Let’s start by looking at what changed in the 2000 edition and carried forward into the latest 2008 edition, starting with ISO 9001’s improvement requirements. In the first line, clause 4.1, the organization has to continually improve the effectiveness of its QMS. How should an organization demonstrate this? Is a programme or even just evidence of improvement available?
Similarly, evidence of commitment to continual improvement of the QMS is required (5.1) and customer focus (5.2) requires aiming to improve customer satisfaction - how does top management demonstrate these things, does anyone even ask?
Top management must also document and communicate their policy (5.3), and include a commitment to continually improve the effectiveness of the QMS and set measurable quality objectives consistent with the policy (5.4). Do we ensure these exist and are live documents in the QMS? Do we challenge the managing director or CEO about their strategy?
Top management also have to appoint someone from management (5.5.2) to report to them on system performance and any need for performance improvement, and they have to review the system at planned intervals to assess whether there are any opportunities for improvement of the QMS (5.6.1 and 2), recording any decisions and actions that come from that review (5.6.3). They then have to allocate sufficient resources (6.1) to achieve the improvements identified.
These requirements come before section 8 entitled ‘Measurement, analysis and improvement’, which identifies further requirements for the QMS including: planned improvement processes (8.1); measuring customer satisfaction and using measures obtained (8.2.1); achievement of planned results for processes (8.2.3); analysis of data to identify potential areas for improvement (8.4), and a whole clause ‘Improvement’ (8.5) where all of the above is summarized (8.5.1). Two subsequent clauses describe how an organization should go about managing corrective action, including the prevention of recurring problems through root cause analysis (8.5.2) and, separately, using proactive measures to identify potential problems to prevent them happening in the first place (8.5.3).
It is my assertion that any organization with all these systems in place will be a true ‘quality’ company, but my estimate is that less than 50% of the one million plus ISO 9001-certified organizations even come close. How can that be? Are all quality professionals paying lip service to these fundamental requirements while implementing systems? Are third-party auditors simultaneously allowing non-compliant companies through to certification?
There is a huge industry built around the success of QMS standards, from standard developers through to quality professionals, consultants, auditors and certifiers, and each has a part to play. We were told all the way to the 2000 launch of ISO 9001 that this edition was a ‘game changer’, moving from a dreary 20 clause ‘document everything’ approach to quality management, to a series of standards built on eight unwavering quality management principles with the plan-do-check-act continuous improvement cycle at their very cores. Wind the clock forward to September 2011 and, despite the new 2008 edition, we are faced with a promise unfulfilled.
So what can we do? ISO 9001 is already widely used and forms a template for continuous improvement. We need to start ‘raising the bar’ in every area so quality professionals are helping to implement systems top management can be proud of, auditors test system effectiveness and challenge top management about the systems they champion, and ultimately customers see proof in terms of continually improving products and services.
Article based on ’ISO 9001 - the foundation for continuous improvement?’ by Paul Simpson.
Paul Simpson, FCQI CQP, is head of brand protection at Noble Denton. He is a member of ISO TC 176 on quality management systems and quality assurance, responsible for developing the ISO 9000 family.