ISO 17025 Accreditation Requirements

ISO 17025 is used to accredit laboratories in certain fields of testing. Getting accredited by NATA to ISO 17025 is not as simple as getting a copy of the ISO 17025 standard and meeting the criteria. NATA uses additional accreditation criteria (NATA’s ISO 17025 additional criteria) based on their interpretation of ISO 17025, industry standards and local criteria when they assess your laboratory.

There can be as many as 20-30 documents covering requirements that may be applied to your laboratory. Whether your laboratory is new to accreditation or wanting to extend your scope, you need to make sure you have covered all of these.

When you sit down and start reading through all of these documents you may get the impression that you have an enormous amount of work to do to meet these requirements. However all of these requirements cover areas you are probably already familiar with.  If you’ve covered these bases, you are already well on your way to meeting NATA’s requirements.

Staff & training

You employ or contract staff to run and work in your laboratory. They have suitable experience and/or qualifications and you supervise those who are still in training. There are job descriptions for each role or person. You give them training when they need it and, for critical tasks, you assess the results of that training. You ‘sign-off’ on staff members when they are ready to work unsupervised.

The physical environment of the laboratory

The laboratory is arranged in such a way as to avoid cross-contamination between samples, and to provide a reasonable and safe working environment for the staff. If methods call for any specific environmental conditions (temperature, humidity, sterility, radiation, vibration levels, etc.) you provide those conditions and monitor them.

When working on-site at clients’ premises, you put in extra effort to make sure these conditions are provided. Access to the laboratory is controlled to the degree necessary, depending on the risks involved. This can be as simple as a sign on the door specifying who can enter.

Test methods for ISO 17025

You use the right methods based on client requirements and technical validity. These may be published or standard methods, or they may be developed in your own laboratory. Either way, you have made sure that the methods can accurately measure the thing that has to be measured in the types of samples you receive.

In-house developed methods are validated to make sure they produce reliable test results. This validation includes working out the measurement uncertainty for the method, which can seem daunting at first. However, we can help you develop a system that, with a little practice, can be easy to follow. 

Laboratory equipment

You have provided all the equipment necessary to perform the testing, and any other processes such as sample preparation. The equipment is able to achieve the necessary accuracy, and complies with any specifications in the methods.

You have up-to-date instructions on how to use the available equipment and you make sure that only trained people use it. You make sure the equipment is checked and or calibrated regularly if it has a significant effect on the test results.

Sampling for ISO 17025 accreditation

Any sampling that you do is based on sound statistics.

Handling of test items

You make sure that all test items are uniquely identified and that they are not damaged by transport, storage, or other factors. You record any problems with the test items before you start processing or testing.

QC and proficiency testing

You have a system of quality control testing and/or proficiency testing that ensures your test results are valid and you monitor the results for trends.

Recording and reporting test results

You keep complete records of testing, including original observations, identity of the staff member, identity of any critical pieces of equipment and any other factors that can affect the test result significantly.

Test reports are factual and can be understood by the client, whilst containing all required information.

Management and quality improvement

 All technical arrangements for smooth running of the laboratory fall under a  management structure that supports laboratory efficiency. You have considered where conflicts of interest may arise within your organisation and you make sure there are enough staff members to do the work.

Key processes such as quoting and/or accepting new work, purchasing, subcontracting and customer feedback are planned and defined. You have documented all of your key processes (including the technical areas) and have a system to make sure staff can access up-to-date versions of all procedures. You keep records of management and quality activities.

You hold regular management meetings to gain perspective on the overall operation of the organisation. You conduct internal audits to make sure your system is still running the way you intended. There is a system for dealing with complaints, improvement suggestions and other non-conformances that leads to improvements in your performance.

NATA’s additional ISO 17025 criteria

The details of these criteria can be found in the following documents that apply in all ISO 17025 fields of testing:

  • Standard Application Document (affectionately known as the SAD!)
  • General Equipment Tables
  • NATA Rules
  • NATA Procedures for Accreditation

You may also need, depending on which field of testing your laboratory is in:

  • (Field of Testing – FAD) ISO/IEC 17025 Application Document
  • 20-30 policy circulars, technical circulars, annexes and information papers.

Take a closer look at NATA’s accreditation criteria.

For help navigating this maze of requirements, fill out the details below and you will hear from us within 48 hours.