How to get an ISO 17025 certification
ISO 17025 certification is the international quality benchmark for the modern testing and calibration laboratory.
ISO 17025 is a powerful model for structuring a robust, continuously improving quality management system that optimizes your lab operation.
Here's everything you need to know about unlocking ISO 17025 accreditation.
Table of Contents
What is ISO 17025 certification?
ISO 17025 certification is a globally recognized quality assurance target for calibration, sampling and testing laboratories. This includes all laboratories that perform these activities, and not just those within the life science sector.
Now for some pedantry.
Like with all ISO 17000 standards, and unlike most other ISO standards, assessment of your laboratory for adherence with ISO 17025 requirements is normally carried out by your national organization responsible for accreditation.
Your lab can therefore only be 'accredited' to ISO 17025, rather than 'certified' by a third party. ISO 17025 certification is therefore not technically possible. The term, though, is still generally used interchangeably with ISO 17025 accreditation, and you can find plenty of content online that refers to ISO 17025 certification.
This distinction is one to bear in mind for accuracy's sake, even though it doesn't affect your pathway to securing ISO 17025 recognition for your laboratory.
What is the meaning of 17025?
Obtaining ISO 17025 accreditation demonstrates that your laboratory produces accurate and precise calibration data and test results, and proves that:
- Your staff are technically competent
- Your test equipment is maintained
- Your measurements and calibrations align with national standards
- Your calibration and test data is underpinned by proper quality assurance
- Your items are correctly handled and transported
- Your testing environment and sampling is performed to the highest quality
ISO 17025 requirements for certification
The ISO 17025 standard is divided into resource, process and management requirements.
Resource requirements address the competence of your personnel, facilities and environmental conditions, equipment and metrological traceability, as well as externally provided products and services.
Process requirements are concerned with the review of requests, tenders and contracts, the selection, validation and verification of methods, sampling, the handling of test and calibration items, technical records, estimation of measurement uncertainty, validity and reporting of results, complaint handling, non-conformances, and control of data and information management.
Management system requirements focus on the general requirements for the management of your laboratory. Topics such as management system documentation, control of this documentation and records, actions to address risks and opportunities, improvement, corrective actions, internal audits and management reviews are addressed.
Benefits of ISO 17025 certification
Why bother pursuing ISO 17025 accreditation and going through the process?
There are a few powerful benefits for your laboratory to consider.
Enhanced credibility
Unlocking ISO 17025 accreditation indicates that your laboratory operates to an internationally accepted benchmark, meeting the highest standards of reliability and quality.
As a result, you can expect increased stakeholder, regulatory and customer satisfaction.
Improved quality management system
To become accredited, a robust quality management system (QMS) must be implemented, which in turn helps streamline laboratory processes, increase efficiency and reduce errors.
Established criteria for performance
Accredited laboratories undergo regular compliance assessments to ensure that their standard of technical expertise is maintained.
ISO 17025 accreditation bodies assess all aspects of a laboratory’s operations associated with the production of accurate and dependable data.
This drives continuous improvement within your laboratory, as any findings identified during an assessment are closely monitored by the accreditation body.
Technically competent staff
Employees performing testing and calibration activities undergo a competency assessment to ensure they have the training and skills necessary to perform their duties.
Global recognition
Test reports and certificates from an ISO 17025-accredited lab are accepted between countries without the requirement for further testing.
This facilitates cooperation between accredited laboratories and other organizations, due to the increased acceptance of test results between countries.
Competitive advantage
Organizations prefer working with accredited laboratories, as they can be more confident in the accuracy and reliability of their test results.
A new client will always be drawn to an accredited laboratory over a non-accredited laboratory.
In the wake of the incredible Theranos scandal, ISO 17025 accreditation goes a long way to assuaging public doubts, too.
The ISO 17025 certification process
So how does ISO 17025 certification - or accreditation - work?
Like any ISO standard, accreditation isn't an overnight task and requires careful, proactive planning for a right-first-time approach.
