List Of Mandatory Documents And Procedures Required For Iso 17025 Accreditation

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The ISO 17025 standard is mainly used for testing and calibration laboratories. ISO 17025 shares many unities with ISO 9000 but ISO 17025 assesses the technical ability in lab testing and calibration services and it applies to organizations that produce testing and calibration results. ISO/IEC 17025 specifies overall requirements for the ability to carry out the tests and calibrations, including sampling. ISO 17025 standard covers the testing and calibration quality systems using standard approaches and laboratory-developed or modified approaches.

The ISO 17025 standard contains the general, structural, resource, process, and management system requirements. The general, structural, and management system requirements relate mainly to the operation and efficiency of the laboratory’s quality management system and the laboratory organization itself. The source and procedure requirements include the factors which regulate the correctness and reliability of the tests and calibrations the laboratory conducts.

The benefit of ISO 17025 certification is not limited to the good result but, it establishes confidence in ...
... management and customers on the test /calibration results as well as test /calibration reports and raises customer confidence as well. It will give a good image of the organization as a Quality producer in the Worldwide Market. It also offers tips on how to do an appropriate analysis of data as well as how to take measurements of the uncertainty and integrity of data and records. It also offers guidelines and better control for maintenance of Gadgets, environment control, protection of test records, etc. ISO 17025 certification helps to establish quality in testing/calibration and reliability, as well as to avoid the risk, also to notice deviations, it also accurate the errors and helps to improve the productivity. So, here is the list of documents and producers that are required during the ISO 1702 certification process.

List of Documents

• Document the range of laboratory activities (clause 5.3)
• ISO 17025 documents for all procedures (clause 5.5c)
• Document competence requirements of personnel (clause 6.2.2)
• Environmental condition requirements (clause 6.3.2)
• Document records of reference materials (clause 6.4.13 f)
• Document an unbroken chain of calibrations (clause 6.5.1)
• All lab requirements documented (clause 7.1.1)
• Documentation of methods and supporting documentation for methods (clause 7.2.1.2)
• Method deviations (clause 7.2.1.7)
• Identification of test or calibration items (clause 7.4.2)
• Decision rule for the statement of conformity (clause 7.8.6.1)
• Basis for opinions and interpretations (clause 7.8.7.1)
• Amendments to reports (clause 7.8.8.2)
• Complaints process (clause 7.9.1)
• Changes to laboratory software (clause 7.11.2)
• Document the entire management system (clause 8.1.1)
• Option A management system (clause 8.1.2)
• Laboratory management shall document the management system (clause 8.2.1)
• Documentation included in or linked to the Management System (clause 8.2.4)
• Document control (clause 8.3.1)
• Document available and distribution contracted (clause 8.3.2 d)

List of Procedures

• Document Laboratory procedures to ensure consistent activities (clause 5.5 c)
• Personnel identification deviations (clause 5.6 b)
• Procedures and records in the lab (clause 6.2.5)
• Environmental conditions monitoring (clause 6.3.3)
• Equipment handling (clause 6.4.3)
• Intermediate check of equipment (clause 6.4.10)
• Reference measurement procedures (clause 6.5.3 b)
• External services (clause 6.6.2)
• Review of requirements (clause 7.1.1)
• Meet customer requirements (clause 7.1.1 d)
• Selection of methods (clause 7.2.1.1)
• Assuring methods are up to date / available (clause 7.2.1.2)
• Method validation (clause 7.2.2.4)
• Handling of test or calibration items (clause 7.4.1)
• Monitoring validity of results (clause 7.7.1)
• Non-conforming work (clause 7.10.1)
• Management reviews the suitability of policies and procedures (clause 8.9.2 c)