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Collection Overview of Laboratory Accreditation
1、 Regarding laboratory accreditation
(1) Definition of recognition:
A formal recognition given by an authoritative institution to an organization or individual for their ability to complete a specific task (laboratory has the ability to conduct prescribed types of testing or calibration).
(2) Function:
a. Indicating that the laboratory has the ability to provide testing and calibration services in accordance with internationally recognized standards;
b. Enhanced the market competitiveness of the laboratory and won the trust of government departments and various sectors of society;
c. Obtaining recognition from laboratory accreditation bodies in countries and regions that have signed mutual recognition agreements with CNAS is beneficial for eliminating non-tariff trade technical barriers;
d. Participate in bilateral and multilateral cooperation in international laboratory accreditation to promote the development of industry, technology, and commerce;
e. CNAS national laboratory accreditation mark and ILAC international mutual recognition joint mark can be used within the scope of accreditation;
f. Listed in the list of approved accreditation institutions of the China National Accreditation Service for Conformity Assessment, and electronically registered and published on the website of the China National Accreditation Service for Conformity Assessment; Accept the supervision and audit of the China National Accreditation Service for Conformity Assessment to enhance the visibility of the laboratory.
(3) Principle:
a. Voluntary application principle
b. Non discrimination principle
c. Expert review principle
d. National recognition principle
2、 The Development of Laboratory Accreditation Activities
æ International:
a. In 1947, Australia established the world's first national laboratory accreditation system
b. European Regional Accreditation Cooperation Organization in the 1970s
c. In 1990, regional accreditation organizations such as EA, APLAC, IAAC, and SADCA were established in Europe, Asia Pacific, the Americas, and Southern Africa
d. 1996 International Laboratory Accreditation Cooperation (ILAC)
æ Our country:
a. Established in September 1994 (CNACL)
b. In September and October 1999, New Zealand, the United States, Singapore, and Malaysia conducted inspections of China's National Laboratory Accreditation Committee in accordance with ISO/IEC Guide 58
c. Joined APLAC in New Delhi on December 3, 1999
d. Joined ILAC on November 2, 2000 in Washington, D.C
3、 The Evolution of China National Accreditation Service for Laboratories
1. In 1986, the former National Bureau of Standards conducted an evaluation of testing laboratories. In 1994, the former National Technical Supervision Bureau established the China National Accreditation Committee for Laboratories (CNACL) based on ISO/IEC Guide 58.
2. In 1989, the former China National Import and Export Commodity Inspection Bureau established the "China Import and Export Commodity Inspection Laboratory Certification Management Committee". In 1996, based on ISO/IEC guideline 58, the "China National Import and Export Commodity Inspection Laboratory Accreditation Committee" (CCIBLAC) was reorganized and renamed as the "China National Entry Exit Inspection and Quarantine Laboratory Accreditation Committee" in August 2000.
3. On July 4, 2004, the former China National Accreditation Committee for Laboratories (CNACL) and the former China National Accreditation Committee for Exit Inspection and Quarantine merged to form the China National Accreditation Committee for Laboratories (CNAL). CNAL, which was briefly known as the China National Laboratory Accreditation Service, has signed mutual recognition agreements with over 40 institutions from more than 30 economies worldwide.
4. On March 31, 2006, the China National Accreditation Service for Conformity Assessment was established in Beijing. The State Administration for Market Regulation has decided to integrate the China National Accreditation Service for Conformity Assessment (CNAB) and the China National Accreditation Service for Laboratories (CNAL) to establish the China National Accreditation Service for Conformity Assessment (CNAS), which is responsible for the unified implementation of accreditation work for certification bodies, laboratories, and inspection agencies. Implemented from July 1, 2006.
4、 The current accreditation status of China National Accreditation Service for Laboratories, the number and fields of accredited laboratories
For details, please refer to the information center on our company's website. Interested parties can further learn about the relevant content on the website of the China National Accreditation Service for Conformity Assessment (CNAS).
5、 The Evolution of Laboratory Accreditation Standards
（1） ISO Guideline 25
1. ISO Guide 25:1978 "Guidelines for Laboratory Technical Capability Assessment" was the first international standard used for laboratory accreditation.
