n
What a standard The ISO 13485. It’s almost fascinating. We can assure you one thing: it requires a lot of work to get the certification even if you are already certified for the ISO 9001 Standard. The ISO 13485 documents control requirements are tougher, traceability is much more complex and not to mention the training requirements.
ISO 13485 introduction
ISO 13485 is a special standard for manufacturers for medical devices (and services). The global village is becoming closer day by day; markets are exchanging goods and knowledge more often. It is true for medical devices and services as well. All around the world companies are exporting medical devices. The ISO 13485 Standard is here to verify that the manufacture and service supply is under supervised criteria. In order to maintain constant requirements the ISO organization developed this standard. The purpose of this standard is to establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services. The ISO 13485 is not a product standard. It’s process oriented. In addition, it’s not enough to establish a quality management system that complies with the ISO 13485 standard; you also need to comply with all relevant products and service technical standards and regulations from the regional place of manufacturing or installing. That means that the organization is examined not only for the ISO 13485 Standard requirements but also for any regulations or legal requirements concerning the medical devices.
ISO 13485 documents control requirements
In this article we will review the additional requirement s for documents control (chapter 4.2 – Documentation requirements) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard. The documents control requirements within the ISO 13485 Standard is a key element of distinction between the two standards. We would have a nice table presenting the ISO 13485 documents control requirements vs. the ISO 9001 requirement for documents control. So let’s start…
4.2.1 General
ISO 9001- The 9001 requires maintaining documents that describe the QMS, its scope, obligatory procedures, procedures required to realize the product and records according to paragraph 4.2.4.
ISO 13485- The 13485 requires all the same but with Documents that are required by national or regional regulations. That means that if this regulation specifies any kind of document to maintain – it is just like any requirement made in paragraph 4.2.4. You would have to implement and maintain it.
Comment- For example – if you are a factory that produces medical devices and the office of health (in your country or region) requires to maintain any kind of licenses (like a business license) – you would be required to present this licenses (valid, of course). The ISO organization is aware that there are many regulations for producing medical devices around the world and the 13485 gives them the same scale as for the standard requirement for documentation.Plus (it’s not over), for any kind of medical device – the organization must maintain a file describing the documents specifying the product (including manufacturing specifications) and documents required by the QMS. This way anyone can trace any documents at any stage of the product realization related to the medical device.
4.2.2 Quality manual
ISO 9001- The 9001 requires maintaining a quality manual that describes the scope of the quality management, the procedures established for the quality management system and the relations between the processes and the QMS.
ISO 13485- During the exclusion chapter -the 13485 requires also to mention the activities that are not applicable during the product realization.
Comment- f there are any requirements during chapter 7 (product realization) that are not applicable, following the product character – the organization can exclude them and mention it within the quality manual. But, if there are any requirements during chapter 7 that are not being performed in the organization but has affect on the product (out sourcing for example) – you must include them in the quality manual because according to the ISO 13485 documents control requirements, you are responsible that those activities would be performed under a QMS.
Also, the quality manual must include the documentation structure in the organization.
4.2.3 Control of documents
ISO 9001- The 9001 requires that document would be approved before use, available and distributed, identified and that the method would be documented.
ISO 13485- The