Here's what to expect.
Choosing an accreditation body
As we've touched on above, ISO 17025 recognition can only be bestowed by a national accreditation body, rather than 'certified' by a third-party service.
The process for obtaining ISO 17025 accreditation therefore begins with requesting it from your appropriate accreditation body, such as:
- American Association for Laboratory Accreditation (A2LA)
- ANSI National Accreditation Board (ANAB)
- United Kingdom Accreditation Service (UKAS)
- Japan Accreditation Board (JAB)
- Standards Council of Canada (SCC)
The following factors should be considered when choosing an accreditation body so that an informed decision can be made about choosing one that aligns with your laboratory’s specific needs and requirements.
International recognition
This ensures that the accreditation is widely accepted and acknowledged. Look for accreditation bodies that are members of international organizations such as ILAC (International Laboratory Accreditation Cooperation) or IAF (International Accreditation Forum).
Accreditation scope
Check the accreditation body's scope of accreditation to ensure it covers the specific testing and calibration activities relevant to the laboratory.
Make sure they have experience and expertise in accrediting laboratories in the specific industry or field required.
Accreditation process and requirements
Understand the accreditation process and the specific requirements set by the accreditation body.
Evaluate whether the process aligns with your laboratory's capabilities, resources and timelines.
Consider factors such as assessment frequency, documentation requirements and the level of technical expertise of the assessors.
Technical competence and expertise
Assess the technical competence and expertise of the accreditation body's assessors. Experienced assessors can better understand your laboratory's operations and provide valuable contextual insights
Cost and fees
Evaluate the accreditation body's pricing structure and fees. Consider not only the initial accreditation costs but also ongoing fees, such as annual maintenance fees.
Support and resources
Consider the support and resources provided by the accreditation body. This can include training programs, workshops, technical guidance or access to resources that can help your laboratory improve its quality management system.
Initial assessment & gap analysis
Make sure you acquire a copy of the ISO 17025 standard to become familiar with the requirements and understand the obligations that your laboratory needs to fulfill.
It’s important to then conduct a gap analysis to examine current laboratory practices against the requirements, so that the areas where your laboratory needs improvement can be identified to meet the standard’s criteria.
Implementing the standard
Now it's time for the proper ISO 17025 accreditation process to begin.
Unlocking ISO 17025 accreditation involves some key steps, including:
- Having the support of senior management
The foundation of any successful implementation requires full backing from your management team. Their backing ensures resources are assigned and there is a full company-wide commitment to the implementation - Determining the organizational context
Define the extent of your company’s daily operations as it relates to ISO 17025, the testing methods that are within the scope of the accreditations, and who your customer is going to be - Identify the roles and responsibilities of personnel involved in the implementation and maintenance of the QMS
Assign specific responsibilities for quality management, technical competence, training, equipment maintenance, and other relevant areas - Address risks and opportunities
Ensure that activities are evaluated to mitigate any identified risks - Define the processes and procedures for the activities undertaken by the laboratory
Once defined, implement these processes, procedures and controls and put a plan in place to monitor the implementation and determine the effectiveness of the established procedures - Conduct training on the ISO 17025 standard
Involve all staff and highlight any changes to daily activities required as a result of the implementation - Contact the accreditation body
So that the assessment process can be planned in order to build an ISO 17025 accreditation roadmap - Operate the Laboratory Management System
Make it the center of the activities conducted within your lab - Evaluate the QMS
Compare it against the requirements of ISO 17025 by conducting regular internal audits to ensure that your system is working as intended - Hold management review meetings regularly
Discuss and share how all areas of your management system are functioning
We'll dive into some of these in more detail later.
Now let's look at some of the adjacent activities you should have in place as you kick-start your ISO 17025 certification journey.
Internal auditing
Conduct regular internal audits to evaluate the effectiveness of your QMS and identify areas for improvement.
These audits should be performed by trained internal auditors who are independent from the areas being audited.
Use audit findings to drive corrective actions and continual improvement.
