Guidance modules on specific aspects of auditing ISO 9001:2000 quality management systems (QMS) are available free of charge from ISO and others are being developed. (The modules are available online only).
Short, easy to read and understand, the guidance modules that make up the "auditing kit" adopt a practical, "how to" approach. They have been developed mainly for certification body personnel carrying out audits of quality systems for organizations seeking an ISO 9001:2000 certificate as independent confirmation of their implementation of ISO's well-known standard.
However, they may also be useful to staff carrying out in-house audits to provide assurance to management about the performance of their organization's quality system, as well as to consultants, trainers and anyone with an interest in quality.
The guidance modules are not endorsed by ISO and are not a product of its standards-development processes. The documents are intended to provide additional assistance to ISO 9001:2000 users, without modifying any of the requirements of the standard.
The documents are being developed by the ISO 9001:2000 Auditing Practices Group (APG) established by ISO (International Organization for Standardization) and the IAF (International Accreditation Forum - www.iaf.nu) - the grouping of national accreditation bodies that verify the competence of certification bodies. The documents are available on the APG Web site at: http://www.iso.org/tc176/ISO9001AuditingPracticesGroup.
The documents so far developed by the APG address the following specific issues in ISO 9001:2000 auditing:
- The need for a two-stage approach to auditing
- Measuring QMS effectiveness and improvements
- Identification of processes
- Understanding the process approach
- Determination of the "where appropriate" processes
- Auditing the "where appropriate" requirements
- Demonstrating conformity to the standard
- Linking an audit of a particular task, activity or process to the overall system
- Auditing continual improvement
- Auditing a QMS which has minimum documentation
- How to audit top management processes
- The role and value of the audit checklist
- Scope of ISO 9001:2000, scope of QMS and defining scope of certification
- Value-added auditing
- Auditing competence and the effectiveness of actions taken
- Effective use of ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
- Auditing statutory and regulatory requirements
- Auditing quality policy and quality objectives
- Auditing the control of monitoring and measuring devices.
The APG recently agreed to develop additional documents on the following topics:
- Auditing customer satisfaction
- Writing nonconformities that are understandable, useful and therefore add value
- Reviewing responses to nonconformities to assure correction and corrective action that is effective.
A link to the documents on the APG Web site is provided too in the ISO 9000/ISO 14000 section on ISO's main Web site. This section also includes the latest versions of the free-of-charge documents comprising the ISO 9000:2000 Introduction and Support Package - another initiative by ISO to facilitate the understanding and implementation of its quality system standards. In addition, the section has a wide choice of free sample articles from ISO's bimonthly magazine ISO Management Systems, which provides a worldwide overview of the ISO 9000 and ISO 14000 families of quality and environmental management standards, including implementation case studies, survey, analyses, viewpoints and debates.