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Achieving Lab Excellence: The ISO 17025 Path

ISO 17025 accreditation plays a crucial role in establishing trust and credibility in testing

Kasturi Chitre

Kasturi Chitre is a Certified Food Scientist and a food quality expert, playing a pivotal role in ensuring quality assurance throughout a product lifecycle with nearly 15 years of industry...

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Testing laboratories act as gatekeepers, safeguarding the safety, quality, and compliance of various products. They meticulously adhere to stringent standards set by governing bodies, ensuring consumers receive safe and reliable food and non-food products. 

These laboratories offer invaluable support to large wholesalers and retailers by rigorously testing their products for a set standard. The credibility of products gracing store shelves of major retailers hinges on the trustworthiness of the testing laboratories behind them. Testing labs can show they are trustworthy in several ways. A common method is toget "accredited" by a well-known group like the International Organization for Standardization (ISO).

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What is an ISO 17025 accreditation?

The ISO sets global standards across various fields like food, healthcare, environment, management, information technology, etc.  These standards are regularly updated to stay in sync with the changing world. ISO 17025 standard is designed specifically for testing and calibration laboratories. This ensures labs are skilled, unbiased, and do things the same way every time, leading to trustworthy test and calibration results.

Why is it important?

Knowing that ISO is an internationally recognized body, ISO/IEC 17025 accreditation status reflects that your laboratory is competent to produce reliable and valid results for the listed scope. It automatically elevates your company’s value in the market. There are several tangible benefits to having your laboratory accredited, both for internal operations and external reputation:

Improved quality management: The accreditation process requires implementing a robust quality management system (QMS). This leads to standardized procedures, improved documentation, and better control over your laboratory's processes, ultimately reducing errors and enhancing consistency in delivering accurate results. 

Enhanced staff training and competence: Accreditation standards emphasize staff qualifications and training. This translates to a more skilled and knowledgeable workforce, better equipped to handle diverse testing tasks and adhere to quality standards.

Increased efficiency and productivity: Streamlined procedures and improved organization within the laboratory contribute to increased efficiency and productivity, allowing you to handle more work while maintaining quality. 

Reduced costs: By minimizing errors and rework, accreditation can lead to cost savings in the long run. Additionally, some accreditation bodies offer discounts on proficiency testing programs and other services. 

Increased client satisfaction: Accredited laboratories demonstrate a commitment to quality and deliver consistent, reliable results, leading to increased client satisfaction and loyalty.

Competitive advantage: In a competitive market, accreditation can set your laboratory apart by demonstrating your commitment to quality and professionalism, potentially attracting more clients and projects. 

Reduced regulatory burden: Accreditation by a recognized body can sometimes streamline regulatory inspections and audits, saving time and resources. 

The lab accreditation process: Where to start 

It can be overwhelming, intimidating, and confusing to dive into the world of audits and accreditation standards. Knowing where to start can also be a struggle. Below are suggested steps based on my own experience of going through this process. 

1. Get familiarized with ISO 17025 standards requirements 

  • The most reliable resource for this purpose is a copy of the most recent version of ISO 17025 standards handbook, titled ISO 17025 - General requirements for the competence of testing and calibration laboratories. It's extensive and can be difficult to digest all the information. My recommendation is to first get comfortable with the table of contents. This will help you to understand the general concepts and requirements, and then you pick sections for more intense reading. 
  • Audit Checklist: This document can give you an idea of the focus areas during an actual assessment. You can also use this list for conducting internal audits as well. It’s easily available on websites of various certified auditing bodies (CAB). 
  • Webinars: Many of the renowned CABs have free webinars on a periodic basis. You can register for these free webinars and educate yourself on specific topics of the ISO 17025 standards.   
  • Form a task force: Form a team with members based on their management, technical, and administrative skills. 
  • Talk to peers and colleagues who have been through the process. Network effectively
  • Hire a consultant to help the lab prepare and do a mock audit

2. Define “scope"

By strategically defining your accreditation scope, you can optimize resources, ensure efficiency, and demonstrate your expertise in specific areas. 

