1. Preparing for Accreditation and the Pre-Assessment Options

2. Background A2LA is  non-profit  non-governmental  independent third party 2,700 Accreditations granted

3. Evaluation of a conformity assessment body to determine technical competence ISO/IEC 17025:2005 and ISO 15189:2012 Management system requirements Technical requirements - competency Used by labs to manage and operate systems Used by accreditation bodies domestically and internationally to evaluate labs Quick Review-Accreditation

4. ISO Standards Uses general terms enabling it to be applied broadly  Adapts to specific program requirements (AOAC) Commercial, governmental and in-house laboratories Laboratories performing routine testing or R&D Large and small laboratories For accreditation purposes tied to a Scope of testing

5. ISO standard approach Empowers laboratory personnel Improves lab productivity and efficiency Reduces need for constant technical oversight Creates synergy between laboratory management and technical staff Provides credibility to outside parties, and international recognition if accredited

6. Accreditation Cycle 2 Year Cycle  Optional pre-assessment  Full initial assessment (first year)  Surveillance assessment (second year)  Renewal assessment (third year)  Annual review (fourth year an off-site review)

7. Preparing for Accreditation Obtain relevant ISO Standard(s) Become familiar with Accreditation Body (AB) website, requirements, policies and website tools Obtain relevant assessor checklists Identify the person in charge of the management system (usually the quality manager) Conduct internal audits to determine gaps or weaknesses and conduct a management review

8. Assessor proposals AB Staff reviews completed application and draft Scope of Accreditation Identifies an assessor or assessment team based on technologies, breadth of disciplines and number of personnel AB proposes assessor or team to the lab AB proposes assignment to the assessor/assessment team Target time is to have agreement within 2 weeks of receiving the application.

9. Assessor preparations Conducts a prior document review of quality manual and supporting procedures  This is to establish notes and questions  Determine readiness of the laboratory  It saves on valuable on-site time  On-site time can focus on record/data review, interviews with staff, observing tests  Prior document review report goes to laboratory

10. Pre-assessment option Planned Pre-Assessment  Lab applies for accreditation and requests a pre-assessment  Lab applies and assessor conducts a prior document review and determines that there are significant gaps or errors in the quality manual and SOPs

11. Planned Pre-Assessment Features Both will involve one assessor Pre-Assessment typically is one day on-site Ideally occurs after the laboratory conducts a gap analysis and internal audit during accreditation preparation Offers one last look or practice before the actual full, initial assessment

12. Pre-Assessment Features cont. The assessor  Explains the requirements  Reviews the status of the lab’s preparations  Points out omissions  Responds to the organization’s suggestions on bringing deficiencies cited into compliance  Does not assist in writing procedures or policies

13. Pre-Assessment-Technical review A general review may be conducted of the organization’s technical capability as part of the walk through of the operations This may include testing accommodations, environment, log books, etc. Focus of pre-assessment is heavily weighted to management system requirements not technical competence

14. Unplanned Pre-Assessment Assessor stops work on an initial assessment due to major findings or a significant number of findings Assessor calls A2LA headquarters to inform/discuss Assessor recommends to laboratory that the initial assessment be converted to pre-assessment Lab decides on path to take If laboratory opts for a pre-assessment, then the planned pre- assessment unfolds

15. Unplanned Pre-Assessment cont. If laboratory opts not to convert the initial full assessment to a pre- assessment despite a looming disaster:  Full, initial assessment continues  Lab must respond and resolve all findings timely  Follow up assessment may be required to determine compliance

16. Pre-Assessment Deliverables Assessor leaves a list of issues and concerns identified either as a short narrative report or partially completed assessor checklist

17. It pays to prepare…and we have the tools to help  Staff  Website  Training

18. Summary Pre-Assessment or Not?  Preparations and support  Conduct extensive internal audits  Customer’s requirements

19. Resources Randy Querry contact info: rquerry@A2LA.org / 301-644-3221rquerry@A2LA.org www.A2LA.org 3 Sources to obtain the ISO standards:  http://global.ihs.com/search_res.cfm?currency_code=USD&cust omer_id=21254020200A&oshid=21254020200A&shopping_cart _id=21254020200A&country_code=US&lang_code=ENGL http://global.ihs.com/search_res.cfm?currency_code=USD&cust omer_id=21254020200A&oshid=21254020200A&shopping_cart _id=21254020200A&country_code=US&lang_code=ENGL  http://webstore.ansi.org/?source=google&adgroup=ansi_standar ds&gclid=CJKDn7_hjb0CFU4aOgodeQoA5g http://webstore.ansi.org/?source=google&adgroup=ansi_standar ds&gclid=CJKDn7_hjb0CFU4aOgodeQoA5g  http://asq.org/index.aspx http://asq.org/index.aspx