in Biology with a minor in Chemistry from Carthage College in Kenosha, WI. She has worked in every aspect of quality management systems and is a sought-after consultant in regulatory and scientific standards. The QM is NOT a step-by-step procedure, or at least it shouldn’t be. This website uses cookies so that we can provide you with the best user experience possible. The approach to ISO/IEC 17025 accreditation is typically summarizing the standard requirements through the use of a checklist. Setting the precedence up front drives uniformity, compliance and standardization into an industry that desperately needs it. Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings. To find the approved certified bodies for ISO certificates, you can go to the IAF website (International Accreditation Forum). ISO International Standards play an integral role. Kathleen, you are right about the gaps where ISO 17025 falls short. National accreditation bodies are responsible for accrediting laboratories to ISO/IEC 17025. ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world. General requirements for the competence of testing and calibration laboratories. This is an international organization where the accredited bodies are registered. ISO/IEC 17025 accreditation provides an added level of trust, respect and confidence in the eyes of regulators and consumers. The laboratory is not offered any clear instruction of how to manage change control, including specific requirements for making changes to procedures and/or test methods, documented justification of those changes, and the identification of individuals authorized to approve those changes. We are committed to ensuring that our website is accessible to everyone. In her lead role at Triskele, Kathleen offers consultation services for GMP implementation, Standard Operating Procedure (SOP) development, audit readiness, validation, and training to testing laboratories, cultivation facilities, and manufacturing facilities. National Fire Protection Association (NFPA). “Testing into compliance”, as this practice is commonly referred to, was ruled unacceptable by the FDA in the highly publicized 1993 court case United States vs. Barr Laboratories. When discrepancies or variances in results are identified (most likely the result of an inadequate TMT), changes to test methods may be made with no justification or data to support the change, and the subsequent method becomes the “validated” method used for final release testing. Your email address will not be published. ISO/IEC 17025 covers the requirements for both testing and calibration laboratories. The document center comes with two basic search options: Filter by category in the column on the left: Clicking on the main categories will open sub-categories. Accreditation bodies are responsible for assessing the quality system and technical aspects of a laboratory’s Quality Management System (QMS) to determine compliance to the requirements of ISO/IEC 17025. © Copyright 2015 - 2021 Innovative Publishing Co. LLC, All Rights Reserved, Other Innovative Publishing Co. LLC Sites: Food Safety Tech  |  MedTech Intelligence. Disciplines for which ANAB offers accreditation include but are not limited to: Accreditation is based on assessment of an agency's technical qualifications and competence for conducting specific testing, calibration, and/or inspection activities within the scope of ISO/IEC 17025 or ISO/IEC 17020 and any relevant field-specific standards included in amplification documents. The Quality Control (QC) laboratory serves as one of the most critical functions in consumer product manufacturing. Laboratories purchase equipment, install equipment with pre-loaded methods and jump in to testing products. Select or deselect the desired categories by ticking the boxes.You can also filter by language and document type in this way. An SOP is a stand-alone set of step-by-step instructions which allow workers to consistently carry out routine operations, and documented training on SOPs confirms an employee’s comprehension of their job tasks. and stay engaged the way you want to! ISO 28000:2007 (Specification for security management systems for the supply chain) is an ISO standard published by International Organization for Standardization which includes requirements of a security management system particularly dealing with security assurance in the supply chain. Cannabis Industry Journal is the industry’s leading online trade journal. The standard was developed by ISO/TC 8 on "Ships and maritime technology" and published … Indoor and outdoor horticulture and agriculture, Personnel training, assessment, and credentialing. Kathleen is an executive member of the ASTM International Cannabis Standards Committee, D37. Accreditation is a sure way for businesses to provide assurance of the quality and authenticity of their products at every step. All of them planned, made as planned, data studied and analyzed for proposing actions to correct, prevent or minimize risks of delivering not valid results. Specifications establish a set of criteria to which a product should conform to be considered acceptable for its intended use. A free publication about ISO/IEC 17025, and how it can help testing and calibration laboratories demonstrate their capacity to deliver trusted results. The controls involve the sampling method, the sample per se, the item to be tested, the testing process and all of the subprocesses or metaprocesses related to the test. Although not required per the current version of the standard, many laboratories develop a Quality Manual (QM). The Code of Federal Regulations, 21 CFR Part 211, Good Manufacturing Practice for Finished Pharmaceuticals, provides the minimum requirements for the manufacture of safe products that are consumed by humans or animals. In some cannabis markets accreditation to the standard is mandatory. Kathleen May, founder of Triskele Quality Solutions, provides insight on where ISO/IEC 17025 accreditation may not be sufficient guidance for cannabis testing laboratories to operate in a compliant and safe manner. There is no mention of requiring a root cause investigation, no requirement to document actions, and most importantly there is no requirement to document a retesting plan, including justification for retesting. Documentation is requested and reviewed to determine if what is provided satisfies the item listed on the checklist, which correlate directly to the requirements of the standard. