ISO 17025 Laboratory Accreditation Service System Certification Service

ISO17025

1. ISO17025 Introduction

ISO17025 is the international standard for laboratory accreditation services. The old version was released in May 2005, with the full title ISO/IEC17025:2005-5-15 "General Requirements for the Competence of Testing and Calibration Laboratories". The ISO17025 standard is a laboratory management standard developed by the International Organization for Standardization ISO/CASCO (International Organization for Standardization/Committee on Conformity Assessment). The predecessor of this standard was ISO/IEC Guide 25:1990 "General Requirements for the Competence of Calibration and Testing Laboratories". The organization that internationally manages laboratory accreditation is the "International Laboratory Accreditation Cooperation (ILAC)", which includes 44 laboratory accreditation bodies, including the China National Accreditation Committee for Laboratories (CNACL).

2. Role and Significance

Laboratories accredited under the ISO/IEC17025:2005 standard enjoy numerous benefits:

(1) It demonstrates that the laboratory has the technical capability to perform calibration/testing in accordance with relevant international criteria.

The basis for CNAS laboratory accreditation criteria is ISO/IEC17025, which is an internationally recognized standard for laboratory quality and technical requirements. When a laboratory obtains CNAS accreditation, it signifies that it has established a quality management system based on international standards. As long as the laboratory strictly adheres to this system, its technical capabilities are guaranteed, and the testing/calibration services it provides to customers can be claimed to meet international standards.

(2) Enhance the laboratory's competitiveness in the calibration/testing market and gain the trust of government departments and the public.

The laboratory's products are test reports or calibration certificates. The quality of these reports or certificates plays a crucial role in the laboratory's reputation and survival, determining its competitiveness. ISO/IEC17025 assists laboratories in quality planning, quality control, quality assurance, and quality improvement through various quality management activities during the production and formation of their "products", ensuring the quality of the laboratory's "products" and services. For laboratory customers, choosing a laboratory with recognized technical capabilities reduces the risk of receiving substandard "products".

Laboratories are important technical support institutions for government departments in supervising and managing various products, providing the basis for government decisions and even policymaking. When government departments, customers, and related parties select a laboratory, the laboratory's capabilities and credibility are particularly important. Accreditation helps build confidence in the laboratory among government departments, customers, and related parties.

National laboratory accreditation is consistent with foreign laboratory accreditation systems and is a voluntary capability recognition activity. Testing technical institutions that have obtained national laboratory accreditation demonstrate compliance with internationally recognized calibration and testing laboratory competence criteria.

It can effectively improve the laboratory's management level, ensure the impartiality and validity of the test data issued by the laboratory, fully demonstrate the laboratory's testing capabilities and impartiality to the public, increase market share, and improve customer satisfaction.

(3) Participate in bilateral and multilateral international laboratory accreditation cooperation and gain broader recognition.

China's accreditation body has signed mutual recognition agreements (MRAs) with APLAC and ILAC. The signing of these agreements has established a "highway" for Chinese laboratories to participate in international activities. After obtaining CNAS accreditation, laboratories can use this pathway to reach other signatories of the agreement, thereby gaining broader recognition. This not only increases exchanges between Chinese laboratories and their international counterparts but also attracts more laboratory customers by leveraging the cost advantages of mutual recognition agreements.

(4) Inclusion in the "National Laboratory Accreditation Directory" to enhance the laboratory's visibility.

CNAS annually compiles and publishes the laboratory accreditation directory, which is a bilingual (Chinese and English) publication provided to domestic laboratories, relevant authorities, and foreign accreditation bodies. For laboratories listed in the directory, this undoubtedly has a positive advertising effect, thereby increasing the visibility of accredited laboratories.

(5) The use of the accreditation mark within the scope of accredited projects.

The accreditation mark is a graphical symbol issued by CNAS to accredited laboratories, allowing them to use it within specified ranges to indicate their CNAS accreditation status. To protect the interests of CNAS and accredited laboratories, CNAS has established strict management requirements for the accreditation mark based on international standards and has defined corresponding measures for misuse and abuse, including litigation when necessary. These measures safeguard the legitimate interests of CNAS and accredited laboratories while also helping to reduce and minimize infringements on their rights.

3. Standard Requirements

1. Management Requirements:

(1) Organization—Clarify organizational responsibilities and establish communication mechanisms;

(2) Management System—Establish policies and a documented system;

(3) Document Control—Manage the approval, issuance, and changes of documents;

(4) Review of Requirements, Tenders, and Contracts—Review customer requirements, tenders, and contracts to ensure compliance;

(5) Subcontracting of Testing and Calibration—Manage subcontracting and subcontractors;

(6) Procurement of Services and Supplies—Manage suppliers to ensure procurement quality;

(7) Service to Customers—Enhance customer communication and provide good customer service;

(8) Complaints—Standardize the handling of complaints;

(9) Control of Nonconforming Testing and/or Calibration Work—Manage nonconformities;

(10) Improvement—Continuously improve the management system;

(11) Corrective Actions—Take corrective actions for identified nonconformities;

(12) Preventive Actions—Take preventive actions for potential nonconformities;

(13) Control of Records—Control the identification, collection, indexing, access, archiving, storage, maintenance, and disposal of records;

(14) Internal Audits—Conduct internal audits of the laboratory according to predetermined procedures or special requirements;

(15) Management Reviews—Conduct management reviews of the laboratory according to predetermined procedures;

2. Technical Requirements:

(1) General—Consider factors affecting the correctness and reliability of testing and/or calibration;

(2) Personnel—Confirm personnel qualifications and provide skills training;

(3) Facilities and Environmental Conditions—Maintain facilities and environmental conditions according to testing and calibration requirements;

(4) Testing and Calibration Methods and Method Validation—Use appropriate methods, validate methods for intended use, evaluate uncertainty, and control data;

(5) Equipment—Manage equipment properly to meet method requirements and interim check requirements;

(6) Measurement Traceability—Should be traceable to SI unit standards or certified reference materials;

(7) Sampling—Clarify sampling requirements and minimize deviations;

(8) Handling of Test and Calibration Items (Samples)—Manage the transportation, receipt, handling, protection, storage, and/or disposal of samples;

(9) Assurance of the Quality of Test and Calibration Results—Use various methods to manage the quality of testing and calibration;

(10) Reporting of Results—Provide test/calibration reports in a standardized manner.