AS/NZS ISO 9001:2008 Quality management systems – Requirements, is now available from Standards New Zealand. The latest edition of the international Standard used by organisations in 175 counties for certification of their quality management systems (QMS), ISO 9001:2008, has been adopted unchanged from the ISO 9001:2008 publication.
Organisations are judged on the quality of their products and services every day – and those judgements determine how well they are meeting the requirements of their customers (including end users). In today's environment, an effective way of achieving high levels of customer satisfaction is critical in order to stay in business.
'The publication of AS/NZS ISO 9001:2008 provides a timely opportunity for organisations to ask themselves, "In all the turmoil of doing business today, have we taken our eyes off the ball? Are we still placing the right emphasis on delivering quality service and customer satisfaction every day?" ' says Diane Baguley, New Zealand delegate to ISO Technical Committee 176. Diane has been involved in several ISO working groups since 1997, including groups drafting ISO 9001:2000, and ISO 9001:2008.
Quality management systems – enabling organisations to deliver quality products and services
Ensuring that products and services are consistently delivered to a high quality standard is even more important when economic times are tough. Retaining existing customers and maintaining a good reputation can save significant cost, not to mention the reduction of wasted materials and time. Further, enabling staff to 'get it right first time' raises the spirits of everyone. Nothing is worse, when you are concerned about your job, than seeing continued waste through faulty processes, and having management that does not listen.
A QMS covers a wide range of topics, including:
- the organisation's top management commitment to quality
- its customer focus
- adequacy of its resources
- employee competence
- process management (for production, service delivery, and relevant administrative and support processes)
- quality planning
- product design
- review of incoming orders
- monitoring and measurement of its processes and products
- calibration of measuring equipment
- processes to resolve customer complaints
- corrective/preventive actions and requirements to drive continual improvement of the QMS
- monitoring of customer perceptions about the quality of the goods and services it provides.
9001 – the benchmark for QMS
AS/NZS ISO 9001 provides internationally recognised requirements for a QMS – applicable to any type of organisation, product, or service – against which an organisation can be assessed. The QMS approach encourages organisations to analyse customer requirements, define the processes that are needed to meet those requirements, and keep those processes under control. It provides a basis for enhancing customer satisfaction through feedback and improvement.
The Standard lays down what requirements a quality system must meet, but does not dictate how they should be met in any particular organisation. This leaves a great deal of scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
As with the preceding editions, certification is not a requirement of AS/NZS ISO 9001:2008. Organisations are free to implement the Standard for the internal and external benefits that it brings to them and to their customers. However, it is recognised that hundreds of thousands of ISO 9001 user organisations have chosen to have their QMS independently certified as conforming to the requirements of ISO 9001.
Who can use AS/NZ ISO 9001:2008?
AS/NZS ISO 9001:2008 can be used effectively by:
- managers, to assess the health and robustness of their organisation for delivering quality products and services, asking, 'Does our management system meet or exceed the minimum requirements that are accepted internationally for quality management?'
- purchasers and suppliers, who can use the requirements as a basis for confidence in the expected performance of a contract
- organisations that gain third party certification of their QMS, to provide independent assurance of confidence in the organisation
- Organisations can remain certified to the year 2000 edition; however, certificates to the year 2000 edition will only remain valid until December 2010.
- Certification to AS/NZS ISO 9001:2008 is not an 'upgrade', and organisations that are certified to the year 2000 edition should be afforded the same status as those which have already received a new certificate to the 2008 edition. Please contact your certification body for details on the certificate transition process.
The use of certification to ISO 9001 was initially dominated by Europe, but the 2007 ISO survey showed that certification was in use in 175 countries. 'It is interesting that the growth in numbers of certified organisations has been dramatic in China over the last few years,' says Diane. 'New Zealand organisations cannot afford to be “asleep at the wheel” when managing quality. An ongoing commitment is essential.'
Examples of changes in AS/NZS ISO 9001:2008
'The Standard has been revised to clarify some requirements and to promote a common understanding of the requirements internationally,' says Diane. 'Current users of AS/NZS ISO 9001:2000 would not expect to find any new requirements. However, they need to consider whether the clarifications have an impact on their current interpretation of the Standard.'
'The “Introduction” now refers to the concept of using risk as a basis for designing a quality management system,' says Diane. 'Many companies are already doing this. It's a useful way to approach quality management systems, whether you are an engineer designing bridges, or a travel agent providing tickets to travellers.'
Control of outsourced processes
'One of the important clarifications is control of outsourced processes,' says Diane. 'The Standard requires the type and extent of control to be applied to outsourced processes, to be defined, and adds some explanatory notes. This has been done because the relationship between this requirement in Clause 4.1, and purchasing requirements, in Clause 7.4, caused some confusion.'
Useful explanatory notes
'A number of changes to the Standard are in the form of additional explanatory notes, that clarify certain requirements, in particular for small and medium enterprises, and the service sector,' says Diane. Some examples are:
- clarification of documentation requirements in Clause 4.2.1
- clarification of 'post-delivery activities' in Clause 7.2.1
- a helpful note on design and development review, verification, and validation in Clause 7.3.1.
Re-ordering requirements for clarity
'There are several examples of re-ordering of requirements for clarity and consistency,' says Diane. 'Clause 8.3, Control of nonconforming product, takes a requirement from one place and adds it into the existing list of the ways an organisation must deal with nonconforming product. The way the Standard read before, it sounded quite impractical to many organisations, particularly in the service industries.'
'To current users, many of the changes in the revision may seem minor, but in some cases the reason for the change was to enable consistent translation into other languages,' says Diane.
Also see article in Touchstone 3 Quality management – revised AS/NZS ISO 9001:2008 Standard available now. http://www.standards.co.nz:81/touchstone/Issue+03/Business/default.htm#1