MS ISO 13485 Standard Certification

The MS ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) in the medical device industry. Compliance with this standard ensures that organizations demonstrate their ability to consistently meet customer and regulatory requirements for medical devices and related services. The certification is mandatory for all medical device manufacturers, importers, and distributors in Malaysia, as per the Medical Device Act 2012 (Act 737). The certification process is overseen by Malaysia's Medical Device Authority (MDA).

• Pre-certification (1-3 months)
  • Initial Gap Analysis: Identify gaps between current practices and MS ISO 13485 requirements.
  • Documentation Preparation: Develop or update necessary QMS documentation
  • Training and Awareness: Conduct training sessions for employees to understand the standard
• Certification Process (3-6 months)
  • Stage 1 Audit: Preliminary audit to assess readiness for certification.
  • Stage 2 Audit: Comprehensive audit to verify full compliance with MS ISO 13485.
  • Addressing Non-Conformities: Implement corrective actions for any identified non-conformities
• Post-Certification (Ongoing)
  • Surveillance Audits: Regular audits by the certification body to ensure continued compliance
  • Continuous Improvement: Ongoing monitoring and improvement of the QMS to maintain certification

• Expertise and Experience
  • TUV NORD Malaysia has extensive experience in certifying organizations across various sectors, including the medical device industry
  • A team of highly qualified auditors with in-depth knowledge of the MS ISO 13485 standard and regulatory requirements
• Comprehensive Support
  • Offers end-to-end support, from initial consultation to post-certification surveillance audits
  • Tailored services to meet the specific needs of your organization, ensuring a smooth certification process
• Global Recognition
  • TUV NORD is globally recognized, adding value to your certification, and enhancing your organization’s credibility
  • Certification by TUV NORD Malaysia is respected internationally, facilitating easier entry into global markets
• Commitment to Quality
  • TUV NORD Malaysia is committed to upholding the highest standards of quality in all its certification services
  • Provides valuable insights and recommendations to help you continuously improve your QMS
• Efficient and Transparent Process
  • Streamlined certification process with clear timelines and minimal disruptions to your operations
  • Transparent communication throughout the certification journey, ensuring you are always informed of your progress

For more information on how TUV NORD Malaysia can assist with your MS ISO 13485 certification, please contact us at:

TUV NORD Malaysia 
Website: www.tuv-nord.com/my 
Phone: +603-2162 3561 
Email: malaysia@tuv-nord.com