2. The 1982 ISO/IEC Guide 25:1982 "Basic Technical Requirements for Testing Laboratories" has been widely applied.
3. The 1990 ISO/IEC Guide 25 "General Requirements for the Competence of Calibration and Testing Laboratories" considers the requirements for calibration laboratories and is closely integrated with the ISO 9000 standard.
GB/T15481-1995CNACL201-1999。
（2） ISO/IEC 17025:1999 "General Requirements for the Competence of Testing and Calibration Laboratories" was officially released on December 15th. This standard has the following four characteristics:
1. Elaborate on the "management requirements" and "technical requirements" that the laboratory should comply with as two separate chapters.
2. We have compiled the requirements related to ISO 9000 and testing and calibration services.
3. Highlighting the technical requirements for sampling, confirmation of testing methods, uncertainty assessment, and traceability of values.
4. Clarified the relationship with ISO9000:1994. ISO/IEC 17025:1999 (CNAL/AC01:2003) GB15481-2000 was released on December 27, 2000 and implemented on September 1, 2001. The accreditation committee began requiring laboratory accreditation to be applied for according to this standard on July 1, 2002.
（3） ISO15189:2003 (E) "Medical Laboratories - Specific Requirements for Quality and Capability" was released in February 2003. ISO 15189:2003 is based on GB/T15481-2000 (equivalent to ISO/IEC 17025) and GB/T19001-2000 (equivalent to ISO 9001), and proposes requirements for the competence and quality of medical laboratories. The relationship between this standard and GB/T 15481-2000/ISO/IEC 17025 is that of a "specific standard" and a "general standard", which concretizes and refines GB/T 15481-2000 "General Requirements for the Competence of Testing and Calibration Laboratories" in the field of medical laboratories.
6、 Comparison between ISO15189 and ISO17025
1. ISO/IEC 17025:1999, as a general requirement for laboratory competence, applies to all laboratories. As long as laboratories (including medical laboratories) strictly comply with these requirements, they can ensure standardized work. ISO 15189 provides a more detailed description of the requirements for quality management in medical laboratories from a medical professional perspective, with stronger specificity and greater convenience for use in medical laboratories.
2. Structurally, 15189 inherits the characteristics described in the two major parts of 17025, but incorporates the idea of process control in terms of technical requirements, which is more conducive to laboratory understanding and operation.
3. In terms of content, the management requirements have added the element of "continuous improvement", while "consulting services" have new content. The scope of restrictions for "commissioned experiments" is different from 17025. The technical requirements have downplayed the requirements for "measurement uncertainty" and "measurement traceability", and clarified the control of the inspection process, such as pre analysis, analysis procedures, and post analysis control.
4. There are many clear requirements for medical laboratories:
1) There are additional requirements for the responsibility of laboratory management, 4.1, 5.1
2) Require backup of files;
3) Require the contract to include a capability evaluation plan for the assessment of capabilities;
4) Commissioned experiments have a different meaning from subcontracting, and require the signing of an agreement and regular review for commissioning;
5) There are clearer requirements for commissioned experimental reports;
6) Request to establish a supply list for reagents, consumables, and standard substances;
7) It is explicitly required that laboratory work not only involves testing, but also provides consulting services;
8) There is a clear need for continuous improvement and regular review of the technical operating procedures of the quality management system;
9) There are more requirements for the input of management review content, and there are also clearer requirements for the frequency of management review;
10) The importance of continuing education and training has been clarified, and the content of training has also been given clearer requirements;
11) Clarify the requirements for personnel capability evaluation;
12) Emphasis was placed on the comfort of the facility environment and the requirements for biosafety;
13) Clear requirements have been put forward for the information points on the inspection application form;
14) Detailed specifications have been established for the sampling process;
15) There are more detailed requirements for the identification, transportation, and handling of samples;
16) Stricter requirements for regular review of verification procedures;
17) There are clearer requirements for the information points in the inspection program files;
18) There are finer requirements for laboratory comparison;
19) Clarify the requirements for system review after inspection;
20) There are clear requirements for handling warning/critical values for inspection results;
21) There are clear requirements for the distribution of reports;
Which standard is better? Is it easier to meet their requirements?
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