The new ISO 13485 preserved the requirement for a Quality Manual in part because it is based on ISO 9001:2015, in contrast to the most recent edition of ISO 9001, which omitted the Quality Manual from requirements for documentation. Given the differences between ISO 9001:2008 and ISO 9001:2015, which were reflected in the new ISO 13485:2016, the standards for the Quality Manual haven't undergone major modifications. The potential to improve and tailor your manual to your business is still a good one at this time.
Why was the Quality Manual Developed?
The majority of firms may create Quality Manuals that formally meet ISO 13485 requirements, but they are unable to appreciate the value of having such a document. Because of this, time and money are wasted creating a long document that no one will ever read. These documents can be over 20, 30, or even 50 pages long, and instead of being an important part of the Quality Management System (QMS), they are just wasteful document that will be recycled.
An organization's quality management system can benefit greatly from a strong quality manual that is succinct and to the point.
- It provides a platform for the organization to communicate its dedication and quality management strategy.
- It's a nice place to list additional requirements clearly and understandably manner in addition to those mandated by clause 4.2.2.
- It demonstrates to stakeholders that the company is skilled at managing the calibre of its goods and services.
- It enables the auditor to conduct a better, more thorough audit of the QMS and, as a result, to make recommendations for system improvement.
- The management representative and the process owners are given a good overhead perspective of the Quality Management System, which is perhaps best of all because who could be better qualified to identify areas for improvement?
How do you do it?
As with any other standard requirement, you must first consider what the standard needs before attempting to keep up with it while writing or updating your Quality Manual. It's not that difficult to develop a solid ISO 13485 Quality Manual when you utilise this method; just make sure to include the components listed in clause 4.2.2:
- A description of your Quality Management System's domain
- A list of any exclusions and the justification for each
- A summary of your processes and how they interact, ideally shown graphically, such as this process flowchart
- Reference to the QMS's documented procedures
What More Could the Quality Manual Have?
Given that the quality manual serves as a reflection of your quality management system, you could wish to add some additional information that you feel is crucial for either your QMS or the reader of the manual. In summary, I would advise you to include the following details about your company in addition to all the other requirements from clause 4.2.2:
- A Concise description of the business (perhaps including a synopsis of its history and the key turning points)
- A basic breakdown of your company's organizational structure that demonstrates how your departments are set up
- Your goals and objectives
- Your procedures and how they interact (flowchart)
- Exceptions from the mandatory requirements, along with an explanation of the exclusion
Source Link: https://isomanualtemplate.wordpress.com/2023/10/17/how-to-maintain-the-quality-manual-for-the-iso-13485-standard/
