IMSM Ltd, Wiltshire
01793 296704

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.

Trusted by over 2,000 companies across the globe

International compliance for laboratories.

Tell me more about this standard...

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:

  1. Management requirements – covering the operation and effectiveness of the quality management system within the laboratory.
  2. 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.

0+

Years of Experience

0

ISO/IEC 17025

0K+

Overall Certificates Issued

0

Months to Implement on Average
ISO Certification Made Simple

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.

Your journey starts here

More information on the Road to ISO Certification

Image link

Learn more about ISO/IEC 17025

Download your free ISO/IEC 17025 Guide

Image link
The Process

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

Next, the IMSM consultant 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. The manual system documentation sets out how your business should operate going forward so that it can deliver ISO/IEC 17025.
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

While the manual is a vital document moving forward, it is even more important that it gets 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 that the understanding and implementation of ISO/IEC 17025 is watertight. This will create consistency across your organisation, transforming your business from day one so it is optimised for efficiency, continual improvement, and greater profitability.

4. Submission to External Auditor

Before you can be awarded the certification, your organisation applies to the third-party certifying body that you have selected to conduct your audit. This audit objectively determines whether your business conforms to ISO/IEC 17025, and the relevant accompanying documentation is accessible through our client portal, IMSMLoop.
Our Benefits

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.

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.

Established ISO Certifiers since 1994
google partner badge

ISO/IEC 17025: Frequently Asked Questions

How do I get ISO/IEC 17025 accredited?
ISO/IEC 17025 is very technical, so achieving ISO/IEC 17025 accreditation can feel 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 you think your business will benefit from this.
Who needs ISO/IEC 17025?
ISO/IEC 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 is the difference between ISO/IEC 17025 and ISO 9001?
Certifications with IMSM are valid for a year. Regardless of how long your ISO 9001 certification is valid, your organisation must demonstrate continuous improvement from the original certification date to the renewal date.
What are the ISO/IEC 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. Accreditation reference materials. Regular documentation of control procedures and technical records. Adequate and validated reagents and test methods. Correct handling of samples.
Is ISO/IEC 17025 mandatory?
No, ISO/IEC 17025 accreditation 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.
This standard contributes to the following Sustainable Development Goals:
03
08
09
10
12
16

High Quality & Prestigious Brands

Advanced services combined with a large experience and fast performance.

“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”

starstarstarstarstar
David Spence, Operations Engineering Manager
Ping Network Solutions

"Our ISO certifications help us provide consistent, quality-focused services that our clients have come to depend on and appreciate.”

starstarstarstarstar
Cherie Sprout, Executive Assistant
Integral Consulting Services, Inc.

“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.”

starstarstarstarstar
Will Gardner, Head of QHSE & Operational Improvement
Pall-Ex Limited

"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. “

starstarstarstarstar
Steve Head, Business Improvement Director
Anderson Dahlen