Explained: Quality planning in ISO 13485
Quality planning determines the plan to use that management system to fulfill the requirements of the organization’s services and products.
Key elements of quality planning
Quality planning is a critical phase in the design of the Quality Management System. It is an important part of QMS that will ensure its effectiveness. During the planning, the medical device organization should consider the key elements and features that are applicable to their quality management system. They should also define all activities required for the realization of their medical device.
It’s all about safe medical device
Yes, the MedDev organization should stay focused on the main goal while creating a quality plan and that is to provide a safe and operative medical device. A medical device that will meet all requirements, and the customers’ and regulations.
The planning outputs manifests as records, documentation, and methods that will support defined activities. The quality planning must cover all the relevant aspects and parts in which the organization is included, such as design and development manufacturing, sales, service, installation, and customer support.
Quality planning, activities, operational resources, and support needed to achieve quality objectives of the quality policy are defined. These plans are typically written with a concise, explicit scope and can be used as a checklist to ensure that a process or project is meeting quality requirements for a site, company, or project.
There are three levels of planning:
- The first level of planning is related to the strategic concept of the MedDev organization, formed by the top management: quality objectives, determining the marketing of a new product, opening a new department, or a yearly business plan with objectives.
Such planning may affect the other levels of the organization and might demand them to plan or change their further activities
- The second level of planning is related to the Quality Management System: results and conclusions of management reviews, an external audit with requirements for corrective actions, and a review by a regulatory body with requirements for new activities, or corrective or preventive actions.
This planning level may affect both directions, up the organizational ladder, or down to the operative levels.
- The third level of quality planning is the operative level: implementing work procedures or instructions, carrying out training, and implementing validation plans with acceptance criteria.
In the standard ISO 13485:2016 requirements are defined, top management of the medical device organization is meant to ensure that:
- The planning of the quality management system is implemented in order to meet the requirements given in General requirements, as well as the Quality Objectives.
- The reliability of the quality management system is maintained when changes to the quality management system are planned and implemented.