Our Commitment
Quality Policy
Last updated: 20 September 2026
BioMY Healthcare coordinates OEM and ODM projects for instant powder beverages and health supplements. We connect your brief with the relevant formulation, manufacturing and quality teams, with specifications and responsibilities agreed before production.
1. Scope
This Quality Policy covers enquiry handling and project coordination by BioMY Healthcare Sdn. Bhd., including discussions about formulation, samples, manufacturing, packaging and quality documentation. Production is carried out through certified manufacturing facilities.
The manufacturing organisation, production site, applicable certificate scope and contracting parties are identified during project qualification and in the relevant written agreements.
2. Our Quality Commitments
The following six pillars define our approach to quality and form the basis of our quality coordination process:
Regulatory Compliance
We coordinate the review of product classification, intended market and applicable manufacturing requirements with the relevant technical teams. Regulatory and certification requirements are confirmed for each project.
Product Specifications and Testing
Product specifications, testing requirements and release criteria are agreed with the manufacturing team. Samples and supporting documentation are reviewed against the approved brief; a facility certificate is not a guarantee of product efficacy.
Certified Standards
Manufacturing is coordinated through facilities with relevant GMP, ISO 22000, HACCP and Halal credentials. These certifications belong to the certificate-holding manufacturing organisation, not automatically to BioMY or every proposed product.
Supplier and Raw Material Integrity
Ingredient specifications, supplier documentation and traceability requirements are reviewed with the manufacturing team. The agreed formula, market and product classification determine the documentation and tests required.
Continuous Improvement
We channel project feedback and quality concerns to the responsible manufacturing and quality teams, coordinate the response and keep the client informed of agreed corrective actions.
Traceability and Documentation
Batch records, traceability and release documentation are managed by the manufacturing facility. The documents supplied to the client and the responsibilities for complaints or recalls are established in the project agreement.
3. Certifications and Accreditations
The following standards relate to the manufacturing facilities supporting our projects. They are not presented as certificates held by BioMY Healthcare itself. The certificate holder, issuing body, production site, scope and validity must be checked for your project:
| Certification | Verification | Scope |
|---|---|---|
| GMP (Good Manufacturing Practice) | Applicable manufacturing certificate and issuing authority | Manufacturing activities listed on the certificate |
| ISO 22000 | Current facility certificate and issuing body | Food safety management systems |
| HACCP | Current facility certificate and issuing body | Hazard analysis and critical control points |
| Halal Certification | Applicable Halal certificate, holder and product scope | Certified site and listed products; confirm your formula separately |
Clients may request copies of current certification documents as part of the supplier qualification process. Please contact us at info@biomyhealthcare.com.
4. Quality Management System
The manufacturing facility manages its quality system. During qualification, discuss the following controls and request the documentation relevant to your product and agreement:
- Documented standard operating procedures (SOPs) for all critical manufacturing and quality control activities.
- A batch manufacturing record (BMR) system that captures all process parameters and quality checks for every production batch.
- An in-process quality control programme with defined critical control points (CCPs) and action limits.
- A finished product release procedure requiring review and approval by a qualified person before any batch is dispatched.
- A change control procedure to manage and document any changes to materials, processes, equipment, or facilities.
- A deviation and non-conformance management system with root cause analysis and CAPA.
- A customer complaint handling procedure with defined investigation and response timelines.
- An annual management review of quality performance metrics and improvement objectives.
5. Client Responsibilities
Responsibilities for manufacturing, product release and quality issues are established with the contracting parties in writing. Clients should also address:
- The accuracy and completeness of product specifications, formulation briefs, and labelling information provided to BioMY Healthcare.
- Ensuring that the finished product, including its labelling and health claims, complies with the regulatory requirements of the intended market.
- Obtaining any product registration, notification, or import/export licences required in the target market.
- Maintaining appropriate storage and handling conditions for finished products after the agreed handover.
6. Contact Us
For questions about our quality management system, certifications, or audit requests, please contact BioMY so we can coordinate with the responsible quality team: