The ISO/IEC 17025 quality management system

The ISO/IEC 15189 standard for medical laboratories is based upon the ISO 9001 standard, and the ISO/IEC 17025 standard which is the focus of this post. Understanding these two standards will make it easier to understand the requirements of the ISO/IEC 15189 standard. The ISO/IEC 17025 and ISO/15189 being technical standards are produced in collaboration with the International Electrotechnical Commission (IEC) which helps publish standards for all electrical, electronic and related technologies.

ISO/IEC 17025 General requirements for the Competence of Testing and Calibration Laboratories is the main standard used by testing and calibration laboratories. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. This standard is used to show that:

1. Organizations operate a quality management system and that

2. They’re technically competent to do the work that they do.

ISO/IEC 17025 makes reference to accuracy, precision, traceability, measurement uncertainty, and method validation which are important in the use of analytical scientific instrumentation for the identification and quantitation of analytes. Most testing labs conduct analytical testing, therefore ISO/IEC 17025 is a good fit.

The current version, ISO/IEC 17025:2017  was published in 2017 and replaces the ISO 17025:2005 version. It is important to ensure that you always use the correct and current version of the Standard.

ISO 9001, ISO/IEC 17025, ISO/IEC 15189

  • Laboratories that conform to ISO/IEC 17025 and  ISO/IEC 15189 standards generally also operate in accordance to the principles of ISO 9001 but ISO/IEC 17025 and ISO/IEC 15189 add the concept of competence which applies directly to those organizations that produce testing and calibration results.
  • Organisations are certified to ISO 9001 but accredited to ISO/IEC 17025 and ISO/IEC 15189. There is a difference between certification and accreditation. 
  •  ISO/IEC 17025 and ISO/IEC 15189 are technical standards produced in collaboration with the International Electrotechnical Commission
  • ISO/IEC 17025 and ISO/IEC 15189 are both accreditation standards and both apply to testing laboratories. However, ISO/IEC 15189 takes into account the specific requirements of the medical environment and patient care. Medical Laboratories engage in a wide range of multi-disciplines, some of which are not a good fit for ISO/IEC 17025 because they are not analytical chemistry in nature.

ISO 17025 standard requirements

The ISO 17025:2017 standard requirements are broadly separated into eight clauses. As in the ISO 9001 Standard, Clauses 1 through to 3 do not include any requirements:

Clause 1_The scope of the ISO 17025 Standard: This explains which organizations should use the standard. Whilst the ISO 9001 standard is generic in nature, ISO 17025 is specific to all organizations performing laboratory activities.

Clause 2_Normative Reference: The Normative References for the ISO/IEC 17025 Standard are:

ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)1) and ISO/IEC 17000, Conformity assessment — Vocabulary and general principles.

These documents are referred to in the text in such a way that some or all of their content constitute requirements for the ISO/IEC 17025

Clause 3_ Terms and Definitions: The dictionary section of the standard, the terms and definitions are given in ISO/IEC Guide 99 and ISO/IEC 17000 and mentioned in Normative references, they are also defined in the standard as they are critical to understanding the requirements of this standard.

3.1-Impartiality iso 17025,Terms and conditions

3.2-Complaint

3.3-InterLaboratory Comparison

3.4-Intra-laboratory Comparison

3.5-Proficiency Testing

3.6-Laboratory

3.7-Decision Rule

3.8-Verification

3.9-Validation

Clause 4_ General requirements

4.1 Impartiality

4.2 Confidentiality

4.1 Impartiality

Presence of objectivity.

No conflicts of interest exist or are resolved so as not to adversely influence subsequent activities of the laboratory.

