A Transition to ISO A Transition Case: History Out with the Old In with the New Susan Holman Financial & HR Manager/Quality Assurance Representative American Certification Body, Inc.
A Transition to ISO 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 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
A Transition to ISO Overview A Quick Overview of ACB Audit Schedule Process Assess Priorities Focus resources Track Critical concerns for ACB Goal: Zero Corrective Actions : )
A Transition to ISO 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.
A Transition to ISO American Certification Body, Inc.
A Transition to ISO Process Assess Priorities Focus Resources Track Progress Prepare for Audit
A Transition to ISO Assess Priorities Transition period: How much time do I have? What are the major provisions of and how do they differ from G65? What areas will need more time to complete? Who can assist?
A Transition to ISO 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 Scheme owners (FCC, IC, EPA) may have other transition period policies.
A Transition to ISO Chapter Sections Critical Parameters Needs ISO Major Provisions
A Transition to ISO Chapter Sections taken from the Table of Contents ISO Major Provisions
A Transition to ISO Step 1 (from TOC) List each section of the standard Self-Analyze Critical Parts of ISO 17065
A Transition to ISO Critical Parameters – what should be addressed first? ISO Major Provisions
A Transition to ISO Step 2 Assign each step a priority 1-5 (1 most critical) Rank Critical Items
A Transition to ISO Focus Resources What needs to be done, and when? Who will do the work?
A Transition to ISO Focus resources Step 3 Re-sort on priority, then assign
A Transition to ISO Needs – once priorities are established, assign each task and indicate a due date for review. ISO Major Provisions
A Transition to ISO Track Step 4 Track Status and assign Due date (work in progress)
A Transition to ISO Internal Audit Schedule under G65
A Transition to ISO Internal Audit Schedule for G17065
A Transition to ISO Internal Audit Schedule-2014
A Transition to ISO Audit Schedule – Disclaimer the small print
A Transition to ISO 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
A Transition to ISO Critical concerns for ACB Impartiality – in a small company, how is impartiality maintained? of ISO/IEC Guide 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
A Transition to ISO 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.
A Transition to ISO Critical concerns for ACB S i z e 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 affords where QM can be trimmed and made more manageable, without losing critical information.
A Transition to ISO 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
A Transition to ISO 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)
A Transition to ISO Critical concerns for ACB More information on changes from Guide 65, see CASCO website: (ref. ANSI training course, November 2013)
A Transition to ISO ISO/IEC Guide 65 ISO/IEC Guide ANSI Cross-Reference of ISO/IEC and ISO/IEC Guide 65 Excel sheet FCC TCB Roles and Responsibilities etc. References & Tools
A Transition to ISO QUESTIONS?IONS
A Transition to ISO THANK YOU! Susan Holman Mike Violette Mobile: