ISO 17021:2006 for Certification Bodies

Performance Improvement Solutions for Your Business Needs November 2006
In this issue

  • ISO 17021:2006 for Certification Bodies
  • What are Layered Audits?
  • ISO/TS16949 Customer Specific Requirements
  • TL9000 Handbook
  • Tips for Selecting a Certification Body
  • Greetings!

    Welcome to Sustaining Edge Solutions E- Newsletter

    Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 14001, and others. This includes process improvement methods Six Sigma, lean enterprise, and other topics of interest to our readers.

    If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.

    Thanks for your support!

    ISO 17021:2006 for Certification Bodies

    The recently released ISO 17021:2006 standard is expected to increase confidence in management system certification.

    Hundreds of thousands of organizations worldwide, their customers, consumers, and regulatory authorities stand to benefit from ISO 17021, Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems. The new standard places rigorous requirements for competence and impartiality on the bodies that offer audits and certification to standards like ISO 9001:2000 (quality management) and ISO 14001:2004 (environmental management).

    ISO 17021 has a huge potential impact since some 888,000 organizations in 161 countries are independently certified to ISO 9001:2000 and/or ISO 14001:2004.

    ISO 17021 has been designed as the single source of internationally harmonized requirements for certification bodies and their activities, not only in relation to ISO 9001:2000 and ISO 14001:2004, but also to new management standards for food safety (ISO 22000), information security (ISO 27001), and supply chain security (ISO 28000), as well as, to others that may be developed.

    Replacing and improving on two ISO Guides (62 and 66), ISO 17021 distills an international consensus on the latest in good practice. In addition, it incorporates guidance developed by the International Accreditation Forum (IAF), an international association of accreditation bodies.

    Requirements for impartiality include the following: demonstration by the top management of certification bodies of the need to avoid conflicts of interest between certification and consultancy, training and internal auditing services; the marketing of certification services; and the subcontracting of audits.

    The certification body is required to set up a committee for safeguarding impartiality. The standard envisages that such a committee could include representatives of clients of the certification body, customers of these clients, trade associations, regulatory bodies, governmental and nongovernmental organizations, and consumer associations.

    Additionally, the certification body is required to implement a management system to ensure its conformity to ISO 17021:2006.

    This standard is now available from the ANSI eStandards Store

    What are Layered Audits?

    What are layered audits? They are a system of audits performed by multiple levels of management, from supervisors up to top management. The intent is to frequently audit key process characteristics to verify process conformity.

    Layered audits have proved so valuable, DaimlerChrysler requires their suppliers of production parts and components to conduct these audits on all manufacturing and assembly lines. The purpose is to ensure ongoing conformity, thereby improving process stability and first-time through capability.

    There are two types of layered audits: 1) Process Control audits and 2) Error and Mistake Proofing Verification audits. Supervisors conduct process control audits once per shift. Plant management performs process control audits once per week. Delegation of this responsibility is not acceptable except in unusual circumstances.

    Error and mistake proofing verification audits are conducted once per shift by qualified employees. Set- up and maintenance personnel, as well as, quality auditors, are typically viewed as qualified. Layered audits consider multiple topics, for example documentation, process parameters, product quality, safety, and housekeeping. And, it is expected that people audit their own work and that their managers audit that work.

    For more information on DaimlerChrysler’s requirements for Layered Audits, Contact Us.

    ISO/TS16949 Customer Specific Requirements

    Organizations seeking or maintaining ISO/TS 16949 certification are required to comply with the Customer Specific Requirements (CSR) for all of their customers that subscribe to ISO/TS 16949.

    A central repository for ISO/TS 16949-related CSR is being set up on the Automotive Industry Action Group (AIAG) web site. The AIAG web page will be a resource for subscribing organizations to post links to their customer specific requirements for ISO/TS 16949. Using this newly established repository will ensure the current revision is available and communicated to suppliers and auditiors.

    To date, Delphi, Visteon, and Timken have established links on the AIAG web site for their ISO/TS 16949 customer specific requirements. To view the repository, go to the AIAG web page and look at the links within the ISO/TS 16949 section.

    TL9000 Handbook

    The new TL 9000 Quality Management System (QMS) Requirements Handbook, Release 4.0, must be used for all audits after June 30, 2007. Auditors must have delta training before conducting a third party audit to R4.0.

    Summary of Changes

    • ISO 9001:2000 Base Remains Unchanged
    • 30% of Adders Remain Unchanged
    • 30% of Adders have Minor Changes
    • 40% of Adders have Major Changes or are New

    These requirements designed to:

    • Ensure intended results instead of specifying methods of doing
    • Emphasize design process quality measurements
    • Add required testing (regression, document verification, stress, abnormal condition, and system), and
    • Broaden the scope of certain requirements, e.g., from software only to common or, hardware and software

    A companion document is the TL 9000 Measurements Handbook (Release 3.5). It is a comprehensive guide to measurements processing, usage, responsibilities, and requirements. This book defines the minimum set of performance measurements to assess progress and evaluate results of quality management system implementation. It identifies performance measurements that are key in the telecom industry which are Common Measurements, Outage Measurements, Hardware Measurements, Software Measurements, and Service Quality Measurements.

    Order the Handbook

    Tips for Selecting a Certification Body

    Did you notice the title of this article refers to “Certification Body” instead of “Registrar”? The new ANAB web site uses Certification Bodies (CBs) like the rest of the world, not Registrars as previously used by the RAB. This terminology change took place when the ANSI-RAB National Accreditation Board became the ANSI-ASQ National Accreditation Board (ANAB).

    As with most of life’s major purchases, it pays to shop around for an ISO 9001 or ISO 14001 certification body (CB). Investigate, ask for and check references, and request the resumes of the CB’s proposed audit team. You’re the customer and the CB provides a service to you. Make sure you get what you pay for, but don’t let price alone be the deciding factor. Look for added value.

    Things to consider when selecting a CB:

    • Accreditation by a reputable body
    • Industry experience, background, and expertise
    • For ISO 9001 CBs, approval to work in the appropriate scope category
    • Recommendations from your clients or customers
    • References provided by the CB
    • Scheduling issues and ability to meet your time frame
    • All aspects of the CB’s fee schedule
    • Your comfort level in establishing a long term relationship with a CB

    Quick Links

  • Our Services
  • ISO 9001:2000 Quick Menu
  • Lean Six Sigma
  • Training Courses
  • Newsletter Archive
  • Comments are closed.