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Comprehensive ISO
Certification Services

From quality management to medical device conformity assessment — ONC delivers internationally recognized certification across Malaysia and Indonesia.

ISO 9001 Quality ISO 14001 Environment ISO 45001 Safety Medical Device CAB
ISO 9001
Quality Management
Build consistent quality systems that win tenders and improve customer satisfaction.
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ISO 14001
Environmental Management
Demonstrate environmental responsibility and meet regulatory requirements.
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ISO 45001
Occupational Health & Safety
Protect your people and build a safe, compliant working culture.
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Medical Device
CAB Services · MDA Act 737
MDA-accredited conformity assessment for medical device registration in Malaysia.
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9001
Quality Checklist
Document Control
Process Management
Customer Satisfaction
Internal Audit
ISO 9001:2015 Internationally Accredited
Quality
Management
Plan · Do · Check · Act
Quality Management System

ISO 9001

ISO 9001 : 2015

Deliver consistent quality, improve customer satisfaction, and enhance operational efficiency. ISO 9001 is the world's most widely adopted quality management standard — and ONC makes achieving it straightforward.

Key Benefits
Win government & corporate tenders — ISO 9001 is a prerequisite for most public procurement and large corporate supply chains.
Improve internal processes and documentation — create clarity in operations, reduce errors, and build institutional knowledge.
Strengthen customer confidence — show customers you have a verified system for delivering consistent, high-quality results.
Get ISO 9001 Quote How It Works
Environmental Management System

ISO 14001

ISO 14001 : 2015

Show your environmental responsibility and compliance. ISO 14001 helps your organisation systematically identify, manage, and improve its environmental performance — building stakeholder trust and reducing operational risk.

Key Benefits
Meet environmental regulations — demonstrate compliance with Malaysian environmental law and international environmental requirements.
Reduce waste and cost — systematic environmental management leads directly to resource efficiency and operational savings.
Enhance sustainability reputation — stand out with customers, investors, and partners who value environmental responsibility.
Get ISO 14001 Quote How It Works
14001
Environmental Aspects
Carbon Emissions
↓ 32%
Waste Reduction
↓ 45%
Water Efficiency
↑ 28%
ISO 14001:2015
DoE Aligned
Environmental
Management
Reduce · Monitor · Improve
45001
Safety Performance
0
Lost Time
Injuries
98%
Safety
Compliance
✓
DOSH
Aligned
ISO
Internationally
Recognized
ISO 45001:2018
DOSH Compliant
Occupational
Health & Safety
Protect · Prevent · Perform
Occupational Health & Safety

ISO 45001

ISO 45001 : 2018

Protect your people and build a safe working culture. ISO 45001 provides a systematic framework to prevent workplace injuries and illnesses, improve employee wellbeing, and demonstrate your commitment to health and safety.

Key Benefits
Reduce workplace accidents — proactively identify hazards, assess risks, and implement controls before incidents occur.
Improve employee morale and trust — when workers feel safe, productivity rises and talent retention improves.
Comply with DOSH and international H&S requirements — meet Malaysian Occupational Safety and Health Act obligations and global standards.
Get ISO 45001 Quote How It Works
MDA-Accredited CAB · Medical Device Act 2012 (Act 737)

Medical Device
Conformity Assessment

ONC Certification Sdn. Bhd. provides independent conformity assessment services for the medical device industry in Malaysia — supporting manufacturers, importers, distributors, and authorised representatives in demonstrating compliance with the Medical Device Act 2012 (Act 737) and applicable MDA requirements.

Scope of Accreditation
ISO 13485 QMS Certification
Technical Documentation Assessment
Conformity Assessment by Verification
Full Conformity Assessment
Readiness Advisory Services
Core CAB Services

Our Medical Device
Assessment Services

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Service 01
ISO 13485 Quality Management System Certification
ONC provides ISO 13485 certification for medical device organisations seeking to demonstrate that their QMS is effectively established, implemented, and maintained in line with international medical device quality requirements.
Initial certification audit
Surveillance audit
Recertification audit
Scope extension or reduction
Transfer of certification
Technical review & certification decision
Service 02
Medical Device Technical Documentation Assessment
ONC evaluates whether submitted evidence demonstrates conformity with applicable regulatory and essential safety and performance requirements — focusing on completeness, consistency, traceability, and adequacy.
Common Submission Dossier Template (CSDT)
Device description and intended use
Risk management documentation
Clinical & performance evaluation evidence
Post-market surveillance documentation
Declaration of Conformity
Service 03
Conformity Assessment by Way of Verification
ONC supports the verification pathway for eligible medical devices, subject to applicable MDA requirements and ONC's approved scope. Aligned with MDA guidance MDA/GD/0068 (Second Edition) and MDA/GD/0070.
Verification for initial device registration
Verification for re-registration
Review of recognised regulatory approval evidence
Review of technical documentation
Verification report issuance
Independent technical review
Service 04
Full Conformity Assessment
For medical devices requiring full conformity assessment, ONC assesses evidence relating to the QMS, technical documentation, post-market surveillance system, and declaration of conformity, in accordance with MDA requirements.
Quality management system evidence
Product technical documentation
Risk management & benefit-risk evidence
Post-market surveillance system
Clinical or performance evidence
Conformity assessment report issuance
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Advisory & Readiness Services
In addition to formal conformity assessment, ONC provides non-regulated readiness services to help organisations identify documentation gaps before formal submission. These advisory services are conducted separately from assessment activities to preserve impartiality and objectivity.
ISO 13485 Readiness Review CSDT / Technical File Gap Review Risk Management File Review Labelling & IFU Gap Review PMS Documentation Review MDA Submission Readiness Check
Why ONC for Medical Device CAB

Impartial. Competent.
Aligned with MDA.

🎯
Focused Expertise
ONC focuses on practical, regulation-aligned assessment for medical device organisations seeking market access in Malaysia.
📜
Regulatory Alignment
Services developed with reference to the Medical Device Act 2012, Medical Device Regulations 2012, MDA guidance documents, ISO 13485 and ISO 14971.
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Clear & Transparent Process
Clients receive structured assessment outputs, clear nonconformity statements where applicable, and transparent reporting.
⚖️
Impartial & Independent
ONC maintains strict impartiality in all formal conformity assessment activities and avoids conflicts of interest.
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Malaysia-Focused Support
ONC understands the Malaysian regulatory environment and supports establishments with assessment services aligned with MDA expectations.
Ready to start your Medical Device CAB journey?
Contact us for a consultation on your conformity assessment requirements.
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Start Your Certification Journey

Your ISO Certificate
is Within Reach

Join hundreds of businesses across Malaysia and Indonesia that have achieved ISO certification with ONC — and gained the credibility, contracts, and operational edge that comes with it.

✓ Free Consultation
✓ Practical Roadmap
✓ ISO Expert Support
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