Cannabis Clearwater can be your partner in preparing for third party inspections and obtaining a permit/licenses.
ISO 9001:2015 is internationally recognized as the international standard that specifies requirements for a quality management system (QMS). The 9001 number represents the identification number in that standard. The 2015 in ISO 9001:2015 represents the latest update to ISO 9001, i.e. year 2015.
To be ISO 9001 certified means that an organization has met the requirements as set forth in the ISO 9001 standard.
Cannabis Clearwater has over a combined 50 years of ISO Certification experience. Our team consists of medical device and pharmaceutical experts that know the correct and fast approach in obtaining an ISO 9001 Certificate. Our 3-Phase System puts us in the lead in the cannabis industry for ISO 9001 certification.
ISO 9001 Certification 3-Phase System
Full system audit (ISO 9001 and GMP), including Gap Analysis and Report
– 1-day on-site audit OR Remote Audit
– Review of Quality System documents and records to evaluate, compliance with regulatory standards and internal procedures
– Gap Analysis of the Company’s Quality System documents and ISO 9001 requirements. (Including but not limited to: Management responsibilities, customer requirements, manufacturing, equipment controls, monitoring & measurement, nonconformities, and corrective actions)
– Gap Analysis of Company’s Quality System documents and 21 CFR part 111, Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling or holding operations for dietary supplements and 21 CFR part 117, Current Good Manufacturing Practice (cGMP), Hazard Analysis and risked-based preventative controls for human food
– A list of recommendations/observations to obtain compliance
QMS Implementation (based on the outcome of Phase I audit)
ISO 9001 and GMP Audit Support (determined by the number of days for audit)
ISO 9001 and GMP Compliance Audit (pending quote from certification body)
As we head up the path to both state and federal regulations with respect to cannabis, the rules and regulations will apply to the cannabis industry. The cannabis industry will abide by ISO 9001 standards just like any other industry that meets the ISO Standards for a Quality Management System.