Watch our webinar recording: How to use internal audits to drive standardization
Management review
Hold periodic management reviews to assess the performance of your laboratory's QMS.
Review audit findings, customer feedback, corrective actions and other relevant data to ensure continual improvement.
Use this review to set objectives, allocate resources and make decisions for further enhancements.
External assessment & accreditation
Engage an accredited certification body to perform an external assessment of your laboratory's compliance with ISO 17025.
This assessment typically includes a thorough audit process, including document review, on-site assessments, and proficiency testing.
Successful completion of the assessment leads to ISO 17025 accreditation and the issuance of ISO 17025 certification.
Surveillance audits & reassessment
Once your laboratory gains ISO 17025 accreditation, you will undergo surveillance audits every year to ensure you're still compliant with the requirements of the standard.
These audits are not as intensive as a reassessment or recertification audit, which is conducted every three years from when the original certification was obtained.
Recertification audits are conducted to ensure that any changes to the ISO 17025 standard, as well as any changes within your organization, have been assessed and implemented accordingly.
Preparing for ISO 17025 accreditation
You should get some core ingredients in place as you plan your ISO 17025 roadmap.
FURTHER READING: Mastering quality management in laboratory environments (12 essential techniques for 2023)
Top management commitment & responsibility
Getting top management commitment to ISO 17025 accreditation is crucial for the successful implementation and maintenance of the standard.
Strategies to ensure this commitment include communicating the benefits and ROI, educating on the objectives of the standard, and ensuring the significance of internationally recognized quality and compliance is understood.
Employee training & competence
ISO 17025 accreditation requires that your laboratory personnel have the necessary training, competence and skills to perform their roles effectively and ensure the accuracy and reliability of test and calibration results.
Here are some key aspects of employee training and competence you should think about:
General training
Provide general training to all laboratory personnel on the quality management principles and requirements of ISO 17025.
This training should familiarize them with the standard's clauses, your laboratory's QMS, and their roles and responsibilities in implementing and maintaining the QMS.
Technical competence
Ensure that personnel possess the necessary technical competence for their specific roles.
This includes a combination of educational qualifications, knowledge, skills, experience, and training related to the specific tests, calibrations, or measurements they perform.
Personnel should be capable of selecting appropriate methods, operating equipment, conducting analyses and interpreting results accurately.
Method validation and verification
Provide training on method validation and verification procedures to personnel involved in developing, validating or verifying testing or calibration methods.
This training should cover the principles, procedures and documentation requirements for establishing the validity and reliability of methods used in your laboratory.
Measurement uncertainty
Train personnel on the concept of measurement uncertainty and its estimation.
They should understand the factors that contribute to uncertainty and how to calculate and report it correctly. This training ensures that personnel can effectively assess and communicate the reliability of measurement results.
Equipment & instrumentation
Provide training on the proper handling, operation, maintenance and calibration of laboratory equipment and instrumentation.
This includes training on the use of measurement standards, calibration procedures and equipment-specific software. Personnel should also be aware of equipment-related quality control procedures, such as regular maintenance, calibration, and verification.
Documented procedures & work instructions
Ensure that personnel are trained on the laboratory's documented procedures and work instructions relevant to their roles. They should understand how to follow these procedures correctly, document their activities, and maintain accurate records.
This training promotes consistency, standardization, and compliance with ISO 17025 requirements.
Proficiency testing
Familiarize personnel with proficiency testing programs and their participation requirements. Provide training on the proper handling of proficiency test samples, blind testing protocols, and result reporting procedures. Personnel should be trained to perform proficiency testing effectively and use the results to evaluate their own performance and identify areas for improvement.
Continuous training & professional development
Promote a culture of continuous learning and professional development within your laboratory. Encourage personnel to participate in relevant training programs, workshops, conferences, and seminars to enhance their technical knowledge, skills, and industry awareness.
Provide opportunities for cross-training and knowledge sharing among team members.
