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