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
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).
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).
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
and FAO Document 15.
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.
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.
Part 1
The questions in Part 1A are general questions relating to the infrastructure of the laboratory and its support facilities.
The total possible (maximum) score for Part 1A is 66. To demonstrate that the laboratory is competent to conduct analytical work, a score of at least 85% (56) should be achieved.
After achieving the minimum requirement for Part 1A, the laboratory may progress onto Part 1B.
Part 1B refers to the technical requirements of the laboratory.
The total possible score for Part 1B is 78.
To demonstrate that the laboratory is capable of performing accurate and traceable analytical work, a minimum score of 80% is
required (i.e. 62).A laboratory which is accredited to ISO 17025:2005, or is working towards accreditation, should aim to achieve a
score of 95% (i.e. 74).
After achieving the minimum requirement for Part 1B the laboratory may progress onto Part 1C.
Part 1C refers to organisational requirements.
The total possible score for Part 1C is 170*.
To demonstrate that the laboratory has the basic requirement to set up a Quality System compliant with ISO/IEC 17025:2005, a
score of at least 70% (i.e. 119) should be achieved, but only if corrective and preventive actions are implemented and documented
to address any scores of <1.
* The maximum possible score may be less than 170 if the laboratory has answered a questions as ‘N/A’.
After achieving the minimum requirement for Part 1C, the laboratory may progress onto Part 2.
0 | No procedure currently available |
1 | Draft version procedure available |
2 | Authorised version of procedure available |
3 | Procedure implemented and operational |
4 | Evaluation of procedure is available (by audit) |
5 | The procedure is fully implemented and meets the requirements of the Quality Management System and ISO/IEC 17025:2005 |
The total score is obtained by multiplying by the score weight. For example, a score of 3 and a score weight of 4 leads to a total score of 12.
For each question the required scoring is indicated in the table.
Each set of questions may be completed separately, or as a whole to cover all aspects of the standard, and need not be done in the order they appear.
Section 1 of ISO/IEC 17025:2005 refers to the Scope of the standard and therefore there are no questions for this section.
Section 2 of ISO/IEC 17025:2005 refers to the Normative References of the standard and therefore there are no questions for this section.
Section 3 of ISO/IEC 17025:2005 refers to the Terms and Definitions of the standard and therefore there are no questions for this section.
Section 4 of ISO/IEC 17025:2005 refers to Management Requirements
The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following:
The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test methods, as well as drawings, software, specifications, instructions and manuals. In this context 'document' could be policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans etc. These may be on various media, whether hard copy or electronic, and may be digital, analog, photographic or written.