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Not all states cover every base like Colorado. The understanding of what qualifies as a Standard Operating Procedure (SOP) is often misunderstood by cannabis operators. Thank you CDPHE! On the other hand, the approach of the standard is metrological, in which the measurements as processes are controlled for assuring their validity contrasting them with the scientific, technical, industrial or legal values. The Laboratory complies with it starting identifying its legal, regulatory authorities, customers, and organization providing recognition requirements as cited in 5.4. All copyright requests should be addressed to copyright@iso.org. A Preventative Maintenance (PM) schedule should be established for eye wash stations, safety showers and fire extinguishers. In my opinion, this is doing cannabis testing laboratories a disservice and setting them up for failure on future accreditations and potential regulatory inspections. A “Culture of Safety” (as defined by the Occupational Safety and Health Administration (OSHA)) is lacking in most cannabis laboratories. Join the Cannabis Industry Journal community Whether it’s going to far-flung lands or just the neighbouring country, we all need a passport to travel. The Government has confirmed UKAS' role as the National Accreditation Body (NAB) following our exit from the EU. Subsequently, the quality of consumer products is determined by design, development, Good Manufacturing Practice (GMP) controls, product and process validations, and the specifications applied throughout product development and manufacturing. Adherence to ISO/IEC 17025, and subsequently receiving accreditation, is an excellent way to ensure laboratories have put forth the effort to establish a QMS. ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories is used to develop and implement laboratory management systems. Kathleen May, Founder and Owner of Triskele Quality Solutions, has more than 20 years’ experience as a Quality professional in the pharmaceutical, medical device and cannabis industries. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. Any use, including reproduction requires our written permission. The A2LA Calibration Laboratory Accreditation Program services customers in all metrology industries and provides opportunities for accreditation in virtually every field of … These requirements are mentioned in ISO/IEC 17025, Step 7.2.2, Validation of Methods, but they are written as “Notes” and not as actual necessities for accreditation acceptance. GC instrumentation requires the use of compressed gas which is commonly supplied in gas cylinders. Providing a model to follow when setting up and operating a management system, find out more about how MSS work and where they can be applied. This project was completed in five months with an annual cost savings of $500,000 and a fourteen-day reduction in cycle-time of product-release to market. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories. The standard speaks to identifying “changes” in documents and authorizing changes made to software but the standard, and subsequently the accreditation criteria, is loose on the requirement of a Change Control process and procedure as part of the QMS. She has held multiple management roles and earned a certification as a Certified Quality Auditor (CQA) from the American Society for Quality. All copyright requests should be addressed to, ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, Improving the integrity of the supply chain on World Accreditation Day, New edition of ISO/IEC 17025 just published, ISO/IEC 17025 — Testing and calibration …. The standard requires the laboratory to utilize “validated” methods. © All Rights Reserved All ISO publications and materials are protected by copyright and are subject to the user’s acceptance of ISO’s conditions of copyright. Finally, Safety Data Sheets (SDSs) should be printed and maintained as reference for laboratory personnel. It also takes into consideration the latest version of ISO 9001. A2LA is the largest and most well-recognized accreditor of calibration laboratories in the United States. Post was not sent - check your email addresses! This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization. More specifically, 21 CFR Part 211: Subpart I-Laboratory Controls, outlines the requirements and expectations for the quality control laboratory and drug product testing. This standard now brings an element of risk assessment. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade. However, there is no verification that the process of either validating in house methods or transferring methods from a vendor were developed using any standard guidance on test method validation to confirm the methods are accurate, precise, robust and repeatable. The intent of a QM is to be a high-level operations policy document. This means that every time you visit this website you will need to enable or disable cookies again. Based on my experience, there has been some leniency given to cannabis testing laboratories seeking accreditation as they are “new” to standards implementation. You can find out more about which cookies we are using or switch them off in settings. Or watches from Switzerland get past border control in Australia? This tracking pixel is cleared from your system when you delete files in your history. But what about products? The most popular standard for the competence of testing and calibration laboratories has just been updated, taking into account the latest changes in laboratory environment and work practices. Additionally, 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls states that appropriate QC operations must be implemented to ensure food products are safe for consumption and food packing materials and components are safe and fit for purpose. Kathleen has worked at Fortune 500 companies such as Abbott Laboratories, Baxter Healthcare, Cardinal Health, Merz North America, Hospira, and Pfizer. We also use cookies to store your preferences regarding the setting of 3rd Party Cookies. This complimentary event will have four webinar presentations, all back-to-back and on the same day. Policies and procedures should be established to define required Personal Protective Equipment (PPE), the safe handling of hazardous materials and spills, and a posted evacuation plan in the event of an emergency. If you disable this cookie, we will not be able to save your preferences. UK accreditation post EU-exit. