ISO 9000

ISO 9001:2008 Analysis

ISO 9001:2008 contains no new requirements and therefore it is questionable whether a revision was indeed necessary. Changes can be processed as an amendment in which case the designation would have been ISO 9001:2000 Amd1 or as a new edition and for reasons unknown ISO decided on a new edition even though the degree of change makes this unwarranted. The rules governing the development of management system standards requires a Justification Study and this was duly carried out in the period 2003 – 2004. Feedback was gathered from ISO working groups, user groups and international surveys and this identified the “need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.” This therefore ruled out any beneficial changes in requirements that would cause users to change their practices. ISO 9001:2008 is therefore a missed opportunity to raise the requirements to a level commensurate with industry best practice but that may come in the next revision. One of the problems with international standards is that they reflect a consensus. There are many groups with a vested interest that will oppose change if it’s too radical no matter how beneficial in the long term.

Although ISO 9001:2008 Annex B does provide an indication of the changes there is no explanation given as to the impact or the reason for change so the following attempts to fill this gap for some of the more significant changes.

External influences (Clause 0.1)

Most users of ISO 9001 probably skip the introductory clauses as they contain no requirements. However, a competent auditor would look to these clauses for guidance on what is considered to be important. It is here that there is now recognition that the management system is influenced by forces external to the organization. Although there is no corresponding requirement in the standard, it would not be unreasonable for an auditor to ask “What analysis has been conducted to determine the impact of changes in the business environment on your quality management system?”

Revision of the process approach (Clause 0.1)

The description of the process approach has changed. Words have been added in order to clarify that processes should be managed to produce the desired outcome. It would therefore not be unreasonable for an auditor to ask “How do you know that your processes are producing the desired outcome?”

Addition of statutory requirements (Clauses 1.1, 1.2, 4.1 & 7.2.1)

The standard now requires organizations to meet customer and applicable statutory and regulatory requirements. There are laws made by statute and regulations for implementing and interpreting these laws which are called statutory regulations. Compliance with a statutory regulation is deemed to be compliance with the law. However there are regulations other than statutory regulations such as those pertaining to a profession and hence it was necessary to clarify this requirement.

Outsourced processes (Clause 4.1)

A number of explanatory notes have been added to the requirements on outsourced processes. There has been an increase in the number of organization’s outsourcing activities they previously carried out in-house as a way of reducing costs. In principle, using experts to perform activities rather than developing the expertise yourself is sound practice but it does raise a number of problems, especially if you think the only cost to you is what you pay the contractor. These notes are intended to change these perceptions as in reality you may have to do more than what you did when the activities were in-house. Your values were internalised naturally, the internal communication systems reached the people doing the job, work was executed through human interaction not legal contracts but now these links are broken unless you take action to migrate these informal but vital elements into your contractor’s management system.

Records procedures and external documents (Clause 4.2.1 & 4.2.3 )

The changes in this requirement rule out the interpretation that

the only records required were those identified in the standard.
a procedure has to be a separate document
any external documents, whatever their purpose, have to be controlled

Management representative (Clause 5.5.2

The change in this requirement means that you can no longer outsource your management representative unless they have a contract of employment that gives you exclusive use of their services.

Removal of reference to product quality (Clauses 6.2.1 & 6.2.2)

The change in the 2008 edition suggests that work affecting product quality is not the same as work affecting “conformity to product requirements” Work affecting product quality expresses a concept that goes beyond product requirements because until such time in the product development cycle that product requirements have been established the only basis for judging quality is the organization’s perception of customer needs and expectations. In situations where the customer defines the product requirements either in performance terms or in conformance terms, this change has no impact. But where the organization has to translate customer needs and expectations into product requirements, it would appear that the standard no longer requires personnel engaged in such translation work (i.e. developing product requirements) to be competent. How this change brings benefits is unclear as it appears to reduce the value of the standard.

Reversion to monitoring and measuring equipment (Clause 7.6)

ISO 9001:2000 clause 7.6 referred to measuring devices but this has now been changed back to measuring equipment. The advantage of using the term devices was that it reflected any form of measurement and so included non-physical forms such as human senses used in wine tasting or documented criteria as is used in the examination of pupils in the education sector.

ISO 9000:2005 defines measurement equipment as measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process. If the measuring instrument can be non-physical then, this change has no impact but the expression “measuring equipment” will be perceived by many to be physical equipment such as oscilloscopes, micrometers, thermometers etc. How this change brings benefits is unclear as it appears to reduce the value of the standard.