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ISO 17025

ISO 17025

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:

  1. Scope

  2. Normative References

  3. Terms and Definitions

  4. Management Requirements


4.1 Organisation
4.2 Quality System
4.3 Document Control
4.4 Review of Requests, Tenders and Contracts
4.5 Subcontracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Client
4.8 Complaints
4.9 Control of Nonconforming Testing and/or Calibration Work
4.10 Corrective Action
4.11 Preventive Action
4.12 Control of Records
4.13 Internal Audits
4.14 Management reviews
  1. Technical Requirements

5.1 General
5.2 Personnel
5.3 Accommodation and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling of Test and Calibration Items
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
Annex A (informative) Nominal Cross-references to ISO 9001:1994 and ISO 9002:1994
Annex B (informative) Guidelines for Establishing Applications for Specific Fields
Bibliography  

ISO 17025 Clauses:
SOME Important Aspects that NATA Assessors Investigate:

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.

Scope
ISO 17025 specifies the general requirements for the competence to carry out tests, including sampling. It covers testing using standard methods, non-standard methods and in-house-developed methods.

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

4.1   Organisation

Includes reference to:

  • Qualified personnel
  • Resources
  • Policies and procedures
  • Organisation and management structures
  • Define responsibilities and relationships
  • Supervision
  • Technical management
  • Quality manager
  • Deputies for key staff.

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.

4.8   Complaints

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:

  • Human factors
  • Accommodation and environment
  • Test and calibration methods
  • Equipment
  • Measurement traceability
  • Sampling
  • Handling of test and calibration items.

5.2   Personnel

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.

5.4.2   Selection of methods

Needs of the client must be considered but must not conflict with Good Laboratory Practice or ethical practice. Linked with Clause 4.4.

5.4.5   Validation of methods

Non-standard methods must be validated, ie confirmed that they do provide suitably accurate and precise results.

5.4.6   Estimation of uncertainty of measurement

A reasonable estimate of uncertainty must be made. Following well-recognised test methods with specific limits to the values of uncertainty of measurement and the presentation of calculated results will satisfy this clause.

5.4.7   Control of data

Software developed in-house must be validated and the validation data held for inspection.

5.5   Equipment

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.

5.6.3   Reference standards and reference materials

The use of reference standards and reference materials is encouraged and should be used where possible as it provides practical realisation of traceability.

5.7   Sampling

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.

5.10.5   Opinions and interpretations

Expressions of opinion and interpretation of results must not be reported under the NATA endorsement without the written authority of the NATA Chief Executive. Exemptions to this rule are:

  • Forensic Science
  • Medical Testing
  • Veterinary Testing.

For example, under the NATA endorsement an opinion can be given regarding the level of a human cancer marker but no opinion can be given for the herbicide level in 'Wee Killem'.

5.10.6   Testing and calibration results obtained from subcontractors

Requires due consideration.


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