ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents

[wywy2020]

since ISO9001:2015 not required any Documented procedure, under what situation that ISO9001:2015 7.5.2 Creating and updating is applicable?

 

[AMIT BALLAL]

Re: ISO9001:2015 - 7.5.2 - Creating & Updating Documents Requirements

This clause speaks about control of documents and records. Even if documented procedures are not required, you'll have to control other documents and records (As required).

As per the terms used in standard, "Maintain documented information" means document to be maintained.

And "Retain documented information" means "Record" to be maintained.

Wherever these two terms are used, it means these are mandatory records and documents to be maintained. Therefore it requires a control.

(Added records and document words just for clarification to those who are familiar with earlier version of QMS standards).

I hope this helps!



Regards,
Amit

 

[Marc]

Re: ISO9001:2015 - 7.5.2 - Creating & Updating Documents Requirements

All companies have various documented procedures of one kind or another which were never required by ISO 9001. In the past ISO 9001 has only required a small number of documented procedures, but that did not mean they were the only procedures/systems which a company would document.

Nothing has really changed significantly. ISO 9001:2015 simply gathered requirements from the old clause 4.2.3.a, b, c, and e. The new clause does add a few examples: description, format, and media, but those were a given to begin with.

That said, when a procedure or process is documented the same stuff applies which have been required for documented procedures for many years such as identification and description (e.g., a title, date, author, or reference number).

In short, the requirements for a document control system haven't changed. If you read through some of these document control discussions you will see that there are hundreds of ways different companies control documents. However, each has the same "basics".

Craig Cochran doesn't stop by here much these days, but here is an article he wrote some years back about document control which he shared here (attached - "Document control article.doc").

Also attached is an old "canned" document control procedure )Document Control2.doc). It contains the basics of a document control system. It is "canned, so take it for what it is - Food for Thought.

Also see: Some more document control related files here.

And there are more in the "Free Files Directory" and the "Cove Members" directory. All the files are free, as always.
.

 

[wywy2020]

Re: ISO9001:2015 - 7.5.2 - Creating & Updating Documents Requirements

This clause speaks about control of documents and records. Even if documented procedures are not required, you'll have to control other documents and records (As required).

As per the terms used in standard, "Maintain documented information" means document to be maintained.

And "Retain documented information" means "Record" to be maintained.

Wherever these two terms are used, it means these are mandatory records and documents to be maintained. Therefore it requires a control.

(Added records and document words just for clarification to those who are familiar with earlier version of QMS standards).

I hope this helps!



Regards,
Amit

do wee need to update the procedure let say in certain time frame to ensure it is always up to date?
or can we still use the 10 years back procedure, provided there is no change in the procedure?

 

[Sidney Vianna]

Re: ISO9001:2015 - 7.5.2 - Creating & Updating Documents Requirements

do wee need to update the procedure let say in certain time frame to ensure it is always up to date?
or can we still use the 10 years back procedure, provided there is no change in the procedure?

There is no requirement that documents have to be reviewed and revised after a pre-determined length of time. So, if the "old" procedure adequately describes a process or an activity, as intended, there is no mandate for it to be reviewed.

Keep in mind that procedures and any other documented command media only serve the purpose to support (as I said) a process or an activity. The ISO 9001:2015 standard does require (in 4.4.1 g) & h)) to evaluate and improve processes over time, as necessary. When and if a process has to be tweaked, changed, improved, etc... you should consider the need for the supporting documentation to be revised accordingly.

Good luck.

 

[Kronos147]

Our internal audit recognized an Opportunity for Improvement. We recognized that our forms for Internal Auditing and Training could have a check box before the signature to go into our Master Document List (a controlled form) and update the "last reviewed date" field to the day of the training or Internal Audit.

Our master document list then can be sorted every once in a while by last reviewed date to see if we can obsolete or update a document.

We are always looking for simple ways to kill two birds with one stone.

 

[QAMTY]

Re: ISO9001:2015 - 7.5.2 - Creating & Updating Documents Requirements

Marc

Under 9001 2015, 7.5.2 (Creating and updating)

b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic)
how to iterpret it? languaje, software version and graphics.
Thanks