Significance and Use
4.1 Having a concise set of QMS requirements allows users of this practice to understand "what" needs to be established, consistently practiced, monitored, maintained, and improved.
4.2 Guidance on "how" and "why" to implement the QMS elements are provided in the referenced guides and practices for each element.
4.3 These QMS requirements can be used as the basis for gap assessments, internal and external audits, training programs, certification programs, an implementation checklist, or a combination of these uses.
4.4 As the regulated cannabis industry moves forward, authorities having jurisdiction are adopting good practice protocols and quality management system requirements. QMS principles are a foundation for good manufacturing practices (GMP), good agricultural and collection practices (GACP), and good laboratory practices (GLP). This practice does not focus on a particular type of cannabis operation. It provides QMS requirements incorporating requirements specific to GMP, GACP, and GLP that can be applied to these operations.
4.5 Each type of operation may need to adapt a requirement to meet certain GACP, GMP, or GLP requirements by documenting the requirement and how it is adapted to meet the specific requirement.
4.6 When a QMS requirement is not applicable to an operation, the operation shall document the reason a requirement is not applicable. By doing this, each requirement is addressed and if the reason is justifiable the operation can be considered in full compliance with these requirements.
4.7 This practice provides an internationally recognized set of requirements that can be used by:
4.7.1 Operations that grow, harvest, process, test, package, or distribute adult-use and medicinal cannabis and hemp to voluntarily implement quality practices;
4.7.2 State and national regulatory agencies to inform good practice and quality-related regulations; and
4.7.3 Third-party training, consulting, and certification bodies to base their services on.
Scope
1.1 This practice covers a concise set of requirements for the elements of an effective quality management system (QMS) for the cannabis industry's agriculture, processing, and testing operations. Related ASTM guides and practices are available or are being written for each of the QMS elements. The available guides and practices are referenced throughout this practice. Guide D8222 provides guidance for establishing a quality management system.
1.2 Understanding the significance and use of these requirements in Section 4 is important to properly meet the requirements.
1.3 This practice applies to all types of operations from cultivation, processing, testing, distribution, and other related operations. If some QMS elements do not apply to a specific type of operation it shall be documented in the operations quality manual as described in 6.2.
1.4 Laws and regulations from authorities having jurisdiction supersede requirements within this practice.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
