ISO 9001:2015

Cannabis Clearwater can be your management representative for ISO 9001:2015. 

 

ISO 9001 Certified, Quality management system

What Is ISO 9001:2015?

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. 

What Does It Mean To Be ISO 9001 Certified?

To be ISO 9001 certified means that an organization has met the requirements as set forth in the ISO 9001 standard. 

What Are The Benefits Of An ISO 9001 Certification?

  1. Abide by ISO 9001 Standards
  2. Internationally Recognized
  3. Increase Customer Satisfaction
  4. Maintain An Effective Quality Management System (QMS)
  5. Establishes Credibility
  6. Lower Costs
  7. Control Corrective Actions
  8. Improve Efficiency
  9. Increase Business Opportunities 
  10. Increase Revenue 
  11. Better Management 
  12. Improve Partnership Relationships
  13. Increase Employee Performance
  14. Lower Employee Turnover
  15. Increase Employee Morale 

Be The First Cannabis Business To Get An ISO 9001 Certification

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 to obtaining an ISO 9001 certificate. Our 3-Phase System puts us in the lead in the cannabis industry for ISO 9001 certification. 

                                                                                    3-Phase System For ISO 9001:2015 Certification  

Phase I

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

Phase II

QMS Implementation (based on the outcome of Phase I audit)

Phase III

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)

 

 

Why Should I Need An ISO 9001 Certificate In Cannabis?

As we head down the path to both State and Federal regulations, 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 meet ISO standards for a Quality Management System (QMS). 

 

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