David Hoyle, the author of the best selling ISO 9001 Quality Systems Handbook and other management systems books, offers his unique observations on ISO 9001:2015 Committee Draft (CD). The second part of his observations will be published in the second issue.
THE NEW STRUCTURE
Ones first impression on looking at the committee draft of ISO 9001:2015 is the major change in its structure. The old 20 elements went out with the 2000 version to be succeeded by five elements loosely based around PDCA. This new version adopts the common structure and terminology for all management system standards that has been approved by ISO in Annex SL to ISO/IEC Directives Part 1 Consolidated Supplement: 2013. These ISO Directives define basic procedures to be followed by technical committees in the development of International standards.
So what’s changed in the structure?
EXPANDING THE GENERAL REQUIREMENTS FOR A QUALITY MANAGEMENT SYSTEM
Section 4 with its current title ‘Quality management system’ has had a real makeover. It was an odd title anyway as the whole standard was about the quality management system. So at last it has been recognized that the system to be established needs to be put in context and so the new title is ‘Context of the Organization’ but there are some issues with this that I will deal with later
MANAGEMENT RESPONSIBILITY DIVIDED AND ENHANCED
Management Responsibility has been split into two sections one on Leadership and another on Planning with the Management Review moved under Performance Evaluation.
Is this good or bad? Well, Management Responsibility was a silly title anyway as everything is management’s responsibility. This is much clearer now but I am concerned that Leadership will now be perceived as a process rather than a principle. The management review requirements are now relocated under Performance Evaluation which is a better place for them.
EXPANSION OF MANAGEMENT REQUIREMENTS
Resource Management now becomes Support of which resource management forms only one part. Resources now include knowledge, infrastructure, measuring devices and process environment (a new term for work environment) but human resources have been omitted, presumably because they are captured by the general requirement for resources (which incidentally captures finance without mentioning it).
The human aspect is addressed under competence, awareness and communication but any specific requirement for sufficient numbers of staff to do the work is absent. It’s interesting that Document Control now moves from section 4 under Support emphasising that the system addressed by ISO 9001 is not a system of documentation.
The new requirements on knowledge will cause much consternation because in the way that they are presently written they are not practical even though the intent is soundly based.
PRODUCT REALIZATION BECOMES OPERATIONS
The core processes are now addressed under the heading of Operations. Perhaps the change in title is appropriate because Product Realization could be misleading with the implication that it excluded design. Section 8 is very similar in structure to the old section 7 except measuring devices have moved under Support and a much better place for it in my view.
Where ISO 9001:2015 departs from the generic guidelines in Annex SL, is in placing nonconforming goods and services under Operations but has retained the generic requirements for nonconforming goods and services in the section on improvement which to me is quite absurd (more on this later).
Another interesting change is that Purchasing and Outsourcing have been brought together under the heading of Control of External Provision of Goods and Services within section 8 on Operations. This will raise a few problems in interpretation as to the difference between outsourcing and purchasing.
MEASUREMENT, ANALYSIS, AND IMPROVEMENT DIVIDED AND ENHANCED
Measurement, Analysis and Improvement has been split into two sections one covering Monitoring, Measurement, Analysis, and Evaluation under Performance Evaluation and a very short section on Improvement (more on this later). Performance evaluation is probably a better heading for this group of requirements and it has overcome an anomaly in the 2008 version in which Verification and Review activities were addressed in several sections (e.g. Management Review is an evaluation activity as is Design Verification, Validation and Review but these are now subsumed under Performance Evaluation.
However it does create a problem because it separates Measurement and Analysis from Control i.e. operations are not complete until the quality of outputs has been determined and action taken on the results. One has to implement requirements in section 9 in order to determine that goods are conforming or nonconforming, implement requirements in section 10 on nonconformity and corrective action then return to section 8 to implement requirements on release the product. It is only a problem if users adopt the same approach to implementation as they did with the previous version by treating every clause as a process.
The new generic section on Improvement seems to have been compiled from the mistaken belief that any action taken to correct a problem or prevent it from recurring is an improvement action. Another possibility is that by placing requirements for Nonconformity and Corrective Action in section 10 they can apply to all other sections in a similar way that the measurement requirements in section 9 apply to all sections.
The authors of ISO 9001:2015 seem to have detected the error and introduced a section on Nonconforming Goods and Services in section 8 and cross referred to the section on Corrective Action in section 10 but this is not a satisfactory solution. Whether they will be allowed to change the generic text of Annex SL remains to be seen. However if one removes the requirements on Nonconformity and Corrective Action one is left with a section containing only three requirements.
The removal of continual from the term continual improvement whilst understandable in a section heading is not sensible in all cases. Continual Improvement has become to be interpreted as gradual or incremental improvement when in fact there are other types of improvement (e.g. breakthrough and transformational improvement). It is one thing to require the system to be subject to continual improvement but another to insist that all improvement of that that system has to be gradual or incremental.
THE GOOD NEWS
The good news is that the proposed revision of ISO 9001 no longer requires any specific documented procedures or a quality manual. Whether procedures and instructions are documented or not documented is for the organisation to decide. However there remain many requirements for documented information describing the results of various activities, what was previously referred to as quality records.
In order to appease the service sector the requirements are now expressed in more general terms than previously with far less use of manufacturing terminology. However, measuring devices was changed to measuring equipment in the 2008 revision and it is now to be changed back again in the 2015 revision – what next I wonder?
The section on Preventive Action has at last been placed under Planning instead of Improvement. However, this will no doubt raise a few eyebrows because the term Preventive Action has gone completely but the concept remains in the form of determining and reducing risks. In fact risk appears 13 times in the requirements. What will happen to all those CAPA forms I wonder?
A good thing in the draft is that all the definitions of the common terms from the ISO Directive are included. There is a note to say that these will be removed and placed in ISO 9000 but I think this would be a retrograde step. Users of ISO 9001 generally do not purchase or read ISO 9000 or indeed ISO 9004. Definitions of terms used in a standard ought to be contained in the standard in which they are used. However, this does not mean there’s no need for a standard on vocabulary that captures terms from several standards within a family.
In the next issue, David Hoyle will address the ambiguities in ISO 9001:2015.
Bio:
David Hoyle Hon CQI. CQP
After a period in aircraft production and the merchant navy following which he qualified as a Chartered Engineer, David Hoyle spent the next 20 years in quality management with British Aerospace on spacecraft development and with Ferranti International on computer system development. Over the next 15 years he operated as a management consultant firstly with Neville Clarke Ltd and then as Director of Transition Support Ltd guiding large and small companies through their ISO 9001 programmes and delivering quality management and auditor training courses throughout the world. This provided a wealth of experience to enable David to begin sharing it with others and over the last 20 years he has published several books on quality management some of which have been translated by national standards bodies into Spanish, Italian, Swedish and Japanese. His ISO 9000 Quality Systems Handbook is now in its 6th edition.