What are Guidelines? Compliance to ISO 9001 Clause 4.2.4

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biboy2012

When is guideline necessary?
What are the characteristics of a guideline?
What is the composition of a guideline? By composition, I mean sections like scope, responsibility, etc.
Is a guideline formatted like a procedure? If not, will guidelines suffice to satisty control of records requirement of ISO 9001? I mean, instead of developing a control of records procedure can I just develop guidelines for control of records?

The reason for asking these questions is that some (or most) documents/forms/records are moving from one department to another. Thought we have a Central File Department that takes care of records to avoid loss and tampering and protects from physical deterioration and damage, but for other departments, how should I spell out the requirements of identification, protection, storage, and retrieval, retention, and disposal?

If I write a control of records procedure, I should be listing all of the tasks to complete the actvity. The action is sequential, written as a series of tasks. (Even though not all departments are doing, for example, disposal of records.) Should I develop a general Control of Records Procedure or just a guideline?

By the way, we are not an ISO 9001 practitioner, I just want to adopt/intigrate 4.2.4 requirement of ISO 9001 in our documentation.

Many Thanks in advance.
 
Last edited by a moderator:

Stijloor

Leader
Super Moderator
Re: Will guidelines sufficient to address section 4.2.4?

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
 

Jim Wynne

Leader
Admin
When is guideline necessary?
What are the characteristics of a guideline?
What is the composition of a guideline? By composition, I mean sections like scope, responsibility, etc.
Is a guideline formatted like a procedure? If not, will guidelines suffice to satisty control of records requirement of ISO 9001? I mean, instead of developing a control of records procedure can I just develop guidelines for control of records?

The reason for asking these questions is that some (or most) documents/forms/records are moving from one department to another. Thought we have a Central File Department that takes care of records to avoid loss and tampering and protects from physical deterioration and damage, but for other departments, how should I spell out the requirements of identification, protection, storage, and retrieval, retention, and disposal?

If I write a control of records procedure, I should be listing all of the tasks to complete the actvity. The action is sequential, written as a series of tasks. (Even though not all departments are doing, for example, disposal of records.) Should I develop a general Control of Records Procedure or just a guideline?

By the way, we are not an ISO 9001 practitioner, I just want to adopt/intigrate 4.2.4 requirement of ISO 9001 in our documentation.

Many Thanks in advance.

If you want to adopt the 4.2.4 requirements as requirements, I think the standard is fairly plain in what's required. If you develop "guidelines" which, if I understand you correctly, would not be mandatory, you aren't in consonance with ISO 9001.

If you want to control records, you should be thinking in terms of types of records, and not what departments they're in.
 
S

samsung

how should I spell out the requirements of identification, protection, storage, and retrieval, retention, and disposal?

As Jim has already indicated that if you intend to structure your record management in line with 4.2.4, you need to have a 'procedure' that is enforced as if it's mandatory. It can be a single procedure applicable for all or there can be more than one procedures if several unconnected activities are being performed in the organization.

I presume that all other procedures are already in place or under development; e.g. inspection, calibration, contract review, design review etc. If so, it would be more practical to cover these provisions (identification, protection, storage, retrieval, retention and disposal) within such procedures. If each department retains their own records, these may vary and as such separate procedures may be required.
 
B

biboy2012

Thank you for highlighting the need for a procedure. Additional clarificatory questions to follow. Will write a draft first. then post it here for further deliberation.
 
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