ISO 13485 Structure and Requirements

Do you want to understand the details of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to the production of medical device. So here is what you can expect to achieve compliance

Clause 4 — Quality Management System

Clause 4 covers two very specific aspects of a Quality Management System: General Requirements and Documentation Requirements.

General Requirements: In evaluation of any ISO standard, there are some systematic requirements that are the driving force for the establishment and implementation of a Quality Management System. The requirements specific to **ISO 13485 Certification** include the following:

• Comply with the ISO 13485 standard.
• Document what needs to be documented.
• Maintain what is required of you.
• Have written procedures in place and ensure the effectiveness of the system that you implement.
• Consider the risk factors in all activities.
• Introduce steps to minimize the risks identified.
• Identify how things should be done to generate your medical device.
• Any systems used in your manufacturing processes should be confirmed to ensure they work as intended and don’t negatively affect your processes.

Documentation Requirements: Most quality systems require a key component, a Quality Manual. Beyond the **ISO 13485 Manual**, an organization should determine the promise that they will make to ensure an environment and culture that can be consistent with putting quality first in all activities. This commitment can be captured with a policy or objective statement.

Clause 5 — Management Responsibility

Management must demonstrate their commitment by showing they can be held accountable for the operations within their organization. Management has an absolute responsibility to support the quality policy, confirm its alignment with the laws of the country of work, and communicate the mission to employees. They are also responsible for a periodic review of operations and improvement within the organization, known as the Management Review.

Clause 6 — Resource Management

Top management has a responsibility to ensure that the Quality Management System is compliant with ISO 13485 and adheres to local regulatory requirements. As a requirement within ISO 13485 certification, top management must ensure that adequate resources are available to perform the work promised by the organization.

Clause 7 — Product Realization

An organization must plan for the journey from conceptualization to implementation. This can include developing a process for documenting how thoughts are initiated, concepts are verified, and products are designed and developed, as well as how to verify and validate to fulfil the requirements for ISO 13485

Clause 8 — Measurement, Analysis and Improvement

Now that your product has been manufactured and has been released for general use, you kind of have a responsibility to ensure that the people have what they want. According to Clause 8, development of a procedure for effectively monitoring and measuring product success must include:

• handling complaints
• reporting events to regulatory authorities
• undergoing internal evaluations through auditing
• continual process and product evaluation internally
• identifying and controlling products that don’t meet the original design requirement
• analyzing data generated and continually improving the process