ISO 9001:2000….The Changes
Jeff Ryall
Well, it's arrived at last. The update to the ISO 9000 series of standards was released late 2000, after a couple of 'false starts', in which the draft documents were published as interim standards. If you started to modify your system based on one of these, you will find that the final release version is different in a number of significant ways.
The process of standards development is a long and tortuous one. The 2000 release updates the previous versions released in 1994. Our observation is that the initial drafts can be described as both ambitious and rough. The consensus-seeking process of standards development tends to iron out the wrinkles, and also 'water down' the requirements. What has emerged from this process with respect to ISO 9001 is a standard which probably describes leading practice of a few years ago.
First, some structural changes…
The most notable change at first reading is that the familiar 20 elements have been dispensed with, and replaced with a grouping of 4 'processes':
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
Largely, this is simply a shuffling of the elements into thematic groups, but there are also a few extra requirements. The most important of these are continual improvement and customer satisfaction.
A few other changes have been made at the structural level:
- A set of 8 Quality Management Principles have been defined. These are very similar to those found in the Baldrige Criteria and the Australian Business Excellence Framework of a few years ago. The Principles form the philosophical foundation for successful application of Quality in the context of the ISI 9001 standard. You can obtain a free document explaining them further - just click through to the British Standards Institute site from the Quality Award Partners® resource links web page (www.qap.com.au/links)
- The supply chain terminology now makes sense (supplier >> organisation >> customer).
- The structure of the ISO 9000 series has been compacted
to essentially four documents:
- (i) ISO 9000 - encompassing the previous ISO 9000.1-3 and ISO 8402
- (ii) ISO 9001 - replacing all of the old ISO 9001, 9002 and 9003
- (iii) ISO 9004 - incorporating ISO 9004.1-3
- (iv) ISO 19011 - replacing ISO10001 &14010-012
A better approach to documentation…
Remember how each of the 20 elements of the 1994 version required a documented procedure, often resulting in a system architecture based on the standard, rather than the organisation's processes? This has changed, and in such a way as to guide people away from 'standards based' systems.
ISO 9001:2000 now mandates that documented procedures address only the 6 system management aspects: document control, records, internal audit, nonconformance control, corrective action and preventive action.
Does this mean that you don't have to have any procedures for the rest of the system?
NO!
The standard has an expectation that there will be a comprehensive set of procedures for the organisation, of a type and form to the extent necessary to ensure the system delivers
"…
consistent products…meeting customer and regulatory
requirements…and enhancing customer satisfaction
through quality assurance and continual improvement." (ISO
9001:2000 Section 3- Scope)
Typically, organisations achieve this through a combination of procedures, competent people, organisational knowledge, communications and other supporting documentation.
The devil is in the detail…
While there are many changes throughout the standard, often simplifying the requirements (a good example is the section on control of inspection, measuring and test equipment), there are 13 which stand out as having major implications for organisations.
#1: 4.2.2 Quality manual
A description of the interaction of the processes in the business needs to be included in the quality manual. (A process map would fulfil this requirement.) See "The Quality Standards Handbook" (www.qap.com.au/books) for an explanation on how to do this.
#2: 5.1 Management commitment
Management now also are required to communicate throughout the organisation the importance of meeting customer, regulatory and legal requirements. In one sense, this is not a new requirement; regulatory and legal requirements should always have been included in the system. It is now specific, and incumbent on management to make it a priority.
#3: 5.2 Customer focus >>> NEW SECTION!
Three things are required here:
1. Determine customer requirements.
2. Meet them.
3. Through this means, aim to achieve customer satisfaction.
This goes further than the 1994 version, and it links with
the determination of customer satisfaction, which appears
later in the standard.
#4: 5.4.1 Quality objectives
This expands & clarifies the 1994 requirements. The objectives need to be measurable, consistent with the policy, and deployed to relevant functions and levels within the organisation.
#5: 5.4.2 Quality planning
Although inferred previously, it is now explicitly stated that management must ensure the integrity of the management system is preserved during periods of change.
#6: 5.5.3 Internal communications >>> NEW SECTION!
The communication processes are now included in the system requirements. They don't need to be documented per se, but they do need to be in place between the various levels and functions, regarding the quality system processes and their effectiveness.
#7: 5.6 Management review
Management review is more definitive than in the 1994
version, but is essentially the same in substance. Its
input has been expanded to embrace the enlarged scope of
the 2000 version.
Review output is now improvement focussed.
#8: 6.1 Provision of resources
Customer satisfaction is the overriding purpose of the resourcing of processes, in addition to implementing and improving the management system.
#9: 6.2 Human resources
Training is now clearly competency linked, and the understanding by people of their role in the organisation is a component of the training system.
#10: 6.3 Infrastructure >>> NEW SECTION!
This expands on the ‘resources’ section in
1994 & 2000, and covers…
·
Buildings, workspace & utilities.
·
Equipment & software
·
Outsourced services
#11: 8.2.1 Customer satisfaction >>> NEW SECTION!
Methods for monitoring customers’ perceptions of how well their requirements have been met need to be determined and applied. (See the other article by David Scott elsewhere in this Executive Briefing.)
#12: 8.4 Analysis of data
Data collection and analysis, with a view to ensuring suitability, effectiveness and improvement of the management system, is required, especially for:
· customer satisfaction
·
conformance to product requirements
·
characteristics and trends of processes and products
·
suppliers' performance
#13: 8.5.1 Continual improvement >>> NEW SECTION!
Continual improvement of the quality management system is to be planned and managed. Various quality system inputs are mandated; quality policy, objectives, audit results, analysis of data, corrective & preventive action, management review.
In summary…
The 1994 version was very prescriptive, basically telling
you
:“This is the system you need to get the outcomes.”
ISO 9001:2000 has an outcome focus:
“
Develop the system you need to get the outcomes.”
What to do next…
The marketing publicity accompanying the new standard would have you believe that unless you rush off and make your system compliant, you will somehow be left behind.
Our advice at Quality Award Partners® is to take your time.
Our contacts within certification bodies tell us that you
don't have to comply until the next triennial audit.
These changes are not simply a matter of redrafting a few
procedures. They are behaviourally focussed, and intentionally
so by ISO. They are also directed toward the senior management
for action and implementation.
We suggest a careful and strategic approach to upgrading
those aspects of your system which don't already meet
the new requirements, so that you move beyond mere compliance,
and really make the investment in change pay off for
your organisation. To really pay off, the development
should be an exercise in organisational learning.
There will be more information in forthcoming issues of
the Quality Award Partners® Executive Briefing. Watch for
the coming roadshow seminars, and ask us how our specially-developed
System Development Support Program™ will help you
improve your business and reduce your risks - and meet
the requirements of ISO 9001:2000 as a consequence.