing ISO 9001 and in our Design and Development department, we have couple of checklists that they use as a reminder of what they need to check for as far as technical stuff that are related to the design quality. Some managers are arguing with me that these should not be controlled. I believe they should as they considered important to insure that all quality aspects are being covered.
What do you think?

Re: ISO 9001 Document Control Requirements - Design and Development Department Checkl

Haddad9921 said:

We are implementing ISO 9001 and in our Design and Development department, we have couple of checklists that they use as a reminder of what they need to check for as far as technical stuff that are related to the design quality. Some managers are arguing with me that these should not be controlled. I believe they should as they considered important to insure that all quality aspects are being covered.
What do you think?

Click to expand...

Clause 4.2.1(d) of the standard requires you to include in the QMS "documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes."

Clause 4.2.3 then states that "Documents required by the quality management system shall be controlled."

If your managers agree that these checklists are required to ensure design quality, then just show them these clauses: the checklists do need to be controlled. Otherwise why keep these checklists? Tear them up.

Re: ISO 9001 Document Control Requirements - Design and Development Department Checkl

It does sound as they are either arguing against ISO9001 requirements or for the scrapping of useless checklists. If they are used to ensure quality because they are needed to ensure quality then they should be controlled.

I wonder if they would like to argue their cause if a CB auditor found them in a re-certification audit? Would they like to make the corrective action now or with top management watching later on?

Re: ISO 9001 Document Control Requirements - Design and Development Department Checkl

Haddad9921 said:

We are implementing ISO 9001 and in our Design and Development department, we have couple of checklists that they use as a reminder of what they need to check for as far as technical stuff that are related to the design quality. Some managers are arguing with me that these should not be controlled. I believe they should as they considered important to insure that all quality aspects are being covered.
What do you think?

Click to expand...

Of course, if you have some terribly complex document control process and they have to give up these documents in the name of "ISO", their reaction may be totally justified. However, for engineering staff, the concept of document control is well understood - as it applies to their design specifications/drawings. Maybe they don't understand the correct purpose of document control because, if these checklists are any good they would want them to be review/approved/available and updated in a consistent manner...