Writing ISO 13485 Quality Manual – Need a tip?
A quality manual is a document that outlines the company’s intentions for managing processes in quality management. It may include rules for all parts of business that affect its capability to produce high quality outcome and meet clients and ISO requirements. These rules define how department managers will implement procedures within the limits defined in the manual.
So, what should be content of your Quality Manual?
These are essential things that are required:
- Structure of the documents – this should be shown in Quality Manual, because it will help understand the categories of documents that are used in the system.
- Scope – this is a relevant part of the quality manual, as it outlines how far the QMS spreads inside the company, and facts any exclusion from the ISO requirements and their justification.
- Procedures– they can be included within Quality Manual, but better yet they can be referenced within it.
- Processes and their interaction – this should be included, preferably in form of a flowchart.
These are essential parts which Manual should include, but these are minimum requirements which should be fulfilled. But, since the it is the mirror of company’s QMS, in order to be more attractive and clearer, additional information can be added.
Recommendation is to add brief description of the company with its mission and vision. Quality policy could be included in the Manual as well. The quality policy is the exact definition of quality that counts within organization and for that reason it should be communicated and understood.
The best way is if it is the part of the Manual.
This also applies for an Organizational chart. An organizational is a diagram that shows the structure of an organization and the relationships and ranks of its parts and positions/jobs within the company. If company is selling their products all over the world, it’s also important to reference which regulation and standards they are following. So, the main standards that company use to implement their quality system.
Let’s summarize – include following in your Manual:
- Process interaction diagrams
- Statements of applicable processes
- Justifications for exclusion
- Organizational chart
- Quality objectives and policy
- References to relevant documents
The Quality Manual is a very valuable document that not only provides guidance to the company’s own staff, but also because both your suppliers and your customers use it as the basic measure to determine and evaluate if your company meets your quality commitment. If it is well created, it can be used as a tool to “sell” the company – it can demonstrate how good the company is and how really it takes its QMS.