Process Review - What is the ISO requirement for reviewing SOPs and quality documentation?

[Falcon419]

What is the ISO requirement for reviewing SOPs and quality documentation?
When changes are needed or we feel a procedure needs to be reviewed of course they are reved up. Do all documents require an annual or 3 year review? How do track this to maintain ISO compliance?

 

[indubioush]

There is no strict requirement on this. However, it is good practice to periodically review quality system documentation to ensure it is adequate. You can do a periodic document review as a standalone task, as part of management review, or as part of your internal audit system. It is up to you.

 

[Randy]

Periodic, which you define the parameters of

 

[qualprod]

What is the ISO requirement for reviewing SOPs and quality documentation?
When changes are needed or we feel a procedure needs to be reviewed of course they are reved up. Do all documents require an annual or 3 year review? How do track this to maintain ISO compliance?

I'm agree with indubioush comments.
Is the right way for me, yo do It in audits, before this, I defined, to review some groups of documents every one year, but this overloaded muy activities, then I changed the way and worked good for me.

 

[tony s]

Do all documents require an annual or 3 year review?

No. There's no statement in the standard that categorically specify a "planned interval" for reviewing documents.

 

[Kronos147]

Documents should be effective. How often does your company need to review to make sure that happens, else what other controls happen?

Are documents reviewed during internal audits and training? Does that count as a review?

 

[Watchcat]

Are documents reviewed during internal audits and training? Does that count as a review?

IMO, a meaningful review of the content an SOP is one that includes, at a minimum, everyone affected by the SOP (which is to say, everyone who should have been involved in its development). I am doubtful that this happens during internal training or audits.

I am in favor of establishing a requirement for periodic review of SOPs that identifies the time period. I have found this approach tends to falter for a number of reasons:

1. There is no SOP that assigns responsibility for tracking periodic SOP reviews, and for preparing and distributing SOP periodic review status reports.

2. Review periods are based on fantasy, rather than reality.

3. No one wants to put a reality-based review period in writing, for fear that it will make them or the company look bad to someone.

 

[Jim Wynne]

Documents should be effective.

How does one define and verify the effectiveness of a document?

 

[junior1505]

Dear Falcon419,
The system does not talk about the periodic review. But as per the clause 10, Improvement, how are you to ascertain the continual improvement taking into the terms of the changing trends and requirements of the customer, internal or external, they are not static. Once you receive any complaint or feedback or make any changes to your process using 6.3, planning of changes. this infact gives you the opportunity to review your documents. Secondly, you can also see 7.5, Documented information, which will help you analyse....

 

[tony s]

In the context of the statement in 7.5.2: "When creating and updating documented information, the organization shall ensure appropriate... c) review and approval for suitability and adequacy", review of documents doesn't drive updating of documents - it's the other way around.