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A Transition Case: History Out with the Old In with the New Susan Holman

A Transition Case: History Out with the Old In with the New Susan Holman Financial & HR Manager/Quality Assurance Representative American Certification Body, Inc. Objectives.

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A Transition Case: History Out with the Old In with the New Susan Holman

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  1. A Transition Case: History Out with the Old In with the New Susan Holman Financial & HR Manager/Quality Assurance Representative American Certification Body, Inc.

  2. Objectives • 1. To present the challenges of a small certification body operating under the FCC Telecommunication Certification Body program in regards to the conversion of the ACB quality system from ISO Guide 65 to ISO/IEC Guide 17065 • 2. To outline a plan to address gaps in the present system • 3. To demonstrate a plan to close gaps and become compliant with ISO/IEC Guide 17065

  3. Overview • A Quick Overview of ACB • Audit Schedule • Process • Assess Priorities • Focus resources • Track • Critical concerns for ACB • Goal: Zero Corrective Actions : )

  4. American Certification Body, Inc. • ACB, Inc. is a U.S.-based Telecommunication Certification Body (TCB) headquartered in McLean, Virginia, with offices in the U.K, Netherlands, Finland (ACB Europe), as well as Taipei, China and Hong Kong (ATCB HIL). • Technical staff has over 200 years combined experience in the EMC Field. • Foreign Certification Body (FCB) for both Canada and Japan, as well as a Notified Body (NB) for Europe. • Certification Body for ENERGY STAR® • Also has the resources to assist with other International Certifications.

  5. American Certification Body, Inc.

  6. Process • Assess Priorities • Focus Resources • Track Progress • Prepare for Audit

  7. Assess Priorities • Transition period: How much time do I have? • What are the major provisions of 17065 and how do they differ from G65? • What areas will need more time to complete? • Who can assist?

  8. Transition Period • Transition period established by ANSI Accreditation Committee during its November 27, 2012 meeting: all Certification Bodies should be accredited by ANSI no later than September 15, 2015 (same as IAF). • Must be assessed by May 2015. • Scheme owners (FCC, IC, EPA) may have other transition period policies.

  9. ISO 17065 Major Provisions • Chapter Sections • Critical Parameters • Needs

  10. ISO 17065 Major Provisions • Chapter Sections taken from the Table of Contents

  11. Self-Analyze Critical Parts of ISO 17065 • Step 1 (from TOC) • List each section of the standard

  12. ISO 17065 Major Provisions • Critical Parameters – what should be addressed first?

  13. Rank Critical Items • Step 2 • Assign each step a priority 1-5 (1 most critical)

  14. Focus Resources • Focus Resources • What needs to be done, and when? • Who will do the work?

  15. Focus resources • Step 3 • Re-sort on priority, then assign

  16. ISO 17065 Major Provisions • Needs – once priorities are established, assign each task and indicate a due date for review.

  17. Track • Step 4 • Track Status and assign Due date (work in progress)

  18. Internal Audit Schedule under G65

  19. Internal Audit Schedule for G17065

  20. Internal Audit Schedule-2014

  21. Audit Schedule – Disclaimer the small print

  22. Critical concerns for ACB • Maintaining Impartiality • Time and Staff resources • Size of Quality Manual • Scope of business • Changes to the standard used for the Quality System

  23. Critical concerns for ACB • Impartiality – in a small company, how is impartiality maintained? • 4.2.6 of ISO/IEC Guide 17065 states: The certification body and any part of the same legal entity and entities under its organizational control shall not: • d) offer or provide consultancy (see 3.2) to its clients. • Consultancy definition 3.2 a): participation in the designing, manufacturing, installing, maintaining or distributing of a certified product or a product to be certified

  24. Critical concerns for ACB • Allocation of Time and Staff resources • As a small company, our staff resources are limited. Most of our staff perform many functions, and it is important to make sure that each function is given appropriate time to complete in a timely manner.

  25. Critical concerns for ACB • Size of Quality Manual • As ACB has grown and added to our scope of accreditation, our Quality Manual has increased in size. • Conversion to ISO/IEC Guide 17065 affords where QM can be trimmed and made more manageable, without losing critical information.

  26. Critical concerns for ACB • Scope of business • In this global economy, growing our business to include other offerings is critical to survival. • Maintaining the Quality system properly is CRITICAL

  27. Critical concerns for ACB • A few changes from ISO/IEC Guide 65: • Restructured the standard • Revised terms and definitions • Improvement on impartiality requirements • Consolidation of management system requirements • Included IAF Guidance and interpretations • Referenced certification schemes • (ref. ANSI training course, November 2013)

  28. Critical concerns for ACB • More information on changes from Guide 65, see CASCO website: • www.iso.org/iso/ppt_presentation_17065.ppt • (ref. ANSI training course, November 2013)

  29. References & Tools • ISO/IEC Guide 65 • ISO/IEC Guide 17065 • ANSI Cross-Reference of ISO/IEC 17065 and ISO/IEC Guide 65 Excel sheet • FCC TCB Roles and Responsibilities • etc.

  30. QUESTIONS?IONS

  31. THANK YOU! • Susan Holman • susan@acbcert.com • 703 847-4700 • Mike Violette • mikev@acbcert.com • Mobile: 240 401-1388

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