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 accreditation.

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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Guide: ISO/IEC 17025 Guide: ISO Certification

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 are the benefits of ISO/IEC 17025?

Improves your reputation
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.
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/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.
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, you will be given a competitive advantage if your competitors do not have ISO/IEC 17025 accreditation.
Improves efficiency
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.

Get an in-depth look at the benefits of ISO/IEC 17025 here.

Steps to getting ISO/IEC 17025 accreditation

Working towards ISO/IEC 17025 certification with IMSM 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 client’s requirements. You and your ISO consultants will agree on reasonable outcomes and delivery dates.
Producing your organisation’s ISO/IEC 17025 manual 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.
Training you to adopt the ISO/IEC 17025 framework
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.
Submission to a third-party external auditor
Before you can be awarded the ISO/IEC 17025 accreditation, 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.

As we have provided excellent support and guidance to your business every step of the way, you can rest assured that your ISO/IEC 17025 accreditation will be successful.

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.

Why IMSM?

Simple: We make it simple. Since 1994, we’ve been helping businesses achieve ISO certification and have over 150 experts worldwide. With 15,000+ clients trusting us to implement their ISOs, we have proven to be experts capable of handling the logistical heavy lifting, saving your company precious time. With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we work with your organisation to make ISO/IEC 17025 implementation as straightforward and beneficial as possible.

We strive to do this with our:

– World-class gap analysis
– Experienced and diverse ISO consultants
– Regular updates, provided through IMSMLoop
– Flexible terms and contract
– Fixed fee
– Full implementation

How can ISO specialists help your business?

Getting started with ISO/IEC 17025 accreditation might seem daunting; this is often the reason why businesses enlist the help of an ISO consultant. For thirty 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.

FAQs

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
What is the difference between ISO/IEC 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 how you work will help you achieve ISO/IEC 17025 accreditation smoothly.
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.
Still have more questions about ISO/IEC 17025?
Check out our blog for more information on the globally renowned ISO/IEC 17025 accreditation and how to start your ISO accreditation journey today.

ISO/IEC 17025 Blogs

Take a look at our most recent blogs relating to ISO/IEC 17025

What is the ISO/IEC 17025 internal audit checklist?

This article will discuss the ISO/IEC 17025 internal audit checklist, including what is covered by the list and how it assists with internal auditing.

What is the difference between ISO/IEC 17025 and ISO 9001?

ISO/IEC 17025 was introduced in 1999 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) as an internationally recognised standard for laboratory competence.

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