How To Structure The Iso 13485 Medical Devices Qms Documents?

By Author: Emma
Total Articles: 28
Comment this article

Do you envision structure of documentation when you think about Quality Management System (QMS) documentation? Perhaps needless processes and concerned much about effectiveness? This is the sad truth for certain businesses, who erroneously believe that the more documentation they provide, the more compliant they would seem. Avoid falling into this trap with your company.

The three main goals of ISO 13485 documentation are as follows:
• To offer an accurate framework for the business's activities
• To improve comprehension of the Quality Management System and promote process consistency
• To demonstrate that the business has accomplished its aims and objectives.
Therefore, when you start writing your QMS documentation, you should concentrate on efficiency and only write procedures and papers that will be advantageous to your company.

Medical Devices QMS Documents Structure
Among the many documents found in a typical QMS are the following:
• Quality Manual
• Quality ...
... Policy
• Procedures
• Quality Plans and Records
Not all information must have a distinct document, however, the ISO 13485 standard mandates that different kinds of information be documented. An organization can use the standard to determine how much documentation it needs and how much detail to add. Small businesses might decide to provide a basic summary of their processes in the Quality Manual, for example.

How to Structure Medical Devices QMS Documentation?
"ISO 10013:2001 Guidelines for Quality Management System Documentation" is a separate standard that guides the quantity and dimensions of documents that your company is likely to require. It also offers instructions on how each document should be organized and what should be included. Some of these ISO 10013 guidelines are summarized here.

Quality Manual: The Quality Manual should contain the rules that apply to the organization, with reasons provided for any that are left away according to ISO 13485:2016 article 4.2.2. The organization itself, including its size, complexity of operations, and personnel skills, will determine the contents of the book and its general structure. Although a small business may likely document its full quality management system in a single manual, a huge multinational corporation might require many quality manuals in addition to all other necessary documentation.

A quality manual should include;
• The table of contents and title
• Details regarding the approvals and versions of the documents
• An explanation of the QMS
• The extent of the QMS
• Any modifications from ISO 13485 and justification for them
• The business process model used by the corporation
Quality Policy: The company’s dedication to quality, compliance with legal and regulatory requirements, and ongoing improvements are outlined in the Quality Policy. It describes your company’s quality targets, which are determined by measuring them. Keep the Quality policy short and simple because some businesses decide to use it for marketing.
Quality Procedures: An organization's quality management system is based on its quality procedures. Their goal is to put procedures in place that will guarantee the business's operations meet ISO 13485 criteria. Quality processes can take many different forms. They can take the shape of stories, which are descriptive; more structured tables; flow charts, which are more shown; or a mix of such formats.

The following components must be incorporated into quality procedures:
• The title to determine the process
• Its objective, or the rationale behind the process
• Defining its scope, or what is and is not part of the process
• The authority, roles, and duties of people doing the procedure
• A list and definition of the documents produced by the procedure's activities
• Identification of modifications, the document's version, and the date of review and approval, in compliance with accepted document management procedures
An explanation of the steps involved in the process (the procedure's major body) that includes what needs to be done, how, when, where, and by whom. In certain situations, the "why" should also be explained, along with the inputs and outputs of the duties, as well as the required materials. If necessary, supplementary.

Records: The low-level records that demonstrate that a process is in place and being carried out by the work instruction or procedure are these. Inspection documents, for instance, provide proof that an inspection was conducted in addition to certain particular conclusions.
Audit Checklist: Audit questions are covered by the ISO 13485 Audit Checklist, which is based on the department- and clause-by-department requirements of ISO 13485:2016. You can create your internal audit checklist by altering this ISO 13485 checklist.