ISO 9001:2008 Support

Some of you may have used the ISO 9001:2000 Introduction and Support Package to ease the move to ISO 9001:2000. Well, the package has been revised at the ISO web site to reflect ISO 9001:2008 and may help you with the transition to ISO 9001:2008.

The package consists of the following seven guidance documents:

1. Guidance on ISO 9001:2008 sub-clause 1.2 “Application”

This document explains the concept of excluding an ISO 9001:2008 requirement from a quality management system, as well as, the need to include your justification in the quality manual. The guidance also includes ten examples to illustrate the reasoning used to determine which requirements of ISO 9001:2008 are applicable to an organization.

The examples are:

1. Customer property (personal data) controlled by a bank (7.5.4)
2. Exclusion of design and development by a contract manufacturer (7.3)
3. Regulators permit the exclusion of design and development (7.3)
4. Outsourced design and development activities (7.3)
5. Traceability of component parts (7.5.3)
6. Design of services (7.3)
7. Post-delivery activities (7.5.1)
8. Validation of processes (7.5.2)
9. Monitoring and measuring devices (7.6)
10. Complex organization – claim of conformity

2. Guidance on the documentation requirements of ISO 9001:2008

This part of the package starts with the basics; what is a document and what are the main benefits of documentation. The guidance also goes over the documentation requirements, including required documents, and other documents that may be needed for the effective planning, operation, and control of your processes.

The document provides guidance for organizations preparing to implement a QMS, as well as, for organizations adapting an existing QMS to ISO 9001:2008. The guidance discusses how to demonstrate conformity with the standard and lists all the required records.

3. Guide to the Terminology used in ISO 9001 and ISO 9004

This document provides a list of important words and terms used in ISO 9001:2008. The authors took great care during the development of ISO 9001 and ISO 9004 to use the correct English words and terms for readability and translation. The objective was to use simple technically accurate terms, and to the greatest extent possible, rely on common dictionary definitions. However, as with most technical subjects, there are terms with meanings that are different from common dictionary definitions.

4. Guidance on the concept and use of the process approach for management systems 

This document provides an understanding of the concepts, intent, and the application of the “process approach” to the ISO 9000 family of standards. The purpose of the process approach is to enhance an organization’s effectiveness and efficiency in achieving its defined objectives. For ISO 9001:2008, that means enhancing customer satisfaction by meeting requirements.

The guidance document defines a “process” and identifies the different types of processes. It also describes the steps to implement the process approach: identification, planning, implementation, measurement, analysis, corrective action, and improvement.

5. Guidance on ‘Outsourced processes’

This document provides guidance on the intent of ISO 9001:2008, clause 4.1, regarding the control of outsourced processes. It defines an “outsourced process” and describes the control of an outsourced process through the application of clauses 4.1 and 7.4.

6. Implementation guidance for ISO 9001:2008

This guidance was developed to help understand the issues that need to be considered during the co-existence period of ISO 9001:2000 and ISO 9001:2008. The new standard clarifies the existing requirements of ISO 9001:2000, as well as, improves compatibility with ISO 14001:2004.

ISO 9001:2008 does not introduce additional requirements, nor does it change the intent of the ISO 9001:2000 standard. The guidance document includes a background section on the ISO 9001:2008 revision process, plus an implementation timeline for the transition to ISO 9001:2008.