CBD ISO V2
CBD ISO – My CBD Cert Resources
The International Organization for Standardization (ISO) is an organization that creates standards for industrial and commercial products and services. ISO differs from GMP in that it focuses on the management of the business firm and how information is reported to ensure issues are responded to. There are several different types of ISO, but some of the most common are:
ISO 9001:2015 is the standard for the requirement of a quality management system ISO 22000:2018 is specific to the development of a food safety management system ISO 45001:2018 is a new standard for occupational health and safety that will replace OSHA’s 18001 standard
Adoption and certification of ISO standards are voluntary and applicable to products that are not part of GMP regulation. Many companies choose to implement ISO in addition to GMP because they are advantageous in streamlining processes, increasing quality and productivity, and ensuring product and workplace safety.
Here is an overview of how ISO 9001 creates a process-focused quality management system (QMS) standard:
All quality system processes must be measured, monitored, controlled, and improved Business and quality objectives must be established for relevant functions at appropriate levels. Business and quality objectives must be measurable
The quality system’s effectiveness is verified by achieving measurable objectives Top management must review QMS planning and ensure it will be sustainable and effective Periodic management reviews assess opportunities for improvement and observe the implementation of changes
ISO 9001 goes beyond simply maintaining a well-documented management system and requires objective measurement and improvement
ISO 9001 AND GMP SUPPLY CHAIN, LABELING, AND DISTRIBUTION ISO 9001 standards for quality management systems are internationally recognized whereas GMP varies depending on location. ISO 9001 is more generic than GMP but helps to fill gaps in supply chain compliance when vendors or subcontractors are not FDA regulated. It is important to be aware that the entire supply chain must meet the requirements of the final product for GMP manufacturers.
If CBD tincture is made in a GMP facility, using ISO 9001 compliant packaging, but then distributed by someone who is not following GMP, the product loses its integrity and cannot be considered “GMP.” While some take sneaky steps with their marketing in order to use GMP symbols on their packaging, it is very unwise to make GMP claims without actual certification of the entire supply chain.
This product is truly GMP from starting materials through distribution. They have passed certifications and are subject to audits by the FDA, provided they have properly registered as a GMP facility with the agency.
ISO label claims are often vague as well. Many manufacturers are placing ISO and GMP logos on their packaging in an effort to appear trustworthy. Consumers are not faced with an easy task in figuring out which component of the product has been manufactured under ISO or GMP, and finding out what certifications a product actually holds is a cumbersome task.
“Many manufacturers are placing ISO and GMP logos on their packaging in an effort to appear trustworthy.”
Ironic as it may be, GMP and ISO were created in response to the public’s outrage over manufacturing methods and lack of safety testing in food and drugs. The battle for transparency in manufacturing has been a tough uphill battle that goes back to the 1900s.
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