Since June 2013 and publication of ISO/CD 9001 : 2015, a lot of comments have been issued, especially in ISO 9001 2015 Revision Discussions Groups on Linkedin.
I’ve read with interest lot of these contributions and even participated to some of them. It’s an honour for me, as French quality engineer and moderator of ISO 9001 : 2015 Revision discussion group on Viadeo (social network dedicated to French speaking people).
SYSTEMS APPROACH IN ISO 9001
The subject I’d like to develop here is about the systems approach in ISO 9001, one of the Quality Management Principles (QMP) in use today. These QMP have been reviewed for 2015 version of ISO 9001 and the decision was made at the end of 2012 to make explicit the 7 QMP, instead of 8 currently, the one suppressed being “System approach”.
What does this mean to the world of ISO 9001? Is it an encouragement to move away from the view of ISO 9001 as a system ?
Some quality specialists (e.g. https://insights.cermacademy.com/2013/09/24-iso-9001-2015-initial-observations-part-ii-david-hoyle/ ) recently questioned the systemic characteristics of ISO 9001 and wondered whether the standard should not aim to be a collection of quality requirements, as if they were part of a check-list, rather than quality management system requirements, which in some extent have to be evaluated as a whole and not only separately.
SO IS ISO 9001: (2015) A SYSTEM STANDARD?
Thus the questions I wonder about are : Is system approach reinforced or not in ISO 9001 : 2015 compared to previous versions? Does it include system attributes? What are the consequences?
First of all, the following facts have to be considered.
The two previous QMP approaches: ‘System Approach’ and ‘Process Approach’ have been merged in a new ‘Process Approach’ QMP. Why is ‘Process’ preferred to ‘System’? This is probably telling something to the user of the standard that doesn’t seem to be in favour of reinforcing the system approach.
In my opinion the reason could be found in the weakness of previous QMP ‘System Approach’ definitions and lack of criteria to be used, specifically: “Identifying, understanding and managing a system of interrelated processes as a system contributes to the organisation’s effectiveness and efficiency in achieving its objectives”.
This is an example of tautological definition where the concept of ‘system approach’ is defined using the word ‘system’! So, the fact of merging the two QMPs can be seen more as an evidence of failure in communication than as an improvement.
Nevertheless systems definition and usage are not totally absent of ISO/CD 9001: 2015 with the definition of ‘Management system’ (“set of interrelated or interacting elements of an organisation to establish policies and objectives and processes to achieve those objectives”).
We don’t know yet what will be the definition of Quality Management System in ISO 9000 : 2015 but if it is written in the same way as in current version we will lead to another tautological definition like « QMS = MS about Quality » which doesn’t help a lot from a practical point of view!
What are the components of QMS? What differences can be stated, if any, between QMS processes and common business processes? Should we consider that these belong to the QMS and others not (see above paper written by David Hoyle)?
Certainly, next draft of ISO 9001 standard would be well inspired to give some useful details on this subject. Let’s wait and see …
IS THE STANDARD COHERENT?
Let’s go deeper in this subject by pointing out a missing word that can be important to the standard as the systems approach. I mean the word ‘coherency’ or ‘integrity’. The current clause 5.4.2 of ISO 9001: 2008 requires : “Top management shall ensure that : … the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.”
This requirement for planning and maintaining the integrity of QMS is one of the main requirements of ISO 9001 and one of which can bring structural benefits to companies which implement quality management.
The word was used in former versions of ISO 9001 (2000 and 2008) but is not present in ISO/CD 9001: 2015 although the definition of ‘Process Approach’ provided in the document states : “Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system”
In clause 6.3 ‘Planning of changes’ of ISO/CD 9001, the criterion “integrity of QMS” has been replaced by “performance of QMS” which is more vague, less system-oriented and less coherent (or consistent) with the definition of process approach. In the sciences as in maths or physics or biology, attributes such as ‘integrity’ or ‘coherency’ are considered intrinsic of the systems approach whereas ‘performance’ may depend on both intrinsic and extrinsic factors.
Why is it any different and should we change this approach for management systems or quality management systems? Is it a good idea to change ‘integrity’ to ‘performance’? I personally fear that this could lead to situations where companies lose interest in the factors and means to produce consistent quality compared to performance results, which may have to rely on luck.
THE COHERENCE PARADOX
Let’s illustrate the use of integrity or coherency criterion in a QMS context. Say an ISO 9001 certified company is evaluating its conformity to the standard on the subject of quality policy.
Clause 5.2 “Quality Policy” requires reviewing quality policy. Assuming the company decided to review its quality policy every year in June, it can still be in conformity.
Clause 9.3 “Management Review” requires reviewing the QMS. Assuming the company usually reviews its QMS every year in September it can still be in conformity.
Without any requirement of coherency or integrity no objection can be raised to that company and e.g. it would be irrelevant, from an ISO 9001 point of view, to ask whether it is coherent or not to review its quality policy in June and its QMS three months later?
That’s for me one main reason to have an ISO 9001 standard designed as a quality management system standard and not as a set or collection of quality requirements. Thus, users of ISO 9001 should require from designers to confirm the system approach of ISO 9001 including requirements and criteria such as integrity or coherency.
Since 1994 version of ISO 9001, the best understanding and benefit of implementation of ISO 9001 has been obtained by considering relationships between requirements (e.g. relationship between clause 5.2 ‘Customer focus’ and clause 8.2.1 ‘Customer satisfaction’ or between clause 5.4.1 ‘Quality objectives’ and clause 7.1 ‘Planning of product realisation’ or between clause 4.1 ‘General requirements’ and clauses 7.1 and 8.2.2 ‘Internal audit’). These interrelated requirements when implemented in a coherent way are evidence of the system approach and provide more benefits than single requirements laid on a check-list evaluation!
CUSTOMER SATISFACTION AND RISK
Everyone is convinced that customer satisfaction is the result of many contributions (individuals and team-work) should agree on the need of system approach to manage quality.
So, can we conclude that 2015 version of ISO 9001 is less concerned by system approach than the current one? In first appearance, we should probably say ‘yes’ but going in more details the answer may be slightly different.
The insertion of new requirements such as risks analysis or understanding the context of the organization or managing knowledge are evidences of reinforcement of the system approach. Inevitably, a company is an open system in interaction with external bodies and in which resources are provided and managed to achieve goals and objectives.
Nevertheless ISO/CD 9001: 2015 doesn’t explicitly provide us with requirements that give opportunities to challenge companies with system approach criteria. This point seems to me an important contradiction and lack of coherency that would be beneficial for ISO 9001 users to fix.
Even if it may be too late to reintroduce the eighth QMP ‘System approach’ at least it should be possible to reaffirm in ISO 9001 some of the systemic characteristics of QMS, especially the requirement for ‘integrity’ or ‘consistency’ of the QMS. In addition with other attributes, such as ‘suitability’, ‘adequacy’ and ‘effectiveness’, wouldn’t it be possible to add ‘coherency’ in clause 9.3 ‘Management review’ in the forthcoming ISO 9001: 2015 standard?
Anyway, that’s my hope!
Bio:
First graduated in mechanics and automation Olec Kovalevsky spent 10 years in Telecommunication industry within project teams. At the end of 90’s he shifted in quality management and started his consultancy, training and auditing job. Dedicated to SMEs he is developing tools and methods to adapt quality standards (as ISO 9001) and related requirements to various types of companies and situations. He wrote two books about quality management implementation and he is very involved in communication about ISO 9001 : 2015 revision. He created a specific French forum on this subject. Please feel free to contact him at olec.kovalevsky@gmail.com.