Presentation on theme: "Establishing a New Accreditation Program in the U.S."— Presentation transcript:
1 Establishing a New Accreditation Program in the U.S. Marlene MooreAdvanced 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 competenceRegulators want integrity, impartiality and competenceExpect accreditation to assure confidence in data generatedLaw requires accreditation or assurance of conformanceConformity 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
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 organizationStandards, Criteria or Protocol developer to ensure information is understood by AB and CABAccreditation Body (AB) to ensure program can be adopted by the AB and ensure interpretations are consistentConformity Assessment Body (CAB) to ensure program can be implemented by the CAB and ensure interpretations are meaningfulLead organization to administer, handle appeals, and coordinate efforts of all parties
5 What does it take? Opportunity Cooperation Understanding CABs want to be accreditedOrganizations that want CABs to be accreditedCooperationAll parties participating openingTransparency (No this is not the President talking)UnderstandingProcess improvementWon’t be perfect first time outDemonstration of consistency of implementation
6 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
7 Criteria, Standards, Protocol By what ever nameFounded on base ISO standard – e.g.; ISO/IEC 17025Develop through consensusBest to ensure transparency and input into the criteriaScientifically SoundEnsures objectivityMust 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
8 Program Goals Implement a national program that is consistent Build 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 programEstablish adoption and formal acceptance of the programContracts, regulation, specification, etc.Develop government acceptance of programProvide input to standards or criteria developer for improvements
9 Program ObjectivesEvaluation of ABs to meet, implement and understand the criteria, standards or protocols.Peer review process using documented proceduresLead organization objective review and assurance of consistent implementation by ABsAllow input from all parties into AB evaluation and lead organization process – Transparency of operationsUser, specifier and public support of program due to quality of the program’s implementationEnsure input into the criteria, standards by everyone including: CABs, ABs and Users
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 tasksAccreditation BodyAuthoritative body that performs accreditationConformity Assessment BodyBody that performs conformity assessment services and that can be the object of accreditation.
12 Definition (not ISO/IEC 17000) AssessmentProcess 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
13 Design Input Identify impartiality and conflict of interest issues Define scope of accreditationDevelop process steps to achieve accreditationApplicationSite visitsSampling processDefine needs of users or specifiersIndustry specific competency assessment criteriaDetermine limitations from ABs and CABsContractual, financial and liability requirements
14 Requirements Adopt process to define requirements Develop AB criteria for accreditationDetermine status of CAB community to meet requirementsDevelop and approve procedures for operationCommunication of the requirements
15 Resources Identify assessors and technical experts Number and qualificationsTraining on operational procedures of ABInitial and on-goingIdentify advisory or stakeholder committeeOther staff and operational needs to meet program needs
16 Implement Program Announcement of launch of Pilot Applications received by ABsMay include a preliminary review prior to acceptanceABs review applications for completenessABs determine if application complete and within scope of programABs process complete application following ISO/IEC 17011Document reviewOn-site assessment with witness of performanceNon-conformances identified, if anyResolution of Non-conformances
17 Implement Program Committee reviews information Committee makes decision on Accreditation or other processLetter sent to CABAcceptance, Rejection or More InformationFor PilotAnnounce first group of accredited CABsContinue program, if accepted by all partiesRevise procedures and adopt to improve programSurveillance and ReassessmentOn-going review and improvements to program
18 Timeline Define program cycle Define timeframe for pilot 2 years, 5 years or other – See ISO/IEC 17011Surveillance yearsWitness assessmentsTime 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!!!
19 Pilot Program Start with Pilot Program Determines if procedures and processes workDefine Timeframe or Trial PeriodMeet with all partiesConsistent and constant communication needsKeep it simpleRemember application information will not be perfectHow do you select applications?When will applicants be accredited?When perfect?!?Revise Program elements after Pilot
20 Implement Program Revise Improve Update Based on inputBased on changes to requirementsBased on complaints, appeals, disputesHave process for emergency changes – Policy or Memos issuedImproveReview procedures and administration processes as necessaryUpdateObtain input from all parties – on goingCommunicate Changes to all partiesNewsletters, announcements, formal letters, etc.