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

[BoardGuy]

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

It seems that your statement of "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”. You seem to be saying that Clause 7.5.2 was the governing clause for review of records and approval of data which it is not.

PO said: “For records, does it applicable for review and approval? E.g every record need for peer review and approval?” Documents to be used for the recording of information need approval under 7.5.2 and 7.5.3 specifically relates to records themselves. Once an approved document is used to collect information as a record it may or may not require review or approval based one of the 21 record requirements found in ISO 9001:2015

 

[howste]

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

You seem to be saying that Clause 7.5.2 was the governing clause for review of records and approval of data which it is not.

What other clause tells you to review records for suitability? I don't see a single one. I see records of reviews, but not reviews of records.

PO said: “For records, does it applicable for review and approval? E.g every record need for peer review and approval?” Documents to be used for the recording of information need approval under 7.5.2 and 7.5.3 specifically relates to records themselves. Once an approved document is used to collect information as a record it may or may not require review or approval based one of the 21 record requirements found in ISO 9001:2015

To answer the OP's question, I said:

"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.

So peer review is NOT required for each record, but the person creating it should ensure it is suitable.

Clause 7.5.2 does not apply to “records”...

This is the statement I disagree with. Clearly 7.5.2 does apply to records.

 

[wywy2020]

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

It seems that your statement of "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”. You seem to be saying that Clause 7.5.2 was the governing clause for review of records and approval of data which it is not.

PO said: “For records, does it applicable for review and approval? E.g every record need for peer review and approval?” Documents to be used for the recording of information need approval under 7.5.2 and 7.5.3 specifically relates to records themselves. Once an approved document is used to collect information as a record it may or may not require review or approval based one of the 21 record requirements found in ISO 9001:2015

Key word here is documented information.
ISO 9000: 2015 now define it as
documented information
information (3.8.2) required to be controlled and maintained by an organization (3.2.1) and the medium
on which it is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.5.3), including related processes (3.4.1);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records (3.8.10)).

so in conclusion it involves both documents and records.

 

[chellemi309]

ISO 9001:2015 Clause 7.5. - Google Forms as document?

I am working for a start up company, and seeking to create and implement a document control system that will meet ISO 9001:2015 requirements. Many people here have existing documents using google docs such as google sheets, google forms.

I am pretty sure I can make the google sheet work to meet ISO requirements for 7.5. , but not sure regrading the google forms.

Part of production is using a google form for the manufacturing batch record, and when it is submitted it gets exported to a log. Can a google form be used as a document, and a log be used as a record? The log has records for several lots produced , not just one.

Has anyone else used google form as a document under ISO 9001:2015

All feedback, and suggestions is appreciated.

Thanks

 

[charanjit singh]

After going through the above posts let me clarify my own thinking:

Maintained Documented Information includes Templates that would be used for recording the relevant information as the evidence of compliance (of specified requirement for retained information). These templates are subject to review and approval to ensure that the records would be adequate enough to meet the specified requirements.

Once the templates are filled-in on completion of the relevant processes by the concerned personnel, they become records (retained information). These records do not need any further review/approval unless of course the relevant template itself calls for this action specifically.

As an example, we have a template for Engg. Change Note that calls for Review & Approval of the requested change. Unless this action is done, the document (change record) is not valid.

Another example is a template for recording the Tensile Strength & Elongation percentage of a test piece which is a maintained documented information. But once the template is filled-in it would be signed by the concerned lab. assistance/inspector as the record and may not require any review/approval unless of course the template calls for it.

 

[chellemi309]

Thanks for the reply. All of my other documents that will be a wiki page or google sheet will be reviewed and approved before release, and same for any changes of the document.

A google form is not a typical format for a "document". The google form resembles Survey Monkey, if you know what that is. You don't see the document as a whole, you see a few questions or text inputs, then click next, until you reach the end. Once they reach the end they hit a submit button. Once submit is hit, all the input from the fields automatically get exported to a google sheet(like excel). Across the row is all the information that was submitted from the form. The next form submitted goes into the next row on the google sheet.

Maybe to be more clear on my questions:
Q.) Can a "record" be across a row on a google(excel sheet), with multiple "records" across each row.. Somewhat, resembling a log of records.
Q.) Or does a "record" technically need to be separated from other records, and can't be on one google(excel) sheet with other records.

In my past experience all records have always been separate, so I never had to question this process before.

All feedback, and comments are appreciated,

Thanks,
chellemi309

 

[howste]

Q.) Can a "record" be across a row on a google(excel sheet), with multiple "records" across each row.. Somewhat, resembling a log of records.

Yes. You get to define how you maintain records.

Q.) Or does a "record" technically need to be separated from other records, and can't be on one google(excel) sheet with other records.

No. There is no requirement to separate records from each other.

 

[chellemi309]

Thanks Howste for the clarification.

If the record requires approval and signature , does your answer still apply.

 

[howste]

ISO 9001:2015 doesn't require approval and signature of each record. If your system requires approval and signature on each record, then you'd probably need to have the (electronic?) signature on each row of the spreadsheet.

 

[QAMTY]

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

Dear Howste

Your last paragraph

"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.

I think it is what we used to do in 2008 version, where we defined a timeframe
to revise documents for adequacy, because sometime they remain the same for a long time, which means are not part of the system improvements.

BTW, at doing this activity , the idea is that document owners revise their documents at time defined (say 2 years from the last change), the evidence in my opinion, could be to change number of revision, even if it was not changed.

I could think in having an email from the owner saying " I have revised the documents xxxx,xxxx,xx ,etc.) and not change the revision on the documents, but is not a good idea.

What do you think in both topics?
Thanks