ISO 17025 Accredited Laboratories

ISO/IEC 17025 is an international standard designed to ensure the competence of testing and calibration laboratories. This standard, first issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 1999, specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. ISO 17025 accreditation is recognized worldwide and provides a benchmark for laboratories to demonstrate their ability to produce valid results.

The ISO/IEC 17025 standard includes specifications for laboratories using standard test methods, non-standard test methods, and other laboratory-developed methods and is the main standard for laboratories performing testing and calibrations. Laboratories that are accredited to ISO/IEC standard 17025 have proven that they are competent to perform testing and calibration. In most cases, producers, manufacturers, suppliers, or other organizations needing testing, will not accept results from unaccredited laboratories or testing facilities.

What is ISO 17025?

ISO 17025 specifies the requirements for laboratories to demonstrate their technical competence and ability to produce precise and accurate test and calibration data. It encompasses a wide range of laboratory activities, including sampling, testing, and calibration performed using standard, non-standard, and laboratory-developed methods. The standard covers two main areas: management requirements and technical requirements.

Management Requirements

Management requirements are primarily related to the operation and effectiveness of the laboratory’s quality management system. These requirements align with the principles of ISO 9001 but with a specific focus on laboratory operations. Key aspects include:

1. Organization and Management: Laboratories must be organized to ensure impartiality, management commitment, and clear responsibilities.
2. Document Control: Procedures for controlling documents and records to ensure they are current and accurately reflect the laboratory’s practices.
3. Review of Requests, Tenders, and Contracts: Ensuring that the laboratory has the capability and resources to meet client requirements.
4. Subcontracting: Managing and ensuring the competence of any subcontracted laboratory work.
5. Purchasing Services and Supplies: Ensuring that all purchased items and services that affect laboratory operations comply with specified requirements.
6. Service to the Customer: Engaging with clients to understand their needs and obtain feedback.
7. Complaints: Handling complaints in a structured and documented manner.
8. Control of Nonconforming Work: Procedures to identify, control, and correct nonconforming work.
9. Improvement: Continual improvement of the laboratory’s quality management system.
10. Corrective and Preventive Actions: Addressing the root causes of nonconformities and preventing their recurrence.

Technical Requirements

Technical requirements address the competence of staff, testing methodology, equipment, and quality assurance of test and calibration results. These requirements ensure that laboratories can produce reliable and accurate data. Key elements include:

1. Personnel: Ensuring that all staff are competent based on their education, training, experience, and skills. Laboratories must maintain up-to-date records of qualifications, training, and experience.
2. Accommodation and Environmental Conditions: Facilities and environmental conditions must not adversely affect the quality of results. Laboratories must monitor, control, and record environmental conditions as required by relevant specifications, methods, or procedures.
3. Test and Calibration Methods: Use of validated methods and procedures for all tests and calibrations. Laboratories must also ensure proper handling, transport, storage, and preparation of test or calibration items.
4. Equipment: Ensuring that all equipment is properly calibrated, maintained, and capable of achieving the required accuracy. Laboratories must maintain records of equipment calibration and maintenance.
5. Measurement Traceability: Ensuring that all measurements are traceable to national or international standards.
6. Sampling: When sampling is part of the testing or calibration, it must be done using appropriate methods to obtain valid results.
7. Handling of Test and Calibration Items: Proper procedures for receiving, handling, protecting, storing, retaining, and disposing of test and calibration items.
8. Assuring the Quality of Test and Calibration Results: Implementing quality control procedures to monitor the validity of results. This may include the use of control charts, participation in proficiency testing, and replicate testing.
9. Reporting Results: Ensuring that test reports and calibration certificates contain all necessary information to be understood by the recipient and to avoid any misinterpretations.

