Tag Archives: ISO 13485 Consultant

Announces to Offer New Service – ISO 13485 Certification Consultancy, one of the largest ISO Consultancy Company in India, announces to offer a new service – ISO 13485 Consultancy. ISO 13485 Certification represents the requirements of quality management system for medical devices. has added one more feather to its cap by including this new service to its wide range of ISO consultancy services, with the aim to provide better system implementation for organizations as per ISO 13485 standard guidelines. The experienced ISO 13485 Consultant of will help organizations in understanding the structure of standard by providing awareness and auditor training. During this ISO 13485 Consultancy, the company is committed to provide proper documentation support to organizations.

With joined hands with Global Manager Group, has already published ready-to-use ISO 13485 Documentation kit to implement fast and effective documentation that fulfils all specific requirements of ISO 13485 international standard, which results in any organization’s quick ISO 13485 Certification.

Steps Followed by for Achieving ISO 13485 Certification

  1. Micro-level survey of the existing system and submit gap analysis report;
  2. Review findings for infrastructure changes to meet ISO 13485 requirements;
  3. Conduct awareness program;
  4. Prepare the ISO 13485 documentation for quick certification;
  5. Training to all level of employees in the organizations;
  6. Train internal auditors for internal auditing of ISO 13485;
  7. Assess the system through first internal audit;
  8. Take corrective actions for non-conformities;
  9. Carry out management review meeting;
  10. Apply for ISO13485 Certification.

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