What is ISO 22716 ?
ISO 22716 is an international standard of good manufacturing practices (GMP) for the cosmetics manufacturing industry and describes the basic principles of applying GMP in a facility that produces finished cosmetic products. This guideline offers organized and practical advice on the management of human, technical, and administrative factors affecting product quality. ISO 22716 provides a widespread approach for an organization’s management of quality systems through practical methods. It covers manufacturing, storing, packaging, testing, and transportation processes. It does not apply to research and development activities and the distribution of finished cosmetic products. Even though the standard focuses on product quality, it does not include the safety of the employees engaged in the production or the protection of the environment. The guideline has been approved and accepted by many global regulatory bodies, such as the Food & Drug Administration (FDA), the International Cooperation on Cosmetics Regulation (ICCR), and the European Committee for Standardisation (CEN).
Benefits of ISO 22716 Certification
Enables the organisation to manage the quality and safety
Implemented easily in all sizes
Levels of Complexity
Improves customer confidence
Controls hazards and risks
Safety Assurance
Check out the Who can be certified ISO 22716 Certification Video
Who can be certified ISO 22716 Certification?
Cosmetics Products
Document required for ISO 22716 Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of ISO 22716 Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Day 1
GAP Analysis, Certification Body, Selection, Cost Estimates
• Finding the GAP between existing system related to ISO 22716 requirements
• Selecting the appropriate certification Body
• Based on the scope of your business & certification Body you choose
Week 1
Developing Documents
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
• ISO 22716 Awareness training for the top management and staff
• Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
• Internal audits identifying nonconformities related to ISO 22716 requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the certification body
Week 12
Certification Body
• ISO 22716 certificates issued for 1 years
Year on Year
Yearly Compliance
• Support of Yearly documentation for audit
ISO 22716 is a set of Good Manufacturing Practices (GMP) Guidelines for the cosmetics industry. Certification to ISO 22716 allows organizations to demonstrate their commitment to safeguarding quality and safety.
Implementing ISO 22716 is an effective way to comply with legal regulations related to consumer safety and product quality. Requirements to GMP for cosmetics can vary but having a management system in place has several benefits.
GMP is a product quality standard, with a focus on getting the right quality product to the only customer of GMP – the patient. Whilst GMP focuses on Production and Quality Control – ISO focuses on the all departments and processes of an organisation.
ISO 22716 is the new guidance for Good Manufacturing Practices (GMP) for the cosmetics manufacturing industry and describes the basic principles of how to apply GMP in a facility that produces finished cosmetic products. This GMP for cosmetics awareness training comprises lectures and workshop exercises.