Americans for Safe Access ISO 17065 Accreditation: THE STANDARD FOR CERTIFICATION BODIES
Americans for Safe Access (ASA) has created the medical cannabis market through the crafting and monitoring of legislation and regulations at all levels of government. As a patient advocacy organization, product safety has been a top priority since our inception in 2002. ASA transformed the medical cannabis movement from a legal and political fight to a new legal marketplace for patients and cannabis providers. As cannabis production moved out of mostly home-grows into commercial settings, we knew we had a responsibility to make sure there was an avenue for all consumers to find safe medicine in this new arena. We also knew that in creating this marketplace outside of Federal oversight, proving this could be done safely would be a key element for this experiment to advance, especially for medical professionals, state governments and new medical cannabis patients.
Through ASA’s Patient Focused Cannabis (PFC) Program, we coordinated experts globally to create product safety standards for growing, processing, testing, and distributing cannabis for human consumption and developed robust education, training and certification to aid companies in meeting these standards for patients. PFC has helped companies and governments globally to navigate and implement product safety standards for cannabis and hemp products available for patients, adult use consumers, and pets. Infact, most states and many countries have adopted PFC standards in their regulations.
In our continued commitment to ensuring safe medication for patients, ASA has achieved accreditation to the ISO/IEC 17065:2012 (Certificate #5284.01) standard for certifying bodies, making our PFC program the first and only compliance program to obtain international accreditation specifically for cannabis! The process of becoming ISO accredited means that ASA’s policies and procedures have been vetted and validated by an internationally recognized organization by highly trained auditors.. While there is still a lot of work to do to ensure patients in the US (and globally) have access to cannabis therapeutics, this a crucial step in the acceptance and integration of cannabis into our society as a real medicine.
Third party certifications are common in many legal industries and markets and work with governments to ensure the safety of products and services to their inhabitants. The PFC standards incorporate all state, federal and international cannabis and product laws and regulations. In the PFC certification process, businesses are given recommendations for improvement and are allowed to make the necessary changes in their procedures and facilities, further preparing them for licensing and regulatory inspections. This can save companies thousands if not millions of dollars in fines, recalls or stalled licensing.
The ISO accreditation validates the work that ASA has been doing through the PFC program since its launch in 2014 and gives clout behind the PFC certification seal for the companies that we have certified. For patients and medical professionals, the PFC seal means that they can confidently add cannabis therapeutics to their health plans knowing there are safe and accurately labeled products on the market. The PFC seal plays a major role in ensuring quality along the supply chain from state to state and from country to country in the hemp for human consumption markets today and will for the medical cannabis market as laws evolve allowing interstate commerce and international trade.
What does ISO mean for Business and Governments?
ISO/IEC stands for the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Together these form the standard setting body that has developed over 23,752 standards, including those for management systems, quality management, information security management, information technology, and occupational health and safety.
ISO/IEC 17065:2012 accreditation is a “Requirement for bodies certifying products, processes and services” and has been in existence since the mid-1990s and used by industries and regulators around the world. ISO/IEC 17065:2012 was developed to create comfort for governments that need to shift oversight responsibilities (i.e. businesses that must adhere to the requirements set by the Food and Drug Administration) to third-parties through certifications.
This is common practice for many goods and services globally but has not yet caught on for companies in the cannabis market, making the cannabis market rely on its own word for determining safety parameters for safety and compliance for cannabis and cannabis products.
Accreditation vs. Certification
While these 2 terms may seem interchangeable, when it comes to being accredited or certified there are some major differences.
The classifications of certification methods include:
First-party certification. “I produce the safest and highest quality medicine because I meet the criteria which I have defined for myself and therefore I can say that my products meet my own criteria.”
Second-party certification. “My company produces the safest and highest quality medicine because the training program that we created is of the highest quality and all our staff have taken it.”
Third-party certification. “My company produces the safest and highest quality medicine because it meets the criteria defined by an impartial association that maintains a universal standard.”
