ISO/IEC 17025 – Laboratory Competence
Does your laboratory perform tests, sampling or calibration? If you want reliable results across the board and an accreditation that will give you the confidence to engage with the global medical market, you should be considering becoming ISO 17025 accredited.
Being awarded ISO/IEC 17025 acts as demonstrative proof of your laboratory’s competency – whether you are publicly or privately owned. As a testing and calibration laboratory, you must stay abreast of the technological and legal developments in your industry and, if you want to operate on a global scale, ISO/IEC 17025 will give you the confidence and accreditation you need. IMSM can walk you through this process and show how it will improve your procedures and validate the way you work.
Who needs ISO 17025?
ISO 17025 is relevant to any laboratory that performs tests and/or calibrations. It stipulates all the requirements these particular labs need to meet as part of a process of demonstrating quality. This includes proving you are technically competent and that this competency produces technically valid results.
What are the benefits of ISO 17025?
- Improves your reputation
As an international standard ISO/IEC 17025 is recognised around the world and is highly regarded within scientific and technical circles. The objective of the ISO/IEC 17025 international standard is to facilitate the global and mutual recognition of testing and calibration results. ISO/IEC 17025 certification demonstrates your commitment to establishing a secure quality management system and delivering reliable results; this increases your credibility, and you will appeal to more customers and stakeholders, as you will also have access to international markets.
- Assures compliance
No matter the size or complexity of your organisation, ISO/IEC 17025 applies to any testing or calibration laboratory. By becoming certified, you must ensure you remain up to date with all the regulatory requirements and legislation that exists both in your country and internationally. When mistakes are made, you must investigate and determine the root cause so that the mistake is not repeated, which is a satisfying prospect to authoritative bodies, the authorities governing your industry.
- Gives you a framework for quality
The ISO/IEC 17025 international standard establishes a framework of requirements for individual laboratories to construct a quality management system that is suitable for your laboratory’s requirements. Becoming ISO 17025 certified is a challenging task for any organisation. The standard operates to very high criteria, so you are always conscious of upholding it through consistent reviews of competency and data integrity.
- Creates more business opportunities
Now that you have increased your reputation, demonstrated your compliance and solidified the guidelines that improve the performance of your laboratory, you will start to attract more clients. Furthermore, if your competitors do not have ISO/IEC 17025 certification, you will be given a competitive advantage.
- Improves efficiency
Your ISO 17025 certification audit will highlight any areas for improvement, helping you identify areas that are costly to you. The certification may appear costly to implement, but you will save time and money in the long run by eliminating the need for retesting as you will be closely following the standard’s requirements.
Steps to getting ISO 17025 certification
With IMSM, the process of getting ISO 17025 certification is a trouble-free step-by-step approach.
- Initial consultation
We help you outline your goals, focusing on what your business wants to achieve and how it defines success, particularly in relation to your clients’ requirements. Together, you and our ISO assessors will agree reasonable outcomes and delivery dates.
- Producing your organisation’s ISO 17025 documentation
Next, the IMSM assessor will audit your existing procedures and help you document the new systems that will help deliver success – both existing and how you will improve these. This documentation sets out how your laboratory should operate going forward so that it can achieve ISO/IEC 17025 certification.
- Training you to adopt the ISO 17025 framework
While the documentation is important moving forward, it is even more important that it is put to practical use. We work with the senior management team to ensure the framework is embedded throughout your organisation. We can also develop and deliver tailored training for staff to ensure the understanding and implementation of ISO/IEC 17025 is robust. This will create consistency across your organisation, transforming your laboratory from day one so it is competent and risk conscious.
- Submission to a certification body
Before you can be awarded the ISO/IEC 17025 certification, your organisation applies to the certification body that you have selected to conduct your audit. This audit is an objective view on whether your business is conforming to the ISO/IEC 17025 international standard.
- ISO 17025 awarded
Once confirmed that you are ISO/IEC 17025 compliant, your organisation will be presented with your certification. This international certification will be recognised by current, potential and future clients as a mark of excellence in testing and calibration laboratories.
Take a look at our case studies to find out how IMSM has helped implement testing and calibration laboratories quality management system from real-life examples, or request a call back for more information about how we can help you.
How do I get ISO 17025 certified?
ISO/IEC 17025 is very technical in nature, so the process of achieving ISO 17025 certification can feel quite overwhelming; this is why many testing and calibration laboratories choose to use the expertise of an ISO consultant – someone who will support and guide you through the implementation process. Our experienced consultants take the lead in auditing your business, helping you use the results to improve your testing and calibration, and your laboratory’s quality management system. There is also room for training if this is something you think your business will benefit from.
Simple: we make it simple. We have been helping businesses achieve ISO certification since 1995 and have over 150 expert consultants operating around the world. With 15,000+ clients that have trusted us to implement ISOs, we are the experts and will do the heavy lifting, saving your company precious time. With a transparent fixed fee and flexible approach, we work with your business to make the process of gaining ISO 17025 certification as straightforward and beneficial as possible.
We strive to do this with our:
• World-class gap analysis
• Experienced and diverse ISO consultants
• Flexible terms and contract
• Fixed fee
• Full implementation
How can ISO specialists help your business?
Getting started with ISO 17025 certification can seem like a daunting process, which is why many businesses choose to use the help of an ISO consultant. We support and guide your business through certification. Our experienced assessors take the lead on auditing your business, helping you use the results to improve your quality management system. If necessary, there is also plenty of room for training.
- What are the ISO 17025 requirements?
When implementing your ISO/IEC 17025 framework, you need to consider the following control factors:
• Suitable facilities and conditions, including calibrated equipment
• Competent, well-managed personnel
• Certified reference materials
• Regular documentation of control procedures and technical records
• Adequate and validated reagents and test methods
• Correct handling of samples
- What is the difference between ISO 17025 and ISO 9001?
ISO 9001 is a standard that helps any business in any industry develop a sound QMS, whereas ISO/IEC 17025’s requirements are applicable specifically to testing and calibration laboratories. Implementing ISO 9001 into the way you work first will help you achieve ISO/IEC 17025 certification smoothly.
- Is ISO 17025 mandatory?
No, ISO/IEC 17025 certification is not mandatory, however it brings your practices up to date with legal regulations and compliances that exist across your industry – many of which will be mandatory.
- Still have more questions about ISO 17025?
Check out our blog for more information on the globally renowned 17025 certification and how to start your ISO certification journey today.
For a free Quotation or Remote presentation by an ISO Specialist, contact us today!
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