ISO 13485 Certification

ISO 13485 in Malaysia 

In Malaysia, as a member of the International Organization for Standardization (ISO), the ISO 13485 standard is recognized and implemented. Malaysian companies involved in the production or distribution of medical devices may seek ISO 13485 certification to demonstrate compliance with international quality management standards

ISO 13485 in Malaysia plays a crucial role in ensuring the safety, quality, and effectiveness of medical devices produced and distributed within the country. Here are some key points about ISO 13485 in Malaysia:

  • Regulatory Compliance: ISO 13485 certification is often a prerequisite for medical device manufacturers in Malaysia to demonstrate their compliance with regulatory requirements. ISO 13485 in Malaysia aligns with the Malaysian Medical Device Act 2012 (Act 737), which governs the registration and sale of medical devices in the country.
  • Quality Management: ISO 13485 in Malaysia sets forth the requirements for a comprehensive quality management system tailored to the specific needs of the medical device industry within the country. This system covers all aspects of the product lifecycle, from design and development to manufacturing, distribution, and post-market surveillance.
  • Market Access with ISO 13485 in Malaysia: ISO 13485 certification is essential for medical device companies in Malaysia seeking access to both local and international markets. ISO 13485 in Malaysia enhances the reputation of Malaysian medical device manufacturers and facilitates global trade.
  • Safety and Effectiveness: ISO 13485 in Malaysia places a strong emphasis on risk management, ensuring that medical devices are safe for patients and users within the country. It also supports the effectiveness and performance of these devices, contributing to better healthcare outcomes in Malaysia.
  • Competitive Advantage: Companies in Malaysia that obtain ISO 13485 certification can gain a competitive edge in the medical device industry within the country. ISO 13485 certification in Malaysia demonstrates a commitment to quality and compliance, which can be attractive to customers and partners.
  • Continuous Improvement with ISO 13485 in Malaysia: ISO 13485 in Malaysia promotes a culture of continuous improvement, which is vital in the medical device industry within the country. Companies are encouraged to monitor and measure their processes, identify areas for enhancement, and take corrective actions to drive product and process improvements.
  • Certification Process: To achieve ISO 13485 certification in Malaysia, organizations within the country must implement a quality management system that complies with the standard’s requirements. The certification process typically involves a series of audits conducted by accredited certification bodies within Malaysia.
  • Auditing and Surveillance in Malaysia: ISO 13485-certified organizations within Malaysia are subject to regular surveillance audits to ensure ongoing compliance. This helps maintain the integrity of the quality management system and the safety of medical devices within the country.
  • Global Recognition with ISO 13485 in Malaysia: ISO 13485 certification in Malaysia is globally recognized, enabling Malaysian medical device manufacturers to compete on an international scale. It aligns with the requirements of various regulatory bodies worldwide.
  • Benefits for Healthcare in Malaysia: Ultimately, ISO 13485 in Malaysia contributes to the overall quality and safety of healthcare within the country by ensuring that medical devices meet the highest standards. It enhances trust in medical technology and fosters better patient care in Malaysia.

IAS is one of the most prominent ISO Certification Bodies in Malaysia providing ISO 13485 certification. IAS has helped many businesses to implement ISO 13485 in Malaysia for their medical devices/equipment with international recognition.

ISO 13485 in Malaysia is applicable to any type of medical device manufacturer, and ISO 13485 certification is granted to an organization that can demonstrate that it has an effective quality management system for medical devices.Certification of ISO 13485 in Malaysia is not limited to product manufacturers, but also includes service providers, distributors, and laboratories that are involved in the life-cycle of a medical device/equipment.

About ISO 13485 Certification

Achieving ISO 13485 certification provides a practical foundation for manufacturers to address the medical device directives, regulations, and responsibilities as well as exhibit commitment to the safety & quality of medical devices.

ISO 13485 is beneficial to many organizations and can be used by suppliers and external parties that are involved with providing medical device products. ISO 13485 certification helps to expand your business locally and in the global market and also helps to impress your clients with the quality of products.

Once you successfully achieve ISO 13485 certification, you can check the status of your certificate by visiting our ISO 13485 certification search Page!

Benefits of ISO 13485 Certification

  • Promotes coordination of regulatory requirements for the manufacturers of medical devices on an international scale
  • Companies that attain ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase consistent high-quality products.
  • ISO 13485 compliant management systems adopt a risk management approach which includes evaluation to identify & estimate risk, and uses risk controls and techniques with a view to eradicating hazardous situations throughout product realization.
  • ISO 13485 certification assures clients that the product complies with all relevant product & service-oriented technical standards & regulations.
  • Emphasizes cleanliness & sterility in the production area which in turn increases efficiency & enhances safety at the workplace.
  • Increased access to more markets globally.

ISO 13485 Certification

How Can Organizations Achieve ISO 13485 Certification?

  • Call IAS for conducting an ISO 13485 audit procedure and discuss the audit procedure specific to your organization.
  • Understand the requirements of ISO 13485 and implement it in your organization before seeking ISO 13485 certification (e.g., documentation, training staff, implementing the system, etc.)
  • Conduct internal audits through trained ISO 13485 Internal Auditors.
  • Compile the collected data and complete the analysis.
  • Conduct a Management review with the help of analyzed data and take decisions to improve the organization’s performance towards company objectives & goals.
  • Complete the audit successfully. (Stage 1 and Stage 2)
  • Closure of non-conformances, if any.
  • Collect and maintain ISO 13485 certification.
  • Comply with the surveillance audit yearly.

Process to Obtain an ISO 13485 Certification with IAS

  • Contact IAS by sending the Application Form and call us for a discussion to guide you in getting ISO 13485 certification.
  • Prepare your organization for ISO 13485 certification by implementing and practicing the standard, monitoring, and continually improving.
  • Majorly, the process of ISO 13485 certification includes 2 stages:
      • Stage 1 Audit: Readiness Audit            
      • Stage 2 Audit: Verifying the Effectiveness of the System
  • The organization applying for ISO 13485 certification will be audited based on an extensive sample of its sites, services, process, products & functions.
  • If there is any deviation observed during the audit, a deviation report will be submitted along with the detailed audit report. According to the grading of the deviations, IAS determines the time required for its closure including the correction and corrective actions which have to be approved by IAS. After the effective closure of Nonconformity, ISO 13485 certification is issued with the scope that was audited.

Why Choose IAS for ISO 13485 Certification?

Integrated Assessment Services Sdn. Bhd. is an experienced ISO certification body that provides comprehensive services for ISO 13485 certification. With IAS, customers can expect:

  • On-going Support – Experienced auditors provide support to companies throughout the entire ISO 13485 certification process, from initial assessment through to post-certification maintenance.
  • Excellent Quality Standards – IAS is accredited by UQAS and meets the highest quality standards for ISO 13485 in Malaysia.
  • Cost-Efficient Solutions – Customers can save money on certification fees with IAS’s competitive pricing structure.
  • Expertise & Guidance – IAS has extensive experience in implementing ISO 13485 in Malaysia and provides personalized guidance and advice.
  • Timely Certification – IAS works quickly and efficiently to ensure that all certification requirements are met in a timely manner.
  • Personalized Solutions – Customers can customize their ISO 13485 certification package to meet their specific needs.

Overall, IAS provides comprehensive services for ISO 13485 certification, helping customers achieve their certification goals in a cost-effective and timely manner. With IAS, customers can be confident that they will receive the highest quality of support and guidance throughout the entire ISO 13485 process.

Contact us today to learn more about ISO 13485 in Malaysia or visit our ISO 13485 certification frequently asked questions page!