ISO 13485 Certification is the universal standard for the establishment and maintenance of an archived quality management system in the medical device industry. If a manufacturer has followed the ISO 13485 Standard, it will have a place where it can ensure local medical regulations, such as the EU Medical Device Directive (MDD), the Medical Device Regulation (MDR), the US FDA 21 CFR 820, and other guidelines that demonstrate a commitment to the quality and security of medical devices.
One of the first things a company should create when developing a Quality Management System (QMS) for a medical device manufacturing business is the Quality Policy (requirement 5.3), as per ISO 13485:2016. Many might be wondering what this ISO 13485 Quality Policy entails and why the QMS needs it. The organization's overall purpose should be defined in the ISO 13485:2016 policy, which is drafted by senior management to guide all staff members about the development and delivery of medical devices to patients.
Important Components of a Quality Policy in ISO 13485:
- Make the policy meet the needs of the company
- Establish a structure for defining organizational quality goals
- Demonstrate a commitment to complying with all requirements
- Determine management commitment
- Implement the Quality Policy
- Maintain a frequent assessment of the Policy
The goal of this high-level policy is to ensure that all employees are aware of it and can follow it, providing a single strategic direction for requirements fulfilment and product development. After that, a company's commitment to quality can be used across the entire organization to lead its quality objectives—the primary goals for improvement that it intends to accomplish—and to keep an eye on how its processes are carried out.
A manufacturer of medical devices must have a Quality Management System which incorporates the ISO 13485 policy. It outlines the organization's dedication to quality and adherence to legal obligations and acts as a guide. To comply with ISO 13485, a quality policy must have the following components:
- Commitment to compliance: Medical device regulations, standards, and guidelines should be emphasized in the policy as well as the organization's commitment to complying with the standard.
- Customer focus: The policy should demonstrate how committed the company is to satisfying customers and fulfilling their needs.
- Risk management: The organization's dedication to recognizing, evaluating, and controlling risks related to the creation, manufacturing, and distribution of medical devices should be covered by the policy.
- Continuous improvement: The organization’s dedication to continuously enhancing its processes, products, and Quality Management System via objective measurements and data analysis needs to be highlighted in the policy.
- Employee competence: The policy should emphasize the value of employee competency and offer a structure for guaranteeing that staff members have the abilities, know-how, and education required to carry out their duties efficiently and effectively.
- Documented processes: The necessity of documenting processes and procedures to guarantee uniformity, traceability, and efficient internal communication should be addressed in the policy.
- Monitoring and measurement: The policy should specify how the company plans to track, measure, and examine key performance indicators to assess the QMS's efficacy and promote ongoing development.
- Management responsibility: The policy requires to specify precisely what the top management's tasks, duties, and authority are when it comes to creating, putting into practice, and overseeing the Quality Management System.
- Supplier management: The organization's methods for choosing, assessing, and keeping an eye on suppliers to guarantee the quality and safety of goods and services acquired should be covered by the policy.
Through the integration of these components into the ISO 13485 policy, entities can exhibit their dedication to manufacturing secure and efficient medical devices that satisfy both regulatory mandates and patient expectations.
Source: https://13485certificationprocedures.wordpress.com/2023/10/28/know-the-necessity-of-having-an-iso-13485-quality-policy/
