ISO/CD 9001:2015 - The 6 mandatory requirement (procedures) are extend to 9

[Filip M.]

Hi,

the ISO/CD 9001 is issued at 3 june 2013.

I read an article that says the 6 mandatory requirement (procedures) are extend to 9 mandatory requirements (procedures).

Can someone list me up those 9 mandatory requirements please ?

Thanks in advance for ea reply.

Best regards,

Filip

 

[Boingo-boingo]

Filip, I mean no offense with my comment, but I find it extremely disheartening to realize that, after 25 years of ISO 9001, "quality" professionals still debate some inconsequential issues such as number of mandatory procedures required by the standard.

We keep dragging the discussion down several levels. A quality management system is NOT a collection of documents. No wonder the quality function is so belittled by the corporate world.

Contrary to what most people say, I could comply with ISO 9001:2008 with one or zero documented procedures.

I think it is totally foolish to embark on this type of discussion, especially because very few people have had access to the Committee Draft.

 

[Marc]

Boingo - So - You are saying that no *documented* procedures are required by ISO 9001?

 

[Boingo-boingo]

Marc, what I am saying is this: ISO 9001 allows procedures to be combined, so I could (if I wanted to) combine the documented procedures for doc control, records control, NCM control, internal audits, CA and PA) into a single documented procedure, if I wanted to. That is the 1 procedure option. Alternatively, I could define the above mentioned processes in to my quality manual and have zero procedures and still satisfy the intent of the standard.

 

[Jim Wynne]

Imagine the clarity, internal continuity and goodness that could be realized if ISO 9001 called for documented processes instead of documented procedures. Everyone conflates "procedure" with "document" and therein lies the confusion.

 

[Marc]

This is what I would like explained:

<snip> Contrary to what most people say, I could comply with ISO 9001:2008 with one or zero documented procedures. <snip>

 

[insect warfare]

Marc, what I am saying is this: ISO 9001 allows procedures to be combined, so I could (if I wanted to) combine the documented procedures for doc control, records control, NCM control, internal audits, CA and PA) into a single documented procedure, if I wanted to. That is the 1 procedure option. Alternatively, I could define the above mentioned processes in to my quality manual and have zero procedures and still satisfy the intent of the standard.

It's true that you could combine these things, but even if your quality manual was the only document that existed and it contained how these requirements are addressed, by the normative definition of procedure you would still have at least 6 of them (procedures), irrespective and independent of the # of documents.

Imagine the clarity, internal continuity and goodness that could be realized if ISO 9001 called for documented processes instead of documented procedures. Everyone conflates "procedure" with "document" and therein lies the confusion.

It is a conflated world. While it takes an astute mind to sift through the pertinent information contained within ISO standards and properly apply it to their situations, I am relieved to know that the people working on the next edition of ISO 9001 are considering eliminating the word "procedure" and replacing that term throughout with "documented information".

Brian

 

[Jim Wynne]

It's true that you could combine these things, but even if your quality manual was the only document that existed and it contained how these requirements are addressed, by the normative definition of procedure you would still have at least 6 of them (procedures), irrespective and independent of the # of documents.



It is a conflated world. While it takes an astute mind to sift through the pertinent information contained within ISO standards and properly apply it to their situations, I am relieved to know that the people working on the next edition of ISO 9001 are considering eliminating the word "procedure" and replacing that term throughout with "documented information".

Brian

"Documented information" might be even worse than "documented procedure." Each of the current specifically mandatory six are requirements for certain types of processes to exist and be document. Furthermore, ISO 9001 "promotes" the process approach. What could be more apt than "documented process"?

 

[insect warfare]

"Documented information" might be even worse than "documented procedure." Each of the current specifically mandatory six are requirements for certain types of processes to exist and be document. Furthermore, ISO 9001 "promotes" the process approach. What could be more apt than "documented process"?

I must concede in part, for I agree that the term "documented process" is more fitting and compatible with the intents and purposes of a process approach than "documented information". Having said that, I think "documented information" is still a little better than "documented procedure" with regard to those who occasionally meditate over to what extent something should be documented. "Procedure" has a connotation all its own with the general public as a full-fledged procedure document, with the purpose, scope, etc. sections that abhor some of us.

Many people see the word "procedure" and instantly misinterpret, leading to overkill in the documenting of simple practices, but if they were to apply "documented information" in the same context, I am of the belief that they would not think so linear and feel they needed to construct a document "with the works" (such as described above) every time they felt compelled to, but instead would fire some synapse in their brains to construct only what is necessary to promote as lean a documentation system as possible (which should be congruent with the process approach).

Hopefully we'll see "documented process" sprinkled throughout the new version like you said; if not, I would still settle for "documented information".

Brian

 

[kgott]

Documented process - a document that describes the flow of how work gets done either in flow chart, text or a combination of both.

procedure or work instruction - this is how the work in xyz process gets done.