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Many laboratories and life science organisations struggle to decide between ISO 9001 certification, ISO/IEC 17025 accreditation and OECD GLP compliance. All three exist to ensure reliability, accuracy and integrity, but they answer different questions.
ISO 9001 asks whether your organisation is well managed. ISO/IEC 17025 asks whether your laboratory is technically competent. OECD GLP asks whether a specific study can be trusted by a regulator.
In Australia, for example, NATA (National Association of Testing Authorities) manages ISO/IEC 17025 accreditation and is recognised by the Australian Government as the national GLP compliance monitoring authority. ISO 9001 sits outside that structure, awarded as certification by a certification body rather than accreditation.
Understanding the similarities, differences and potential integration of these three frameworks is crucial for organisations aiming to meet client expectations and regulatory requirements.
What is ISO9001?
ISO 9001 is the international standard for quality management systems. It applies to any organisation in any sector, of any size, whether that is a laboratory, a manufacturer, a consultancy or a hospital.
The current edition is ISO 9001:2015. A revised edition has reached final draft stage and is expected to be published in September 2026, with a transition period for certified organisations. Confirm the current edition and transition timelines on iso.org before planning certification work.
ISO 9001 applies to any organisation, regardless of industry, size or product. It focuses on the management system: leadership, customer focus, the process approach, risk-based thinking and continual improvement.
Does not assess technical competence to perform a specific test, calibration or study.
ISO 9001 certification is frequently a procurement, tender or supply chain requirement because provides assurance to customers that that the company:
- Demonstrates a consistent, well-governed approach to quality across the whole organisation
- Shows commitment to customer satisfaction and continual improvement
ISO9001 is a quality management system foundation that other standards can build on.
What is ISO/IEC 17025 Accreditation?
ISO/IEC 17025 is the international standard for testing and calibration laboratories.
It applies to all organisations performing tests and calibrations (standard, non-standard, or lab-developed methods).
People seek ISO/IEC 17025 accreditation because it:
- Focuses on technical competence, valid methodologies, and equipment calibration
- Enhances credibility by ensuring reliable, reproducible results
- Demonstrates technical competence
- Ensures accurate, consistent test results
- Builds trust with clients, regulators, and stakeholders
What is GLP Accreditation?
When it comes to being ‘accredited’ for GLP, the only accreditation scheme that exists in Australia is OECD GLP.
What is OECD?
The Organisation for Economic Co-operation and Development (OECD) is an international organisation that works together with governments, policy makers and citizens, to establish evidence-based international standards and find solutions to a range of social, economic and environmental challenges.
The OECD Principles of Good Laboratory Practice (GLP) apply to non-clinical environmental and health safety studies.
OECD GLP has the following scope:
- It focuses on studies assessing the safety of chemicals and chemical products
- It emphasises organisational processes, documentation, and reporting
- It requires traceability of study conduct and outcomes
People seek OECD GLP accreditation to:
- Ensures regulatory acceptance of study data worldwide
- Demonstrates credibility in safety assessments
- Provides transparency and traceability for critical non-clinical studies
Similarities Between ISO9001, ISO/IEC 17025 and OECD GLP
All three frameworks:
- Emphasise quality, integrity, and reliability of operations
- They require proper documentation and traceability
- Demonstrates credibility in safety assessments
- Provides transparency and traceability for critical non-clinical studies
- They encourage continual improvement and oversight
Key Differences Between ISO/IEC 17025 and OECD GLP
Following are what distinguish the two accreditation scheme.
ISO 9001:
- Broadest scope → any organisation, in any sector
- Focuses on management system effectiveness, customer satisfaction and continual improvement
- Does not evaluate technical competence or the validity of individual results
- Results in certification by a certification body
ISO/IEC 17025:
- Broad within the laboratory sector → testing and calibration labs across industries
- Focuses on technical competence, method validation, measurement uncertainty, and equipment calibration and maintenance
- Includes management system requirements that can be met through Option A (the requirements set out in Clause 8) or Option B (a management system conforming to ISO 9001 that also supports consistent fulfilment of Clauses 4 to 7)
- Results in accreditation by a body such as NATA
OECD GLP:
- Narrowest scope → non-clinical health and environmental safety studies
- Stronger focus on traceability of study conduct, raw data and reporting
- Unique requirement: each study must have a designated Study Director, supported by an independent Quality Assurance function
- Results in compliance monitoring and recognition by a national authority rather than accreditation to a standard
In short: ISO 9001 is managerial and universal, ISO/IEC 17025 is technical and laboratory-specific, and OECD GLP is organisational and study-specific.
