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 17065
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
A Transition to ISO 17065
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 17065
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 17065
American Certification Body, Inc.
A Transition to ISO 17065
Process
•
•
•
•
Assess Priorities
Focus Resources
Track Progress
Prepare for Audit
A Transition to ISO 17065
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?
A Transition to ISO 17065
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.
A Transition to ISO 17065
ISO 17065 Major Provisions
• Chapter Sections
• Critical Parameters
• Needs
A Transition to ISO 17065
ISO 17065 Major Provisions
• Chapter Sections taken from the Table of
Contents
A Transition to ISO 17065
Self-Analyze Critical Parts of ISO 17065
Step 1 (from TOC)
List each section of the standard
A Transition to ISO 17065
ISO 17065 Major Provisions
• Critical Parameters – what should be
addressed first?
A Transition to ISO 17065
Rank Critical Items
Step 2
Assign each step a priority 1-5 (1 most critical)
A Transition to ISO 17065
Focus Resources
Focus Resources
What needs to be done, and when?
Who will do the work?
A Transition to ISO 17065
Focus resources
Step 3
Re-sort on priority, then assign
A Transition to ISO 17065
ISO 17065 Major Provisions
• Needs – once priorities are established,
assign each task and indicate a due date for
review.
A Transition to ISO 17065
Track
Step 4
Track Status and assign Due date (work in
progress)
A Transition to ISO 17065
Internal Audit Schedule under G65
A Transition to ISO 17065
Internal Audit Schedule for G17065
A Transition to ISO 17065
Internal Audit Schedule-2014
A Transition to ISO 17065
Audit Schedule – Disclaimer
A Transition to ISO 17065
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
A Transition to ISO 17065
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
A Transition to ISO 17065
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 17065
Critical concerns for ACB
ize
S
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.
A Transition to ISO 17065
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 17065
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 17065
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)
A Transition to ISO 17065
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.
A Transition to ISO 17065
QUESTIONS?IONS
A Transition to ISO 17065
THANK YOU!
Susan Holman
susan@acbcert.com
703 847-4700
Mike Violette
mikev@acbcert.com
Mobile: 240 401-1388
A Transition to ISO 17065