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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. By the way, if you are really interested in the ISO 13485 Standard, check the next web site - www.13485quality.com. So let's start...
| ISO 9001 | ISO 13485
| Comment | 4.2.1 General
| | | 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.
| 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.
| 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
| | | 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.
| During the exclusion chapter -the 13485 requires also to mention the activities that are not applicable during the product realization.
| If 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. Please review this site: QualityManualTemplates.com - it provides solutions for Quality manuals and documents control requirements - it might help you. Who knows?!? | 4.2.3 Control of documents
| | | | The 9001 requires that document would be approved before use, available and distributed, identified and that the method would be documented. Here is an article specifying the ISO 9001 Documents control requirements. | The 13485 requires that documents must be review and approved before use. And to document it.
Another requirement is that document would bear a validation period defined to every type of document under the QMS. In any case the period would be not less than two years from the date of product or other period if required by any regulations.
| This requirement ensures that every change in any document would be reviewed under an authorized function in the organization.
Validation time is required to last as long as the medical device. That way, if, at any time in the future, you would have to make some interrogation about the product – you would have its documents at hand. In any case, the validation time won't be less than what is required within the regulatory requirements concerning the medical device. | 4.2.4 Control of records
| | | | The organization must maintain records in order to prove his conformity to the standard's requirements. The standard requires that the records would remain legible, identified and retrievable. The 9001 requires, also maintaining a procedure that describe the documents under the QMS and how one must handle them. Here is an article specifying the ISO 9001 Records control requirements. | The 13485 requires that the records would be retrievable for at least the life time of the medical device and in any case not less than two years from the date of product or other period if required by any regulations.
| The reason for this requirement is as mentioned above. If, in any case, you would have to trace back any information about the medical device, you would have all the documents that are relevant to the realization process. This is a medical device. People's life could be dependent on this device! You must have all the information about this device for any case. |
SUMMERY - You are required to include any regional regulations within your documents control process - you must maintain all documents required by these regulations and refer to them within the documents control procedure
- If there are any processes that are not realize within the organization but has affect on the product – you must include these processes in the Quality management system scope
- You must maintain review and approval of any of your documents within the documents control process
- Any document within the quality management system must have a validation period
- Any document related to the realization process must be retrievable for at least the life time of the product or as specified by any regulation
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