Validate your Lab | ISO 17025 Laboratory Management System

iso 17025 laboratory management system

Suppose your organization owns a laboratory or depends on one’s results to produce a good or service. You might have come across the word ‘ISO 17025’ in that case. But what is ISO 17025, might one ask?

What is ISO 17025?

ISO 17025 Laboratory Management System is the leading international standard that describes the general requirements for laboratories’ competence, impartiality, and consistent operation. It was developed by the International Organization for Standardization (ISO) and has been used since 1999.

This accreditation standard is very common to the ISO 9001 standard. However, it has more specificity in the requirements for competence for all laboratories, regardless of size or extent of the scope, that produces testing and calibration results.

It is of utmost importance to understand that ISO 17025 is not a certification but a standard that specifies requirements for a quality management system. This is also referred to as accreditation.

Both certifications and accreditations are essential to ISO and Quality Management Systems; however, even though they are similar, they differ in their meaning, albeit used interchangeably. ISO accreditation is granted to organizations for certain activities, while ISO certification covers the company as a whole. This means that ISO accreditation is a recognition of the competence to work to specified standards and, for this reason, normally encompasses the principle of quality management systems

This standard aims to ensure that testing and calibration laboratories provide competent services to their clients by defining how they should operate to achieve this goal. It seeks to provide confidence in the results provided by a laboratory and also aims to protect clients from poor quality test results by setting out requirements for operational procedures within a laboratory (including documentation).

The standard is designed as an international standard because many different types of organizations perform testing or calibrating activities; these include industrial manufacturing companies, government agencies, universities, and research institutions. The same principles apply regardless of who performs the tests or calibrations or what equipment is used.

So, ultimately, ISO 17025 accreditation will allow laboratories to implement a quality management system (QMS) to improve their ability and be consistent and repeatable in their results. The QMS will give the basis for accreditation from an accredited body (national body), which will formally recognize a demonstration of competence. This QMS is a prerequisite for a lab to become accredited.

Do Industries need ISO 17025 Laboratory Management System?

ISO 17025 is typically focused on the technical competence of analysis, be it the actual testing of products or specialized software relating to calculations.

This accreditation mainly applies to laboratories because it assures that they operate effectively and safely. Laboratories can enhance their facilities and receive professional recognition from a well-known and reputable organization by following the guidelines provided in this collection of ISO standards.

However, ISO 17025 is not only for laboratories but also for regulatory agencies, certification bodies, peer-reviewing schemes, and laboratory clients, among others. Many regulatory bodies and suppliers won’t accept a lab’s testing and calibration results as reliable if it doesn’t have an ISO 17025 accreditation. Many rely on ISO 17025 for testing and calibration because numerous organizations, authorities, and clients can use it.

The following are further examples where ISO 17025 Laboratory Management System is deemed critical:

  • Analysis laboratories, for example, water, petroleum, dairy
  • Regulatory authorities
  • Healthcare – microbiological testing, DNA, testing of cleanrooms
  • Construction laboratories – concrete products, asphalt
  • Software inspection – testing online gaming systems
  • Environmental – ambient air quality, soils and land, marine sediments, calibration bodies


Whether you’re after ISO Certification, internal audits, or results-oriented consultancy, Luke has the plan for you. Reach out to him and start your journey today.
ISO Consultant in Malta


Luke has a plan for you whether you want ISO certification, internal audits, or results-oriented consulting. Contact him immediately to begin your adventure.

How to Implement ISO 17025 Laboratory Management System

While reforming the company’s processes may appear gruesome, we can promise you that it is not as bad as it may seem.

To ensure that you are on the right track, we have even decided to share a simple 9-step guide to ensure that you get off on the right foot in getting your accreditation for the ISO 17025 Laboratory Management System.

  1. Learn about ISO 17025 Laboratory Management System
  2. Perform a Gap Analysis for your organization
  3. Plan and manage your project – set up goals in relation to achieving ISO accreditation
  4. Train the employees according to the ISO 17025 Standard
  5. Document your Quality Management System
  6. Implement your Quality Management System and put it to the test
  7. Audit your Quality Management System and perform the necessary changes
  8. Get ready for the external audit done by the accreditation body
  9. Get your accreditation – congratulations!

