ISO/IEC 17025 is an international standard that applies to any organisation that performs testing, sampling, or calibration. The globally recognised standard aims to ensure the reliability and validity of results, build confidence in laboratory outputs, and demonstrate a laboratory has achieved a level of competence, impartiality, and operational consistency.
The Benefits of ISO/IEC 17025 accreditation
ISO 17025 is often required in settings where the output impacts safety, regulatory compliance, or product quality, but there are more ways in which having ISO 17025 accreditation can benefit an organisation:
- Evidence of a quality management system (QMS) that meets strict international standards, for confidence in the accuracy and reliability of results.
- Standardised processes and documentation to reduce errors, rework, and wasted resources.
- International recognition to facilitate the acceptance of results across different countries and avoid the need for repetition.
- Demonstrate technical competence, including laboratory staff, equipment, and methods.
- Customer confidence and trust to strengthen the business reputation and competitive advantage.
- Capture and effectively solve problems while driving continuous improvement.
Meeting the requirements of ISO 17025 ensures laboratories demonstrate the presence of comprehensive policies and procedures that are essential for the management of laboratory activities, whilst also assuring clients that their services adhere to globally recognised standards.
What are the Key Requirements of ISO 17025?
A robust QMS is pivotal to the success of ISO 17025. The ISO 17025 Quality Management System ensures that laboratories operate in a controlled, consistent, and transparent manner, thereby supporting technical competence and impartiality. It must adhere to a well-defined structure in line with ISO 17025 standards and organisational requirements.
ISO 17025 laboratories are legally identifiable entities with a well-defined management structure. The standards require that roles, responsibilities, and authority be assigned and documented for accountability, along with risk assessments and measures to maintain impartiality. Additionally, the QMS must protect against conflicts of interest that could undermine the validity and integrity of results.
Here is an outline of the ISO 17025 standards and clauses:
- Scope – Define the ISO 17025 standard, its target audience, and its objective.
- Normative References – References and highlights of guidelines
- Terms and Definitions – Define the terms used in the standard
- General requirements
- Impartiality – measures to prevent any pressuring factors from manipulating, compromising, or altering the quality of the testing results
- Confidentiality – measures to ensure that the results and other key information remain private
- Structural Requirement – Outline requirements on the laboratory’s basic structure and its processes
- Resource Requirements – Divided into six clauses outlining the requirements for resources
- General
- Personnel
- Facilities and Environmental Conditions
- Equipment
- Metrological traceability
- Externally provided products and services
- Process Requirements – Divided into eleven clauses outlining operational requirements
- Review of Requests, Tenders and Contracts
- Selection, Verification, and Validation of Methods
- Sampling
- Handling of test or calibration items
- Technical Records
- Evaluation of measurement uncertainty
- Ensuring the validity of results
- Reporting of results
- Complaints
- Nonconforming work
- Control of data and information management
- Management System Requirement – follows the ISO 9001 requirement. Two options are available, depending on the organisation’s QMS setup.
- Option A – Organisations without ISO 9001:2015 certification
- Option B – Organisations with ISO 9001:2015 certification
- Management system documentation
- Control of management system documents
- Control of records
- Actions to address risks and opportunities
- Improvement
- Corrective actions
- Internal audits
- Management reviews
1. Understanding ISO/IEC 17025:2017 Standard
To effectively implement the ISO/IEC 17025:2017 standard, begin by thoroughly studying the standard to understand its requirements. It is important to interpret these requirements in the context of the specific needs and operations of the organisation.
Following this, conduct a gap analysis to evaluate current practices by comparing them against the standard’s criteria to help identify areas where existing procedures meet the requirements and highlight gaps that need to be addressed for compliance.
Common Pitfall
Inadequate understanding of the standard. This often occurs due to staff turnover, which dilutes the knowledge of the standard’s requirements, especially among junior staff.
How to Avoid
Provide regular, targeted training for all staff, assign responsibility for monitoring updates, and include compliance discussions in reviews. Discuss with experts or consultants if the organisation has difficulties interpreting the standard or identifying an approach.
2. Define a Clear Structure and Responsibilities
The ISO 17025 organisation should clearly outline its structure, roles, and responsibilities to ensure that management tasks are well defined in accordance with ISO/IEC 17025. Management needs to be committed to quality and the organisation must specify who has authority, who possesses the required competence, and who has oversight over the processes.
Common Pitfall
Unclear roles and insufficient staff competence. Vague job roles and inconsistent training can lead to staff not fully understanding their responsibilities or the impact of their actions on compliance.
How to Avoid
Clearly define and communicate roles, maintain up-to-date competence records, and encourage questions and feedback.
3. Personnel, Training and Competence
Your organisation should document their training approaches, clearly outlining the specific requirements tailored to each team role. Additionally, it is essential to define the methods to assess and monitor the competence of individuals, ensuring that these processes are documented for accountability and consistency.
Common Pitfall
Unclear definition of competence. The definition of staff competence is either unclear or lacks objective evidence to support the staff’s competence.
How to Avoid
Clearly define competence requirements, retain any objective evidence, and conduct ongoing monitoring of competency.
4. Documentation System
Your organisation should establish a list of foundational documents and detail the specific requirements for each document. An example documentation system may include the following components:
- Quality Manual – This document serves as the framework of the QMS.
- Policies – These documents explicitly describe the organisation’s objectives.
- Standard Operating Procedures (SOPs) – These procedures outline the methods for achieving the stated policies.
- Work Instructions – These documents provide detailed guidance on the execution of each process step, commonly used in technical environments.
- Forms and Templates – These serve as records and evidence of compliance with established protocols.
