Minimum number of procedures to satisfy ISO9001 requirements

C

Carrie11

#1
Hi

I am new to the forum and could do with a bit of guidance. :bigwave: I am reviewing a Quality Manual and Procedures Manual which I have inherited. The format still appears to be to the 1994 standard i.e. a procedure for everything. As I understand it the 2000 edition only requires 6 mandatory documented procedures. Am I correct in my understanding and has anybody achieved certification with this minimum amount of procedures?

Thanks
 
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Jim Wynne

Staff member
Admin
#2
Hi

I am new to the forum and could do with a bit of guidance. :bigwave: I am reviewing a Quality Manual and Procedures Manual which I have inherited. The format still appears to be to the 1994 standard i.e. a procedure for everything. As I understand it the 2000 edition only requires 6 mandatory documented procedures. Am I correct in my understanding and has anybody achieved certification with this minimum amount of procedures?

Thanks
Six is the "magic" number, but the number of documented procedures you have should be determined by needs of the business, not the requirements of the standard (assuming you have the ones required).
 

Colin

Quite Involved in Discussions
#3
Agree with Jim on this. However, I recently worked with a client who had just 5 documented procedures (documents and records were combined) and they had certification. Was it a good system? Not really, the company did not understand it and asked me to help them develop some more documented procedures.
 

Jim Wynne

Staff member
Admin
#4
Agree with Jim on this. However, I recently worked with a client who had just 5 documented procedures (documents and records were combined) and they had certification. Was it a good system? Not really, the company did not understand it and asked me to help them develop some more documented procedures.
You can have just one document that addresses all of the required procedures. (Note that "procedure," as in the phrase "documented procedure," is synonymous with "process."
 

Colin

Quite Involved in Discussions
#5
You can have just one document that addresses all of the required procedures. (Note that "procedure," as in the phrase "documented procedure," is synonymous with "process."
Jim, nice to see that point clarified in CD1 of the proposed revised version too.
 
V

vanputten

#6
Hello Jim:

Is the phrase "documented procedure" really synonymous with "process?" I do not agree based on the way you have written this but I think I understand your intent.

We may have many, may processes. ISO 9001 only requires 6 processes to be documented in as many documents as the oprganization chooses to have.

Also, there are many clauses that say an organization must have as many processes and documented procedures as needed by the organizaiton to have an effective management system. "Effective" is consistent product that meets requirements and satisfies the customer.

So my answer to the original question is that ISO 9001 requires as many documented procedures as you need but at least 6 processes must be documented.

Regards,

Dirk
 

Jim Wynne

Staff member
Admin
#7
Hello Jim:

Is the phrase "documented procedure" really synonymous with "process?" I do not agree based on the way you have written this but I think I understand your intent.

We may have many, may processes. ISO 9001 only requires 6 processes to be documented in as many documents as the oprganization chooses to have.

Also, there are many clauses that say an organization must have as many processes and documented procedures as needed by the organizaiton to have an effective management system. "Effective" is consistent product that meets requirements and satisfies the customer.

So my answer to the original question is that ISO 9001 requires as many documented procedures as you need but at least 6 processes must be documented.

Regards,

Dirk
If "procedure" isn't synonymous with "process" in the phrase "documented procedure," then why is the word "documented" necessary?
 
#8
Welcome to the Cove, Crainford :bigwave:
Am I correct in my understanding and has anybody achieved certification with this minimum amount of procedures?
In line with the previous responses I suggest that you focus less on the minimum number of procedures and more on what the users of your system need.

As has been said there is a number of things you have to describe in a written procedure (Clause 4.2.1c)...

You are also required to have documents "needed by the organization to ensure the effective planning, operation and control of its processes" (Clause 4.2.1d).

Finally, there is my longtime favourite: Clause 4.2.1, note 2...
ISO9001:2000 said:
The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
This note is important, imo: It allows you to build a reasonable system, adapted to the needs of your organization.

/Claes
 
V

vanputten

#9
Hello Jim:

Thank you for helping me to see the light.

I agree. Within the phrase "documented procedure", the word "procedure" is synonymos with the word "process."

Thank you helping me understand.

Regards,

Dirk
 

Jim Wynne

Staff member
Admin
#10
Hello Jim:

Thank you for helping me to see the light.

I agree. Within the phrase "documented procedure", the word "procedure" is synonymos with the word "process."

Thank you helping me understand.

Regards,

Dirk
No problem. The issue stems from the fact that the ISO writer(s) could have just said "documented process" to begin with, knowing that many people associate "procedure" with a document.
 
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