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The path to ISO/IEC 17025 accreditation isn’t as hard, or as tricky, as lab gossip makes it out to be. If you are prepared, your lab can be accredited in three short months. Photo: Plastics Color Corporation

Ten years ago, finding a manufacturer with an onsite, accredited lab was very rare. To receive certification, developers had to ship their product from the manufacturer to the closest ABC Research Laboratory. Sending products to an outside lab meant time wasted and money lost for the product developer – and an opportunity missed for the manufacturer.

The extra step in the product cycle didn’t go unnoticed by manufacturers – most simply didn’t know how to capitalize on it. The 1999 release of ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories) changed everything because the new standard made it easier than ever to bring everything under one roof.

Manufacturers should have jumped at the opportunity to receive their ISO/IEC 17025:1999 accreditation. Unfortunately, high standards and precise accountability have ironically led many manufacturers to contemplate whether the process is worth the effort. Companies that overcome their angst receive instant creditability. A better understanding of ISO/IEC 17025 will allow more manufacturers to feel comfortable with the accreditation process. 

Getting To Know ISO/IEC 17025

Located in Switzerland, the International Organization for Standardization (ISO) creates a consensus-based standard for global solutions. ISO is made up of 162 members, with only one member per country. Members are required to join technical committees according to their national economic, social and environmental priorities. A panel of experts, selected from the appropriate technical group, is responsible for voting on ISO standards. ISO members from the selected technical group vote on drafts as needs are established. Draft standards receiving at least 75 percent of the vote become an ISO standard.

The International Electrotechnical Commission (IEC) “provides a platform to companies, industries and governments for meeting, discussing and developing the International Standards they require.” IEC partners with ISO to ensure that international standards fit together seamlessly.

ISO/IEC 17025 went to a vote in late 1999 and was adopted internationally in 2000. Approved as a replacement for ISO/IEC Guide 25 and EN 45001, ISO/IEC 17025 established all of the general requirements for the competence of testing and calibration laboratories undertake. ISO 17025:1999 shared some requirements with ISO 9001:1994, the standard for quality management systems, which forever tied the two regulations together.  

In 2000, ISO 9001 was amended, which meant ISO/IEC 17025 needed to be updated as well to reflect the change. ISO members approved the change and ISO/IEC 17025:2000 became the standard that labs need to follow. Unfortunately, because ISO/IEC 17025 and ISO 9001 are so closely associated, the two standards are often confused.

Roger Muse, Vice President of Business Development for ANAB and author of What's in a Name: Accreditation vs. Certification?, explains why ISO 9001 isn’t sufficient for labs looking for accreditation. “ISO 9001 is a certification that applies to an entire organization,” he said. “While effective as a management evaluation tool, ISO 9001 does not have enough technical content to provide assurance that the test, inspection or calibration data is accurate and reliable.” Being ISO/IEC 17025 accredited means your lab operates a management system, is technically competent and is able to produce technically valid results. A laboratory can be ISO 9001 certified, but not be an ISO/IEC 17025 accredited lab. But if a lab receives ISO/IEC 17025 accreditation, then it will also have met the qualifications for ISO 9001 certification. Understanding the difference between certification and accreditation can also help you comprehend ISO/IEC 17025 a little better. See the sidebar, "Certification Versus Accreditation", for more details.

The Accreditation Process

The path to ISO/IEC 17025 accreditation isn’t as hard, or as tricky, as lab gossip makes it out to be. If you are prepared, your lab can be accredited in three short months. Those who are not as prepared can find themselves on a journey lasting as long as a year and a half. How long you take is up to you. Study guides, training courses and kits can help you prepare. A kit can cost $75 and a guidebook $320, or you can enroll in a course for $510.

If you are ready to bring everything in-house by getting your lab ISO/IEC 17025 accredited, you should choose an independent, non-profit organization. Every accrediting body follows ISO standards, so the steps for accreditation will be roughly the same. The main difference is the optional practice and pre-assessment options the accrediting bodies make available.

