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ISO 9001:2008 Quality Management Systems

The ISO 9001:2008 Quality Management Systems - Requirements standard has been published by the International Organization for Standardization (ISO). This version of the standard clarifies existing requirements related to outsourcing, personnel competencies, work environment, and identification & traceability. An appendix to the standard identifies all revisions.

The International Accreditation Forum (IAF) has determined that accredited registrars (organizations who issue ISO certificates) will have one year to transition to the new ISO 9001:2008. Organizations holding ISO 9001:2000 certificates must upgrade to ISO 9001:2008 by October 2010. The upgrade to ISO 9001:2008 may occur during a regularly surveillance audit or renewal audit.  

On November 15, 2008, the International Organization for Standardization (ISO) also published the significantly enhanced companion guidelines: ISO 9004:2008 Managing for Sustainability - A Quality Management Approach. 

ISO 9001 is the most widely used quality management standard with nearly one million certificates issued worldwide.

Orion Canada client AMITA Corporation was the first in North America to be registered by an accredited registrar to ISO 9001:2000 (registered on December 15, 2000, see press release)! 

Minimize your effort in complying to ISO 9001. Orion Canada Inc. will get your quality system compliant to the international standard for good management quickly and painlessly ... after all, you are not in business to learn new standards! Also ask us about our workshops on the changes to the new standard.

The Highlights

  • ISO 9001:2000 was the most anticipated international standard in history.
  • The ISO 9001:2008 standard is a minor update which clarifies terminology but adds no new requirements to the standard
  • ISO 9001:2008 has five broad categories of quality management: 
      1) Quality Management System
      2) Management Responsibility,
      3) Resource Management,
      4) Process Management
      5) Measurement, Analysis and
           Improvement. 
  • The standard only requires six procedures, although most quality systems have more than the specified minimum. Orion Canada specializes in lean and efficient quality systems. 
  • The quality management standard represents the accepted minimum requirements for a well managed organization. However, the generic standard does not prescribe how to comply with its requirements. Orion Canada specializes in designing management systems that not only comply with industry best practices, but that deliver significant bottom-line contributions in terms of improved effectiveness, better efficiency and high rates of customer satisfaction. 
  • The Quality Management Process Model upon which the ISO 9001:2008 is based is provided below.

  • Transition Planning Guidance for ISO 9001:2008 is available from the ISO 9000 Technical Committee ISO/TC 176/SC 2. Contact Orion Canada to learn more about their simplified process for upgrading to the new standard.
  • The Table of Contents from ISO 9001:2008 is listed below:

ISO 9001:2008 Table of Contents

Electronic copies of the ISO 9001:2000 standard may be ordered through the American Society for Quality. Below is the Table of Contents of the ISO 9001:2000 standard:

Contents

1 Scope
1.1 General
1.2 Application
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Annex A (informative) Correspondence between ISO 9001:2008 and ISO 14001:2004
Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008
Bibliography