ISO 9001:2015
ISO 9001: A general standard for quality management systems that helps organizations ensure they meet customer and regulatory requirements.
- ISO Management System design, implementation, maintenance
- Gap analysis and system readiness assessments
- Development & review of policies, procedures & documentation
- Internal auditing to assess effectiveness
- Identify improvement opportunities
- Corrective and preventive action guidance
- Compliance with relevant ISO standards regulatory requirements
- Management review facilitation and performance evaluation
- Staff training and competence development
- Support during certification and surveillance audits
ISO 13485:2016
ISO 13485: Specific to the medical device industry, focusing on consistent quality and safety throughout a medical device's lifecycle.
- ISO Management System design, implementation, maintenance
- Gap analysis and system readiness assessments
- Development & review of policies, procedures & documentation
- Internal auditing to assess effectiveness
- Identify improvement opportunities
- Corrective and preventive action guidance
- Compliance with relevant ISO standards regulatory requirements
- Management review facilitation and performance evaluation
- Staff training and competence development
- Support during certification and surveillance audits
ISO 22000:2018
ISO 22000: A food safety management system standard to ensure the safety of food products throughout the supply chain.
- ISO Management System design, implementation, maintenance
- Gap analysis and system readiness assessments
- Development & review of policies, procedures & documentation
- Internal auditing to assess effectiveness
- Identify improvement opportunities
- Corrective and preventive action guidance
- Compliance with relevant ISO standards regulatory requirements
- Management review facilitation and performance evaluation
- Staff training and competence development
- Support during certification and surveillance audits
REGULATION R638
Regulation R638 is formally titled “Regulations Governing General Hygiene Requirements for Food Premises, the Transport of Food and Related Matters” under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972.
We assist organisations in achieving and maintaining full compliance with R638 by providing:
Our goal is to help your business operate confidently and legally within South Africa’s food safety framework — protecting both your customers and your brand reputation.
- Guidance on legal and regulatory requirements for food premises
- Support in preparing for municipal health inspections
- Assisting obtaining the Certificate of Acceptability (COA)
- Development and review of hygiene and food safety procedures
- Assessments, evaluate facility design, equipment & process flow
- Staff hygiene & food safety training aligned with R638
- Internal audits, corrective action, support compliance gaps