What are actual requirements of a Quality Manual in organization according to ISO 13485?

Organizations sometimes only go through the quality manuals to meeting every single requirement the ISO 13485 standard lists for their Quality Management System (QMS).But a document like ISO 13485 manual is much too long and difficult to understand to be of any use to employees of organization. The ISO 13485 standard addresses regulations quality system for the production of medical devices.

The requirements of the ISO 13485 manual will be communicated to all employees of company in whole or in part, depending on the scope of responsibilities of the employee and the impact on the quality system and product integrity.In essence, The ISO 13485 Manual for Medical Devices describes the company's quality management system and defines authorities and responsibilities scene of personnel within the system. With the standard of ISO 13485, the manual also includes procedures or references for all activities, including QMS to describe companies' compliance.

Externally, The ISO 13485 manual is used to introduce QMS to customers and other external organizations or individuals. The manual focuses on customer satisfaction and continuous improvement and familiarizes them with the controls that have been implemented, and assures them that the integrity of the QMS is maintained. And internally ISO 13485 manual used to guide employees of the company through the ISO 13485 standard requirements.

Following are the ISO 13485 requirements of a quality manual:

1. The Scope of QMS:

The QMS Scope is a description of what your company does such as of Medical Devices distribution, MRI Machine’s software design, etc. and the boundaries of Quality Management System. It will be stated on the ISO 13485 certificate and it needs to be agreed upon with the certification body. In the inclusion in your scope, you need to list any exclusion from the ISO 13485 standard. According to customer specifications many companies manufacture products, and don’t actually design any products.

2. Documented procedures:

There are quite a lot of that requirements of ISO 13485 procedures in an organization to document in the quality manual. Mandatory documented procedures include:

Control of documents

Control of records

Internal audit

Control of non-conforming products

Corrective and preventive actions

Validation of computer software

Customer specifications

Monitoring and measurement

Applicable Servicing and installation

Management review

Work environment and contamination control

Design and development

Validation of sterilization and sterile barrier systems

Identification and traceability

Preservation of product

Calibration or verification for measuring equipment

Feedback and complaint handling

Reporting to regulatory authorities

Advisory notices, reworks, data analysis

In addition to these required ISO 13485 documents, there is a requirement for companies to develop documentation for any procedures. Graphically, Procedures that are shown like flowcharts can be included right in the quality manual. It’s simpler to include references to these documents in the quality manual. The quality manual of ISO 13485 can serve as a kind of quick-reference guide to company procedures.

3. Descriptions of processes and their interactions:

Top-level flowchart is illustrating the basics of your organization’s processes, with arrows showing how they interact and is the easiest way to accomplish.

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