Supersedes ISO Guide 25 and has recently been adopted by NATA (1/7/00) as the professional standard for laboratories. ISO 17025 is a standard specifically developed to cover the QA requirements of testing and calibration laboratories. A calibration laboratory would calibrate measuring equipment (eg thermometers and pressure gauges) and provides a certificate to its client regarding the level of accuracy of the equipment.
The clauses of ISO 17025 are:
ISO 17025 Clauses:
NOTE: these brief notes are not a substitute for ISO 17025 and do not purport to be a 'Quality System'. They are merely an introduction to some aspects of ISO 17025 as a training tool.
ISO 17025 includes the management system requirements of the ISO 9000 series thus laboratories accredited to ISO 17025 may state that they operate in accordance with either ISO 9001 or ISO 9002.
4. Management Requirements
Includes reference to:
The laboratory must be an entity that is legally responsible. It is important that manage any potential conflicts of interest are managed so that the quality of results is not compromised.
4.2 Quality System
The laboratory shall establish, implement and maintain a quality system appropriate to its scope of activities. This clause covers all those aspects that must be in the Quality System Statement. Reference to ISO 17025 must be made.
4.3 Document Control
The laboratory shall establish and maintain procedures to control all documents that form part of its quality system. This ensures that only the latest version of documents is available for use.
Provides very specific direction on how document control is to be demonstrated.
4.4 Review of request, tenders and contracts
The laboratory shall establish and maintain procedures for the review of requests, tenders and contracts. More prescriptive than the previous ISO Guide 25 to align with ISO 9000 series.
4.5 Subcontracting of tests and calibrations
The laboratory is required to subcontract work to only competent subcontractors. Wherever possible, subcontractors will be required to be NATA accredited. Relevant evidence needs to be obtained and retained to support this requirement.
4.6 Purchasing services and supplies
Signified policies and procedures required and require a 'purchasing document'.
4.7 Services to the client
Not a prescriptive clause but NATA expects to see a statement of the laboratory's policy. The laboratory shall afford clients or their representatives cooperation to clarify the client's request.
The laboratory shall have a policy and procedure for the resolution of complaints received from clients or other parties. Complaints may concern the quality of the results provided or their late supply.
4.9 Control of nonconforming testing and/or calibration work
The laboratory shall have a policy and procedure that shall be implemented when any aspect of the operations does not conform to the specified procedures. New area to coincide with ISO 9000 series which deals with non-conforming testing/calibrations/results and there needs to be reference to immediate corrective action in such cases.
4.10 Corrective action
The laboratory shall establish a policy and procedures for implementing corrective action when nonconforming work has been identified. Required as part of the Quality System. Requires specific procedures be defined for cause analysis, selection and implementation of corrective action, subsequent monitoring and follow-up audits.
4.11 Preventive action
Action plans shall be developed, implemented and monitored to reduce the likelihood of nonconformances if reduction of such nonconformances is needed.
4.12 Control of records
The laboratory shall establish and maintain procedures for identification, collection, storage, maintenance and disposal of quality and technical records.
4.13 Internal audits
The laboratory shall periodically, and in accordance with a schedule and plan, conduct internal audits of its activities to verify that its operations continue to comply with the laboratory's Quality System and ISO 17025.
4.14 Management Reviews
The laboratory's Executive Management shall, in accordance with a predetermined schedule and plan, conduct a review of the Quality System to determine continuing suitability and effectiveness, and to make necessary changes or improvements.
5. Technical Requirements
Include reference to:
Goals should be set for education, training and skills of laboratory personnel.
5.4 Test and calibration methods and method validation
Client must be advised and accept any method deviations. It would be good practice to make a record of discussions with clients although this is not required.
Calibration shall be indicated by labelling of equipment or other acceptable means of identification.
5.6 Measurement traceability
Traceability to the International System of Units (SI) may be required depending on the circumstances, eg customer requirements or legislative requirements.
Where methods or specifications do not specify sampling procedures, the laboratory will be required to develop sampling plans for taking of the original sample and associated sub-samples. Sampling plans are not prima facie acceptable for accreditation without NATA approval.
AS 1199:1988, Sampling Procedures and Tables for Inspection by Attributes, and AS 1399:1999/Amdt-1, Guide to AS 1199, form the basis of a standard to ensure the quality assurance of sampling procedures.
5.10 Reporting the results
The laboratory shall report results accurately and clearly and in line with any specific instructions in the test methods. The test reports are to contain certain specified information such as name and address of client and laboratory, identification of the method used and relevant signatures.
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