How Can A Quality Manual Be Developed To Meet Iso 13485 Standard Requirements?

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One of the essentials to developing a safe and efficient medical device is the best quality management system (QMS). And for your QMS to fit into that category, you'll need to comply with the requirements of ISO 13485:2016, an international standard for quality management systems for medical devices, which requires the use of a quality manual. A quality manual may be thought of as your QMS's user guide.

A quality manual's goal is to make the QMS navigation easier for you, your team, and any stakeholders or auditors. The company's QMS goals and purpose should be expressed in the quality manual, along with the roles and duties for the upkeep of the system and carrying out quality activities. As a result, you must produce a quality manual that conforms with the relevant clauses of ISO 13485:2016 and is both informational and user-friendly. Let's see how? But, firstly understand the requirements of the ISO 13485 quality manual.

What requirements does the ISO 13485 quality manual incorporate?
Your ISO 13485 manual must include the following four essential topics under ISO 13485:2016:
• Explain the scope ...
... of your QMS. Include any clauses you have eliminated, as well as your explanation for doing so.
• Describe or include a reference to your QMS's standard operating procedures (SOP).
• Explain any QMS processes that interact.
• Give a brief description of the QMS documentation's structure.

The ISO 13485 standard allows manufacturers to create an ISO 13485 quality manual in whatever way they consider suitable, as long as it satisfies the four basic requirements. Keep in mind that your quality manual is not supposed to be a book-length document. Medical device manufacturers frequently believe that they must produce a huge tome that covers every aspect of ISO 13845. Yes, that technically meets the standards for a quality manual, but it's worth examining if that method results in an effective quality manual.

The quality manual will be accessed by employees, customers, regulatory agencies, investors, and other key stakeholders at some point. As a result, you must develop a streamlined, readable ISO 13485 manual that fits the four primary standards while being concise. Now let’s understand what should the quality manual contains.

What information should a quality manual contain?

After outlining the broad specifications for a quality manual, let's examine what is required to meet each of them:

Scope: In the quality manual, you must explain the scope of your QMS requirements, as well as any exclusions you have established. Just the parts of clauses 6, 7, and 8 may be excluded, so keep that in mind. This quality manual is for all Laboratories organizations situated at, as an example. You might also list or provide a summary of the tasks carried out in each of those areas like design and development, internal audits, etc. Include an explanation for every requirement you are excluding along with the reason it does not apply to your product. So, be as specific as you can when explaining your reasons; you might need to explain them in an audit!

List your QMS Standard Operating Procedures
There are several standard operating procedures (SOPs) that ISO 13485 requires companies to document or reference in the quality manual, including:

1. Validation of computer software
2. Customer specifications
3. Monitoring and measurement
4. Servicing and installation
5. Management review
6. Control of documents
7. Control of records
8. Internal audit
9. Design and development
10. Control of non-conforming products
11. Corrective and preventive actions
12. Identification and traceability
13. Preservation of product
14. Calibration or verification for measuring equipment
15. Work environment and contamination control
16. Validation of sterilization and sterile barrier systems
17. Feedback and complaint handling
18. Reporting to regulatory authorities
19. Advisory notices, reworks, data analysis

Describe process interactions
This quality manual requirement's goal is to demonstrate how your various processes interact with one another. Including a process flowchart that illustrates the interdependencies and interactions between your processes is one of the simplest methods to illustrate this. Regardless of the approach you use, it must display the inputs and outputs of each relevant process. The manufacturing and design procedures you use are not included in this flowchart. Additionally, relevant factors are management accountability, supplier assessment, and risk-based approaches.

Document structure
An idea of your document structure will also be necessary for your quality manual. You may imagine a pyramid with the quality manual at the top, your SOPs and work instructions in the middle, and your document records (such as records of internal audits) at the bottom. You may organize your documentation any way you choose, as long as you can explain it in your quality manual.

Additional factors to consider
There are a few "nice-to-haves" you might wish to include in your quality manual in addition to the first four sections:
• It makes it appropriate to highlight your quality policy because your quality manual serves as your user's manual.
• A quick explanation of your business, its goals, and objective
• A list of all definitions and abbreviations
• An organizational chart that lists job titles but not necessarily the people who are holding those positions
• A list of the laws and standards you are adhering to

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