It's important, too, to maintain records of employee training and competence assessments as evidence of compliance with ISO 17025 accreditation requirements.
Regularly review and update your training needs and competence requirements to address changes in methods and technologies.
Appropriate documentation
Like any ISO standard, ISO 17025 certification is impossible without a properly maintained set of controlled documents.
ISO 17025 accreditation requires the implementation and maintenance of appropriate documentation to ensure the effective operation of your laboratory and compliance with the standard's requirements.
Some key documents to get in place include:
Quality manual
Provides an overview of your laboratory's QMS.
It outlines your laboratory's quality policy, objectives, scope of accreditation, and general procedures for implementing ISO 17025 requirements.
Procedures
Such as those for sample handling, method validation and equipment calibration describe specific processes and activities within the laboratory.
They provide step-by-step instructions on how to perform tasks in a consistent and standardized manner.
Work instructions
Provide specific guidance on how to perform individual tests, calibrations or measurements, and ensure consistency and accuracy in the execution of technical processes.
Quality records
Include calibration certificates, test reports, proficiency test results, audit reports, training records, non-conformity reports and management review minutes.
These records provide documented evidence of your laboratory's activities, decisions and compliance with ISO 17025 certification requirements
Forms & templates
Ensure the consistent recording and documentation of relevant information.
Examples include equipment logbooks, training record templates and customer feedback forms.
Method documents
Describe the specific test or calibration methods used in your laboratory and ensure standardized and consistent approaches to measurement processes.
Policy documents
Outline your laboratory's policies and guidelines related to specific areas such as quality, health and safety, data confidentiality and ethical considerations. These documents provide a framework for decision-making and guide your laboratory's behavior and actions.
Ensure that this documentation is easily accessible to relevant personnel, properly version-controlled and readily available for external audits or assessments.
Documentation should be maintained in a manner that allows for traceability, retrieval and retention according to your laboratory's document control procedures and any other applicable legal or regulatory requirements.
Implementing the QMS
An effective QMS is vital for ISO 17025 certification. Core QMS ingredients to get in place include:
- Defined scope
Determine the scope of your laboratory's activities that will be covered by the QMS. Consider the types of tests or calibrations performed, the equipment used and the personnel involved. - Project team
Form a dedicated project team or designate a management representative who will oversee the implementation process. Ensure that the team members have the necessary knowledge, authority and resources to drive the implementation effectively - Quality policy and objectives
Develop a quality policy that reflects your laboratory's commitment to quality and compliance with ISO 17025. Define measurable quality objectives that align with your laboratory's strategic goals. Ensure that the policy and objectives are communicated to all personnel and regularly reviewed for effectiveness. - Training and competence program
To evaluate and verify the competence of your personnel through assessments, qualifications, certifications, or other means as required. - Equipment management
Develop procedures for equipment selection, calibration, maintenance and measurement traceability. Ensure that equipment is suitable for its intended use and regularly calibrated and maintained. Establish procedures for handling, storage, and protection of equipment to ensure accuracy and reliability of measurements - Non-conformities and CAPA process
For identifying, documenting, and addressing non-conformities that occur within your laboratory. Develop a process for investigating the root causes of non-conformities and implementing corrective actions to prevent their recurrence. Monitor and review the effectiveness of corrective actions taken.
To make this process easier and maximize internal control and engagement, consider digitizing your laboratory quality management system into an eQMS.
Ensuring laboratory equipment calibration & maintenance
Your laboratory can't function in a compliant way if its equipment is defective and falling to pieces.
Ensuring laboratory equipment calibration and maintenance in compliance with ISO 17025 involves implementing robust processes and procedures.
You'll need some key equipment management components in place, including an equipment inventory, calibration cadences, calibration SOPs and requirements for each asset, equipment identification and labeling, and a change control process to manage changes to equipment, such as modifications, repairs, or replacements.
Quality control procedures
In a similar way, you'll need to establish strong quality control procedures to monitor and verify the performance and reliability of your lab's test and calibration results.
