Marlene MooreAdvanced Systems, Inc.

Establishing a New Accreditation Program in the

U.S.

OutlineWhy have an accreditation program?Who do you involve?What does it take?How do you establish?

Why have a Program?Users or Specifiers want competence to be assured

Expect accreditation to assure competenceRegulators want integrity, impartiality and

competence Expect accreditation to assure confidence in data

generatedLaw requires accreditation or assurance of conformance

Conformity Assessment Body wants to demonstrate acceptable performanceExpect accreditation to demonstrate to its clients that it

is dedicated to the demonstration of competency, impartiality, integrity and acceptable performance to meet client needs

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

What does it take?Opportunity

CABs want to be accreditedOrganizations that want CABs to be accredited

CooperationAll parties participating openingTransparency (No this is not the President talking)

UnderstandingProcess improvementWon’t be perfect first time out

Demonstration of consistency of implementation

How do you establish?Determine Criteria, Standards, Protocols –

By whatever nameDevelop Program GoalsDefine Program ObjectivesEstablish Operational ProceduresDefine Timeline for ProgramEstablish and Implement Pilot ProgramImplement Program

Criteria, Standards, ProtocolBy what ever name

Founded on base ISO standard – e.g.; ISO/IEC 17025Develop through consensus

Best to ensure transparency and input into the criteria

Scientifically SoundEnsures objectivity

Must not be based on the following:Police the private sectorbased on hearsayThat’s the way I want it – orThat’s the way it has always been done so it is right

Program GoalsImplement a national program that is consistentBuild recognition process among ABs to ensure

uniform implementation of requirementsWork with a lead organization to implement

recognitionDevelop or Revise lead organization procedures to

ensure national program Establish adoption and formal acceptance of the

programContracts, regulation, specification, etc.

Develop government acceptance of programProvide input to standards or criteria developer for

improvements

Program ObjectivesEvaluation 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

Operational ProceduresDefinitions

ISO/IEC 17000Specifier or RegulatorResolve Conflicts

Program DevelopmentDesign InputAccreditation RequirementsResourcesImplementation

Document Procedures

Definition Accreditation

Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks

Accreditation BodyAuthoritative body that performs accreditation

Conformity Assessment BodyBody that performs conformity assessment

services and that can be the object of accreditation.

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 accreditationNote: 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

Design InputIdentify impartiality and conflict of interest

issuesDefine scope of accreditationDevelop process steps to achieve accreditation

ApplicationSite visitsSampling process

Define needs of users or specifiersIndustry specific competency assessment criteria

Determine limitations from ABs and CABsContractual, financial and liability requirements

RequirementsAdopt process to define requirementsDevelop AB criteria for accreditationDetermine status of CAB community to

meet requirementsDevelop and approve procedures for

operationCommunication of the requirements

ResourcesIdentify assessors and technical experts

Number and qualificationsTraining on operational procedures of AB

Initial and on-goingIdentify advisory or stakeholder committee Other staff and operational needs to meet

program needs

Implement ProgramAnnouncement of launch of PilotApplications received by ABs

May include a preliminary review prior to acceptanceABs review applications for completeness

ABs determine if application complete and within scope of program

ABs process complete application following ISO/IEC 17011Document reviewOn-site assessment with witness of performanceNon-conformances identified, if anyResolution of Non-conformances

Implement ProgramCommittee reviews information Committee makes decision on Accreditation or

other processLetter sent to CAB

Acceptance, Rejection or More InformationFor Pilot

Announce first group of accredited CABsContinue program, if accepted by all partiesRevise procedures and adopt to improve program

Surveillance and ReassessmentOn-going review and improvements to program

TimelineDefine program cycle

2 years, 5 years or other – See ISO/IEC 17011Surveillance yearsWitness assessments Time frame for visits (6 months, annual, etc.)

Define timeframe for pilotShould never be less than 6 months.Give more time not less –

There will be problems – do not try to rush the process!!!

Pilot ProgramStart with Pilot Program

Determines if procedures and processes workDefine Timeframe or Trial PeriodMeet with all parties

Consistent and constant communication needsKeep 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

Implement ProgramRevise

Based on inputBased on changes to requirementsBased on complaints, appeals, disputes

Have process for emergency changes – Policy or Memos issued

ImproveReview procedures and administration processes as

necessaryUpdate

Obtain input from all parties – on goingCommunicate Changes to all parties

Newsletters, email announcements, formal letters, etc.

Questions

Thank You

Marlene MooreNewark, Delaware

mmoore!@advancedsys.com302 368 1211