What is ISO/IEC 17025?
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality, and consistent operation of laboratories performing testing and calibration activities.
It is the primary benchmark used in the UK and globally to demonstrate that laboratory results are technically valid, reliable, and traceable to national and international standards.
In the UK, accreditation to ISO/IEC 17025 provides formal recognition of laboratory competence, accepted by regulators, courts, and customers worldwide.
Key Requirements of ISO/IEC 17025
Impartiality
Identify and manage risks to impartiality. Laboratory activities must be undertaken impartially and free from commercial or financial pressures.
Personnel Competence
Personnel must be trained, assessed, and authorised. Competence requirements must be defined for each role affecting laboratory results.
Equipment & Facilities
Equipment must be suitable, calibrated, and maintained. Environmental conditions must be controlled and monitored.
Method Validation
Methods must be appropriate, validated, and controlled. Standard methods must be verified for use in the laboratory.
Metrological Traceability
Measurement results must be traceable to SI units or other recognised references through an unbroken chain of calibrations.
Measurement Uncertainty
Evaluate and report measurement uncertainty. Understand the factors contributing to uncertainty in your results.
Benefits of Accreditation
✓ Regulatory Acceptance
Results from accredited laboratories are accepted by UK regulators, courts, and government bodies without additional verification.
✓ International Recognition
ILAC MRA means your results are accepted in over 100 countries, facilitating international trade and removing technical barriers.
✓ Customer Confidence
Demonstrate technical competence through independent third-party assessment, building trust with customers and stakeholders.
✓ Reduced Errors
Systematic quality management reduces technical errors, rework, and disputes over results, improving laboratory efficiency.
✓ Competitive Advantage
Win contracts where accreditation is specified, including government tenders and regulated industry requirements.
✓ Legal Defence
Accredited results carry weight in legal proceedings and disputes, providing defensible evidence of technical validity.
Laboratory Sectors We Support
Chemical Testing
Environmental, materials, pharmaceutical analysis
Biological Testing
Microbiology, food safety, clinical samples
Calibration
Dimensional, electrical, temperature, pressure
Construction Materials
Concrete, aggregates, soils, asphalt
Mechanical Testing
Tensile, hardness, fatigue, NDT
Environmental
Water, air, soil, emissions testing
The Accreditation Journey
Gap Analysis
Assess your current laboratory operations against ISO/IEC 17025 requirements to identify gaps and develop an implementation roadmap.
System Development
Develop quality manual, procedures, method validation protocols, uncertainty budgets, and competence frameworks tailored to your laboratory.
Technical Implementation
Implement method validation, equipment calibration programmes, traceability chains, and proficiency testing participation.
the national accreditation body Assessment Support
Support through the accreditation body application, document review, and on-site assessment process to achieve successful accreditation.
Frequently Asked Questions
What's the difference between ISO 17025 and ISO 9001?
ISO 9001 is a general quality management standard, while ISO 17025 specifically addresses laboratory competence including technical requirements for valid results. ISO 17025 incorporates quality management but adds detailed technical requirements.
How long does accreditation take?
Typically 9-18 months depending on your starting point, scope complexity, and resource availability. We help you plan realistic timelines and milestones.
Do we need accreditation for all our tests?
No, you can seek accreditation for specific tests or calibrations within your defined scope. Many laboratories start with core activities and extend scope over time.
What is proficiency testing and why is it required?
Proficiency testing involves analysing samples from external providers and comparing your results against other laboratories. It's an essential tool for demonstrating ongoing competence.
How Much Does ISO/IEC 17025 Cost?
The cost of ISO/IEC 17025 certification varies based on several factors. Some consultants and certifiers adopt charging models based on the project's complexity, company size, and sometimes even the company's turnover.
At Certigence, our pricing is straightforward, calculated by multiplying an agreed day rate by the number of days work. This is based on the work to be done, mitigated by any the company has done already or will be doing internally. This ensures clarity and transparency, giving you a clear understanding of the commitment before the project commences.
We provide a free telephone or Zoom consultation with one of our consultants to find out enough about your organisation to be able to make a formal proposal without charge or obligation. This allows you to research costs for free before making any commitments!
How Can Certigence Consultants Help?
Certigence's extensive consultant network spans the entire UK and has been operating ISO systems expertise combined with industry know-how for over 25 years. This dual proficiency enables them to comprehend your unique needs and translate them into certifier-accepted procedures that genuinely suit your organisation's operations.
Our services encompass full or partial ISO system development and implementation, including GAP analysis and customised internal training to support system functionality. We craft organisation-specific reports tailored to your activities.
Beyond initial implementation, we conduct internal audits, facilitate management review meetings, and offer ongoing maintenance for short, medium, or long terms. Our presence during certification stages, if desired, ensures assessors avoid unnecessary complexity. Furthermore, we offer pre- and post-certification review services to address certifier-raised concerns, reinforcing your ISO system's effectiveness.
Process Overview
Initiation and Assessment Discussion
We engage in a free, no-obligation discussion to understand your existing systems and operations, allowing us to generate a formal proposal.
Work Commencement and Collaborative Development
Upon acceptance, collaborative work commences to create and install systems, involving you and your team to ensure alignment with your needs, your understanding and acceptance of the results and compliance with ISO standards.
Initial Assessment (Stage 1): Ensuring Systems Meet Standard
the national accreditation body reviews that systems cover all relevant parameters correctly. You may choose to have our consultant present during the initial assessment to assist with any questions the certifier may have.
Final Evaluation (Stage 2): Achieving Certification
The consultant ensures internal audit, management review, and training aspects are covered. accreditation body conducts the conclusive Stage 2 assessment, verifying operational systems' alignment with Standard requirements. Upon successful completion, you attain Certification.
Why Should You Use a Certigence Consultant?
At Certigence, we match your requirements with suitable consultants based on their industry expertise, proximity, and compatibility. In the event of a consultant's unavailability, a substitute can step in promptly, avoiding project disruptions and re-hiring expenses. Our consultants have often previously worked with certifiers, learning that side of the procedure – facilitating a seamless Certification process.
This commitment reflects in our track record – a 100% first-time certification success rate spanning over 25 years.
Ready to Speak? What Happens Next?
After contacting Certigence, you'll receive an email or a call from the Director or a consultant. Discussions about needs, timelines, reasons, and costs occur. A consultant will directly engage with you to understand your requirements and system alignment. A formal proposal is then presented for your consideration. Charges apply only from that point if you proceed with the proposal.
Achieve Laboratory Accreditation
Partner with our laboratory accreditation specialists to achieve accreditation to ISO/IEC 17025 and demonstrate your technical competence.