The documents and information of the QMS must be controlled. This is a key element of a QMS. The main idea is to provide control over the documents necessary for the operation of the QMS. The main idea is to provide control over the documents under the quality management system and to eliminate any confusions and mix-ups of different documents from different sources for different functions with different status.
Extent, scope, and size of documents
The term documents refers to the specification and information and the medium on which it is contained (like paper; magnetic, electronic, or optical computer disc; photograph; or master sample), for example a record, specification, procedure document, drawing, report, or standard necessary for the planning and operation of the QMS coming from any source and the medium on which it is contained. A principle that must be considered when planning and defining your documents is as follows: the amount and details of the documentation must be relevant to the
- Planned results
- Type or class of medical device
- Regulatory requirements
- Safety requirements
The extent, scope, and size of documents in organizations are affected by the following factors:
- The size of the organization
- The level of complexity, functionality, and interrelations between its processes
- The qualifications of the employees
- Quality objectives
- Regulatory requirements
A good example to demonstrate this is choosing between maintaining a process, a procedure, or a diagram. How can it be determined when a procedure is needed and when a process should be charted? The extent of the documentation of a process will be determined according to the parameters mentioned earlier. earlier. Choose a process and evaluate the following:
- How many departments and organizational units are included under the QMS?
- What is the level of its complexity? Do I need to document only the principles and main steps of the process or each activity?
- What is the level of the personnel’s qualifications? Do I need to provide them with a general guideline or a detailed description of the work instruction?
- How can I measure the effectiveness of this process? Do I need to collect results of this process? Do I need to analyze the results, or is it enough to just review the output?
- Does the documentation assist me in achieving quality objectives?
- What are the applicable regulatory requirements? Do they demand a certain level of documentation?
- What are the relevant safety requirements? Do the safety requirements demand a certain level of documentation?
Regulatory requirements for controls of documentation
When regulatory requirements require the implementation and integration of certain controls of documentation or certain activities for managing documentation of the QMS, they shall be identified, planned, established, and implemented, f or example, procedures for managing health records of patients and users of the MD. The ISO 13485 Standard gives such regulatory requirements the same scale as any standard requirement for documents when it relates to the realization of the product. In practice, you must identify such requirements and include them in the method for controlling documents.
Format and structure of documents
The structure and the format for each type of document will be determined. The objective is to constitute unity when creating a document. In other words, to create a situation where all types of documents look alike in the organization, to avoid different formats or structures, and to reduce confusion and uncertainty. The types of formats may be text, flowcharts, tables, a combination of the three, or any other method that will serve the organization.
The format and structure of the document will determine the content of the document—what the document must contain. I suggest here a few elements that could appear on a document but are not obligatory:
- Title
- Review, approval, and revision
- List of changes
- Purpose
- Scope
- Responsibility and authority of executing the activities
- Description of activities
- Required records
This webpage contains only a fragment of the chapter 4 – Quality management system from the book:ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition published by:
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