Documentation Requirements and Quality Manual of ISO 13485:2016

Quality Manual iso13485

In the previous article, it was explained what is expected from your organization in the beginning. The General Requirements of the standard were described. As you already know, everything you do, it has to have some evidence that it was done, it has to be documented.

Documented QMS

In Documentation Requirements of ISO 13485:2016 standard defined how organizations are required to document all statements regarding their Quality Management System.

The organization should make a promise that they will be consistent with putting quality first in all activities and they can capture it with a policy or objective statement.

In the clause of Documentation Requirements is stated that the organization, in QMS documentation, will include:

• documented statements of quality policy and objectives,

• the Quality Manual with Scope of the quality management system,

• required procedures and records, and

• any documents that are essential for planning, operation, and control of the organization’s process.

The Quality Management System consists of multiple components, including completed documentation of the organization’s quality policy, quality manual, procedures, work instructions, quality plans, and records.

A key part of your Quality Management System is the Quality Manual.

For MedDev companies included in one or more steps of life-cycle of medical device, is a required certain document by ISO 13485:2016 standard.

And that document is practically a quality management system designed for medical device manufacturers.

If you are manufacturing medical devices for use in the U.S., your organization will need to prove compliance with FDA regulations.

If you plan to distribute it internationally, you have to be compliant with ISO 13485:2016.

Purpose of Quality Manual:

• It is your guide for your company, to help you meet all applicable regulatory requirements, achieve certification with ISO 13485:2016 standard for medical device companies

• It should represent the culture of quality of your organization

• It delineates authorities, inter-relationships, and responsibilities of the personnel responsible for performing within the system

• It is intended to outline the structure of the documentation used in the quality management system.

• It is intended for internal use, to guide the company’s employees through the various requirements od the ISO standard

• It must be met and maintained in order to ensure customer satisfaction, continuous improvement

• It provides necessary instructions that create an empowered workforce

Requirements for creating your Quality Manual

• The scope of Quality Management System, with included details of and justification for any exclusion or non-application

• Documented procedures for the quality management system, or reference to them

• Described interactions between the processes of the quality management system

The common approach of organizations for satisfying this quality manual needs is creating a long-lasting policy-level document. It breaks down the to various sections of ISO 13485:2016 standard and describes how the medical device company addresses the clauses. This approach is acceptable.

Most organizations created quite a few burdens and obstacles regarding documentation and it doesn’t have to be this way. By now, you could get to the conclusion that documentation should be about defining processes and maintaining the required records to demonstrate that these processes are being followed. Documentation is key for objective evidence. Objective evidence to support your personnel through the design, development, manufacturing, and support of medical devices.

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One reply to “Documentation Requirements and Quality Manual of ISO 13485:2016”

  1. Anders B. says:

    Where can I find a good template for establishing the Quality manual?

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