Other ISO Standards
Enhance your organization's compliance with complementary standards.
What Is ISO 13485?
ISO 13485 is an internationally recognized Quality Management System (QMS) specifically tailored for medical device manufacturers. Based on the ISO 9001 framework, it ensures that organizations meet strict quality and regulatory requirements, making it an essential standard for companies involved in the design, development, production, and servicing of medical devices.
ISO 13485 is also a key requirement for obtaining CE certification, serving as a quality assurance module that ensures medical devices adhere to industry and legal standards.
Purpose of ISO 13485
ISO 13485 is designed to:
By implementing ISO 13485, manufacturers can ensure their products meet global health and safety expectations while building trust and credibility in the industry.
What Are the Benefits of ISO 13485?
Organizations that obtain ISO 13485 certification gain multiple advantages, including:
Opportunities for Assessment & Development – Continuous improvement in operational practices
Increased Quality Awareness – Establishes a strong culture of quality management
Enhanced Medical Device Design & Production – Ensures efficiency at all stages
Regulatory & Legal Compliance – Aligns with international standards and regulations
What Does ISO 13485 Cover?
ISO 13485 outlines structured processes to ensure consistent and effective medical device production. These processes cover the entire life cycle of a medical device, including:
Who Can Obtain ISO 13485 Certification?
ISO 13485 certification is essential for all institutions and organizations involved in medical device production, distribution, and servicing. It is particularly relevant for:
How to Get ISO 13485 Certified?
ISO 13485 certification is issued by accredited certification bodies that verify compliance with global standards. NUSTAR conducts audits to ensure businesses meet all requirements. Key steps include:
After receiving the application form from the client, the application is subject to acceptance and confirmation after the application review. NUSTAR will share the Proposal for a 3-year period with the client. Upon acceptance of the quotation, the audit schedules are planned according to pre-determined dates agreed upon mutually.
The schedule for the Stage-1 Audit Plan will be communicated to the Client. Stage-1 Audit involves verification of the management system documentation during an onsite review of the client organization. An Audit Report is issued identifying any areas of non-conformity and the corrective actions, if any, that need to be taken.
The schedule for the Stage-2 Audit Plan will be communicated to the Clients. Stage-2 Audit involves a verification process to identify the closure of Stage-1 findings, any deviations, non-compliance, or improvement areas. The client shall submit a plan for Corrective Actions on acceptance of any Audit Non-conformity identified by the Audit Team.
On submission of the Audit Report by the Audit Team leader, the Competent Technical Reviewer will conduct an impartial review of the report & CAPA to make the Certification Decision. Upon approval, the Certificate of Registration is issued to the Client by the CEO (subject to clearance of all payments as per the invoices issued).
The Surveillance Audit shall take place either on an annual or six-month basis for every certified organization as per the Audit Plan for the Three-Year Certification Cycle to ensure the continued validity of the certificate.