Informational Required Documents/Records in ISO 9001:2015

[Paul Simpson]

So, there is no “identified” traceable INDIVIDUAL connected to product release, is there?

In the case of an automated release, I would say it is the person that owns the process. There is a case for the person that approves the software.

On another topic, am I the only person who gets annoyed by the indiscriminate use of "quote marks" and BOLD CAPS when debating an issue?

 

[Big Jim]

It's a very good question, Beth. You have homed in on one of the few areas of ISO 9001 where the requirement gets quite specific.

Take your example: if the control plan says you measure the first off and then each 10th piece there has to be a record of those measurements having been done. There are many ways of documenting those measurements having been made and that is up to you to decide. IMHO, the one-liner would not be enough.

Fast forward to releasing the product to the customer (to the point of 8.6). The (traceable) individual would have to look at the control plan (however termed) to determine that all the measurements (1st off, 1 in 10 pieces from your example plus any other checks, tests, measurements required in the plan) have taken place and that the evidence of conformity is available before they allow the product to be despatched.

Paul, in all politeness, please show me the shall.

 

[Sidney Vianna]

On another topic, am I the only person who gets annoyed by the indiscriminate use of "quote marks" and BOLD CAPS when debating an issue?

Yes, apparently so. Not sure what you mean by "indiscriminate". Maybe the british "netiquette" of emphasizing terms is different.

 

[Bev D]

I use bold italics and quotation marks as they were intended: To emphasize points especially in a longer post. I do use caps when I want to yell

 

[Paul Simpson]

Paul, in all politeness, please show me the shall.

'In all politeness' - guess there has to be a first time for everything, Jim.

In all politeness, Jim. The post I replied to quotes the clause number. You can read the shall(s) as well as I. We may come to different conclusions, of course.

 

[Big Jim]

'In all politeness' - guess there has to be a first time for everything, Jim.

In all politeness, Jim. The post I replied to quotes the clause number. You can read the shall(s) as well as I. We may come to different conclusions, of course.

Obviously it isn't as clear to me as it seems to be to you. Please show me the shall to support your line of thought on the topic.