If you are still unsure how to kickstart the process, worry not, as Luke Desira will help you along your journey to get accredited. Should your organization fail to get accredited, even after Luke’s help, he will give you your money back (beware, though, his clients have never failed an external audit!)

Benefits of Implementing ISO 17025 Laboratory Management System

The six main benefits of implementing a Management System are as follows:


ISO 17025 Laboratory Management System is internationally recognized, and the accreditation is highly regarded among the scientific circles, and nowadays a must for legislation compliance. The standard gives laboratories more credibility and demonstrates the reliability of their testing and results.

Compliance Assurance

Most legislations nowadays look for ISO 17025 accreditation in laboratories. This accreditation will clearly show adherence to safety requirements, which satisfy authoritative bodies and provide the assurance of consistency and accuracy in their test results.


Gaining ISO 17025 Laboratory Management System is not easy, as it requires consistency within its QMS, with consistent review of the standard and ensuring continued competence in all its technical processes. This will require periodic audits, annual proficiency or interlab comparisons, and also re-assessments every four years.

Increase in Business

With increased competency, better performance, and assured compliance, clients can rest assured that the process is reliable and conducted with the utmost accuracy. Such accreditations give laboratories added advantages over their competition, ensuring that results can be easily repeatable.


With the ability to continually evaluate staff, methods, and equipment, ISO 17025 Laboratory Management System will ensure that the laboratory’s processes are continuously optimized and are producing the most accurate results. Staff roles and competencies are also kept in check, resulting in greater accountability and a more reliable laboratory environment.

Save Time and Money

Even though accreditation can be costly to maintain and requires continuous validations and verifications, this is significantly outweighed by its time and cost-saving benefits. Labs will no longer be required to run analyses in duplicates to verify their results, especially for compliance certification or retesting products.

Definitions used in ISO 17025 Laboratory Management System

Impartiality – to ensure that the laboratory has an unbiased opinion about the result of the test being performed – avoiding a personal interest

Complaint – Dissatisfaction by any person or organization with a laboratory, relating to the activities carried out by the same laboratory.

Interlaboratory Comparison – Performance and evaluation of measurements or tests on the same or similar parameter by two or more laboratories with predetermined conditions. E.g.: Lab 1 and Lab 2 analyze the same water sample for pH levels to compare the results.

Intralaboratory Comparison – Performance and evaluation of measurements or tests on the same or similar parameter within the same laboratory with predetermined conditions. E.g: Lab 1 analyses the pH for a particular sample, by two separate laboratory analysts.

Proficiency testing – Evaluation of laboratory performance against pre-established criteria by means of interlaboratory comparisons.

 Laboratory – A body that performs testing, or calibration, or sampling associated with subsequent testing or calibration.

 Decision Rule – Rules that decide what needs to be done when results exceed set limits. E.g: pH analysis has a compliance range of 6.5 to 9.5. The uncertainty of measurement is 0.5. Thus lab 1 may create a decision rule, that any samples in the 6 to 10 range may not be compliant and will be flagged as dubious.

 Verification – Objective evidence that analysis or equipment fulfills specific requirements. Important to note that verification is different from validation. A validation test may require calibration, with a certified material, but verification is just proving that the analysis or equipment is showing accurate results.

 Validation – verification that the specified requirements are adequate for the intended use.

Interested in Learning more?

Luke Desira is an ISO management system consultant who realizes that achieving ISO accreditation is never easy – learn how to achieve ISO 17025 accreditation here! To further learn about ISO 17025 Laboratory Management System and the implications of software validation in ISO 17025, click here!

Anything can go wrong when implementing ISO Standards, and your organization should be made aware of such mishaps before they occur! All management systems based on ISO Standards that are implemented should pertain directly to the organization’s objectives, and ISO 17025 – Testing and Calibration Laboratories should be no different. Have a look at the ISO Certification specialised by Industry to understand in which category your organization falls.

Luke offers a variety of ISO certification services that puts him as the number 1 ISO Certification consultant in Malta. He can help you achieve ISO accreditation efficiently. When ready, take the first step to success and call Luke Desira.

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