‘Retained Document Information’ in ISO 9001:2015

You mean records?

ISO 9001:2015 does a lot of things right, but using clear language isn’t one of them.

One of the most glaring examples is the transformation of the word “records” into “retained documented information.” That's right, the standard’s updaters took one word and turned it into three. And the three words aren’t nearly as intuitive as the one word they replaced.

Regardless of what you call them, records are the proof of something happening. They are historical, referring to past events. As such, they aren’t revised. Records might be “corrected” in some cases, but they are never revised. Only documents are revised. (We’ll address documents and their status in ISO 9001:2015 in a future article.) The primary control method for records is one of housekeeping: knowing where they’re stored, who’s responsible for retaining them, and how long they’re kept.

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Retained information (Records) required in ISO 9001:2015

Thanks a lot for wonderful information. However, how can an auditor verify if management reviews conducted periodically?

Typically they will ask to

Typically they will ask to see a schedule for Management Review Meetings and/or dated Management Review Records which can verify if your Management Reviews are occuring at the frequency that you claim.

QMS

Good day please help me understand this

what are the most important criteria of good quality polity and good quality objectives

also what is the scope required by ISO 9001 2015

what are list for retaining documented information

calibration record requirements

Is there a place to find out the exact requirements for information to include on calibration records for IS0 9001:2015? It is my understanding the requirements are as follows: 1. As found/as left readings

2 calibration date

3 next calibration due date

4 instrument standard used

5 frequency of calibration

I was recently responsible for helping to create new calibration work instructions to be included on calibration records while my boss was out on medical leave. We use SAP software and it serves as our calibration records. When I created the work instructions, I included everything above, but left out #5 since it is on a master document containing a list of calibration instruments. We had a 3rd party audit soon afterwards and he said everything looked good. My boss got back a few weeks later and nailed me for not including #5 on each calibration record. Also, I left the instrument used field blank to be filled out by the technician at the time of calibration. My boss said the calibration instrument used field must be pre-populated (first time he told me this), even though we have multiple instruments that can be used to calibrate and the technician doing the calibration would fill this out at the time of calibration. The auditor only viewed calibration records already done, not the calibration form itself, so he didn't know the instrument field was blank.

Is the specified accuracy of the instrument being calibrated required to be part of the calibration record? It is on the same master document mentioned above with the frequency of calibration.

I have every intention of complying with my boss, but I would also like to verify the information he told me with a 3rd party such as yourself. Is the frequency required on the calibration itself or just need to be documented and easily found elsewhere?

Records

Hi Chad, Let me run this past a few of my sources and get back to you. I will post in this area or email you directly. Thanks Dirk

re:calibration record requirements

Dirk,

Have you had any responses from your sources on this?

Chad

Sorry for the delay

Sorry for the delay Chad. I heard back from one of our authors, Denise Robitaille:

You:Is the specified accuracy of the instrument being calibrated required to be part of the calibration record? It is on the same master document mentioned above with the frequency of calibration.

Denise: ISO 9001:2015 requires: "The organization shall ensure that the resources provided... are suitable for the specific type of monitoring and measurement activities being undertaken..." Example: If you have a scale that reads in ounces, it probably won't have the accuracy to verify a product in milligrams. How you document this is your choice.

You: Is the frequency required on the calibration itself or just need to be documented and easily found elsewhere?

Denise: ISO 9001:2015 requires: "...calibrated or verified, or both, at specified intervals.." It is reasonable to infer that if the intervals are to be specified, this information must be maintained in some form of documented information. The location is up to the organization.

Hope that helps

Dirk

re:calibration record requirements

Thanks Dirk. Basically it sounds like our requirement of documenting the same information in two places is above and beyond what ISO 9001:2015 requires. It was inferred to me that by not doing this we were going to have a CAR written against us. Since a lot of details are left up to the organization, I assume we are judged by our own standards as well as ISO 9001:2015 standards when getting audited or re-certified. Problem is I have not been able to find our standards in written form so I know exactly what to expect, I've had to take my boss' word for everything. Anyway, thanks again for your response.