This introductory guide provides insight into how ISO 17025, the main standard for laboratories, can help your company, why it is important, its basic layout, and what the implementation entails.
ISO/IEC 17025 is the international standard that sets out the general requirements for the competent, impartial, and consistent operation of laboratories. It specifies the activities that must be included in laboratory operations to promote confidence in its ability to produce valid and consistently reliable testing, calibration, and sampling results.
ISO/IEC 17025:2017 is the current, revised standard. The standard was published with collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
Whereas certification according to ISO 9001 or ISO 14001 is recognition that an effective management system is in place, ISO/IEC 17025 includes recognition of the technical competence of laboratories. Accreditation is a formal declaration by an Accreditation Body, after assessment and confirmation, that a laboratory is effective in meeting the requirements of ISO 17025 to perform tests according to its accredited scope.
The standard and accreditation are used by independently owned and operated laboratories, as well as those that are part of larger organizations, irrespective of the industry and size, which are involved in sampling or measurement activities. This includes regulated government and public sectors, as well as non-regulated sectors. ISO/IEC 17025, together with ISO 9001, is the basis for ISO 15189, which specifies particular requirements for competence and quality, as well as accreditation of medical laboratories.
Testing laboratories determine the characteristics of an item of interest for conformity assessment. An example is testing a cereal sample (the item of interest), to see if the amount of pesticides it contains meets the legislated limits (the conformity). Calibration laboratories, on the other hand, compare a measurement instrument of unknown accuracy to one of known accuracy. For example, calibration can be used to ensure that the scale at the airport (the unknown) will accurately weigh your luggage by comparing the readings across against certified mass pieces (the known).
Laboratory sampling, testing, and conformity assessment are crucial enabling factors for technology and trade. ISO/IEC 17025 assists in the harmonization of procedures and standard methods, facilitates cooperation between laboratories and other bodies, and promotes the acceptance of results between countries.
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.
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.
Accreditation begins by having a copy of the standard and knowledge of ISO 17025:2017. Contract an ISO 17025 accreditation body and address their requirements. Plan your training, as all personnel must get through some training, especially employees who will be responsible for management and technical activities and those acting as internal auditors.
The next step is to define and document the laboratory activities for which you seek accreditation, along with the quality objectives of the laboratory. This gives the context to determine to what extent risks should be controlled and processes documented.
Follow with doing a gap analysis between what your laboratory is doing and what the standard requires.
Onto documentation - a manual, while not required, is a good place to document your laboratory policies and objectives. Several procedures are needed, and a number of records must be linked together, kept, and maintained.
What about the application process? Before you can apply for accreditation, you must meet the accreditation body’s requirements, have all the mandatory procedures documented, and have the records to show that the implementation is complete. You must have an active internal audit program, as well as records of all management reviews and method validations. After a remote review of the documentation and activities, the accreditation body will approve recommendation and schedule the accreditation audit. The assessors generally like to see about six months’ worth of activity and record keeping (objective evidence) at the time of the audit, before recommending you for accreditation.
There are a number of training options recommended for various personnel. They are:
ISO/IEC 17025:2017 familiarization training. Before the start of an ISO/IEC 17025 implementation project, the implementation teams should be completely familiar with all of the subject matter contained in the standard. The intent of the standard and each clause should be fully understood, as well as what documentation is required. Introduce the culture of a process approach to activities, risk-based thinking, and evidence-based decision making. Other laboratory employees should have a basic understanding of the standard to start with, gradually adding more training and knowledge as time goes by.
Additional process and management requirements training. This should include actions to address risks and opportunities, effective nonconforming work specification, corrective action and cause analysis, and control of data and information management (computer systems validation).
Internal auditor training. Internal auditors must be trained in accordance with ISO 19011. Internal auditors must know not only the standard, but also how to conduct an audit. Certification for an individual is possible by doing an ISO 17025 Lead Auditors training course certified by the Chartered Quality Institute’s (CQI) International Register of Certified Auditors (IRCA).
Technical training. This includes method validation and evaluation of measurement uncertainty training, as well as quality control training. Some type of formal training is necessary for personnel who are responsible for the quality of results being reported.
To implement ISO 17025 easily and efficiently, use our ISO 17025 Documentation Toolkit that provides step-by-step guidance and all documents for full ISO 17025 compliance.
Tracey Evans