As predicted a new iS09001 Standard has been finalized and is now available. Rather like its predecessor it arrived in time-just!

Throughout the development we have been assured that the document would not contain major revisions, just a collection of “amendments or clarifications’. An amendment is said to be a change that will address known issues, but not introduce new or remove existing requirements, while an examination of available material suggests this to be so only if your interpretation of the original standard matches that of the reviewing panels. Should you happen to have a different interpretation of a requirement then any clarification might be seen as a major change.

All of that having been said it does appear that most of the proposed changes are indeed a clarification or simply a re-ordering of text.

Because many of the changes are not immediately obvious the compilers have included an annex to the standard that will identify where changes have been made from the text of the year2000 standard. Although this will aid the search for document differences, it will still be necessary for each organisation to formally assess the changes to determine the impact on their local management systems.

It will be seen that where changes have been made to the original (2000) text, these alterations are frequently no more than a re-ordering of the material, and in these cases the re-ordering has generally been successful in achieving the clarification objective.

Interesting and long overdue for this auditor, is the move away from the term ‘Quality Requirements’ - whatever they might be. The standard now refers to “product requirements’ in several areas previously using Quality Requirements as a descriptive term. No reasons have been given for any of the changes, and regardless of the strength of argument against changes this one is welcome and long overdue, since ‘quality requirements’ is a term with no valid definition.

Summary of significant changes.

Introduction. This section is simply an introduction containing no requirements directly applicable to business registration. It does however contain guidance notes worthy of study, and changes here are reflected later in the standard. Amongst these are the introduction of statutory and legal as additions to the existing term regulatory. This reflects the existing interpretation of regulatory as being defined by law, whether criminal or civil. Determine has been substituted for identify throughout the standard, as in ‘the organisation shall identify determine……….’

4. Quality Management System. In addition to the general changes first shown in the introduction, the section contains a multitude of minor amendments that can reasonably be considered textural improvements. There are other changes that a diligent auditor might view as changes to the requirements including those that impose additional or relax existing requirements.

Process measurement has in the past been viewed as a mandatory requirement for all processes, the standard now reads ‘monitor, measure (where applicable), and analyse these processes…..’

A recognition that the mandatory procedures required by the standard can be combined within a common document simply reflects the reality of many management systems, where typically the requirement for a procedure for Corrective action (8.5.2) and Preventive action (8.5.3) are included within a common document.

External document control now requires that documents ‘determined by the organisation to be necessary for the planning and operation of the quality management system are identified and their distribution controlled….’

5. Management responsibility. Key change here is the addition of a requirement that the Management representative (5.5.2) is a member of the organisation’s management. This in no way prevents the outsourcing of key management processes to professional providers (e.g. Quality audit), but requires the authority for the management system to remain with an accountable member of the management team.

6. Resource management. A general recognition that the achievement of the previously mentioned “conformity to product requirements” is affected by the competence and performance of the organisation’s employees has led to changes within this section to reflect this. Training to achieve an acceptable level of competence is now qualified by ‘where applicable’. Work environment now has a detailed addition outlining its intended scope of application.

7. Product Realisation. This section has a multitude of text amendments, with little of significance that might require attention to an organisation’s management system.

8. Measurement Analysis & Improvement. Again a series of minor changes to the text and layout, but a few changes that auditors will surely latch unto as significant in the ongoing search for evidence of conformance. Internal audit, now contains a specific requirement to maintain records of both audits and their results.

For the product, “evidence of conformity with product acceptance criteria shall be maintained’, and records to indicate the person authorizing release of the product ‘for delivery to the customer’, are welcome additions.

Altogether these changes from the current IS09001 standard should be welcomed for their clarification of requirements, but also for what may be considered additional material beyond ‘clarification’.

Category: ISO9001, Uncategorized | Tags: Development, ISO9001:2008