Can Laboratories Integrate ISO9001, ISO/IEC 17025 and OECD GLP?
Yes. These frameworks are designed to layer rather than compete.
Many organisations start with ISO 9001, which gives them a functioning management system: document control, records, internal audit, management review and corrective action. ISO/IEC 17025 then adds the technical layer, covering competence, methods, equipment, measurement uncertainty and the reporting of results. Clause 8 of ISO/IEC 17025:2017 makes this relationship explicit, allowing a laboratory that already operates an ISO 9001 management system to use Option B rather than rebuilding from scratch.
Extending into OECD GLP builds on both, but introduces study-specific roles and processes, most notably the Study Director, the study plan, and an independent Quality Assurance programme. NATA encourages GLP test facilities to also seek ISO/IEC 17025 accreditation for the testing component of their GLP activities, so that technical competence is formally recognised alongside GLP compliance.
Note: ISO 9001 certification on its own does not demonstrate technical competence to produce valid test or calibration results, and it is not accepted as a substitute for ISO/IEC 17025 accreditation or GLP compliance where those are required.
For many organisations, ISO 9001 and ISO/IEC 17025 together offer a comprehensive framework that enhances technical competence and quality management while positioning them well for compliance with other standards, including OECD GLP. Together they demonstrate to clients and regulatory bodies that the organisation operates to internationally recognised quality standards, ensuring the reliability and integrity of its results.
Short Version: ISO/IEC 17025 vs OECD GLP, which one should you pick?
All three ensure quality and reliability, but they answer different questions.
ISO 9001:
- For any organisation, in any sector
- Focuses on the management system, customer focus and continual improvement
- Does not assess technical competence
ISO/IEC 17025:
- For testing and calibration laboratories
- Focuses on technical competence and quality management
- Applicable to all labs, regardless of size or scope
OECD GLP:
- For non-clinical environmental and health safety studies only
- Ensures high-quality, reliable test data on chemical and material safety
- Emphasises traceability and study oversight
Similarities:
- Ensure quality and integrity
- Require documentation, training, and handling of non-conformities
- Regular audits and reviews
Differences:
- ISO 9001 is the broadest, covering the whole organisation
- ISO/IEC 17025 adds technical competence for testing and calibration
- OECD GLP is specific to non-clinical safety studies
- GLP requires a Study Director for each study
- ISO 9001 system is certified, ISO/IEC 17025 system is accredited, and GLP compliance is monitored
Decision matrix for choosing between ISO/IEC 17025 and OECD GLP
If you’re unsure which framework fits your organisation, this quick comparison of ISO 9001 vs ISO/IEC 17025 vs OECD GLP highlights the key differences and benefits:
|
Criteria |
ISO 9001 |
ISO/IEC 17025 |
OECD GLP |
Consideration |
|
Scope |
Any organisation, in any sector |
Testing and calibration |
Non-clinical environmental and health safety studies |
Choose based on your activities and who relies on your results |
|
Objective |
Ensure a consistent, well-managed quality system |
Ensure competence in testing and calibration |
Ensure quality and integrity of safety studies |
Consider the organisation’s primary function |
|
Technical requirements |
Technical competence is not formally assessed. The focus is on the system that ensures staff training and competence |
Focus on technical competence, method validation, and calibration |
Less emphasis on technical specifics, more on study conduct and data integrity |
Consider management vs technical vs study focus |
|
Management system |
Comprehensive QMS, strong emphasis on continual improvement |
Comprehensive QMS, continual improvement required |
Specific QMS requirements for study conduct, less focus on continual improvement |
ISO 9001 and ISO/IEC 17025 are broader in QMS scope |
|
Documentation |
Documented information proportionate to the organisation |
Detailed on method validation, calibration, and quality control |
Detailed on study plans, study conduct, raw data, and reporting |
Match with the lab’s documentation practices |
|
Personnel |
Competence, awareness, and clearly defined responsibilities |
Technical staff competence, training, and qualifications |
Roles and responsibilities defined, including Study Director and independent Quality Assurance |
Assess staffing and roles needed |
|
Form of recognition |
Certification by a certification body |
Accreditation by a body such as NATA in Australia |
Compliance monitoring and recognition by a national authority (NATA in Australia) |
Consider what clients and regulators will actually accept |
|
Regulatory recognition |
Widely accepted commercially, rarely mandated by regulators |
Widely recognised by accreditation bodies worldwide |
Required for certain regulatory submissions in health and environmental safety |
Consider regulatory needs |
