What Is ISO 13485?
Medical Devices
ISO 13485:2016 is a globally recognized standard dedicated to medical devices, providing a robust framework for establishing a quality management system. This standard applies to organizations involved in the design, production, installation, and servicing of medical devices and related services. Medical devices encompass a wide range of products, including instruments, machines, implants, and in vitro reagents, used in the diagnosis, prevention, and treatment of diseases and medical conditions. Given the critical nature of the medical industry, safety and quality are paramount, driving manufacturers to adopt ISO 13485:2016 to ensure a robust quality management system and mitigate risks associated with device use. This standard guides organizations in strengthening their risk management approach and meeting regulatory requirements. Hospitals and medical device suppliers increasingly demand ISO 13485:2016 certification from manufacturers. As part of the ISO family, this standard is recognized worldwide, with accredited certification bodies issuing certificates accepted globally.
Benefits of ISO 13485:2016:
- Customer satisfaction
- Reduced operating costs
- Improved overall performance and compliance
- Increased efficiency and cost savings
- Consistent management of regulatory compliance
- Globally recognized standard
- Attracts new customers
- Retains existing customer confidence
- Acceptable for international organizations
ISO 9001 certification process:
- Gap Analysis: Experts conduct a thorough analysis of the client’s existing system, identifying gaps in documentation, implementation, employee awareness, and compliance.
- Implementation: The client works to address the identified gaps, with support from the technical team, to meet the ISO 9001 standard requirements.
- Audit Preparation: The client prepares for the certification audit, with assistance from the technical team.
- Initial Audit (Stage 1 and 2): The certification body conducts a two-stage audit to assess the client’s management system.
- Certification: If successful, the certification body issues an ISO 9001 certificate valid for one year.
- Surveillance Audits: The certification body conducts annual surveillance audits for the next two years to ensure continued compliance.
- Re-audit (Recertification): After three years, a full re-audit is conducted to renew the certification cycle.
Cost of ISO 13485
Certification
The cost of ISO 13485 certification varies depending on the organization’s size, complexity, and industry, so please contact us for a customized quote.