4.2 Confidentiality

Implies that the laboratory will ensure the management of all information obtained or created during lab activities

Clause 5_ Structural RequirementsISO 17025 Requirements, Structural Requirements

5.1 Legal Identification

5.2 Management Responsibility

5.3 Range of Laboratory Activities

5.4 Requirements

5.5 Organization

5.6 Authority and Resources

5.7 Communication and Integrity

This clause helps laboratories in organizing their structure. There is a need to ensure that the laboratory is a legal entity and that the identity of the Laboratory is clearly defined. If the laboratory is part of a bigger organization it should be clear where it stands in the organization chart/Organogram. Management should be clearly identified, including responsibility in ensuring the maintenance of the Quality Management System. The scope of the QMS is defined in the Range of Laboratory activities (calibration, testing or sampling) for which the Laboratory seeks accreditation. The laboratory needs to define the requirements to be met and these should include requirements of the  ISO/IEC 17025 standard, the laboratory’s customers, regulatory authorities and accreditation bodies at a minimum. Personnel with defined authority must be in place to implement, maintain and improve the management system, this may involve appointing a Quality Officer who reports to management on issues pertaining to Quality. Resources must be made available e.g QMS activities must be budgeted for. Management ensures management system communication and meeting customer requirements as well as maintaining the integrity of the management system.

Clause 6_ Resource Requirements

6.1 General ISO 17025 requirements, Resource requirements

6.2 Personnel

6.3 Facilities and Environmental Conditions

6.4 Equipment

6.5 Metrological Traceability

6.6 Externally provided products and services

This clause defines the requirements for all the resources required to perform laboratory activities. Resource requirements encompass personnel, facilities, equipment, systems and support services. This is a competency-based standard, therefore duties and descriptions have to be clearly defined, policies and procedures must be in place to ensure that recruitment processes attract suitable people who will be hired, inducted, trained and competency assessed to ensure competence. Laboratory conditions need to be suitable to perform all activities and not affect the validity of the results, these environmental conditions should be defined, controlled and maintained within set standards. The laboratory shall have access to the proper equipment required for the performance of laboratory activities. Records for all equipment which can influence laboratory activities, including the handling, transport, storage, use and maintenance of equipment shall be maintained. Internal and external maintenance and preventative maintenance and calibration shall be planned and conducted to ensure full functionality of the equipment. Calibration must be performed by an accredited competent laboratory so that measurement results are traceable to the International System of Units (SI). Where products and services are provided by external providers, the laboratory must ensure that these are satisfactory, requirements for externally provided products and services must be defined, reviewed and maintained.

Clause 7_Process Requirement

7.1 Review of requests, tenders and contract

7.2 Selection, verification and validation of methods
7.3 Sampling                                                                                          ISO 17025 requirements, Process Requirements

7.4 Handling of test or calibration items

7.5 Technical Records

7.6 Evaluation of Measurement Uncertainty

7.7 Ensuring the validity of results.

7.8 Reporting of Results

This requirement ensures that all the Laboratory processes from receipt of test/calibration right through to reporting of results are controlled. It required the es that there are appropriate documented procedures and methods for all activities carried out by the Laboratory. Records of activities should also be retained as evidence that procedures have been performed according to requirements.

The laboratory must have a procedure for transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items. Records should include the original observations, data and calculations, and be recorded at the time they are made. If changes are made, these amendments need to be tracked to previous versions or to the original observations. The laboratory must develop a procedure for monitoring the validity of their results. The main goal is to understand if the system or process is efficient. Managing customer complaints is important and you must have a documented process to receive, evaluate and make decisions on how to handle ISO 17025 complaints. The laboratory must retain records of nonconforming work, and if the lab believes nonconformities may take place again, the lab needs to take corrective action. The lab needs to ensure that the information management system used for collection, processing, recording, reporting, storing and/or retrieving data is validated for functionality. This includes the proper function of interfaces within the laboratory information management system. If there are changes made to software configuration or modifications to commercial software, they need to be authorized and validated before used.

Clause 8_Management System Requirements

Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. ISO 17025 gives the organization an option to first implement the requirements of ISO 9001 as this essentially is what the Management requirements of ISO 17025 are.

 


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