HCi Journal

How to upgrade to ISO9001:2000

... and how to get the most out of the new standard with the least amount of effort

The new version of ISO 9001, which you will need to comply with at your next triennial assessment, is mostly a drastic rearrangement of the old standard in order to fit it into a new 'process model'. It's a bit like putting it through a blender to give it a smoother look. The older version of the standard had a rather ad-hoc structure, but the rearrangement means going through the tedious exercise of linking your current quality system documentation with the new Standard's provisions.

To help with this task, here are our suggestions for identifying the new key 'elements' of the Standard. Forget the preliminary sections (Introduction, Scope, etc). These need to be understood but don't need to be related to any specific parts of your quality system.

Step one in your upgrade program is to use the codes in the table below to cross-reference your existing process reference documentation (policies, procedures, and performance support documents) to each part and section of the new standard. This will help you identify where you need to make detail changes to your existing processes.

Parts

Sections - Code

QUALITY MANAGEMENT SYSTEM

General requirements - 01

Document requirements - 02

MANAGEMENT RESPONSIBILITY

Management commitment - 03

Customer focus - 04

Quality policy - 05

Planning - 06

Responsibility authority and communication - 07

Management review - 08

RESOURCE MANAGEMENT

Provision of resources - 09

Human resources - 10

Infrastructure - 11

Work environment - 12

PRODUCT REALIZATION

Planning of product realization - 13

Customer related processes - 14

Design and development - 15

Purchasing - 16

Production and service provision - 17

Control of monitoring and measurement devices - 18

MEASUREMENT ANALYSIS AND IMPROVEMENT

General - 19

Monitoring and measurement - 20

Control of nonconforming product - 21

Analysis of data - 22

Improvement - 23

Additions to the Standard

Having addressed this first priority of bringing your old system into line with the new, you can turn your attention to covering the new requirements of the Standard. Apart from a smattering of detail changes, there are only three major conceptual additions to the Standard. These can be described as:

  1. the 'whole business'
  2. customer focussing
  3. continuous improvement

All the additions to the Standard fall under one of these three headings. The difficulty with implementing them, however, is that they are scattered all over the Standard and are duplicated in a number of places. To help sort this problem out, here are our checklists for what to cover under each heading.

The whole business

This is the most straightforward area. The new Standard requires you to include all aspects of the business in the quality system that affect product or service quality. Notably this means that if you do design work you must include design processes in your system (ISO 9002 has been retired). It also means that you can no longer pick and choose the Divisions to certify. So step two is to do a 'gap analysis' to see which relevant areas of the business are not covered.

It also suggests that you use ISO 9001 as the basis on which you handle all your compliance management. This means integrating it with other Standards that follow the ISO 9000 model such as Environmental Control, OH&S Management, and even specific legislation such as the Trade Practices Act or the Privacy Act. This is very sensible because all these 'codes' either have common core elements or should have them, in order to be managed properly for compliance. Core elements constitute such things as document control, internal audits, corrective and preventive action, etc. So step three is to do a plan for integrating all requirements into a single compliance management system.

Customer focussing

The Standard now puts a lot of emphasis on customer requirements and customer satisfaction. Here is the checklist:

  1. top management have to make sure that customer requirements are determined and satisfaction enhanced (presumably this means supervising processes, rather than requiring them to do these things themselves)
  2. the quality representative must promote awareness of customer requirements throughout the organisation
  3. provide the resources necessary to enhance customer satisfaction and meet customer requirements
  4. communicate with customers to get feedback, including via customer complaints
  5. have processes in place to collect and monitor information about customer satisfaction
  6. collect and analyse data to monitor customer satisfaction, check product conformity, characteristics and trends in process performance, and monitor supplier performance

So step four means designing, documenting and implementing processes to underpin customer focussing activity.

Continuous improvement

We say continuous, they say continual. We prefer 'continuous' because it links more closely with the 'total quality' movement that gave rise to the concept of improving processes through measurement, analysis, creative problem solving, and minimising statistical variation. Here is your checklist:

  1. continually improve the effectiveness of the quality system (this is the blanket requirement)
  2. having identified the processes needed for the quality system, determine the sequence and interaction of these processes, and continually improve them
  3. top management has to make sure that quality objectives are set for all functions and at all levels and these must be measurable
  4. personnel must be aware of the importance of what they do, the context in which they do it, and how they contribute to meeting quality objectives
  5. top management has to ensure that the integrity of the quality system is maintained when changes are made to the system
  6. outsourced processes must be controlled as part of the quality system
  7. there must be evidence of top management commitment and continual improvement
  8. top management have to ensure that there are communication processes in place and that communication takes place regarding the effectiveness of the quality system
  9. when reviewing the effectiveness of the quality system, top management must look for opportunities for improvement and any need to change the quality policy and quality objectives
  10. when reviewing the operation of the quality system, outputs must include ways of improving the quality management system, ways of improving the product to better meet customer requirements, and changes to resource requirements
  11. the organisation must continually improve the quality system using the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review

So step five is to design, document, and implement processes to underpin continuous improvement.

Go for the full value-add

While you are doing these things to upgrade your quality system, why not go for the full value-add and also look at:

  • improving the structure and presentation of your documentation (fine-tuning it to user needs can make a huge difference)
  • putting your process reference information online; or if it is already online, lifting it to full professional standards (there many different online presentation strategies available so make sure you have the one that suits your organisation best)

A six step program: summary

So to get the most out of upgrading to ISO 9001:2000, carry out these six steps:

  1. cross-reference your existing reference documentation (policies, procedures, and performance support documents) to each part and section of the new standard, and check where detail changes need to be made to existing processes
  2. do a 'gap analysis' to see which areas of the business are not covered by the Standard but should be
  3. do a plan for integrating all your compliance requirements into a single compliance management system
  4. design, document and implement processes to underpin customer focussing activity
  5. design, document, and implement processes to underpin continuous improvement
  6. go for the full value-add by reviewing the structure, presentation, and delivery of your documentation

Further help

These older articles may also be of interest:

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Additional keyword: ISO9000:2000

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