Quality specification for analysis and calibration laboratories

iso iec 17025

This standard is the main standard used by measurement and calibration laboratories. It was previously known as (ISO Guide 25), but the standard in force now (ISO / IEC 17025) was issued in 1999. For the year, the requirements of ISO 9001 are included in this standard, but our specification is the focus of presentation and discussion, adding an artistic dimension by containing requirements Technical to prove the efficiency of measurement and calibration laboratories.

An amendment was made to this specification in 2005, when there was an agreement that this specification should be compatible with the new version at that time of the ISO 9001 specification. This specification was issued for the first time in 2001, and on May 12, 2005, the amended version was issued by the competent committee.

Among the most important amendments was the great emphasis on the responsibility of senior management and the requirement of the importance of continuous improvement of the management system, especially with regard to communication with customers. The standard contains two sets of requirements, administrative and technical.

The administrative requirements are related to the quality of the “management system”, while the technical requirements are related to the efficiency of the analysis staff, the methods of analysis, the devices used, the methods of controlling the quality of analyzes, issuing reports, and others. Laboratories use this standard to implement a quality system designed to improve their ability to produce validated results.

This specification is also the basis for obtaining accreditation from a specific accreditation body. Since this specification relates to proving competence, accreditation is simply an acknowledgment by a neutral body of the competence and competence of the laboratory.

There is a basic requirement for obtaining accreditation, which is “documenting the system”, that is, writing it in the document that the standard calls the “quality file”. This document contains laboratory policies and procedures for how to comply with the requirements of this specification.

administrative requirements

1. Organization
2. Management system
3. Document control
4. Review of requests, tenders and contracts
5. Subcontracting of tests and calibration
6. Purchasing services and supplies
7. Service to customer
8. Complaints
9. Control of nonconforming testing and/or calibration work
10. Improvement
11. Corrective action
12. Preventive action
13. Control of records
14. Internal auditing
15. Management review

technical requirements

1. General requirements
2. Personnel
3. Accommodation and environmental conditions
4. Test and calibration methods and method validation
5. Hardware
6. Traceability
7. Sampling
8. Handling of test and calibration items
9. Assuring the quality of test and calibration results
10. Reporting the results

How to obtain a guarantee of the technical competence of the laboratory

Many countries do this through Laboratory Accreditation, which is an independent method for laboratory accreditation, unlike ISO 9001, that adopts standards and procedures developed specifically for assigning technical competence.

A group of technical experts (including the audit leader) conducts a comprehensive field assessment of all factors in the facility that can affect the production of technical information. The standards are based on an international standard, ISO/IEC 17025. This standard is used to evaluate laboratories on a global scale, and focuses on special factors. Relevant to the ability of the laboratory to produce accurate and valid data for tests and calibrations, including:

• The technical competence of the staff
• The validity and appropriateness of the methods used
• The possibility of tracking measurements and calibrations to international standards
• Appropriate measurement uncertainty
• Appropriate, calibrate and maintain test instruments
• Test environment
• Taking the sample, handling and transporting it from the tested materials
• Ensure the quality of test data, inspections and calibrations
It also covers aspects covered by ISO 9001, and the facility is repeatedly tested to maintain standards of its technical expertise and is required to participate in formal competency programs or to compare laboratories as evidence of its competency.
In order for the evaluation body to be accepted and recognized internationally, the accreditation system must comply with the requirements of the standard:
ISO/IEC 17011: General Requirements for bodies providing assessment and accreditation of conformity assessment bodies.

The result :
• There is a difference between the purpose, criteria and focus of the ISO 9001 quality system standards and those of ISO / ECE 17025 laboratory documentation
• The latter to ensure technical competence
• Maintaining ISO 9001 with ISO/ECE 17025 may be an option if the laboratory has functions other than analysis, such as accounting, teaching, sales, information service.


Important conditions when processing laboratories

The technical competence of a laboratory means its ability to perform the functions entrusted to it with high efficiency, in a timely manner, and at a reasonable cost, and the technical efficiency of the laboratories depends on a number of factors, including what are technical factors, and what are administrative and organizational factors, and the following factors are the most important determinants of the efficiency of a laboratory:

Rehabilitation, training and technical expertise for laboratory workers.

The availability of good equipment for the laboratory – accurate equipment, high quality chemicals, good control, periodic calibration, and regular preventive and periodic maintenance.

Availability of standard specifications for examination, testing and calibration methods.

An approved and reliable system for quality control and assurance.

Adequate procedures for quality control and assurance.

Effective procedures for review and auditing within the laboratory.

Appropriate sampling and handling practices.

Accurate procedures for Walt testing


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