ISO 17025:2017
ISO 17025
ISO/IEC 17025:2017 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
ISO/IEC 17025:2017 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2017, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2017 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2017 is not intended to be used as the basis for certification of laboratories.
Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2017.
STRUCTURE OF ISO 17025
The ISO/IEC 17025:2017 structure is divided into five main sections that contain the requirements for laboratory accreditation.
Section 4: General Requirements. This section covers impartiality and confidentiality, two requirements that are vital for maintaining the trust and confidence that the users of tests and calibrations place in the laboratories they use. Impartiality implies that the laboratory will not allow commercial, financial, or other pressures to compromise the quality of results. Internal issues, personal relationships, or other conflicts of interest are addressed and resolved. Confidentially requires the laboratory to keep all results and information private.
Section 5: Structural Requirements. This section defines the basic organizational components of a laboratory, its range of activities, and its commitment to an effective management system. It states that an accredited laboratory must be a legal entity or part of a legal entity, which is responsible for its testing and calibration activities. Section 5 sets management’s responsibilities in an accredited laboratory and their responsibilities to customers, regulatory authorities, and organizations that provide recognition. Section 5 also defines the basic requirements for personnel, the authority given to them, and the resources needed to carry out their duties.
Section 6: Resource Requirements. There are six clauses that address the requirement for the laboratory to have available the personnel, facilities, equipment, systems, and support services necessary to perform its laboratory activities.
Section 7: Process Requirements. This section covers 11 core processes to improve efficiency. The section begins with the Review of Requests, Tenders and Contracts.
The Selection, Verification and Validation of Methods is one of the most technical and most important parts of the standard. Sampling, the handling of test items, and technical record keeping are covered here. Ensuring the validity of results is the quality monitoring and control function in the laboratory. Several tools for monitoring are listed, and the requirements for proficiency testing are explained.
The standard goes into much detail regarding the reporting of results. Requirements are laid out for dealing with complaints and nonconforming work. A focal point in this electronic age is clause 7.11, Control of Data and Information Management.
Section 8: Management Systems Requirements. This is where Options A & B come in. Option B applies if the laboratory is part of a larger organization, or if it has its own effective management system in accordance with ISO 9001:2015. Here, the management system requirements specified in clauses 8.2 to 8.9 are covered by the existing QMS, as long as laboratory activities are included and the laboratory is capable of demonstrating its fulfillment of ISO 17025 clauses 4 to 7. If the laboratory’s Quality Management System is independent of any other management system, Option A applies and the laboratory must comply with Section 8’s requirements.
This section covers eight activities, including QMS documentation such as policies and objectives, control of documentation and records, addressing risks and opportunities, improvement, and corrective action.
It ends with the internal audit and management review. Once again, this standard only gives you the general requirements; therefore, it is best to consult ISO 19011 (Guidelines for auditing management systems) to fill in the details for internal audits.
BENEFITS OF ISO 17025 FOR YOUR ORGANISATION
The benefits range from strategic, to external business, to internal improvement. A few are highlighted here:
Increasing customer confidence. Accreditation to ISO/IEC 17025:2017 demonstrates that a laboratory is capable of providing consistently valid results, that the individuals performing the work are competent, and that all accredited measurement results can be traced back to the International System of Units (SI) or appropriate references. This is the primary objective for your customers, so that results are accepted between countries.
Creating a proactive risk-based business and quality culture, not reactive. Defined activities, policies, and quality objectives are the foundation for the strategic direction of the organization. A culture of risk-based thinking drives cost-effective operations and evidence-based decision making. The laboratory must plan actions to address risks and drive improvements and ensure that major quality risks related to tests and calibrations are known and controlled (carried out the same way every time).
Assuring your laboratory’s creditability. Your test and calibration methods must be reviewed and audited to ensure that you are using the latest technology and documentation available. Assessment by a third-party accreditation body verifies that tests and calibrations are done correctly by trained laboratory professionals.
Creating an environment of professionalism and pride. A third-party assessment, in which auditors look over your shoulder and examine all of your work, is tough - but, once it’s over, the auditee will feel a sense of accomplishment and pride. Third-party accreditation provides a sense of pride for the entire organization.