Calibration verification, quality control samples and internal QC cadences should all be established.
These checks may include monitoring instrument performance, verifying reagent or solution integrity, or conducting regular equipment maintenance and calibration (as above!)
Frequently asked questions about ISO 17025 certification
Let's wrap up this ISO 17025 certification - accreditation - whistle-stop tour by looking at some FAQs.
Who needs ISO 17025 certification?
Any laboratory involved in calibration, sampling and testing can obtain ISO 17025 certification.
Remember, although ISO 17025 certification is not mandatory, it is highly valued and often required by organizations and regulatory bodies as proof of a laboratory's competence, reliability and adherence to international standards.
How much does ISO 17025 accreditation cost?
The cost of obtaining an ISO 17025 certification can vary depending on several factors, including the size and complexity of your laboratory, the scope of accreditation, the level of existing QMS implementation, the need for external consultants, and the certification body chosen for the assessment.
It's advisable to contact certification bodies, consultants, or relevant organizations to obtain cost estimates tailored to your laboratory's needs and requirements.
How long does ISO 17025 certification take?
Much like estimating the cost, the exact time it takes to obtain a certification to ISO 17025 is hard to estimate.
Factors such as your laboratory's readiness, operational maturity, level of commitment, availability of resources and the efficiency of the certification process will all impact your timeline.
Plan for an approximately 3-6-month process, with the possibility for some variation.
What's the difference between ISO 17025 and ISO 9001?
ISO 17025 and ISO 9001 are both international quality management standards, but they have different focuses and applications. Key differences between the two include:
|
17025 |
9001 |
|
|
Scope |
Specific to testing and calibration laboratories. It provides requirements for the competence, impartiality, and consistent operation of laboratories performing testing or calibration activities. ISO 17025 focuses on technical aspects, ensuring the accuracy and reliability of test and calibration results. |
Applies to any organization in any industry or sector. It provides requirements for a QMS and focuses on meeting customer requirements, enhancing customer satisfaction, and continuously improving the organization's overall performance. |
|
Process approach |
Emphasizes a process-based approach to laboratory activities, focusing on the effectiveness and efficiency of testing and calibration processes. The standard addresses technical competencies, method validation, measurement uncertainty, and equipment calibration, among other specific laboratory-related aspects. |
Has a broader focus on the entire organization's processes. ISO 9001 addresses areas such as customer focus, leadership, resource management, product/service realization, and continual improvement across all functional areas of the organization. |
|
Customer focus |
The customer focus in ISO 17025 is primarily on meeting the specific requirements of the laboratory's clients in terms of accurate and reliable test/calibration results. It includes factors such as confidentiality, responsiveness, and effective communication of results. |
The customer focus in ISO 9001 is broader, encompassing understanding customer needs, meeting customer requirements, and enhancing customer satisfaction throughout the organization. It includes aspects beyond just test/calibration results, such as product/service quality, on-time delivery, and customer feedback management. |
|
Recognition |
Certification issued by third-party services. |
Accreditation issued by national accreditation body. |
Because ISO 9001 is so broadly applicable, it can complement your ISO 17025 accreditation.
Some laboratories choose to pursue compliance with both, with ISO 9001 addressing the overall QMS of your organization and ISO 17025 specifically addressing the technical competence and reliability of your testing/calibration activities.
Staying competitive with ISO 17025 accreditation
ISO 17025 accreditation is a complex and demanding process, but it enhances your laboratory's credibility, reputation and international recognition by forcing you to prioritize the integrity, quality and trustworthiness of your testing and calibration activity.
To make your ISO 17025 journey even easier, consider how to optimize your laboratory quality management system with targeted tool investment.
Qualio brings your ISO 17025 certification components - document, training, CAPA and supplier management - into a single cloud-based system connecting your entire lab operation.
See how one of our Australian customers turned to us to lift the quality of their laboratory to the next level with ISO 17025 certification.
Book a demo of our ISO 17025 eQMS software to see how it works!
