CARO News

ISO/IEC17025 Explained By An Accredited Laboratory

Posted on June 23, 2021

Over the past several months, you may have noticed us shamelessly promoting the expanded scope of testing now available through our Edmonton Laboratory (if you haven’t, you need to check this out!)

This nonstop chatter about accreditation may have you wondering – “What’s the hype around ISO accreditation?”, “What does it mean to have successfully completed the accreditation process?”, and “How does proficiency testing and method validation factor in?”

Well, pull up a chair, and we’ll take you through the accreditation journey!

What Is ISO Accreditation?

The International Organization for Standardization (ISO) is an international conglomerate of standards organizations who share the responsibility for setting global standards for quality, safety, and security across many sectors.   As an example of the breadth of their influence, there are ISO standards for child seats for cars, medical devices, food safety management, and much more.

ISO/IEC17025 was developed jointly by ISO and the International Electrotechnical Commission (IEC) under the responsibility of the ISO Committee on conformity assessment and is the measuring stick for testing and calibrating laboratories across Canada.  Irrespective of the body that does the accreditation (CALA, SCC, etc.), it is the standards that are accepted internationally as the sign of consistent, high quality work.

ISO/IEC17025 strategies and guidelines for laboratories provide guidance with respect to:

• Authentication of methods,
• Control of data,
• Training and evaluation of staff,
• Equipment calibration and quality of reporting.

It also clearly outlines individual responsibility for upholding all aspects of the quality management system.  Similarly, ISO15189 applies to medical laboratories to assess quality management and competency.

How Hard Is it to Get ISO Accredited?

For a laboratory like ours in Edmonton, the accreditation process can take anywhere from six weeks to a year or more, depending on the systems already in place.

The initial accreditation process includes a thorough overview of the following:

• All test methods
• Operational procedures
• Validation studies
• Internal audit records
• Management review records
• Proof of implementation of a management system

… And much more

Suffice it to say that no stone goes unturned.  If you are interested in more information on how to get started and what to expect as a new laboratory, check out the A107-Guidelines for New (Applicant) Laboratories.

In addition to the initial laboratory accreditation which verifies that your laboratory has the proper quality and tracking systems in place, each individual method can also be accredited.  As a part of individual method accreditation, laboratories are required to participate in round robin studies, called Proficiency Testing (PT) studies.  More on that below.

What Happens After ISO Accreditation?

One year after the initial assessment is complete, and every 2 years henceforth, onsite assessments are performed by certified auditors.  These assessments include but are not limited to:

• Side-by-side audits of techniques and equipment
• Interviews with staff
• Review of relevant documentation

According to the team at the CANADIAN ASSOCIATION FOR LABORATORY ACCREDITATION INC. (CALA), an independent accreditation body, auditors are required to exceed a minimum threshold of years of laboratory experience and undergo rigorous training to ensure consistency in assessments.

For emerging industries such as the Cannabis testing industry in Canada, we often get asked about the experience and ability of the auditors to properly assess Cannabis methods.  According to CALA, although Cannabis testing is a newer industry in Canada, the testing of plants and plant material, as well as handling similarly complex matrices, is nothing new to their team.  Although the auditors may not have a background in Cannabis testing specifically, they are experienced with the related reference methods, analytes, similar matrices, instrumentation, and underlying chemistry that are the cornerstones of cannabis testing.

What is Proficiency Testing?

Proficiency Testing, or PT (because scientists love acronyms!), is a 3^rd party administered validation of your data with respect to normalized standards, as well as in reference to other laboratories.  This ensures not only accuracy on behalf of the lab, but also consistency within the industry.  There are many organizations that conduct proficiency testing (or round robin) studies in Canada, and participation in these programs can be voluntary or required as a part of ISO certification.  Voluntary participation is often used by laboratories to ensure their systems and staff are performing optimally, and that their internal checks and balances are functioning.

Accreditation Vs. Method Validation

Accreditation, as you have seen above, is a lengthily process that is conducted by a third-party.  It is a measure of your quality to an international standard.  Many industries required a laboratory to achieve accreditation as a prerequisite of their data being accepted by various government and private organizations.  These industries rely on the experience of the accreditors to ensure that the data used in important decision-making processes is generated by laboratories with a proven quality reputation.

Method validation, on the other hand, is the basic requirement to show that a method ‘works,’ and that the data it produces is both accurate and appropriately precise for the intended purposes.  Method validation is a key component of any quality management system and is generally overseen by the laboratory generating the data.  Method validation summaries are often submitted for verification as a part of the accreditation process, which then goes on to assess and confirm the validation through audits, PT, etc.

For Our Cannabis Clients – How Are ISO and GMP Related?

This question carries a very detailed response, and as such should be addressed by the standards professionals. Thankfully, those very professionals are taking questions like this and providing well thought out and detailed answers online.  Head over to Advisera.com for sample of some common responses.

The Coles notes: the two are complimentary and fulfill very important roles for various aspects of product release.  GMP, or Good Manufacturing Practice guidelines, provide guidance to industries who are manufacturing or producing a product, addressing all aspects of the production process from fabrication to wholesale.  Included within these practice guidelines are principles around quality assurance and quality control testing, which is where the congruency with ISO comes in.  As described above, ISO/IEC17025 standards are laboratory-specific standards for quality management that ensure technical competency.  A laboratory who carries ISO/IEC17025 accreditation may satisfy GMP criteria as it relates to quality of testing – in both cases, methods must be fully validated and adhere to quality control standards.

If you have any other questions about our NEW accredited parameters in Edmonton or about working with an accredited Cannabis testing laboratory, please connect with us via email: [email protected].

If you are looking to take the path of accreditation, there are many great resources available through CALA’s website.