ISO 13485 is a regulatory standard that specifies the requirements of a quality management system (QMS) for organizations manufacturing medical devices. The standard requires the company to prove its ability to deliver medical devices and services that meet the customer requirements as well as the applicable regulatory requirements under the ISO certification consistently. The organization can be involved in manufacturing medical devices, supplying them, storing, distributing, servicing or installing them. ISO 13485 requirements are applicable to any organization regardless of its size.

What Is an ISO 13485 Quality Manual?

An ISO 13485 quality manual is an official document that outline’s the organizations plans for managing and implementing different processes in quality management. It usually includes all parts of the business that affect the capability of the organization to meet client requirements, produce high-quality products and other outcomes and fulfill ISO requirements. The rules serve as a guideline for different department managers on how they should implement procedures while adhering to the limitations defined in the quality manual.

medical devices being manufactured under strict quality control

Essential Components of an ISO 13485 Quality Manual

The quality manual can include several components to make the QMS clearer and more attractive and make it easier to implement. The essential parts of the quality manual required by the ISO include:

STRUCTURE OF THE DOCUMENTS — the structure of documents in the quality manual will help the team understand the various categories of documents that are used and required in the QMS.

SCOPE — The scope of the QMS should clearly be mentioned to show how far the system spread within the company and whether any departments or areas of business are excluded from the ISO and what is the justification for that.

PROCEDURES — The quality manual should include a detailed outline of the procedures that must be changed and will be affected by the implementation of the QMS. If the procedures are not clearly detailed in the document, they should at least be referenced in it.

PROCESSES AND INTERACTIONS — The processes that will be implemented to comply with the requirements of the QMS must be included in the quality manual, preferably in the form of a detailed flowchart, to explain their interaction with various departments and procedures.

Additional Components

ISO experts also recommend adding brief information about the company, along with the mission and vision within the quality manual. An organizational structure of the company showing various roles and positions within the organization can also be added or referenced for a more comprehensive detail of the QMS process being implemented.

Consult with ISO Experts in Cleveland, OH

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