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ISO/IEC 17025: Laboratory Competence
Does your laboratory perform tests, sampling, or calibration? If you want reliable results across the board and accreditation that will give you the confidence to engage with the global medical market, you should consider becoming ISO/IEC 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.
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What is ISO/IEC 17025?
ISO/IEC 17025 is an international standard that sets out the general requirements for the competence of testing and calibration laboratories. It applies to all organisations performing laboratory activities, regardless of size or the scope of their testing and calibration services.
The standard focuses on two key areas:
- Management requirements – covering the operation and effectiveness of the quality management system within the laboratory.
- Technical requirements – addressing the competence of staff, the methods used, equipment, and the environment for testing and calibration.
ISO/IEC 17025 ensures that laboratories produce valid, reliable results and can demonstrate their technical competence to customers, regulatory bodies, and accreditation authorities.
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What are the Benefits of ISO/IEC 17025?
As an international standard, ISO/IEC 17025 is recognised worldwide and 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 accreditation 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.
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.
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/IEC 17025 accredited is a challenging task for any organisation. The standard operates to very high criteria, so you are always conscious of upholding it through consistent competency and data integrity reviews.
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, you will be given a competitive advantage if your competitors do not have ISO/IEC 17025 accreditation.
Your ISO/IEC 17025 accreditation audit will highlight any areas for improvement, helping you identify areas that are costly to you. The accreditation 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/IEC 17025 certification
With our excellent support and guidance you can rest assure that your ISO/IEC 17025 certification will be successful.
1. 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 client’s requirements. You and your ISO consultants will agree on reasonable outcomes and delivery dates.
2. Producing System Documentation
You will be able to view the manual system documentation, along with most other relevant documentation, on our client portal IMSMLoop. It offers a comprehensive insight into the progress of your ISO implementation, along with copies of the relevant audit reports, certifications, and any necessary corrective actions. The portal serves as a central hub for tracking your ISO journey.
3. ISO/IEC 17025 Framework Adoption
4. Submission to External Auditor
Why choose IMSM?
Simple: We make it simple. Since 1994, we've helped businesses achieve ISO certification, with over 150 experts worldwide and 15,000+ clients trusting us to implement their ISOs. We've proven to be experts at handling the logistical heavy lifting, saving your company valuable time.
With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we collaborate with your organisation to make any ISO implementation as straightforward and beneficial as possible.
- World-class gap analysis
- Experienced ISO consultants
- Regular updates
- Flexible terms and contract
- Fixed fee
- Full implementation
Experienced ISO Consultants
How can ISO Specialists help your business?
Getting started with ISO certification might seem daunting; this is often the reason why businesses enlist the help of an ISO consultant. For 30 years, we've supported and guided organisations like yours through certification. Our experienced consultants take the lead on auditing your business, helping you use the results to enhance your quality management system. If necessary, there is also plenty of room for training.
ISO/IEC 17025: Frequently Asked Questions
How do I get ISO/IEC 17025 accredited?
Who needs ISO/IEC 17025?
What is the difference between ISO/IEC 17025 and ISO 9001?
What are the ISO/IEC 17025 requirements?
Is ISO/IEC 17025 mandatory?
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“We decided to use IMSM to help and support us through the process. We were fairly new to this as a company and to have a company like IMSM guiding us through the requirements saved us time and gave us the confidence to present to the external auditors, knowing we had everything covered”
"Our ISO certifications help us provide consistent, quality-focused services that our clients have come to depend on and appreciate.”
“We can now demonstrate, via externally internationally recognised accreditation, that Pall-Ex is the number one pallet network for quality. This also allows us extensive yearly external auditing by our certification provider against a measured standard.”
"Our IMSM Assessor put in a lot of time and effort; they did a really good job for us, helping to organise what we had here. We had a lot of the pieces in place, they just weren’t put together, which IMSM helped us to do. We have a system in place now and we continually follow up on everything. “