Management Of the Competence of Testing and Calibration Laboratories- ISO 17025
Verifying the technical competence of a laboratory according to the international standard ISO 17025 to perform specific types of inspection, measurement, and calibration tests in a specific field such as electrical, chemical, petroleum, construction, and building testing laboratories, measurement and calibration laboratories, and other fields. We accredit laboratories in all fields according to the international standard ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories), as well as accrediting medical laboratories according to the international standard ISO/IEC 15189 (Requirements for accreditation of medical laboratories), which gives customers of these laboratories confidence in the quality of the services they provide.
ISO 17025 is a standard developed specifically for laboratories. This international standard helps laboratories prove their competence in obtaining correct results. This enhances confidence in their work and brings global recognition to the organization. It provides requirements for conducting tests and calibrations including sampling. Moreover, ISO 17025 helps laboratories to develop and maintain their overall quality management system performance.
Importance of ISO 17025 Laboratory Management Certification:
ISO 17025 certification is an approval that laboratories have an advanced management system and provide accurate testing and calibration results. It applies to all laboratories that conduct testing and calibration. This internationally recognized certification helps you to achieve new business opportunities even from abroad. Moreover, obtaining ISO 17025 certification increases customer confidence in test results and laboratory processes.
Benefits of Obtaining ISO 17025 Certification:
ISO 17025 certification offers the following benefits to an organization.
- Ensures better control over laboratory operations
- Demonstrates the efficiency of laboratories in obtaining correct results
- Satisfied customers and clients
- Improves customer confidence in test and calibration data
- Enhances traceability and ensures global recognition
- Eliminates the need to retest products
- This applies to all laboratories that perform testing and calibration
While the standard applies to any laboratory regardless of its size, type, or sector, some sectors are more concerned and primarily concerned with relying on ISO 17025. These include:
- Medical testing laboratories: Medical laboratories that perform tests on patient samples, such as clinical chemistry, microbiology, and pathology laboratories, were early adopters of ISO 17025 to demonstrate the reliability and accuracy of their test results.
- Environmental testing laboratories: Environmental testing laboratories, including those that test air, water, soil, and hazardous waste samples, were also early adopters of ISO 17025 to demonstrate the reliability and accuracy of their test results.
- Food and beverage testing laboratories: Laboratories that test and inspect food and beverage products for safety, quality, and compliance with regulatory requirements have adopted ISO 17025 to demonstrate the reliability and accuracy of their test results.
- Materials testing laboratories: Laboratories that test and inspect materials, including metals, plastics and construction materials for mechanical, chemical, and physical properties have adopted ISO 17025 to demonstrate the reliability and accuracy of their test results.
- Pharmaceutical products laboratories: Laboratories that test pharmaceutical products for purity, potency, and safety have adopted ISO 17025 to demonstrate the reliability and accuracy of their test results.
ISO/IEC 17025:2017 Specification Terms:
The most important stage in the project life cycle is the distribution of all documents to those concerned in the laboratory, then applying the updated procedures using all the attached forms, and keeping those records as evidence of the application, in addition to monitoring the application process to ensure the optimal use of the documents and achieving the desired goal in the presence of a strong occupational health and safety management system.
Sixth stage: Internal Audit
At this phase, the earlier activities are assessed to confirm they were executed correctly, and it also guarantees the ongoing effectiveness of the information security management system and the dedication of all personnel to their assigned roles and responsibilities. The consulting team prepares the internal audit plan, followed by a comprehensive internal audit of the entire system.
Stage Seven: Management Review Meeting
One of the most important requirements of the international standard ISO 17025 is to ensure the support of senior management in implementing the quality system, and to demonstrate its commitment to it, in addition to reviewing the overall performance of the facility and providing the required resources, where the consulting team will assist the facility management in implementing the internal review with complete professionalism.
ISO/IEC 17025:2017 Specification Clauses:
The mandatory requirements of ISO 17025 are items 4 to 8, which means that all of these requirements must be implemented in the facility that wants to comply with the standard.
The requirements from Sections 4 to 8 can be summarized as follows:
4- General requirements
4 -1 Impartiality
4 -2 Confidentiality
5- Structural requirements
6- Resource requirements
6 -1 General
6 -2 Personnel
6 -3 facilities and environmental conditions
6 -4 Equipment
6 -5 Metrological traceability
6 -6 Externally provided products and services
7- Process requirements
7 -1 Review of requests, tenders, and contracts
7 -2 Selection, verification, and validation of method
7 -2 -1 Selection and verification of method
7 -2 -2 Validation of method
7 -3 Sampling
7 -4 Handling of test or calibration items
7 -5 Technical records
7 -6 Evaluation of measurement uncertainty
7 -7 Ensuring the validity of results
7 -8 Reporting of results
7 -8 -1 General
7 -8 -2 Common requirements for reports (test, calibration, or sampling)
7 -8 -3 Specific requirements for test reports
7 -8 -4 Specific requirements for calibration certificates
7 -8 -5 Reporting sampling – specific requirements
7 -8 -6 Reporting statements of conformity
7 -8 -7 Reporting opinions and interpretations
7 -8 -8 Amendments to reports
7 -9 Complaints
7 -10 Nonconforming work
7 -11 Control of data and information management
8- Management system requirements
8 -1 Option
8 -1 -1 General
8 -1 -2 Option A
8 -1 -3 Option B
8 -2 Management system documentation Option A
8 -3 Control of management system documents Option A
8 -4 Control of records Option A
8 -5 Actions to address risks and opportunities Option A
8 -6 Improvement Option A
8 -7 Corrective action Option A
8 -8 Internal audits Option A
8 -9 Management reviews Option A
Entities that need to apply the ISO 17025 laboratory efficiency and calibration standard
- All measurement, testing, and calibration laboratories, whether separate or within industrial facilities.
- Laboratories that established within factories, food companies, and petroleum companies.
- Medical laboratories
- Manufacturers of reference materials
- Measurement and calibration laboratories
- Entities providing efficiency tests
- Private and governmental laboratories that are concerned with implementing tests.
- Laboratories interested in obtaining accreditation and documentation of their test and calibration results with certification from an internationally recognized accreditation body.
In general, ISO 17025 can be applied to any laboratory that performs testing, calibration, or sampling and wants to demonstrate the reliability and accuracy of its results, regardless of the sector or industry in which it operates.
Guidance for Consulting and Training
We have the knowledge and experience to help institutions and individuals, comply with the requirements of the Saudi Standards and Quality Organization, the Saudi Food and Drug Authority, and other entities that impose legal and mandatory requirements in the Saudi market.