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What is ISO 13485? A Step-by-Step Guide to Medical Devices Quality Management
ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), ISO 13485 provides a comprehensive framework for a Quality Management System (QMS) in the medical device industry.
Why Adopt ISO 13485? Adopting ISO 13485 helps manufacturers comply with the EU Medical Device Regulation (MDR) and other regulations. It demonstrates a commitment to the safety and quality of medical devices. Starting with management support and identifying customer requirements, you will need to develop documentation including the Quality Policy, Quality Objectives, and Quality Manual. These define the scope and implementation of the QMS. Additionally, you will need to create mandatory and additional processes and procedures necessary for your organization to properly deliver your product or service.
Importance of ISO 13485
Why is ISO 13485 Important? ISO 13485 provides a framework for ensuring that medical devices consistently meet regulatory and customer requirements. Compliance with this standard demonstrates a commitment to producing safe and effective medical devices. It helps companies meet regulatory requirements in many markets worldwide. ISO 13485 helps identify and mitigate risks associated with the design, development, and production of medical devices. It also improves processes and increases efficiency, leading to better products and higher customer satisfaction.
Current Version of ISO 13485
What is the Current Version of ISO 13485? The latest revision of ISO 13485 is from March 2016. Key updates include a focus on risk, clarification of management and training responsibilities, improvement to facility requirements, better alignment of design and development requirements with regulations, more emphasis on supplier control, traceability procedures, complaint handling, and product cleanliness requirements. Although ISO 13485:2016 came out after ISO 9001:2015, it aligns with ISO 9001:2008, as the changes in ISO 9001:2015 were deemed unnecessary for medical devices.
Requirements and Structure of ISO 13485
ISO 13485:2016 specifies requirements for a Quality Management System to produce medical devices and related services that consistently meet customer and regulatory requirements. The standard applies to organizations regardless of size and type.
Structure of ISO 13485:2016:
Scope
Normative References
Terms and Definitions
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis, and Improvement
Key Clauses of ISO 13485
Clause 4 – Quality Management System
General Requirements: Adhere to the standard, document what needs to be documented, and maintain required documentation. Have written procedures, ensure system effectiveness, consider risk factors, and minimize risks. Identify and follow legal requirements. Maintain responsibility for outsourced work and confirm systems used in manufacturing.
Documentation Requirements: Quality Manual, policy or objective statement, control of documents, and control of records.
Clause 5 – Management Responsibility
Management must demonstrate commitment, accountability, and alignment with the laws of the country. They must support the quality policy, communicate the mission to employees, plan, delegate authority, and conduct periodic reviews known as Management Review.
Clause 6 – Resource Management
Top management must ensure adequate resources for the work promised by the organization. This includes personnel, infrastructure, consumables, equipment, succession planning, and risk aversion. Managing daily workflow and planning for future retirements is critical for success in medical device manufacturing.
Clause 7 – Product Realization
Organizations must plan from conceptualization to implementation. This includes documenting how ideas are initiated, verified, designed, developed, and validated to fulfill ISO 13485 requirements. Communication is critical throughout this process.
The key is to follow the process from planning to inputs, outputs to review, verification, and validation. Documenting changes and retaining files are critical. Defining and tracking supplies, retaining critical information, and determining how to verify products should be documented clearly within procedures.
Clause 8 – Measurement, Analysis, and Improvement
After manufacturing and releasing your product for general use, ensure it meets customer expectations. According to Clause 8, develop procedures for effectively monitoring and measuring product success, including:
Handling complaints
Reporting events to regulatory authorities
Undergoing internal evaluations through auditing
Continual process and product evaluation
Identifying and controlling nonconforming products
Analyzing data and continually improving the process
These steps are based on the Plan-Do-Check-Act cycle, driving and maintaining improvements within the organization. To learn how to implement ISO 13485 requirements
ISO 13485 vs. Other Standards
ISO 13485 vs. EN ISO 13485 ISO 13485 is an internationally recognized standard issued by the International Organization for Standardization (ISO) for creating a Quality Management System in the medical device industry. EN ISO 13485 is a parallel standard issued in the European Union. The requirements of these two standards are identical, and the entire ISO 13485:2016 standard is included in the EN ISO 13485:2016 document.
The European version (EN ISO 13485) includes tables aligning ISO 13485:2016 requirements with three EU directives for medical devices. With the release of the EU Medical Device Regulation (EU MDR) in May 2017, it is expected that a new version of EN ISO 13485 will show closer alignment with the EU MDR.
ISO 13485:2016 vs. 13485:2012 EN ISO 13485:2012, published on January 24, 2012, replaces EN ISO 13485:2003. The global standard ISO 13485:2003 text remains unchanged, with only the foreword and annexes in the European version revised. For new requirements of ISO 13485:2016 vs. 13485:2003, refer to Annex A in the new ISO 13485:2016.
ISO 9001 vs. ISO 13485 Although ISO 13485:2016 is a stand-alone standard, it is based on ISO 9001:2008. ISO 9001 is an internationally recognized standard for any industry. ISO 13485 includes additional requirements specific to medical device manufacturers.
Is ISO 13485 Mandatory?
No, ISO 13485 is not mandatory. You can create a QMS that suits your organization, as long as it meets legal and regulatory requirements for medical devices. Although ISO 13485 is not required for EU MDR compliance, the EU MDR regulation requires a QMS, and ISO 13485:2016 is the only QMS standard listed in the EU’s harmonized standards.
The reference to ISO 13485 in the EU harmonized standards indicates that implementing ISO 13485 requirements will meet all EU MDR QMS requirements.
