Achieving ISO/IEC 17025 accreditation is one of the best ways an organization can stand out among their competition. If you’re not already familiar, ISO/IEC 17025 is an internationally-recognized published standard that details the general requirements for the competence of testing and calibration laboratories. Becoming ISO/IEC 17025 accredited showcases your organization’s commitment to quality and the integrity of its work—increasing your overall competitive advantage.
Review each of these steps as you begin the accreditation process:
1. Understanding accreditation.
One of the first things to consider is the difference among accreditation, certification, and other commonly associated services. These terms have distinct differences. Accreditation refers to recognition given to an organization or, more specifically, a conformity assessment body (CAB), by an authoritative body, such a A2LA, and conveys formal demonstration of its competency to carry out specific conformity assessment tasks such as testing or calibration.
Other frequently confused terms in the industry include management system certification and registration. Both terms are a third-party attestation that a management system complies with a defined set of requirements (such as ISO 9001). Management system certification is often confused for accreditation, and an organization should consider whether they have need of attestation of their competence for specific activities (accreditation), or a certification that its management system is appropriately functioning (management system certification).
2. Find a copy of the standard.
Once you’ve made the decision to become ISO/IEC 17025 accredited, find a copy of the standard and familiarize yourself with it. The standard itself is made up of 8 components: Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements. While all the components provide value and must be met for accreditation purposes, the most essential components are the Resource, Process, and Management System Requirements.
The Management Systems Requirements are associated with your laboratory’s management system, whereas the Resource and Process requirements outline the elements that determine the adequacy, correctness, and reliability of the tests or calibrations your laboratory performs. Some organizations may choose to hire a consultant to help them understand the standard and implement the requirements into their system. This is not a required step and should only be determined after reviewing the standard and evaluating the time and resources available to achieve compliance to the requirements. A copy of the ISO/IEC 17025:2017 standard may be purchased from the International Organization for Standardization (ISO) at www.ISO.org.
3. Determine training needs.
Providing all laboratory staff with a general ISO/IEC 17025 training course can assist in illustrating how every individual in the organization has a role in the accreditation process. This can be done in-house or through a public venue, and a variety of training options can be found through a simple internet search. Training can be done early in the process to help laboratory personnel gain an understanding of the standard and the overall goal of accreditation. A2LA’s preferred training vendor is A2LA WorkPlace Training.
4. Begin documentation.
Once you’ve reached this point, whether you are working independently or with a consultant, the next task should be to document all your organization’s policies, systems, programs, procedures, and instructions to the extent necessary to ensure consistent application and quality results. This means that there should be objective evidence to demonstrate that the level of detail found in your documentation is adequate for producing the desired and required outcome consistently. For this step, a consultant would be able to review the laboratory’s procedures to ensure they are in compliance with ISO/IEC 17025 requirements, but they should only be used as a resource to provide guidance and recommendations. Ultimately, you are the expert of your own organization.
There are templates available to assist you in structuring your documentation. Examples of procedures may also be found online from other organizations who have been through the accreditation process, such as the US Food and Drug Administration (FDA) or United States Department of Agriculture (USDA). These may provide some insight as to what is expected in ISO/IEC 17025 compliant procedures. Preparing the documentation of your laboratory operations can be the most time-consuming step in this process and may take several months to complete.
5. Implement updated policies, processes, and procedures.
Once you have documented your policies, you are now ready to begin implementation. Implementation is demonstrated through thorough record keeping and showing that the process and procedures have indeed been followed.
This step can begin while the procedures are still being documented, as this may help you determine if the procedures are adequate, appropriate, and detailed enough for your system and processes.
6. Conduct an internal audit.
Per section 8.8 of ISO/IEC 17025, an internal audit must be conducted prior to your accreditation body assessment by a qualified internal auditor whether it’s a member of the laboratory’s staff or a contracted consultant. The purpose of an internal audit is to determine if your lab is in compliance with both the requirements of ISO/IEC 17025 and your own management system documentation. Keep in mind that there are no specific internal auditor training requirements specified in the ISO/IEC 17025 standard and external third-party audits do not meet this requirement.
The results of the internal audit should identify any gaps or weaknesses in the laboratory’s system and determine if additional resources are needed to ensure compliance. Keep sufficient records of the internal audit results and any follow up actions taken. The outcome of the internal audit may help determine if the laboratory is, in fact, ready for an external assessment, or if additional work is needed before applying for accreditation.
7. Perform management review.
Per section 8.9 of ISO/IEC 17025, the lab must complete a management review at planned intervals to ensure continued suitability and identify areas for improvement. The management review is typically conducted by the laboratory’s top management, which has the authority and resources necessary to make changes based on the inputs (e.g. suitability of polices, corrective actions, complaints, feedback, etc.) that are identified in section 8.9.2 of the standard. The lab will determine who these individuals are, but they are typically those who leadership positions such as President, Quality Manager, Technical Manager, etc.
8. Evaluate accreditation bodies.
Next, you should research, evaluate, and choose an accreditation body (AB). Along with examining its past performance, customer service, and technical ability, it’s also important to ensure that the accreditation body you choose is a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). Just as the accreditation body assesses CABS, accreditation bodies that are ILAC MRA signatories are assessed by each other.
Additional information regarding ILAC and its signatories may be found at www.ilac.org. A current list of the signatories to the ILAC Arrangement including scopes and dates of admission to the MRA are included in the Signatory Search section of the ILAC website mentioned above. You may also download a PDF version of the list of ILAC MRA signatories from the “ILAC MRA and Signatories” page of the ILAC website.
A2LA is among the largest accreditation bodies in the world and the only independent, 501(c)3, non-profit, internationally recognized-accreditation body in the United States. With more than 4,000 actively accredited certificates, A2LA has accredited certificates in all 50 US states and more than 50 countries.
9. Apply for accreditation.
After deciding which accreditation body you will use to obtain your accreditation, you are encouraged to ask specific questions related to the accreditation process. Each accrediting body’s process will slightly differ, so it is a good idea to develop familiarity with it and their staff. They may have additional requirements and policies which must be implemented in addition to ISO/IEC 17025. The accreditation body can also provide valuable customer service to assist you through the process.
10. Market your accreditation.
Accreditation improves your organization’s ability to make more informed decisions and manage risk. It also helps you stand out from the crowd and gives you a competitive edge. After you have spent your valuable time and resources becoming accredited, promote your accreditation at every opportunity. Some of the most common ways in which organizations promote their accreditation include:
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- social media
- press releases
- tradeshow displays and handouts
- flyers, catalogs, and brochures
- clothing
- email messaging
- letterheads
- business cards and postcards
- quotes, proposals, and solicitations
- websites and blogs
If you have any questions about the process, you can always contact your accreditation body to discuss any references to your accreditation that you wish to publish. You are encouraged to promote your accreditation to acknowledge the hard work put into achieving accredited status!
The process of becoming accredited, from initial research to final accreditation, can be involved and timely. ISO/IEC 17025 accreditation and the activities that support it should not be viewed as something additional to or separate from the laboratory’s current processes, but rather as a living, evolving complement to the way in which the laboratory operates. For more information about A2LA accreditation services, contact us at info@A2LA.org.