Benefits of ISO 17025 Accreditation

ISO 17025 accreditation offers numerous benefits for laboratories, enhancing their reputation and operational efficiency. Key benefits include:

1. International Recognition: ISO 17025 accreditation is recognized globally, enhancing the laboratory’s reputation and providing a competitive advantage.
2. Customer Confidence: Accreditation demonstrates the laboratory’s commitment to quality and competence, instilling confidence in customers and stakeholders.
3. Regulatory Compliance: Many regulatory bodies and industry standards require or prefer ISO 17025 accreditation, facilitating compliance with regulatory requirements.
4. Improved Efficiency and Effectiveness: Implementing ISO 17025 helps laboratories streamline their processes, improve their quality management system, and reduce errors.
5. Continual Improvement: The standard’s emphasis on continual improvement helps laboratories to enhance their performance over time.

The Accreditation Process

Obtaining ISO 17025 accreditation involves several steps, each designed to ensure that laboratories meet the standard’s rigorous requirements. The process includes:

1. Preparation: Understanding the requirements of ISO 17025 and identifying any gaps in current practices.
2. Implementation: Developing and implementing a quality management system that meets the standard’s requirements. This includes training staff, documenting procedures, and validating methods.
3. Internal Audit and Management Review: Conducting internal audits and management reviews to ensure the system is functioning effectively.
4. Application: Submitting an application to an accreditation body, along with the necessary documentation.
5. Assessment: Undergoing an on-site assessment by the accreditation body, which will review the laboratory’s quality management system, technical competence, and compliance with ISO 17025.
6. Corrective Actions: Addressing any nonconformities identified during the assessment.
7. Accreditation Decision: The accreditation body reviews the assessment findings and decides whether to grant accreditation.
8. Surveillance and Reassessment: Regular surveillance and reassessment visits by the accreditation body to ensure ongoing compliance with ISO 17025.

How Contract Laboratory Supports Laboratories Needing ISO 17025 Testing

ISO 17025 accreditation is a critical standard for laboratories, ensuring their competence and reliability in producing valid test and calibration results. For laboratory scientists and researchers, adherence to ISO 17025 provides a framework for quality management, continuous improvement, and international recognition. By implementing and maintaining compliance with ISO 17025, laboratories can enhance their credibility, meet regulatory requirements, and achieve excellence in their operations.

Contract Laboratory has helped many laboratories find ISO/IEC 17025 certified laboratories to perform their testing such as:

• LONG-TERM TESTING. Large spirits company needs ISO 17025-certified independent laboratories for periodic analysis of a variety of spirits and cordials. The analysis will consist of (at a minimum) % alcohol and specific gravity of various types of spirits and cordials.
• ISO 17025 accredited electrical laboratory needed for qualification testing of Medium Voltage Cables rated 5- through 46kV per AEIC CS8, Section 15 for the 120 Day Accelerated Water Treeing Test followed by test protocol to include Electrical Measurements, High Voltage Time Test, Physical Measurements, and Tree Count.
• ISO 17025-certified laboratory is needed with validated methods for e-vapor products testing for harmful constituents. Execution of a DOE to support a regulatory filing look for harmful and potentially harmful constituents (HPHC) in e-Vapor products.
• ISO 17025 Pharmaceutical analytical chemistry laboratory needed for USP Testing of Lidocaine HCL Injection – ID test and Assay, for Heparin Lock Flush – Assay, and particulates for both IAW USP <788>.
• LONG-TERM TESTING: ISO 17025 Environmental Microbiology Laboratory needed for Testing, Water Quality Testing, Water Portability testing, 740 samples.
• ISO 17025 Accredited Laboratory needed for Anti-vibration glove testing according to ANSI/ASA S2.73 or ISO 10819. Mechanical vibration and shock – Hand-arm vibration or
• ISO 17025-certified laboratory is needed to conduct osmolality tests that report the results in mOsm/kg water units for a sample
• ISO 17025 Laboratory needed for baby shampoo testing for MDMD hydantoin content in baby shampoo.
• ISO 17025 Pharmaceutical Laboratory needed for Pharmaceutical Equivalence test report for Injection product with raw data. Included: – Test items: description, assay by titration, purity by GC, qualitative tests, loss on drying, foreign insoluble matter, sterility, endotoxin, and pyrogen test. Test methods: compendial methods listed in Japanese Pharmacopoeia

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