Americans for Safe Access’ ISO 17065: THE STANDARD FOR CERTIFICATION BODIES

This post was originally published on SafeAccessNow.com

American’s for Safe Access has achieved accreditation to the ISO/IEC 17065:2012 (Certificate #5284.01) standard for certifying bodies through it’s PFC program, making it the first compliance program to obtain international accreditation specifically for the cannabis industry.

The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) 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. The ISO/IEC 17065:2012 accreditation is defined as “Requirement for bodies certifying products, processes and services.” Its predecessor, ISO/IEC Guide 65, has been in existence since the mid-1990s and has been 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.

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.”

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.

 This accreditation further validates the PFC program as a standard setting body in the United States.

Accreditation vs. Certification

Let’s start with some background information first, namely what is accreditation and what is certification. While these 2 terms may seem interchangeable, and generally are, when it comes to being accredited or certified there are some differences.

Most people who work in the cannabis industry have heard the word “certification” but not many may truly understand what that word actually means. Even fewer people may know that there is an international conformity assessment standard that exists for the operation of a certifying organization and a formal vetting process, known as accreditation.

This standard is known as ISO/IEC 17065:2012, “Requirement for bodies certifying products, processes and services.” Its predecessor, ISO/IEC Guide 65, has been in existence since the mid-1990s and has been used by industries and regulators around the world. While many industries have shifted towards requiring third-party certifications for companies where regulators have oversight responsibilities (i.e. businesses that must adhere to the requirements set by the Food and Drug Administration), the cannabis industry is falling far behind.

Accreditation is given by an organization known as an accreditation body (AB), and most are signatories of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA), often referred to as the ILAC-MRA. The ILAC-MRA outlines a set of standards by which AB’s must adhere to. These AB’s may perform assessments which result in accreditation to a specific standard, such as ISO 17025, which is the standard for analytical and calibration laboratories. In our case, we have been accredited to the ISO/IEC 17065:2012 standard for bodies certifying products, processes, or services.

Certification includes a set of requirements put in place by a certification body, and must also include criteria with which the certified product, process, or service must meet in order to be compliant. For example, how is a consumer to know that a business is producing safe medicine without knowing how the criteria of producing safe medicine is defined.

The importance of certification cannot be understated and should be taken more seriously by the cannabis industry, if they are to achieve a level of uniformed compliance that so many other industries already utilize. Other certifications include Telecommunication Certification Body (TCB) program of the U.S. Federal Communications Commission (FCC), and the ENERGY STAR program of the U.S. Environmental Protection Agency (EPA). While there are many other cannabis certification programs in the industry, PFC is the only certification program in the cannabis industry that has been accredited to this level of a standard.

ISO Accreditation

The Pyramid of Accreditation: At the peak of the pyramid are Standard Setting Bodies like ISO, the second level are Accreditation Bodies like A2LA and ANSI, the third level are Certifying Bodies like our PFC program or Materials Analytical Services, the base of the pyramid are PFC Certified Businesses like CannaSafe and PhytaTech.Because PFC is independent of the ILAC-MRA, and because of our specific accreditation, we are referred to as a certifying body (CB) and as such issue business certifications. The certifications that PFC issues are part of our certifying scheme, which was thoroughly audited during our ISO/IEC 17065 accreditation process. The PFC certifying scheme includes the PFC Standard, along with the various checklists that we use when we conduct assessments.

In addition to the certifying scheme, our process for how we train PFC auditors and how we monitor certified businesses was also evaluated during the ISO 17065 accreditation process. The overall process took over a year 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 Certifying Scheme

The certifying scheme is what defines the PFC program and 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. It was developed from the American Herbal Products Association (AHPA) Recommendations for Regulators and the American Herbal Pharmacopeia’s Cannabis Inflorescence Monograph. In order to be the strongest standard possible, the Code of Federal Regulations sections relating to Good Agricultural (Collection) Practices, Good Manufacturing Practices, and Good Laboratory Practices that are applicable to cannabis and hemp operators were included. The strength of the 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, 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 as further evidence that we are adhering to our certifying scheme.

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.

What does this mean for companies that are already PFC certified or are interested in getting certified?

The process of becoming ISO accredited means that our policies and procedures have been vetted by an internationally recognized organization by highly trained auditors. Businesses that are PFC certified can know that the process by which their operation is being assessed has been verified to the highest international standard possible.

In the cannabis and hemp industries, only laboratory operations are required to seek outside accreditation, most often to the ISO/IEC 17025:2017 standard for analytical and calibration laboratories. States are currently evaluating additional requirements such as GMP (Good Manufacturing Practices), which evaluates whether a company is compliant with a specific section of the Code of Federal Regulations, usually to either the pharmaceutical or dietary supplement sections.

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