Common Pitfall
Poor control of documentation and records. Labs may update their view of this as administrative, leading to the use of obsolete documents, a lack of change tracking, and informal records.
How to Avoid
Ensure only current documents are in use, regularly audit records for completeness, and train staff on documentation importance.
5. Risk Assessment and Management
The ISO 17025 organisation should implement an effective and proactive risk management process designed to identify, assess, prioritise, and respond to both risks and opportunities. Conduct risk assessments and undertake periodic reviews to ensure ongoing effectiveness.
Common Pitfall
Weak risk management – risks to impartiality, validity, and reliability are often overlooked, and risk registers become outdated.
How to Avoid
Identify and assess risks regularly, update assessments with changes, and develop and review mitigation plans periodically
6. Measurement Uncertainty
The ISO/IEC 17025 organisation needs to ensure that all measurements are traceable to the International System of Units (SI). Furthermore, it is essential to calculate and assess measurement uncertainty, reporting such findings in accordance with the guidelines established by the International Laboratory Accreditation Cooperation (ILAC).
Common Pitfall
Incomplete identification of uncertainty sources.
Failing to consider all relevant components, such as those from sampling, environmental factors, equipment precision, or even unclear testing requirements.
How to Avoid
Systematically identify and quantify all significant sources of uncertainty, creating an uncertainty budget (a table listing these factors).
7. Internal Audit and Management Review
The ISO 17025 organisation should carry out internal audits to assess compliance with established systems and evaluate their effectiveness. Furthermore, it is important to conduct management review meetings to analyse performance trends, address any instances of non-compliance, and formulate strategies for continuous improvement.
Common Pitfall
Weak internal audit and management review processes. These are frequently treated as mere tasks rather than opportunities for improvement, relying on outdated checklists and failing to analyse trends or risk data.
How to Avoid
Foster a culture that views audits and reviews as improvement opportunities, train auditors to probe deeply, and use meaningful data to inform decisions.
8. Data Integrity and Records Keeping
Records must be kept in a manner that facilitates the reconstruction of work processes and ensures traceability. It is important to document a procedure that delineates the specific data to be recorded.
Common Pitfall
Incomplete technical records – staff under time pressure may omit critical details, such as operator identity or environmental conditions, which undermines traceability.
How to Avoid
Clearly specify required information, train staff for accurate record completion, and regularly audit records for completeness and quality
9. Quality Control and Validation
An ISO 17025 organisation should systematically document and delineate processes pertaining to method validation, proficiency testing, quality control assessments, and inter-laboratory comparisons, as applicable. It is essential to validate laboratory software, automation systems, and analytical methodologies to ensure their fitness-for-purpose, accuracy and reliability.
Common Pitfall
Lack of performance monitoring – insufficient monitoring of quality control data and instrument performance over time, delayed trend detections.
How to Avoid
Monitor and analyse performance – utilise key performance indicators and other metrics to monitor trends in quality control data, enabling prompt detection and correction of issues.
10. Externally Provided Services
Your organisation should assess, select, and approve external providers based on their ability to fulfil the laboratory’s technical and quality standards. It is essential to regularly monitor the performance of these external providers to ensure continued compliance with established criteria.
Common Pitfall
Poor control of externally provided services. Labs may not consider the criticality of external supplies, leading to a lack of formal verification or reliance on unaccredited services.
How to Avoid
Define approval criteria for all suppliers, monitor and review their performance, and keep records of evaluations and actions.
The Steps to Accreditation
ISO/IEC 17025 accreditation signifies a strong QMS, which means it is not simply a quick checklist for an organisation to demonstrate, but rather requires careful planning and dedication, to demonstrate a commitment to quality.
The accreditation journey consists of:
- Gap assessment – involves identifying deficiencies within the organisation’s procedures and aligning them with the requirements of the standard. It necessitates cross-functional input and strong leadership from a quality lead to guide the assessment process.
- Documentation preparation – organisations implementing ISO/IEC 17025 often become overwhelmed with documentation, including determining what documentation is needed and avoiding unnecessary complexity in the procedures to meet the standard’s requirements.
- Training – competency plays a crucial role in ISO/IEC 17025, including ensuring staff are appropriately trained on the standard’s requirements relevant to their roles.
- Readiness Audit – UKAS initial assessment can seem intimidating, and it might be. Before your first ISO/IEC 17025 initial assessment, it is important to let your staff practise and understand what to expect during a UKAS assessment.
- Internal Audit – Regular internal audits are a requirement of ISO 17025 to demonstrate ongoing monitoring and compliance with the standard. This can often be overwhelming, as staff must be trained and assessed as competent to audit, then temporarily removed from their usual duties to carry out these audits. This can be particularly challenging when there is a shortage of staff or qualified personnel. Additionally, potential conflicts of interest can complicate matters, resulting in non-compliance with ISO 17025 requirements.
- Optimisation – the accreditation does not stop here. The ISO 17025 requires continuous improvement and optimisation.
ISO 17025 – An Investment in Quality, Trust, and Credibility
Achieving ISO/IEC 17025 accreditation is more than a compliance exercise – it is an investment in quality, trust, and credibility that strengthens your organisation’s technical competence and reputation.
With hands-on experience and deep knowledge of the standard, at The Knowlogy we offer comprehensive support; creating tailored documentation, delivering role-specific training, conducting mock assessments to overseeing internal audits. Our experienced team not only helps you prepare for accreditation but also works with you to streamline and optimise your quality management system, ensuring it is both compliant and efficient.
By partnering with The Knowlogy, your organisation gains a trusted guide to navigate the ISO/IEC 17025 journey with confidence and long-term success.
Get in contact to see how we can help your organisation succeed.