ISO 13485 - Quality Management System requirements

Main Menu

Key Concepts

Content View Hits : 39305

ISO 13485 Standard quality management system general requirements

The main processes of the quality management system are to be documented within the quality manual or procedures. This is the main idea of any quality manual. In any case, do yourself a favor and present within the quality manual a list of the processes included under the quality management system. It would save some explanations during the Audits. The relations and sequences between the main processes must be defined, documented and implemented. First let's understand the basics

ISO 13485 Standard documentation requirements - General requirements

Paragraph 4.2.1 General requirements - is a general paragraph that presents the main documentation requirements of the quality management system rregarding your QMS – Policies, Processes, work instruction, requirements for records (Forms etc.) and the records themselves. . The specific requirements are mentioned during the next paragraphs. In this article we will review the general requirements for documentation of the ISO 13485 with reference to the ISO 9001 Standard.

ISO 13485 Standard documentation requirements - Quality manual requirements

4.2.2 Quality manual

ISO 13485 Standard documentation requirements - Quality manual requirements

ISO 13485 Standard control of douments requirements

The documents control requirements within the ISO 13485 Standard are a key element of distinction between the two standards. The main idea is to eliminate any confusion and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called "Documents Control".

ISO 13485 Standard control of records requirements

In a direct relation to documents control, we will deal now with the records control requirements. The ISO 13485 Standard requires a definition of what records we must preserve as part of our quality system. Within the documents control we define what is a document and the method to manage it in various aspects: versions control, editions, distribution, elimination etc. Now we must define what are the documents included within the quality management system and how we would behave with them during the processes.

Joomla! is Free Software released under the GNU/GPL License.