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While the ISO 9001 Standard requires to continually improving the effectiveness of the quality management system with use of elements such as Quality policy, quality objectives, performing audits, data analysis, CAPA and management reviews, his younger cousin, the ISO 13485 Standard, specifically describes how he expects the organization to perform continual improvement…
The main difference between the ISO 9001 Standard and the ISO 13485 Standard is that the ISO 13485 Standard requires that the effectiveness of the quality management system would be maintained and preserved. How?
The organization may achieve it while carrying out improvements throughout the quality management system? How? Make a change. Where? Your quality policy, quality objectives, performing audits, data analysis, CAPA and management reviews - the quality management elements created. The idea is that outputs or requirements of the above may summon a change and that change would bring the improvement. It is similar to the ISO 9001 Standard but the ISO 13485 Standard requires documentation. - The organization is required to maintain a documented procedure describing how, and with which elements and cases he shall obtain the continual improvement. Which elements of the quality management system are intended to be improved.
- As for advisory notices, the organization is required to determine and document a process of implementing any advisory notices. For example, if a new requirements for medicines is regulated in some region, organizations (which provide medicines or manufacture medicines in this region and are ISO 13485 certified) are required to maintain a documented procedure that describes the process of receiving this new requirement, implementing and executing it. The documentation must include responsible parties or functions. The job description of these certain functions (related to advisory notices) must include this responsibility.
- The organization is required to document any customer's complaint and the investigation followed. I always say, in any case you conduct the investigation, so now you are required to document it as well. Where actions, during the treatment of the customer's complaint, were taken outside the organization, information should be maintained. The records should be included under the records control procedure (the famous 4.2.4).
- When a customer's complaint was not followed by any action, the reason should be documented and approved by a suitable authority. It would be documented who is authorized to close any customer's complaint without any action.
- Where any regulatory or regional requirements, requires that a notification must be made (to the authorities) where changes were implemented within the organization – a documented procedure must be maintain describing the process of notification and the responsible. For example, if the organization changes one of the components of its product, and it is required to be approved by any authority, it is required to define and maintain a documented procedure describing the process of notification.
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