a transition to iso 17065 a transition case: history out with the old in with the new susan holman...

A Transition to ISO 17065

A Transition Case: History

Out with the OldIn with the New

Susan HolmanFinancial & HR Manager/Quality Assurance

RepresentativeAmerican Certification Body, Inc.


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


Overview

• A Quick Overview of ACB• Audit Schedule• Process

• Assess Priorities• Focus resources• Track

• Critical concerns for ACB• Goal: Zero Corrective Actions : )


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.


American Certification Body, Inc.


Process

• Assess Priorities• Focus Resources• Track Progress• Prepare for Audit


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?


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.


• Chapter Sections• Critical Parameters• Needs

ISO 17065 Major Provisions


• Chapter Sections taken from the Table of Contents



Step 1 (from TOC)List each section of the standard

Self-Analyze Critical Parts of ISO 17065


• Critical Parameters – what should be addressed first?



Step 2Assign each step a priority 1-5 (1 most critical)

Rank Critical Items


Focus Resources

Focus Resources

What needs to be done, and when?

Who will do the work?


Focus resources

Step 3Re-sort on priority, then assign


• Needs – once priorities are established, assign each task and indicate a due date for review.



Track

Step 4Track Status and assign Due date (work in

progress)


Internal Audit Schedule under G65


Internal Audit Schedule for G17065


Internal Audit Schedule-2014


Audit Schedule – Disclaimer the small print


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



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



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.



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.



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 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)



More information on changes from Guide 65, see CASCO website:

www.iso.org/iso/ppt_presentation_17065.ppt

(ref. ANSI training course, November 2013)

http://www.iso.org/iso/ppt_presentation_17065.ppt


• 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.

References & Tools


QUESTIONS?IONS


THANK YOU!Susan Holman

[email protected] 847-4700

Mike [email protected]

Mobile: 240 401-1388

mailto:[email protected]

mailto:[email protected]

a transition to iso 17065 a transition case: history out with the old in with the new susan holman...

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