1. Establishing a New Accreditation Program in the U.S.
Marlene Moore
Advanced Systems, Inc.

2. Outline Why have an accreditation program? Who do you involve?
What does it take?
How do you establish?

3. Why have a Program? Users or Specifiers want competence to be assured
Expect accreditation to assure competence
Regulators want integrity, impartiality and competence
Expect accreditation to assure confidence in data generated
Law requires accreditation or assurance of conformance
Conformity Assessment Body wants to demonstrate acceptable performance
Expect accreditation to demonstrate to its clients that it is dedicated to the demonstration of competency, impartiality, integrity and acceptable performance to meet client needs

4. Who do you involve? Everyone – even if no interest…at first….
Data users or specifiers in need of a program to ensure that the data is generated by a technically competent organization
Standards, Criteria or Protocol developer to ensure information is understood by AB and CAB
Accreditation Body (AB) to ensure program can be adopted by the AB and ensure interpretations are consistent
Conformity Assessment Body (CAB) to ensure program can be implemented by the CAB and ensure interpretations are meaningful
Lead organization to administer, handle appeals, and coordinate efforts of all parties

5. What does it take? Opportunity Cooperation Understanding
CABs want to be accredited
Organizations that want CABs to be accredited
Cooperation
All parties participating opening
Transparency (No this is not the President talking)
Understanding
Process improvement
Won’t be perfect first time out
Demonstration of consistency of implementation

6. How do you establish? Determine Criteria, Standards, Protocols –
By whatever name
Develop Program Goals
Define Program Objectives
Establish Operational Procedures
Define Timeline for Program
Establish and Implement Pilot Program
Implement Program

7. Criteria, Standards, Protocol
By what ever name
Founded on base ISO standard – e.g.; ISO/IEC 17025
Develop through consensus
Best to ensure transparency and input into the criteria
Scientifically Sound
Ensures objectivity
Must not be based on the following:
Police the private sector
based on hearsay
That’s the way I want it – or
That’s the way it has always been done so it is right

8. Program Goals Implement a national program that is consistent
Build recognition process among ABs to ensure uniform implementation of requirements
Work with a lead organization to implement recognition
Develop or Revise lead organization procedures to ensure national program
Establish adoption and formal acceptance of the program
Contracts, regulation, specification, etc.
Develop government acceptance of program
Provide input to standards or criteria developer for improvements

9. Program Objectives
Evaluation of ABs to meet, implement and understand the criteria, standards or protocols.
Peer review process using documented procedures
Lead organization objective review and assurance of consistent implementation by ABs
Allow input from all parties into AB evaluation and lead organization process – Transparency of operations
User, specifier and public support of program due to quality of the program’s implementation
Ensure input into the criteria, standards by everyone including: CABs, ABs and Users

10. Operational Procedures
Definitions
ISO/IEC 17000
Specifier or Regulator
Resolve Conflicts
Program Development
Design Input
Accreditation Requirements
Resources
Implementation
Document Procedures

11. Definition Accreditation Accreditation Body Conformity Assessment Body
Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks
Accreditation Body
Authoritative body that performs accreditation
Conformity Assessment Body
Body that performs conformity assessment services and that can be the object of accreditation.

12. Definition (not ISO/IEC 17000)
Assessment
Process undertaken by an accreditation body to assess the competence of a conformity assessment body, based on particular standard(s) and/or other normative documents and for a defined scope of accreditation
Note: Assessing the competence of a conformity assessment body (CAB) involves assessing the competence of the entire operations of the CAB, including the competence of the personnel, the validity of the conformity assessment methodology and the validity of the conformity assessment results.
NOTE: This is not an Audit

13. Design Input Identify impartiality and conflict of interest issues
Define scope of accreditation
Develop process steps to achieve accreditation
Application
Site visits
Sampling process
Define needs of users or specifiers
Industry specific competency assessment criteria
Determine limitations from ABs and CABs
Contractual, financial and liability requirements

14. Requirements Adopt process to define requirements
Develop AB criteria for accreditation
Determine status of CAB community to meet requirements
Develop and approve procedures for operation
Communication of the requirements

15. Resources Identify assessors and technical experts
Number and qualifications
Training on operational procedures of AB
Initial and on-going
Identify advisory or stakeholder committee
Other staff and operational needs to meet program needs

16. Implement Program Announcement of launch of Pilot
Applications received by ABs
May include a preliminary review prior to acceptance
ABs review applications for completeness
ABs determine if application complete and within scope of program
ABs process complete application following ISO/IEC 17011
Document review
On-site assessment with witness of performance
Non-conformances identified, if any
Resolution of Non-conformances

17. Implement Program Committee reviews information
Committee makes decision on Accreditation or other process
Letter sent to CAB
Acceptance, Rejection or More Information
For Pilot
Announce first group of accredited CABs
Continue program, if accepted by all parties
Revise procedures and adopt to improve program
Surveillance and Reassessment
On-going review and improvements to program

18. Timeline Define program cycle Define timeframe for pilot
2 years, 5 years or other – See ISO/IEC 17011
Surveillance years
Witness assessments
Time frame for visits (6 months, annual, etc.)
Define timeframe for pilot
Should never be less than 6 months.
Give more time not less –
There will be problems – do not try to rush the process!!!

19. Pilot Program Start with Pilot Program
Determines if procedures and processes work
Define Timeframe or Trial Period
Meet with all parties
Consistent and constant communication needs
Keep it simple
Remember application information will not be perfect
How do you select applications?
When will applicants be accredited?
When perfect?!?
Revise Program elements after Pilot

20. Implement Program Revise Improve Update
Based on input
Based on changes to requirements
Based on complaints, appeals, disputes
Have process for emergency changes – Policy or Memos issued
Improve
Review procedures and administration processes as necessary
Update
Obtain input from all parties – on going
Communicate Changes to all parties
Newsletters, announcements, formal letters, etc.

21. Questions

22. Marlene Moore Newark, Delaware mmoore!@advancedsys.com 302 368 1211
Thank You
Marlene Moore Newark, Delaware