Last week I attended the 2023 A2LA Conference as an A2LA 17025 assessor. What a useful conference for accreditation assessors AND for lab personnel as well! Save the date for next year's conference April 21 - 24, 2024 in Denver, CO!
As a supporter of continuing education and training, this is just one of many useful conference & training events! Check out my Useful Links & Resources page for a list of upcoming conferences & training events.
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Here are the Top 10 ISO/IEC 17025 A2LA Assessment Deficiencies:
#10 A2LA R103 General Requirements for Proficiency Testing for ISO/IEC 17025 Labs: (PT5) "The documented (PT plan) shall include or be accompanied by a risk assessment of the level and frequency of the PT to be performed by the laboratory."
#10 Deficiency: Labs are missing inclusion of this Risk Assessment of the level & frequency of the PTs to be performed.
#9 ISO/IEC 17025:2017, Clause 7.1.3: "Decision rules for statements of conformity shall be defined and communicated and agreed with the customer."
#9 Deficiency: Labs making statements of conformity on test or calibration reports are not defining/communicating and gaining customer agreement before doing the work.
#8 ISO/IEC 17025:2017, Clause 6.6.2 (a through d): Procedures, actions, and records required for external providers of products and services that affect laboratory activities.
#8 Deficiency: Labs are especially missing procedures for and the records of on-going monitoring of external providers (of products and services).
#7 A2LA P102 Policy on Metrological Traceability (T1) External Calibration Service: For equipment and reference measurement standards that must be calibrated, the calibration shall be conducted by:
A calibration laboratory accredited to ISO/IEC 17025 by a mutually recognized Accreditation Body; or,
A National Metrology Institute (NMI) including designated institutes whose services are covered by the CIPM MRA; or,
A U.S. State Weights and Measures facility with a current certificate of measurement traceability. Please see http://www.NIST.gov for a copy of current certificates.
#7 Deficiency: Equipment & reference measurement standards that must be calibrated do not have calibration records that meet the requirements of A2LA P102 (T1).
#6 ISO/IEC 17025:2017, Clause 8.9.3 (a through d): Management Review Output requirements records.
#6 Deficiency: These required Management Review outputs are not recorded.
#5 ISO/IEC 17025:2017, Clause 7.8.2.1 (a through p): Requirements for calibration certificates and test reports.
#5 Deficiency: The most commonly cited deficiency is for 7.8.2.1.j) where the date of issue is missing on certificates & reports.
#4 ISO/IEC 17025:2017, Clause 6.2.5 (a through f): Procedures and Records for personnel competence, selection, training, supervision, authorization, and monitoring.
#4 Deficiency: Each of these subclauses (a through f) were cited about equally as often.
#3 ISO/IEC 17025:2017, Clause 6.4.6: Requirements for when measuring equipment shall be calibrated.
#3 Deficiency: The most commonly cited equipment as not calibrated are for reference standards (which are used to calibrate other equipment).
#2 A2LA R205 Specific Requirements - Calibration Laboratory Accreditation Program: 4.7.1
1) Every CMC uncertainty shall take into consideration the following standard contributors, even in cases where they are determined to be insignificant, and documentation of the consideration shall be made:
Repeatability (Type A)
Resolution
Reproducibility
Reference Measurement Standard Uncertainty
Reference Measurement Standard Stability
Environmental Factors
NOTE: It should be noted that scope components such as resolution, may also contribute to other components such as repeatability. Therefore, simply combining all components on an equal basis could result in an overstatement of the measurement uncertainty.
2) The CMC uncertainty shall also:
Include those significant contributors that apply to the measurement.
Include those significant contributors required by a method/procedure associated with the measurement.
#2 Deficiency: Measurement uncertainty budgets supporting calibration lab CMCs on their scope(s) of accreditation do not include consideration and documentation of the required components in A2LA R205, 4.7.1 sections 1) & 2).
Aaaaaaand the #1 ISO/IEC 17025 A2LA Assessment Deficiency is........
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#1 ISO/IEC 17025:2017, Clause 8.9.2 (a through o): Management Review inputs requirements records.
#1 Deficiency: The most commonly cited deficiency is for 8.9.2 m) Risk Identification.
Whew! That's quite a list! You may be wondering what to do with this information. Here's where to start:
Review your procedures and records.
Perform a comprehensive internal audit.
Perform Corrective Actions for the identified deficiencies.
Evaluate the effectiveness of your corrective actions.
Celebrate your successes and improvements!
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OTHER HELPFUL REFERENCES:
Order your signed copy of the ASQ Metrology Handbook, 3rd Ed
Download your free copy of the Demystifying ISO/IEC 17025 ebook
Still need help or would you like an outside set of eyes to perform your internal audit?