Informational Required Documents/Records in ISO 9001:2015

[qusys]

Then they are required as a customer requirement

Yes, of course. I intended in addition to the ones required as customer requirements.
The same thing for documented information ( procedures) that could be maintained, not required by ISO 9001 standard, but that the organization decides to have to better manage their processes, given the complexity or other risks that they has assessed to be effectively managed.

 

[Big Jim]

Yes, of course. I intended in addition to the ones required as customer requirements.
The same thing for documented information ( procedures) that could be maintained, not required by ISO 9001 standard, but that the organization decides to have to better manage their processes, given the complexity or other risks that they has assessed to be effectively managed.

If it is found in use then that is evidence that the organization has determined that it is needed.

 

[beth.s0321]

I am trying to figure out the best way to retain evidence of 8.6, release of product. Specifically the evidence of conformity with the acceptance criteria. Can we have something as simple as a check list of final inspection with job #, date, and person who inspected the items? Or does it need more specific information?

Example:

We have a webbing cutter that the operator sets up to measure and cut a certain number of pieces. The set up for the machine says operator measures the 1st piece and then every 10th piece. So does this check have to be recorded and each measurement documented?

One case we measure and cut each piece manually. A job could have 120 of these pieces, do each of these measurements have to be documented or just one line that says "measured and cut per BOO/BOM" and then the qty and initials of the operator?

 

[John Broomfield]

Is what you do now effective? If so, why change it?

If not, issue a corrective action request that results in the actions and records you need to assured of releasing quality services and products. Then update your management system accordingly.

 

[Big Jim]

I am trying to figure out the best way to retain evidence of 8.6, release of product. Specifically the evidence of conformity with the acceptance criteria. Can we have something as simple as a check list of final inspection with job #, date, and person who inspected the items? Or does it need more specific information?

Example:

We have a webbing cutter that the operator sets up to measure and cut a certain number of pieces. The set up for the machine says operator measures the 1st piece and then every 10th piece. So does this check have to be recorded and each measurement documented?

One case we measure and cut each piece manually. A job could have 120 of these pieces, do each of these measurements have to be documented or just one line that says "measured and cut per BOO/BOM" and then the qty and initials of the operator?

That should suffice. You can do more if you think you need more to have appropriate control.

 

[ChrisM]

We have a webbing cutter that the operator sets up to measure and cut a certain number of pieces. The set up for the machine says operator measures the 1st piece and then every 10th piece. So does this check have to be recorded and each measurement documented?

As the saying goes, if it isn't documented, it didn't happen. You may not have to record the result of every measurement but if there isn't even a tick-sheet, how would you prove to an auditor that every 10th piece had been measured? It's a bit of a tricky one because if for example you place every 10th piece on a fixture to check length and so long as it fits, production continues, you may have a hard job proving to an auditor that this is taking place, and only if there is a fail would you record the result and stop the process to take action. This is assuming it's a human process. If it were automated, the machinery may not need to make any records, only for example to stop and sound a warning tone if it detects a failure. Making sure that your process if sufficiently well documented would help, but again you could be at the mercy of a pedantic auditor

 

[beth.s0321]

Is what you do now effective? If so, why change it?

If not, issue a corrective action request that results in the actions and records you need to assured of releasing quality services and products. Then update your management system accordingly.

Well, for evidence, we have nothing right now and I am just trying to determine what is truly needed. When I first read the standard I did not see a need for recording each measurement, but the more I read it, recording the measurement is the only way to have evidence of the conformity.

 

[Sidney Vianna]

As the saying goes, if it isn't documented, it didn't happen.

Saying by whom? The overwhelming majority of things happen without a record being generated. Why? In most cases, generating a record would be a non value added activity. Muda.

Record creation, including its extent, like most things, should be the result of a risk based assessment. Every day billions of products get sold online and the customers/consumers are blissfully uninterested about a “record of conformity”.

 

[Jim Wynne]

As the saying goes, if it isn't documented, it didn't happen.

And if it is documented, it might have happened.

 

[ChrisM]

The saying has been made by at least one of my former Bosses.
I have also known records be falsified (dates, values and name/initials of person who supposedly created the record).
Does this go to show that no record is worth the paper that it is written on ?? There has to be an element of trust somewhere along the line