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. Accreditation Process
Application for Accreditation
(Tests, Methods, Equipment, Detection limits, Technicians, Sites)
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. Accreditation Process
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)

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 –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 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 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, or Tracy Szerszen- Perry Johnson Laboratory Accreditation, Inc. 755 West Big Beaver Rd, Troy, MI Tel: (248) Thank you!!