Just as in grade school, the assessor does not want you to fail. You should have all the information you need to succeed on the test. But unlike grade school, you have a chance to fix your mistakes. There’s no big “F” and no detention to worry about. Take a look at ANAB and A2LA, two of the country’s premier accreditation bodies’ scope of accreditation.

The ANAB Accreditation Process

  1. Quotation
  2. Application
  3. Introductory visit (Optional)
  4. Document review
  5. Practice (Optional)
  6. Assessment
  7. Planning visit (Optional)
  8. Accreditation assessment
  9. Corrective action and/or follow-up visit
  10. Accreditation decision

The A2LA Accreditation Process

  1. Application
  2. Document review
  3. Pre-assessment (Optional)
  4. On-site assessment
  5. Deficiencies
  6. Corrective action process
  7. Accreditation decision

The accreditation process is built to be transparent, but that doesn’t mean it will be easy.

ISO/IEC 17025 Challenges

While the steps for accreditation are clearly defined, the process is different for every organization seeking approval. The length of time and the ease or difficulty of the accreditation process depends on your team’s experience and preparation. “Organizations that tend to stumble during the accreditation process do so because they get overwhelmed,” Muse said. Some organizations see all of the requirements and just freeze. Others are deterred from starting the process at all.

A financial commitment is also tied to your accreditation. The cost will depend on the number of tests you are running each year and the number of labs you have needing accreditation. The cost for the first year is approximately $8,000, and around $3,500 each year thereafter to maintain the accreditation. For most companies, these fees should be minimal in the big picture, but they are additional expenses to consider.

Failing is always a fear, but it is not likely if you are putting in the necessary work. Any opportunities are laid out in a corrective action plan, and as long as you respond, and resolve, all the deficiencies in the time allotted within the standards, you should have no problem overcoming any issues.

ISO/IEC 17025 Benefits

The ISO/IEC 17025 accreditation will improve your lab quality and your marketability. For more than six years, Plastics Color has proudly owned and operated two accredited labs, one in Illinois and another in North Carolina. Plastics Color was among the first in its industry to seek accreditation and Jennifer Presnell, Corporate Quality Systems & Regulatory Affairs Manager, believes the ISO/IEC 17025 accreditation gives the company a distinct advantage over the competition. “Having the ISO/IEC 17025 accreditation allows us to validate our methods, our technicians and our equipment,” she said. “The ISO/IEC 17025 accreditation also ensures our customers that our process produces a quality product that is repeatable. ISO/IEC 17025 is a difficult standard to maintain, but it gives our company a higher level of credibility in many critical fields such as the medical and pharmaceutical industries. It’s the effort that sets us apart from the competition.”

The ISO/IEC 17025 accreditation provides suppliers instant credibility. “Some manufacturers hesitate getting accredited because their customers don’t require it. Others simply don’t want to put their people through the demanding process,” Presnell said. “But it says something about your company to complete the accreditation process. You can brag about your company and your people as much as you want, but customers don’t have to just take your word for it when you have ISO’s stamp of approval. It’s validation of your investment of time, methods and money.”

Setting The Standard

The unknown is often scarier than the task at hand. Such is the case with ISO/IEC 17025 accreditation. But as long as you prepare, lean on experienced team members and follow the correction action plan (some deficiencies are normal, so don’t sweat it) you will be just fine. The path to ISO/IEC 17025 accreditation may be long and hard, but the reward, in the end, is well worth the effort. Let your customers know that you are compliant with the industry standards and you understand the process and reasoning behind the regulations. Show them you are ISO/IEC 17025 accredited.

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SIDEBAR: Certification Versus Accreditation

People often confuse the terms certification and accreditation. While similar, the words have very different meanings.

Accreditation: Third-party recognition, by an authoritative body, documenting that the approved party is capable of executing the specified tasks and standards as defined by the accrediting agency. The process provides confirmation of accuracy and reliability of test results.

Certification: Ensures a product, management system or personnel conforms to specified requirements. This approval process does not provide confirmation of accuracy or reliability of test results.

On an organization flow chart, accredited bodies would be at the top and certifications would be below. An accredited body issues certifications, but a certified body cannot issue an accreditation.

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