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FAO Laboratory Audit Tool

FAO Laboratory Internal Audit Tool for Testing Laboratories compliant with ISO/IEC 17025:2005

Objective

The objective of this auditing tool is to enable organisations to assess their Quality Assurance performance against the requirements of operating an appropriate Quality Management System and the requirements of an appropriate international quality standard, such as EN ISO 9001:2015 or ISO/IEC 17025:2005.

Running the Lab Audit Tool

There are 3 ways to use the FAO Lab Audit Tool:

Run the FAO Lab Audit Tool on the Feedipedia website

Run the FAO Lab Audit Tool on your own computer (Windows only)

Run the FAO Lab Audit Tool on your own website

Documentation

Scope

The auditing tool covers the requirements of operating an appropriate Quality Management System and the requirements of an appropriate international quality standard, such as EN ISO 9001:2015 or ISO/IEC 17025:2005. It does not cover the requirements of Environmental Management or Occupational Health and Safety Management (such as ISO 14001:2015 or BS OHSAS 18001:2007).

For which laboratories

The auditing tool is applicable to every size and type of organisation which provide a laboratory testing service. Although aimed at feed analysis laboratories the principle would apply to any type of testing and/or calibration laboratory. It may also be useful for laboratories seeking accreditation to ISO 15189:2012 (Medical Laboratories – Requirements for quality and competence).

Who should perform the auditing

It should be completed by those familiar with the requirements of a Quality Management System and the appropriate standard.

Further information on the implementation of a Quality Management System is available in FAO Document 14 (http://www.fao.org/docrep/014/i2441e/i2441e00.pdf) and FAO Document 15 (http://www.fao.org/3/i3535e.pdf).

What information does it provide

The auditing tool will provide an assessment of how well an organisation has its procedures under control and identify those operations which would benefit from improvement and review.

Structure of the tool

The auditing tool consists of four parts (1A - Laboratory Infrastructure, 1B - Technical Performance, 1C - Organisation and Quality Assurance Requirements and 2 - Requirements of ISO/IEC 17025:2005), each of which includes a series of questions which produce a numerical score. The parts should be attempted in order and a total score reviewed once each part is complete. Each part may be repeated as many times as is appropriate. Only when a suitable score is attained should the organisation move onto completing the next part.

Unless indicated as ‘N/A’ (not applicable), scores of zero or less indicate opportunities for improvement. These should be addressed by identifying appropriate Corrective and Preventive Actions (CAPA).

Where a question has a number in the ‘score weight’ column, the score that you give should be multiplied by this figure to achieve the total score (e.g. a score of ‘1’ with a score weight of ‘3’ = 1 x 3). Some score weighs may be negative numbers and therefore produce negative scores. The total score for each part is achieved by adding all weighted scores together for that part of the audit.

The laboratory should calculate its total score for each part (the total score, including items that are regarded as N/A as indicated in the fourth column). However the laboratory should be careful identifying issues as N/A, especially in part 2 sections 4.2 – 4.15 and part 2 sections 5.1 – 5.10.

The questions in Part 1A are general questions relating to the infrastructure of the laboratory and its support facilities.

Part 1B refers to the technical requirements of the laboratory.

Part 1C refers to organisational requirements.

Part 2 refers to the specific requirements of ISO/IEC 17025:2005.

Key:    N/A – not applicable               N/K – not known                      Shaded areas are to be ignored (or no score weight to be applied; in other words the score weight is 1).