Criteria for selecting scope: 

The relevance of selecting the right accreditation tests depends on your goals. Align accreditation testing with your goals of client demand that directly address their needs to build strong relationships. For market expansion, prioritize tests with high demand, profitability, and market relevance to attract new business and increase value. 

Simplicity. Accreditation can be overwhelming, so begin with fewer, simpler tests that fall within your expertise. Choose tests requiring minimal equipment to minimize documentation and calibration needs. Starting small reduces administrative complexity and eases your journey into accreditation. 

Unbroken chain of calibration. Each piece of equipment and material involved in the test process must possess an unbroken documented history of calibration and traceability. Therefore, meticulous attention to calibration and traceability is essential to uphold the integrity of the testing process and the validity of the results obtained. 

3. Gap analysis 

Gap analysis refers to identifying the gap between where you are now and where you need to be. This step is critical in understanding areas of improvement. Below are few primary focus areas for conducting a gap analysis:

a. Processes: Make a list of all the various steps involved throughout the process. Then, investigate each step to understand what you're doing versus the requirements. For example, you can pick a final test report and track it back to see if all the related documents are in place. 

b. Employee training: Employees performing the test in your scope should be trained and there should be training records to prove their competencies. 

c. Method validation: Be ready to produce documents to show that your testing method is standardized and validated. 

d. Test and calibration materials: There are specific guidelines in the standard on the reference or test material. For example, calibration standards for the test need to have an ISO 17025 certification.  

e. Equipment: sometimes the original equipment manufacturer’s (aka OEM) technical support team can be a very useful resource for gaining access to the right information. For example, identifying a current version of the firmware of your equipment.

f. Environment: Understand what the requirements are for monitoring the environment and required documents. For example, certain tests are temperature- and humidity-sensitive so maintaining a temperature and relative humidity records become crucial.

4. Develop a requirement list 

After completing your gap analysis, prioritize addressing missing requirements.  Create a clear action plan outlining specific steps to tackle each one. Proactive internal identification is key and thorough gap closure through corrective actions ensures your lab meets all accreditation standards and sets you up for success. 

5. Select a conformity assessment body 

There are numerous options available when selecting an audit body to grant accreditation status. Below are a few points to consider during the selection process: 

a. Client/management requirement: Get an understanding of whether your client or company management is inclined toward a specific CAB.  

b. Schedule matrix: An accreditation audit isn't a one-time occurrence. Each CAB follows a specific schedule for evaluating laboratories. This could involve a 2- or 4-year cycle, depending on the auditing body's procedures, including on-site audits and document reviews in alternating years. It is essential to evaluate schedules of CABs to effectively plan and prepare for the accreditation process. 

c. Cost: Various CABs impose different fees for their services. It is advisable to request quotes for an entire audit cycle to accurately budget for the costs associated with accreditation. 

d. Process for expanding scope in the future: Understand how easy or difficult the process is to expand in scope in the future.  

e. Process for non-conforming work: It's beneficial to gain an understanding of the audit body's philosophy regarding the classification of major versus minor findings during an audit. 

f. Proficiency testing requirements: In simpler words, you'll get a mystery sample to test. The results will be checked against known answers. The aim is to assess the laboratory’s performance and accuracy. Each CAB has a specific requirement for proficiency testing schedules, some require more frequent checks than others.

6. Documentation 

Preparing for an initial audit involves creating and organizing extensive documentation, especially if you lack a QMS. The standards provide specific formats for policies, procedures, and related documents. You can also find online templates and examples. However, this process takes time, effort, dedication, and perseverance.

7. Internal audit and corrections 

When preparing to conduct your initial internal audit, you can utilize a checklist provided by the CAB you've chosen. Typically, these checklists are available on their website. There are also online resources available for internal audits. If any findings arise from an internal audit, you may need to initiate corrective actions and address them before proceeding to apply for the first assessment. 

8. Pre-assessment and correction   

Conduct a thorough pre-assessment, make necessary corrections, and schedule your first audit.  

Achieving ISO 17025 accreditation requires dedication, but a systematic and methodical approach paves the way for success. The rewards are substantial. Accreditation validates your commitment to quality, safeguarding both your clients and your lab's reputation. It's a mark of excellence that sets you apart.