How To Prepare A Good Quality Policy According To The Iso 13485 Standard

By Author: Rohan
Total Articles: 82
Comment this article

To demonstrate an organization's ability to provide medical devices and related services that consistently meet customers' needs and applicable regulatory requirements, a quality management system (QMS) standard for the medical device industry, ISO 13485, was developed. This standard outlines requirements for an organization to design and implement a QMS. For those who create, produce, and sell medical equipment, ISO 13485 is essential. By adopting this standard, manufacturers can show a clear commitment to the safety and quality of medical devices, as well as a realistic platform on which to satisfy international legislation and their responsibilities. Your Quality Policy is one of the first things organization must create by ISO 13485:2016 when developing a Quality Management System (QMS) for a medical device manufacturing company. Thus, individuals might be curious as to what this Quality Policy is and why the QMS requires it.
The ISO 13485 Quality Policy Document should be the organization's overall goal, and it is established by top management to direct everyone in the organization on how medical devices will be created ...
... and provided to customers. Every employee of the company should be aware of and understand this top-level policy so that everyone can work together strategically to meet needs and produce products. Commitment to quality can then be employed throughout the organization as a focus on how procedures are conducted and as a guide for the organization's quality objectives—those primary improvement goals that the company intends to attain. Also, an ISO 13485 procedure document must be created for easier understanding to ensure that all the procedures are followed.
What makes a quality policy necessary?
The organization's goals for providing medical devices are reflected in the Quality Policy, which also serves as a roadmap for the commitment to achieving quality objectives. So, internal organizational decision-making can be regulated through the Quality Policy.
For instance, a manager evaluating the resource requirements of their process might ask themselves, "Will changing this resource requirement improve our ability to meet customer and regulatory requirements?" if your quality policy ensures that the medical devices you provide will meet both customer and legal criteria. If the response is negative, another choice that will aid in achieving the objectives of the business should be chosen.
How do you write the ISO 13485 Quality Policy?
Although, indeed, ISO 13485 standard does not contain many requirements that must be met, the Quality Policy for a medical device company must comply with the following requirements:
• This means that the policy cannot be directly duplicated from another source; rather, it must be personalized to your organization and apply to what you do.
• The policy must state that you're committed to adhering to an effective QMS as it relates to the particular and distinctive product, as well as to comply with any legal requirements that apply to you about your medical devices, including any that are regulatory in nature. A common occurrence in Quality Policy is management commitment to minimizing all risks to provide a safe and efficient medical product.
• The policy outlines how the quality objectives will be proposed and provide a framework for our quality goals. So, it is common to add promises that will serve as a foundation for these quality goals your firm wants to accomplish, including on-time delivery or product development.
• To ensure that everyone is aware of this top-level QMS objective, the policy must be made known to all corporate personnel as well as interested parties when necessary.
• Also, a procedure for reviewing the Quality Policy regularly is required to make sure it still aligns with the organization's strategic goals and direction as well as the evolving requirements and expectations of interested parties.