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Laboratory Controls. If you have any questions or suggestions regarding the accessibility of this site, please contact us. All ISO publications and materials are protected by copyright and are subject to the user’s acceptance of ISO’s conditions of copyright. Any use, including reproduction requires our written permission. Sign up for the FREE Cannabis Industry Journal Newsletter and stay on top of the latest industry news! Providing advice on the type of sample and testing that may be required. Equally as critical, for product testing laboratories in particular, is the objective to establish GxP, “good practices”, to ensure test methods and laboratory operations verify product safety and quality. Sorry, your blog cannot share posts by email. Stay tuned for announcements on the agenda, registration page and speaker lineup. Their “papers” are often in the form of documents such as certificates that prove they have passed the various rules and requirements of their new country. Accreditation bodies are responsible for assessing the quality system and technical aspects of a laboratory’s Quality Management System (QMS) to determine compliance to the requirements of ISO/IEC 17025. Originally known as ISO/IEC Guide 25, first released in 1978, ISO/IEC 17025 was created with the belief that “third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures”7. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration. ISO/IEC 17025 is useful for any organization that performs testing, sampling or calibration and wants reliable results. These specifications are specifically the validated test methods and procedures and the established acceptance criteria for product release and throughout shelf life/stability studies. Being in operation in Colorado, and having testing certification credentials also being given from the Colorado Department of Public Health and Environment (CDPHE), the gaps you spoke of above are all covered. I can only hope that as potency testing for hemp becomes more Federally Regulated, these gaps will be filled, but it will not happen in the near future. It is not an uncommon practice for cannabis laboratories to use the QM as the repository for their “procedures”. Based on ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, and ISO 9001, Quality management systems - Requirements, ISO 15189 includes five additional criteria for medical laboratories . Gas chromatography (GC) is a common test method utilized in an analytical testing laboratory. Your email address will not be published. The objective of any laboratory seeking accreditation is to demonstrate they have an established QMS. Subsequently, there is no requirement to define, document, and justify changes to test methods. Find out more about accreditation regulations, the MOU between BEIS and UKAS, government policy, our membership of EA, the UKCA & CE UKNI marking, and EU-UK trade agreements. However, for product testing laboratories specifically there are a number of “gaps” within the standard and the accreditation process. ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful. National accreditation bodies are responsible for accrediting laboratories to ISO/IEC 17025. Safe laboratory practices are not addressed at all in ISO/IEC 17025. ISO Accreditation. I agree with Rosario, above, in that ISO 17025 should not be the “catch all” that many states are relying on for cannabis testing standards. The documentation and management of Out of Specification (OOS) testing results is perhaps one of the most critical liabilities witnessed for cannabis testing laboratories. The committee is focused on the development of standards in seven technical areas: I appreciate your points of view. ISO/IEC 17025 accreditation is pursued by many laboratories as a way to set them apart from competitors. Specifications are proposed, justified and approved as part of an overall strategy to ensure the quality, safety, and consistency of consumer products. The new version covers technical changes, vocabulary and developments in IT techniques. Both food and drug products must be tested against established specifications to verify quality and safety, and laboratory operations must have the appropriate processes and procedures to support and defend testing results. In an increasingly globalized world, trade and traceability is getting trickier as supply chains get longer and more complex. Below are my “Top Five” that I believe have the greatest impact on a cannabis testing laboratory’s ability to maintain compliance and consistency, verify data integrity and robust testing methods, and ensure the safety of laboratory personnel. There is no formal verification (what is known as a Test Method Transfer (TMT)) by the laboratory to demonstrate the method validated by the vendor on the vendor’s equipment, with the vendor’s technicians, using the vendor’s standards and reagents, performs the same and generates “valid” results when the method is run on their own equipment, with their own technician(s), and using their own standards and reagents. You won't want to miss this extraction and concentrates event. How do bananas from Costa Rica get through customs in France? The last version of ISO/IEC 17025 was published in 2005 and, since then, market conditions and technology have changed.