ISO 13485:2016 is the most important international standard for a quality management system (QMS) for companies in the medical device industry. It defines the requirements that any organization, regardless of its size or role (whether manufacturer, distributor, or maintenance provider), must adhere to in order to ensure that medical devices are safe, effective, and meet global legal and regulatory requirements.
The primary objective of the standard is to align quality requirements with the stringent regulatory requirements in the healthcare sector. ISO 13485 imposes a systematic framework that covers the entire product lifecycle, from design and development, through production and installation, to after-sales.
Essential characteristics and requirements of the standard
ISO 13485 is characterized by its deep focus on critical aspects of medical device safety, making it more stringent than other generic quality standards:
1. Risk management and organizational focus: The standard mandates a risk-based approach to almost every process. The organization must identify, assess and control risks related to the safety and performance of the medical device throughout its lifecycle. It also requires strict compliance with relevant local and international legal and regulatory requirements (e.g. CE marking or FDA requirements).
2. Design and development control: The standard establishes detailed requirements for design and development procedures, includingValidationandVerification,and ensures that changes are fully controlled and documented, especially for medical device software.
3. Supply chain management: There are enhanced requirements to control suppliers and outsourced processes. Suppliers should be evaluated based on the risk they pose to the quality of the medical device.
4. After-sales monitoring: The standard emphasizes the need for robust mechanisms for collecting and reviewing user feedback, managing complaints, and effectively handling product recalls or safety advisory notices.
The role of development experts in qualifying you for ISO 13485
Given the sensitivity of the medical sector and legal documentation requirements, our experts play a vital role to ensure a smooth transition to compliance and accreditation:
- Gap Analysis and Organizational Compliance: Our role begins with a thorough assessment of your current quality systems and their alignment with ISO 13485 requirements and the national and international regulatory requirements applicable to your medical device.
- Risk system design and documentation: We guide your team in implementing systematic risk management across all processes. We support you in documenting the quality management system, developing manuals and standard operating procedures that ensure product safety.
- Team qualification and training: We offer specialized training programs (including internal auditors) to ensure that staff in design, production and procurement departments understand the requirements of the standard and the impact on their role, especially in terms of document and record control.
- Prepare for audit and certification: We conduct internal audits to assess system readiness and help you address any non-conformities prior to the certification body’s audit, minimizing the likelihood of certification rejection and ensuring fast and secure access to global markets.
Strategic advantages of implementing the standard
Achieving ISO 13485 certification is a strong demonstration of your commitment to delivering quality products, which translates into:
- Market access: Facilitates international regulatory approvals (e.g. CE marking), opening doors to European and many other markets that recognize this standard as a prerequisite.
- Building trust: Increase the confidence of customers, hospitals, and health practitioners in the safety and performance of your medical device.
- Continuous improvement: Build a culture of quality and continuous improvement that minimizes errors, defects, and the risk of product recalls.
- Operational efficiency: Standardize and document processes, reducing costs due to non-conformances or errors.
