ISO 9001:2015 Clause 7.5.2 - Is Review and Approval applicable to Records?

[wywy2020]

Documented information now includes procedure and records.

7.5.2 Creating and updating
c) review and approval for suitability and adequacy.

For records, does it applicable for review and approval?
e.g every record need for peer review and approval?

 

[Pancho]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Documented information now includes procedure and records.

7.5.2 Creating and updating
c) review and approval for suitability and adequacy.

For records, does it applicable for review and approval?
e.g every record need for peer review and approval?

Hi Wywy,

The first paragraph of 7.5.2 is key: "When creating and updating documented information the organization shall ensure appropriate:"

"Appropriate" review and approval of a document is what will ensure that you deliver quality. Your organization determines that.

For example, in our organization, a few records may require a supervisor's review and approval. Some may also require review and approval by the client. Many more may require no review nor approval by anyone.

Hope this helps!

 

[wywy2020]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Hi Wywy,

The first paragraph of 7.5.2 is key: "When creating and updating documented information the organization shall ensure appropriate:"

"Appropriate" review and approval of a document is what will ensure that you deliver quality. Your organization determines that.

For example, in our organization, a few records may require a supervisor's review and approval. Some may also require review and approval by the client. Many more may require no review nor approval by anyone.

Hope this helps!

Thanks for the reply. SO the key word here is "appropriate" mean the organization decide it on their own.

Is there a scenario that the organization deem it is appropriate but somehow auditor feel it is not? haha

 

[Pancho]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Thanks for the reply. SO the key word here is "appropriate" mean the organization decide it on their own.

Is there a scenario that the organization deem it is appropriate but somehow auditor feel it is not? haha

That is indeed possible, but if you show quality, the auditor has no argument. Conversely, if you are having non-conformities caused by inadequate review or approval, then such activities (or their absence) are not appropriate.

 

[wywy2020]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

That is indeed possible, but if you show quality, the auditor has no argument. Conversely, if you are having non-conformities caused by inadequate review or approval, then such activities (or their absence) are not appropriate.

It looks like ISO 9001 is always subjective then....more to judgment by auditor. And can be differ auditor to auditor....

 

[Pancho]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

It looks like ISO 9001 is always subjective then....more to judgment by auditor. And can be differ auditor to auditor....

Of course ISO 9001 is subjective. Quality is subjective. But it is your clients who's really judging whether or not you are providing it.

Auditors are not there to ding you. They are to help you spot quality issues that your own people may miss. Know the standard and demand from auditors quality in their own service.

 

[BoardGuy]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Clause 7.5.2 does not apply to “records” as there is no requirement related to retaining documented information as evidence of conformity within in this clause. The clause that relates to records would be Clause 7.5.3.

There is, however, requirements related to records such as release of product and services found in Clause 8.6 (i.e. receiving, in-process and final inspection). This clause requires product be released by a relevant authority with traceability to the person authorizing the release. In this case, let’s say, an inspector releasing product to the customer. A review of ISO 9001 finds that there are 21 required records each containing specific requirements.

 

[howste]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Clause 7.5.2 does not apply to “records” as there is no requirement related to retaining documented information as evidence of conformity within in this clause. The clause that relates to records would be Clause 7.5.3.

I have to disagree. 7.5.2 is about creating and updating documented information, which by definition (ISO 9000:2015 3.8.6 Note 2) includes both documentation and records. The standard does not have to use the word "retain" for it to refer to a record, but in general it does. The requirements in a, b, and c must be applied to both documents and records when "appropriate" as pointed out by Pancho above.

Here's my take on this clause applying to records:

"Identification and description" helps us to index, access, and find records.

"Format and media" ensures the records are created and stored appropriately instead of on sticky notes, cocktail napkins, or on the back of the operators hand.

"Review and approval for suitability and adequacy" should be done for every record (in my opinion) at a minimum by the creator so that we know the record is readable and has the correct information in it. Other approvers may also be added if the organization believes it would add value.

 

[BoardGuy]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

I would disagree based on your reference to your reference “a, b, and c”. When a record (retained document information) is completed the reviewer would not verify that the title, issue date, author and/or reference number (7.5.2, a) of the record as being suitable and adequate (7.5.2, d). Additional when the record was completed its format for recording information would not need suitability approval at each completion (7.5.2 b & c).

When I performed a line by line review of ISO 9001:2015, Clause 7.5.2 and found this clause to correlate to the control of document Clause 4.2.3 of ISO 9001:2008 as follows:

7.5.2, 1st Sentence: Formally 4.2.3.b
7.5.2.a: Formally 4.2.3.g
7.5.2.b: Taken from ISO 9000:2005, 3.7.2, Note 1
7.5.2.c: Formally 4.2.3.a, b, & g

I would say that this clause is indicating that the format and media for recording information as retained document information (record) must address these requirements before document issue (electronic or hard copy). An ongoing review of “a, b, and c” each time the document is used is not required.

 

[howste]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

I would disagree based on your reference to your reference “a, b, and c”.

I'm not sure what part of my post you're disagreeing with. I'll just reply to each part of your post to clarify what I mean.

When a record (retained document information) is completed the reviewer would not verify that the title, issue date, author and/or reference number (7.5.2, a) of the record as being suitable and adequate (7.5.2, d).

A person filling out a form should verify that they used the right form and the correct version of the form. If no form exists, there should be some control in the QMS telling them how they should create and identify the record.

Additional when the record was completed its format for recording information would not need suitability approval at each completion (7.5.2 b & c).

Again, when filling out a form, they should verify that they used the right form. If there's not a form to fill out then there should be another QMS control to tell them what media to use etc.

When I performed a line by line review of ISO 9001:2015, Clause 7.5.2 and found this clause to correlate to the control of document Clause 4.2.3 of ISO 9001:2008 as follows:

7.5.2, 1st Sentence: Formally 4.2.3.b
7.5.2.a: Formally 4.2.3.g
7.5.2.b: Taken from ISO 9000:2005, 3.7.2, Note 1
7.5.2.c: Formally 4.2.3.a, b, & g

I agree that those are close equivalent clauses. But because in the old standard they lived in 4.2.3 does not mean that they don't apply to records now. The 2015 standard is a new standard and must be read in its own context. Also "identification" is found in 4.2.4 of the 2008 version.

I would say that this clause is indicating that the format and media for recording information as retained document information (record) must address these requirements before document issue (electronic or hard copy).

I agree. These are part of the QMS controls you would have to ensure that the records being created are suitable and adequate.

An ongoing review of “a, b, and c” each time the document is used is not required.

I agree with this statement too, but it's implying things that I didn't say. The standard does not say that a, b, and c are reviewed each time a record is created. It requires the organization to ensure that controls to ensure appropriate a, b, and c are in place when the record is created.