Interesting Discussion Potential Issues for Auditing ISO 9001:2015

[Jen Kirley]

What are you talking about? Are those requirements?

It is a question, asked by an ex-Document Control Administrator. There is a (7.5.3.2) requirement for control of changes (e.g. version control). How does the control work at the process level: that is, how can a user of a printed version be sure it is the correct version if the document does not list its version? Is the process to list a version identifier only after its first version? That could work.

 

[AndyN]

It is a question, asked by an ex-Document Control Administrator. There is a (7.5.3.2) requirement for control of changes (e.g. version control). How does the control work at the process level: that is, how can a user of a printed version be sure it is the correct version if the document does not list its version? Is the process to list a version identifier only after its first version? That could work.

Check the bills in your purse. How do you know you have the latest version?

 

[tony s]

Clause 7.5.3.2c mentioned: "the organization shall address the following activities, as applicable... control of changes (e.g. version control)"

The manual here is on its initial release and hasn't been revised, thus the auditee can assert that they deemed "not applicable". The primary intention of the clause statement is "control of changes" and not "version control" - that's why it is enclosed as an exempli gratia (for example). The manual may not have a document number/code and a version number but other means of knowing whether the manual is the current one can be verified by a competent auditor. Exempli gratia:

• first, ask the manager, or QMR or the document controller if there are other versions of the manual;
• or ask if the manual is the latest version;
• if in doubt or you don't trust any of the three auditee:
  • compare the copy held by the auditor with the other copies;
  • if the document controller maintains the master, compare it with the master;
  • if it doesn't have a version number, look for its date of issue to compare with the other copies

 

[Yukon]

Ask yourself these questions:
1. When a document is changed how are the changes communicated?
2. How are obsolete drawings removed from use?
3. How do personnel know they have the correct version of the document?
4. Who is responsible to make changes ?

 

[Jen Kirley]

Check the bills in your purse. How do you know you have the latest version?

They are dated. Did you not describe the quality manual as not identifying its version?

 

[AndyN]

Did you not describe the quality manual as not identifying its version?

Correct.

 

[Jen Kirley]

Correct.

And so, in the interest of understanding the process, I am again asking: How would the user know he/she is working with the current information (version) if the document does not identify its version?

 

[Yukon]

Having a quality manual is no longer a requirement of ISO 9001:2015. If you chose to have one so be it. I. Don't care what date is on it anymore than I would care what date is on the newspaper in the cafeteria. A QM is irrelevant, not required, redundant.

 

[Jen Kirley]

Having a quality manual is no longer a requirement of ISO 9001:2015. If you chose to have one so be it. I. Don't care what date is on it anymore than I would care what date is on the newspaper in the cafeteria. A QM is irrelevant, not required, redundant.

I guess that depends on what's in it.

 

[Yukon]

Regardless of the contents 4.2.2 as defined in ISO9001:2008 is no longer an auditable requirement of the standard. You can put in it what ever you like.