Does a QMS defined by the element-by-element approach meet the intent of 4.1a?

Let's look at what is arguably the first effective requirement of the standard, ISO 9001:2008, 4.1a: "[The organization shall] determine the processes needed for the quality management system and their application throughout the organization (see 1.2)."

Just FYI, ISO 9001:2008, 1.2: "All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where are exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

Finally, please assume the following situation describes what is meant by the "element-by-element" approach, language taken from "ISO/IAF Audit Practices Group Guidance On: Identification of processes" (5 June 2009), #4: "The auditor/auditee considers that each clause or subclause of ISO 9001 must be defined as a separate process."

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Re: A question about ISO 9001:2008, 4.1a

I can't answer the poll question either way because of the way that it's worded. A QMS that's documented element-by-element meets the intent of 4.1(a) if the processes needed by the QMS and their application have been determined.

Re: A question about ISO 9001:2008, 4.1a

The process approach required by ISO 9001:2008 requires the management and control of the interactions between processes, process elements and activities and the interfaces between the functional hierarchies of the organization. So it is inadequate to just define each element, but also define the interactions and the assignment responsibilities to them.

Re: A question about ISO 9001:2008, 4.1a

ISO 9001 Guy said:

Finally, please assume the following situation describes what is meant by the "element-by-element" approach, language taken from "ISO/IAF Audit Practices Group Guidance On: Identification of processes" (5 June 2009), #4: "The auditor/auditee considers that each clause or subclause of ISO 9001 must be defined as a separate process."

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The language of the above document further adds

"If the auditee considers this as the right approach, it is recommended that the techniques outlined in section 2 (above) should be used."

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And further:

5. Is the process approach as described in the 'Introduction' to ISO 9001 a requirement of the standard?

The description of the process approach in the 'Introduction' to ISO 9001 is purely informative and does not introduce a set of additional requirements by itself. Clause 4.1 specifies the steps necessary to implement a process approach with regard to quality management system processes, the Notes to clause 4.1 providing examples of processes needed for the quality management system. Audit methodologies must be oriented, accordingly, towards analyzing the processes of the organization.

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IMO, all the 'elements' (including those related to determination/ application of the processes) of ISO 9001 have been meticulously designed with the intent that if those are followed appropriately, the intent of the standard is well achieved.

The standard has nowhere indicated to get rid of the 'elemental' approach and nor it has mandated (only promoted) adopting the process approach. The guidance document referred above also upholds the same notion and leaves it to the sole discretion of the auditee who, if considers it a right approach "it is recommended that the techniques outlined in section 2 (above) should be used"

Re: A question about ISO 9001:2008, 4.1a

Each seperate clause meets the definition of "process". Each has specific inputs, desired or required outputs and something has to be done in the middle to make it happen...They each can be either monitored or measured for effectiveness.

Of course one has to be able to have both an objective point of view about the subject and not be tunoptic to see this.

The current narrow way of thinking many have in this field is such that their views could fit through the eye of a very small needle.

Re: A question about ISO 9001:2008, 4.1a

Randy,

Thank you for chiming in.

Stijloor.

Re: A question about ISO 9001:2008, 4.1a

jkuil said:

The process approach required by ISO 9001:2008 requires the management and control of the interactions between processes, process elements and activities and the interfaces between the functional hierarchies of the organization. So it is inadequate to just define each element, but also define the interactions and the assignment responsibilities to them.

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Much of the argumentation and discussion in this thread is (in my humble opinion) caused by the Man Rep simply not having sufficient confidence that that their system conforms - coupled with the ability to demonstrate how it is effective in meeting Company and Standard requirements.

All our Systems are aligned to the way we do business and do not refer at all to the requirement of whatever Standard.

However:- in order to ensure that we effectively comply to the standard (which is the function of the Man Rep) we correlate the following in Spreadsheet format.

All requirements of the Standard- together with some everyday language "comments" explaining the intent of the relevant clause are listed - including typical questions (from knowledge and experience).
that an Auditor is likely to ask.

In separate columns we identify how our System addresses those requirements; together with a link to the most appropriate documentation, (processes, records, instructions or whatever). The dominant Process Owner is also listed in a separate column.

In this way the appropriate answer to any Auditor Question is readily available; including the interaction between the requirements of the Standard.

So! we have a complete summary of theoretically; how we effectively comply to the appropriate Standard.

Next! we simply sort that Database according to Process Owners. This identifies responsibility and educates the Process Owners not only as to which Processes they are responsible for but also provides a cross reference to any specific Standard requirements their Process may be addressing.

Note:- on the same Database we identify a changing history of historical, current and planned internal audit areas, example questions and results. In this way we evaluate theoretical compliance to actual compliance.

Once set up, the system is easy to operate for all concerned.

The basis for our system is that WE know and can demonstrate exactly how we effectively comply with the Standard. This alleviates potential argumentation with the Auditor. i.e. This is how we address that! and this is why we can demonstrate what we do is effective. If the Auditor doesn't like it, then they must demonstrate that what we do is NOT effective.

If they can demonstrate this - we will address it. If they want to "suggest improvement" we will of course listen, but NO AUDITOR will accept responsibility for the implementation of their "improvement suggestions" when what is already in place conforms.!

If anybody would like an "example" of our System, send a personal message and I will be only to pleased to provide.

Re: A question about ISO 9001:2008, 4.1a

Jim Wynne said:

I can't answer the poll question either way because of the way that it's worded. A QMS that's documented element-by-element meets the intent of 4.1(a) if the processes needed by the QMS and their application have been determined.

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Absolutely correct. These YES / NO questions spark debate but simply cannot be answered on such a generic and wide sweeping basis.

4.1a is not a complex clause. Its meaning should not be extrapolated to meet guidance that the organization might never even see.

Re: A question about ISO 9001:2008, 4.1a

Richard Pike said:

The basis for our system is that WE know and can demonstrate exactly how we effectively comply with the Standard. This alleviates potential argumentation with the Auditor. i.e. This is how we address that! and this is why we can demonstrate what we do is effective. If the Auditor doesn't like it, then they must demonstrate that what we do is NOT effective.

If they can demonstrate this - we will address it. If they want to "suggest improvement" we will of course listen, but NO AUDITOR will accept responsibility for the implementation of their "improvement suggestions" when what is already in place conforms.!

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Fantastic thoughts Richards. After all an organization designs it's Business System for itself; not for the CBs. CB Auditors only need to look at if the system under scrutiny conforms to what it claims to & meets the intent of the standard.

BTW, ISO 9001 can also be "used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements."