After having followed and and also participated in the “ISO 9001:2015 Revision Discussion” on Linkedin, started by Sidney Vianna, I found it interesting to have a closer look at a particular issue

I started a new discussion in Linkedin named: “Shall it be a requirement to apply a process approach?” and this is what I learned from the consensus opinions.

My original query post  was (July 20, 2013):

“A new requirement in ISO/CD 9001 is that the organization shall apply a process approach.  The process approach requirements look nice, but it is necessary to look at the consequences of adding these requirements on top of all the other requirements on the management system processes.

ISO 9001 (2015) IS DECLARED TO BE PROCESS BASED
Which are the quality management system processes?  When reading the draft carefully enough you will find that in principle every requirement in the whole draft refers to a process.  As a rule you will

• Find a requirement stating who shall do something.
• Find the required output.
• Find or be able to image what is the input.

Thus the requirement to apply a process approach applies to every requirement in the draft.

(A very small number of the requirements are not clearly expressed as processes, some of those taken directly from Annex SL, Appendix 2 express the requirement in an indirect way but obviously the requirement still refers to a process)

PROCESS CHALLENGES
Applying the process approach requirements on top of the other requirements will cause problems:

• When interpreting the requirements.
• When implementing the requirements.
• When auditing the requirements.

The possible benefit will not outweigh the amount of job.  I am afraid that not even 3rd party auditors will be happy when using the new toolbox.  In my opinion the requirement to apply a process approach should not be added to ISO 9001.”

275 ISO PROCESS MAY BE IMPACTED
3 days later I also posted my finding that, by application of the definition of “process”, the number of processes concerned by the requirements in ISO/CD 9001 could be considered to be at least about 275.

The issue received great interest.  Many views and questions were presented by the participants.  I include here a number of examples, most of which are worth thinking about. Please note that some of these were directly contradicted by other inputs which are not necessarily shown in this list.  They are entered in the same order as they were posted in the discussion.

• “ISO/CD 9001 expressly requires processes to be established in a few particular cases.”
• “The requirement should be applied to Clause 8 ‘Operation’ only.”
• “The requirement should remain in the new version of the standard.”
• “The process approach should be for all business processes.”
• “Requirements demanding a process approach are already present in ISO 9001:2008.”
• “A ‘standard-based approach’ exists, which disturbs the application of the process approach.”
• “An alternative to applying the process approach is to stick with the functional approach using evidence from satisfied customers.”
• “The “functional approach” may result in people overlooking the interrelationship & interfaces with other functions and such shortcomings can be overcome by adopting a process approach.”
• “The meaning of the concept “standard-based approach” and the way in which it actually exists in real life is not clear.”
• “Each company should be left free to define their processes.”
• “The Process Approach has been embodied in ISO 9001 for 13 years now and people claim it is not understood.”
• “The process approach requires cross functional involvement.”
• “The way to require application of a process approach needs to be modified in relation to how it is expressed in ISO/CD 9001, 4.4.2.“
• “The 10 steps of the process approach are good as guiding principles, but they should be applied only where they are really effective.”
• “If management defines “development” as one process, it is one process. If management defines “development” as 22 processes, it is 22 processes.”
• “With the advent of social and professional networks, ISO’s standard development process will be scrutinized, critiqued and criticized like never before.”
• “How do I distinguish between a QMS process and any other process?”
• “A QMS process is one composed of activities that impact the quality of a company’s products and services.”
• “What is the difference between

(a) processes needed for the quality management system (4.4.2, a)
(b) quality management system processes (6.1, 2^nd para, b, 1)
(c) quality management system and its processes (7.1.5, 1^st para)
(d) processes needed to meet requirements (8.1, 1^st para)
(e) processes of the quality management system (8.3, NOTE 1)?”

• “The standard always assumed organizations would take a natural process approach to quality management.”
• “What is the nature and role of a “procedure? (many inputs although not directly related to the subject).”
• “ISO/CD 9001 suffers from poor clarity when interpretations can be so different.”
• “If this discussion is a representative indication of the SC 2/ WG 24 work, it won’t be easy to solve.”
• “The standard provides requirements for applying a process approach, but it is not the intention of the standard to explain what the process approach is.”
• “Explaining what the process approach is should be the job of CB auditor trainers, consultants, and somewhat the responsibility of CB auditors, too.”
• “Not even the TC 176 representatives can clearly communicate what the process approach is, in pragmatic, real-world cases.”

Among the most diligent contributory you will find Dan Nelson and David Hoyle.

QUALITY IS CLARITY AND CONSISTENCY, BUT …
The opinions demonstrated in the discussion were very divergent.  I think it is impossible, by a direct analysis of what has been written, to find anything about which there is an agreement.  Thus, it is not easy to make a summary of the discussion that indicates any results.

My own conclusions include the following, which are actually also directed to ISO/TC 176/SC 2/WG 24 (hopefully somebody with connection to that Working Group will read this):

• The Process Approach as such is good as a guiding principle, where it belongs.
• The meaning of the requirements for application of the Process Approach, as formulated in ISO/CD 9001, is not clear and it is likely to lead to very different interpretations.
• The requirements in ISO/CD 9001 include different ways to denote the processes for which they shall apply.  A consistent approach in that respect is necessary in order not to confuse the readers.
• In case of some activities referred to in ISO/CD 9001 it is expressly required that a process shall be established.  In case or other activites, which are felt to be “processes” to the same degree, there is no such requirement.  A consistent approach in that respect is necessary in order not to confuse the readers.

The discussion was closed on August 12.  The total number of inputs was 301.  Please find the whole discussion on http://www.linkedin.com/groups/Shall-it-be-requirement-apply-4437530.S.259589458?qid=6545f0aa-9069-444e-a191-b2a4831a4f26&trk=group_items_see_more-0-b-ttl

Bio:

After completing his MSc degree in Metallurgical Engineering at the Royal Institute of Technology in Stockholm, Lennart Brandt started his professional life at the Materials Laboratory of Asea in Västerås, Sweden. Later he moved to the Corporate Staff Quality, which was responsible for co-ordination and supporting the Asea Group companies worldwide in respect of Quality Management. Lennart’s role was, in particular, to develop the corporate QMS and conduct audits within the Asea Group. When the work on ISO 9001:1987 started, Lennart took active part in the review of the drafts. In 1990 Lennart was nominated Swedish expert in ISO/TC 176, and after some involvement in the work on ISO 10013 (Quality manuals) he concentrated on ISO 9001 (At that time Asea had been merged into the new ABB Group the head quarter of which was located in Zürich, Switzerland). He continued his activities in ISO/TC 176 up to the completion of ISO/9001:2008 and work in the Task Group Future Revision. Lennart left ABB in 2004 after maintaining various positions all with some connection with quality management. After that he started a one-man consulting firm which is still in operation.