Furley Bioextracts holds ISO 13485 and FSSC 22000, supported by Food Halal, GMP, HACCP, NPRA and FDA. This page explains what each one means for a brand that is choosing a contract manufacturer.
Key takeaways
- ISO 13485 covers medical device quality management.
- FSSC 22000 covers food safety management for food and supplement powders.
- Food Halal, GMP, HACCP, NPRA and FDA support the markets you plan to sell in.
- Tell us your category and market and we confirm which apply.
What does ISO 13485 mean for a brand owner?
ISO 13485 is the international quality management standard for medical devices. It requires documented, controlled processes for production, supplier control, traceability, risk-based decisions, corrective and preventive action, and complaint and records management. For a brand owner it means the batch records and change control that distributors, tenders and regulators ask for. It applies to our medical device consumables.
What does FSSC 22000 mean for a brand owner?
FSSC 22000 is a certified food safety management scheme covering hazard control, prerequisite programmes and management of the supply chain. It applies to our food and supplement powders and sachets, and gives your customers and retail partners a recognised benchmark for food safety.
What do Food Halal, GMP, HACCP, NPRA and FDA add?
ISO 13485
Medical device quality management
Our medical device consumables are manufactured under an ISO 13485 quality management system, with documented processes, traceability, change control and complaint handling.
FSSC 22000
Food safety system certification
Our food and supplement powders and sachets are made under FSSC 22000 food safety management, which brings structured hazard control and supplier discipline to every batch.
Food Halal
Halal-certified food manufacturing
Food Halal certification supports brands that sell into Malaysian and international Halal markets. Tell us your target market in the brief.
GMP
Good manufacturing practice
GMP governs how we make, test, record and release product, from incoming materials to finished goods.
HACCP
Hazard analysis and critical control points
HACCP identifies and controls food-safety hazards at the points in the process where they matter.
NPRA
Malaysia's National Pharmaceutical Regulatory Agency
NPRA is the Malaysian regulator for health supplements and cosmetics. We plan projects around its registration and notification requirements.
FDA
US Food and Drug Administration
For brands planning US-market products, we plan formats, labelling inputs and documentation around FDA requirements.
Which certification applies to my product?
| Product category | Leading systems | Also relevant |
|---|---|---|
| Medical device consumables | ISO 13485 | GMP |
| Supplement sachets and powders | FSSC 22000, GMP, HACCP | Food Halal, NPRA |
| Food sachets and powders | FSSC 22000, HACCP | Food Halal, GMP |
| Canisters | FSSC 22000, HACCP | Food Halal, GMP |
| Cosmetics | GMP | NPRA, Food Halal on request |
Each standard covers a different part of the business. Tell us your category and target market in your brief and we will confirm which apply to your project and which documents we can share.
Standards and regulators referenced
- ISO 13485:2016, Medical devices: Quality management systems (International Organization for Standardization)
- FSSC 22000 food safety certification scheme (Foundation FSSC)
- National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- US Food and Drug Administration (FDA)
Certification questions
Is Furley Bioextracts ISO 13485 and FSSC 22000 certified?
Yes. Furley Bioextracts holds ISO 13485 for medical device quality management and FSSC 22000 for food safety management, alongside Food Halal, GMP, HACCP, NPRA and FDA.
Which certification applies to my product?
Medical device consumables fall under ISO 13485. Food and supplement powders and sachets fall under FSSC 22000, GMP and HACCP, with Food Halal where relevant. Cosmetics are made under GMP and planned around NPRA notification. Tell us your category in the brief and we will confirm.