Learn How To Prepare A Quality Manual That Complies With The Iso 13485 Standard

By Author: John
Total Articles: 198
Comment this article

The quality manual is a document that describes the context of the organization's QMS. It's a required approach for ensuring that you're following certain standards and requirements inside your procedure. One of the cornerstones to bringing a safe and effective medical product to market is an efficient quality management system (QMS). To fall into that category, your QMS should adhere to ISO 13485 criteria, the international standard for medical device quality management systems, which includes the requirement for a quality manual.

Consider a quality manual to be the QMS's user handbook. A quality manual's goal is to assist individuals, the team, and any stakeholders or auditors in navigating the QMS. The quality manual should also convey the company's QMS's purpose and objectives, as well as set roles and responsibilities for system maintenance and quality activities. As a result, organizations must produce a quality handbook that meets ISO 13485 requirements while also being informative and easy to use. Here's how it's done:

What are the ISO 13485 quality manual requirements?

ISO 13485 requires ...
... that the quality manual cover four key elements:
• Describe the scope of the QMS. Include any clauses that have been excluded and a justification for excluding them.
• List or reference the standard operating procedures of the QMS.
• Describe any interactions of QMS processes.
• Provide an outline of the structure of QMS documentation.

The standard allows producers to structure a quality manual however they see fit, as long as it fits the four key criteria. Remember that the quality manual is not intended to be a book-length text. Medical device makers frequently believe that they must produce a massive tome that covers every aspect of ISO 13845. And, while this may legally meet the standards for a quality manual, it's worth analyzing whether it results in a meaningful quality handbook.

At some time, all of the employees, customers, regulatory authorities, investors, and other key stakeholders will need to read your quality handbook. As a result, you must produce a streamlined, readable quality manual that fits the four primary standards while remaining concise.

What should a quality manual contain?

Now that we've defined the strong objectives of a quality manual, let's look at what it takes to meet each of them:

Scope: In the quality manual, it is critical to clarify the scope of the QMS requirements, along with any limitations that have been created. Remember that only parts of clauses 6, 7, and 8 can be removed. Also provide a brief description or summary of the activities carried out at each of those addresses as well (design and development, internal audits, etc).

Provide a reason for why you are avoiding any requirements that do not apply to the product. When recording any rationales, be as precise as possible; the organization may have to defend them in an audit! It is also important to clarify the roles and duties of any third parties that are working with, such as manufacturing and sterilizing companies, and offer their complete contact information.

Understand the List of 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. Control of ISO 13485 documents
2. Control of ISO 13485 records
3. Internal audit
4. Control of non-conforming products
5. Corrective and preventive actions
6. Validation of computer software
7. Customer specifications
8. Monitoring and measurement
9. Servicing and installation
10. Management review
11. Work environment and contamination control
12. Design and development
13. Validation of sterilization and sterile barrier systems
14. Identification and traceability
15. Preservation of product
16. Calibration or verification for measuring equipment
17. Feedback and complaint handling
18. Reporting to regulatory authorities
19. Advisory notices, reworks, data analysis

It is crucial to note that ISO 13845 does not need each process to be written out step by step in the quality manual; the standards simply require a list or index of the manufacturer's SOPs. To comply, an organization can also develop a "Documented Procedures" appendix within the quality manual and include the procedures stably. This might have two columns, one to reference the ISO 13485 section number or title and the other to reference the method.

Describe process interactions: The purpose of this quality manual requirement is to specify how the various processes interact with one another. One of the easiest methods for demonstrating this is to include a process flowchart that displays the interdependence and interactions of the processes. Whichever technique is used, the inputs and outputs of each associated process must be displayed. Management responsibility, vendor selection, and risk-based approaches all play important roles.

Document structure: A document structure outline will also be required for the quality manual. The quality manual can be pictured as the apex of a pyramid, with SOPs and work instructions in the middle and document records at the bottom. It is entirely up to the organization how they format their documentation, as long as it is properly explained in the quality manual.

Additional: Apart from the above four segments, these are a few things that benefit the quality manual:

• The Quality Policy
• A brief description of the company, its mission, and its vision
• A list of any definitions or abbreviations
• An organizational chart detailing job titles, not necessarily who holds the title currently
• A list of the regulations and standards