ISO 13485 QUALITY MANAGEMENT SYSTEM CERTIFICATION FOR MEDICAL DEVICES

If your organization designs, develops, produces, installs or services medical devices, it will be necessary to achieve certification in ISO 13485 in order to meet regulatory requirements in some markets. The standard is based on ISO 9001:2000 but does not include the ISO 9001 requirements for continual improvement and customer satisfaction. Instead, it requires additional documented procedures applicable to medical devices sector.

Online application for Management System Certification

Contact us if you wish to transfer your certification from another accredited certification body to SIRIM QAS International.

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  • Give assurance to authorities that your medical devices manufacturing business has developed and implemented an internationally accepted quality management system.
  • Meet compliance with regulatory requirements that govern the supply of medical devices and related services.
  • Gain access to markets where regulatory requirements apply to the import of medical devices.
  • We are accredited by the United Kingdom Accreditation Service (UKAS) for provision of certification services to ISO 13485.
  • Our recognition by International Accreditation Body ensures worldwide acceptance of your products and services.
  • Our highly experienced and professional auditors are competent in a wide range of sectors.
  • We offer the option of combined certification audits of two management systems (Quality and Medical Devices to minimize disruption to your organization.
  1. Submission of Questionnaire
  2. Issuance of Quotation
  3. Submission of Application
  4. Stage 1 Audit
  5. Stage 2 Audit
  6. Recommendation & Approval
  7. Issuance of Certificate
  8. Surveillance Audit/Recertification

Downloads

1. Brochure | 23 MB

2. Guideline for Certification | 126 kB

3. Questionnaire | 139 kB

4. Appendix | 101 kB

5. Application Form | 84 kB

6. Application For Transfer of Certificate | 23 kB