ISO/IEC 17025:2005 Audit Checklist

ISO/IEC 17025 provides laboratories with an opportunity to demonstrate they operate efficiently and produce reliable test and calibration results, increasing customer confidence in test and calibration data provided. In addition, results generated can now be accepted worldwide.

Accreditation to industry standards can benefit any laboratory that performs testing, sampling or calibration services – this applies to manufacturers, regulators, inspection bodies and product certification organizations alike.

Test Procedures
A laboratory shall establish and implement procedures for carrying out tests or calibrations and record these in its quality system, to ensure accurate results are produced consistently. Any deviations from established methods must be documented, technically justified and authorized prior to being made official.

All testing and calibration results should be reported accurately, clearly, and unambiguously, with opinions or interpretations clearly documented separately. Furthermore, laboratories should implement procedures for estimating measurement uncertainty; estimates may differ depending on the method employed but a reasonable estimation must be provided.

This checklist presents all of the criteria from ISO/IEC 17025:2005, “General requirements for calibration and testing laboratories”, in an easily understandable checklist format. It serves as an excellent means of assessing Laboratory Management Systems as they prepare to be assessed by an Accreditation Body (AB), as well as gap analysis to detect any areas where nonconformances exist.

Sampling Procedures
A laboratory must establish procedures for documenting sampling as part of testing or calibration activities it undertakes, including procedures for recording sampling procedures used, identification of samplers used and environmental conditions (if applicable) under which samples were collected. Furthermore, this includes procedures related to transportation, receipt, handling, protection, storage retention and disposal of tests, calibrations and samples.

One major takeaway laboratories should realize from this revision is its increased visibility of Sampling. Not only has its significance been raised through a dedicated section but is now integrated into elements like 6.6.1 (externally provided services), 7.2.2.1 (validation of methods including uncertainty), 7.8.1-7.8.5 (reporting requirements).

Assessors will look for evidence of participation in a proficiency testing program when making their assessment decisions. Assessors want to see the schedule and results from your program so they can avoid deficiencies during an inspection or assessment.

Data Analysis
The ISO/IEC 17025 standard specifies requirements for laboratories to maintain their quality systems, unlike certification standards such as ISO 9001 which require laboratories to demonstrate compliance and technical competence within a defined scope of accreditation.

Accrediting laboratories requires them to have a documented quality system which has been reviewed and approved by an Accreditation Body recognized by ILAC, including procedures for evaluating external supplies and services that could have an effect on results quality.

Laboratory must establish internal auditing policies and schedules. Audits should take place at least annually and cover all areas of its quality system. Having a checklist for questions covering each department makes internal audits simpler for auditors as they conduct logical internal reviews which help continuously improve quality systems as well as ensure records don’t get overwritten when corrections are made, making internal auditing an essential tool in continuous quality improvements and recording corrections in original documents.

Reporting
Accrediting laboratories under ISO/IEC 17025 requires them to demonstrate that they operate under a documented quality system tailored to their Scope of Accreditation, while assuring any services or supplies supplied from third parties do not negatively impact laboratory operations.

A laboratory should establish and implement procedures for dealing with customer complaints, along with a plan and schedule for conducting internal audits on its quality system. Furthermore, its quality management systems must also be reviewed and approved by an external auditor.

Document requirements for accreditation of labs typically include an explanation of its policies and procedures as well as records of calibration and testing performed. Assessors should have access to these records when conducting evaluations of laboratories. It is imperative that documents are updated when methods or equipment change within the laboratory; additionally they must be easily read.