Third-party certification is a method of certification that is independently developed and verified thereby reducing conflict of interest and providing validity to a product of service. Third party certification adds a level of assessment, unrelated to the company, that helps assure safer and more reliable products. When a company goes through third party certification, they undergo evaluations to verify that a given set of standards are met and then assessed by a group of individuals, that are unbiased, independent, and experts in the given field they are assessing. While there are a few third-party certification bodies out there, only ASA has gone through their own audit and assessment, known as ISO.
Historically first or second-party certification have been the norm for many cannabis businesses. However, some cannabis businesses are now choosing to look for training providers and organizations that can assess them from an unbiased viewpoint to help them stand out as well as to help them feel confident that the medicine they are producing or selling is safe for consumers.
According to ISO “The overall aim of certifying products, processes or services is to give confidence to all interested parties that a product, process or service fulfils specified requirements. The value of certification is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfilment of specified requirements by a third party.”
Without third party certification, consumers are left to trust cannabis businesses that what they are declaring as safe and high quality is true.
Accreditation is an international conformity assessment standard that formally vets a certifying organization on their set of standards.
To be ISO accredited, ASA went through a years-long accreditation process to further validate the PFC program as a standard setting body in the United States. Meaning that the standards we created through our PFC program have been assessed to the highest international conformity. While there are other cannabis certification programs, PFC is the only certification program for cannabis that has been accredited to this level of a standard.
The Accreditation Process
As a certifying body (CB), ASA issues business certifications through our PFC program as part of our certifying scheme. During our ISO/IEC 17065 accreditation process, the PFC Standard, our process for how we train PFC auditors, how we monitor certified businesses, along with the various checklists that we use when we conduct assessments were thoroughly audited. The overall process took years to complete and included a witness audit where the auditor who was performing the PFC assessment watched as a live PFC assessment was taking place.
The PFC Standard
In 2009, Americans for Safe Access began working with American Herbal Products Association (AHPA) and the American Herbal Pharmacopeia’s to create Recommendation for Regulators and the Cannabis Inflorescence Monograph. These were the first product safety standards available for cannabis. Building on these cannabis specific tools, in 2011 ASA incorporated the Code of Federal Regulations sections relating to Good Agricultural (Collection) Practices, Good Manufacturing Practices, and Good Laboratory Practices to create the PFC standards for laboratories, cultivation, manufacturers and distribution centers.
The PFC program includes the standard along with the checklists that are used to perform assessments. The PFC Standard is a set of guidelines that provide a system of processes, procedures, and documentation to ensure that Cannabis products such as cannabis, cannabis-derived products, hemp, and hemp-derived products have the strength, composition, purity, and identity they claim to constitute or possess. The PFC Standard helps to ensure businesses remain compliant despite changing regulations. From the standard, the checklists that are used to assess each operator are developed. When a business applies for certification they receive a copy of the standard along with all applicable checklists, making it a fully transparent process.
The Accreditation Process
Like the PFC Business Certification process, our accreditation followed a similar path. We had to fill out an application to determine we were eligible to get accredited. Upon submission and approval of our application we were sent a copy of the ISO 17065 standard along with the checklist that we would be audited to. Our policies and procedures, including how we perform assessments, how we train assessors, what our emergency action plans are, and what our health and safety requirements are were all reviewed to ensure they met the criteria of the standard. Additionally, all records related to our policies and procedures were reviewed. Records are the demonstration that what you say you are doing in your SOPs is actually being done and are the evidence required. Further, the audit team was required to witness a PFC assessment taking place..
When all policies, procedures, records, and evidence were deemed acceptable, the checklist and related items were sent to an Accreditation Council. The Accreditation Council (AC) is independent of the auditor and the person performing the audit is not permitted to indicate whether they think the business should be awarded or denied accreditation. The AC is then tasked with reviewing the information and making a decision, and in our case we have been successful and awarded ISO 17065 accreditation as a certifying body.
Consumers deserve to know that their products are safe, governments need to ensure that consumers are getting safe goods, and companies need to know how to provide safe products.
This can be achieved through ASA’s PFC Program which is now ISO accredited. . PFC certification means that a cannabis product or service has been verified to the highest international standard possible. Patients deserve nothing less.
To learn more about ASA’s PFC program, visit our PFC website.
To read the press release announcing our accreditation, click here.
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