What is ISO 17025 certification?
ISO 17025 certification is a globally recognized standard it specifies general requirement for the competence of testing and calibration laboratories. The standard used to improve and implement laboratory management system.
- Certified laboratories will gain worldwide recognition for its commitment to quality, competency
and consistent results.
- Delivers a fundamental for other quality systems related to laboratories such as GLP (Good
- The quality and effectiveness is continually improved.
- It safeguards the laboratory’s data integrity in case of legal consequences.
Understanding the sub clauses of clause 5 of ISO 17025 certification – Structural Requirements
Clause 5 of the standard sets out criteria for Structural Requirement. This clause is divided into 7 sub-clauses and defines the basic organizational components at the laboratory, its range of activities and commitment to an effective management system.
Clause 5.1 requires that the laboratories needs to be recognized as a legal entity so that it can be held responsible for its activities. Whenever laboratory is a part of a large organization then it shall be defined as an integral part of an organization that is legally identified. This may be in the form of a document from the authorities for the verification of laboratories existence as a legal entity or its relation to the parent organizations and it may vary from country to country.
Clause 5.2 needs a laboratory to identify the management who is overall responsible for laboratory operation. Here management means the person or group of people who guides and controls a laboratory operation at the top level.
Clause 5.3 states that laboratory shall define the range of activities to be covered under reaccreditation scope as per ISO IEC 17025 this scope shall not include any externally provided laboratory activities on an ongoing basis. This means that the laboratory is expected to be credited for activities for which it is competent to perform by utilizing its own resources only. Additionally, the accreditation scope shall be documented.
Clause 5.4 says that laboratory activities under the scope of accreditation shall be conducted in a way to meet the requirements of ISO 17025 requirements of customer’s requirements of regulatory bodies and any other organizations providing recognition.
ISO 17025 certification is published by the international organization for standardization (ISO) for General requirements for the competence of testing and calibration laboratories, and ensure about the technology and guidelines of laboratories to produce the accurate result of the testings and facilitate cooperation between laboratories and other bodies across the world wide.
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