What has changed in ISO 9001:2008?

Here's a summary of the changes to ISO 9001 in 2008.

1. There are no new requirements in this version. This is significant, because a 'requirement' is something you must do.
2. All the changes are minor. They consist of changes of wording: clarifications and modifications to words or phrases and a few extra notes or examples (see below). Most are small additions or changes, with a few deletions.
   The intent is to make the meaning of a requirement clearer, to improve compatibility with ISO 14001 and/or assist translation to other languages.
3. The new version was published in mid-November 2008.
4. From that date, for a new certification you can choose certification to the 2000 or 2008 version.
5. After one year (from Nov 2008) all recertifications/new certifications will be to the 2008 version. Two years later, certifications to the 2000 version will no longer be valid.

Some examples of the changes, with clause numbers are:

4.2.1: modified to clarify that a single document can cover requirements for one or more procedures (eg, combine requirements for corrective action & preventive action into 1 procedure, or cover 'nonconformity' within another procedure rather than having a separate one)

6.4 Now clarifies what 'work environment' includes, and gives examples such as noise, temperature, humidity

8.2.1 Note added with some ideas on how customer satisfaction can be measured.

General advice: Get a copy of the new version, study the changes, and think about how (or if) the changes affect your system. Note, for example, the advice that you can address multiple requirements in a single procedure (we already have). Notice how the Standard has made it very clear that if you subcontract any part of your service or product out, this doesn't in any way remove or alter your responsibility to meet your customers' requirements.

ISO publishes new edition of ISO 9001 quality management system standard

ISO published ISO 9001:2008, the latest edition of the International Standard used by organizations in 175 countries as the framework for their quality management systems (QMS).

ISO 9001:2008, Quality management system – Requirements, is the fourth edition of the standard first published in 1987 and which has become the global benchmark for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.

ISO 9001:2008 contains no new requirements compared to the 2000 edition, which it replaces. It provides clarifications to the existing requirements of ISO 9001:2000 based on eight years’ experience of implementing the standard worldwide and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.

All ISO standards – currently more than 17 400 – are periodically reviewed. Several factors combine to render a standard out of date, such as technological evolution, new methods and materials, new quality and safety requirements, or questions of interpretation and application. To take account of such factors and to ensure that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to confirm, withdraw or revise the documents.

ISO/TC 176, which is responsible for the ISO 9000 family, unites expertise from 80 participating countries and 19 international or regional organizations, plus other technical committees. The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176.

This review has benefited from a number of inputs, including the following: a justification study against the criteria of ISO Guide 72:2001, Guidelines for the justification and development of management system standards; feedback from the ISO/TC 176 interpretations process; a two-year systematic review of ISO 9001:2000 within ISO/TC 176/SC2; a worldwide user survey carried out by ISO/TC 176/SC 2, and further data from national surveys.

ISO Secretary-General Alan Bryden commented: “The revised ISO 9001 results from a structured process giving weight to the needs of users and to the likely impacts and benefits of the revisions. ISO 9001:2008 is therefore the outcome of a rigorous examination confirming its fitness for use as the international benchmark for quality management.”

ISO/TC 176/SC 2 has also developed an introduction and support package of documents explaining what the differences are between ISO 9001:2008 and the year 2000 version, why and what they mean for users. These documents are available on the ISO Web site.

Although certification of conformity to ISO 9001 is not a requirement of the standard, it is frequently used in both public and private sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts. Up to the end of December 2007, at least 951 486 ISO 9001:2000 certificates had been issued in 175 countries and economies.


ISO (which does not itself carry out certification) and the International Accreditation Forum (IAF) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008. The details of the plan are given in a joint communiqué by the two organizations which is available on the ISO Web site.
ISO 9001:2008, Quality management system – Requirements, costs 114 Swiss francs and is available from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department.