Preparing for a 17025 Initial Assessment

1. Preparing for a 17025 Initial Assessment Douglas Berg, Testing Program Manager, Perry Johnson Laboratory Accreditation, Inc. (PJLA) March 11, 2015

2. First …. Thank You

3. What is an “Assessment” • It is a process to determine or evaluate the technical competence of a laboratory: testing, calibration, reference material producer, inspection, etc. • ISO/IEC 17025:2005 – Testing, Calibration • ISO/IEC Guide 34:2009 – Reference Material Producers • ISO 17020:2012 – Inspection Bodies • ISO 15189:20012 – Medical Laboratories

4. About PJLA • Private accreditation body that accredits testing and calibration laboratories, reference material producers, and field sampling organizations to International and National Standards (i.e. ISO/IEC 17025, ISO Guide 34 DoD ELAP, TNI NEFAP) • Operating since 1999 • Located in Troy, MI • Over 700 Accredited Organizations • Also offer training sessions (free webinars, public training and on-site training • Obtain international approvals to accredit organizations by (ILAC and APLAC)

5. Application for Accreditation (Tests, Methods, Equipment, Detection limits, Technicians, Sites) Accreditation Process Documentation Review (Quality Manual, Technical Procedures, Proficiency Tests) On-Site Assessment (Review of quality system and technical requirements (technicians, equipment, environmental conditions, records, traceability, measurement uncertainty data, proficiency testing) All tests and elements of the standard assessed. Post Assessment Activities Nonconformances issued after the assessment/labs have 60 days to submit corrective action (including root cause and objective evidence)

6. Final Review/Accreditation Decision All paperwork including report, nonconformites, checklists etc. are reviewed by an independent review committee to grant or deny accreditation (typically completed 2-4 weeks after CA submission) Certificate Issuance Upon a favorable review by accreditation decision committee; includes test field, tests performed, method, equipment used and detection limit as applicable; published on PJLA website Surveillance Assessments Conducted on-site 1 year from the initial accreditation assessment; Ensure labs are maintaining accreditation-proficiency testing, internal audits, management review, complaints, corrective actions, assessment of the lab for a portion of the scope Reassessments 2 Years from the initial accreditation-similar to the initial accreditation (full scope assessed, all elements of the standard, accreditation review process and updated certificate) Accreditation Process

7. Options Prior to Initial Assessment • Some labs may choose to have a preassessment before initial assessment • It is distinct and separate from the initial assessment • It is not part of the assessment/accreditation process • It is not required • It is not “consulting” • It is not “auditing/assessing” into “compliance” • It does not obligate the organization pre-assessed • It is an exposure to the overall on-site assessment process – notification/agenda, opening, assessing, evidence, documenting, reporting, closing, etc. • It is a shorter (1 day of on-site time typically) activity • It is an an evaluation and indication of an organization’s readiness to proceed • It is a ”no” /“low” risk activity

8. Options Prior to Initial Assessment-Preassessment Cont’d –What We Do • Review of documentation • “Policy” and “Procedure” (“intents”/”purpose”/”what” and “how/who/when/etc” • Looks at requirements organizations miss in ISO requirements and the Accrediting Body’s (AB) Policies and Operating Procedures applicable to the organization or Conformity Assessment Body (CAB) • Look at records, how they are organized and kept • A report – much like/same as an assessment report • A list/identification of findings that is potential deficiencies/non-conformities and/or observations relative to: • The CAB/organization does not need to respond to the “findings”

9. Common Findings • Did not have/read a copy of ISO/IEC 17025 –OK this happened once – but had to mention it • Roles and responsibilities of Technical Management and Quality Manager not defined • Documents of external origin not identified or controlled: standards, rules/regulations, AB policies, etc. • A master list of controlled documents does not exist

10. Common Findings • Subcontractors not identified, qualified, or evidence of qualification not available • Suppliers not identified/listed, qualified, or evidence of qualification not available • Customer feedback not being sought • No policy, procedure, records for “complaints” • Non-conforming tests/calibrations/materials not handled or documented (resolution) • Corrective actions – no root cause or follow up

11. Common Findings • No preventive actions – potential problems/needed improvements • Records not identified, retention times not defined • Changes to records – “obliterations” noted • Technical records not identified per requirements – also items “recorded”, “a record made”, “defined”, “plans”, “lists: etc. – not in “records” • A complete round of internal audits not done (needed before the assessment) – internal audit plan, procedure does not exist - -must address all elements

12. Common Findings • A management review not done (needed before the assessment) – a schedule and procedure does not exist (can be part of other meetings …) • Current reports (remember they are not accredited yet) do not meet the requirements of ISO/IEC section 5.10, ISO Guide 31 (reference materials), or the AB policies for traceability and/or uncertainty – for accredited reports/certificates

13. Common Findings • A procedure for the estimation of uncertainty does not exist or has not been applied • Internal calibrations do not meet the requirements for traceability (incl. uncertainty) expressed in ISO/IEC 17025 and the AB policies • No procedure for the use/non-use of of the AB symbol or other recognition body symbols/marks

14. Common Findings • Not having at least one acceptable proficiency testing activity completed before the initial assessment • Not having 4 year proficiency plan spanning the scope prepared before the initial assessment • Calibration sources that do not comply with requirements of ISO/IEC 17025 etc. or the AB traceability policy (driven by ILAC policies)

15. Other Findings • No arrangements to ensure personnel are free from undue external and internal financial, commercial and other pressures • No procedures to ensure and protect customer’s confidential information • Quality objectives not defined (linked to Management Review) • Other requirements

16. How Many Findings? • Typically it is in the range of 10 to 20 findings • The largest has been 54 findings !! (2 assessors) – an initial assessment turned into a pre-assessment (this is allowed in PJLA procedures if an initial assessment with no previous pre-assessment has significant issues)

17. QUESTIONS?? & CONTACT INFO Doug Berg, dberg@pjlabs.com or Tracy Szerszen- tszerszen@pjlabs.com Perry Johnson Laboratory Accreditation, Inc. 755 West Big Beaver Rd, Troy, MI 48084 Tel: (248) 519-2603www.pjlabs.com Thank you!!