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Chapter 7.5 - Production and service provision |
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Chapter 7.5 (Production and service provision) actually indicates the control required over the realization processes. This chapter places elements to allow your production and service provision to be under sufficient controlled conditions. In this chapter are the main additional requirements of the ISO 13485 Standard. Beside the "regular" quality requirements, the ISO 13485 Standard has its unique requirements. These requirements appear as expansions to the paragraphs. For example paragraph 7.5.1 has its expansions 7.5.1.1 – 7.5.1.3. These expansions are simply, additional requirements. This is the only chapter where expansions of paragraphs are presented. Either way, chapter 7.5 is complicated and places complex requirements (by the ISO 9001 Standard), and now comes his cousin, the ISO 13485 Standard and complicates matters even more. Let's review the additional requirements. Open the standard in front of you, take a deep breath and plunge… |
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ISO 13485 Standard Control of production and service provision requirements |
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At this point the ISO 13485 Standard differs himsekf from the ISO 9001 Standard. In other more realistic words, thing are getting more complicated. From chapter 7.5.1 until chapter 7.5 (includes) there are "extra" requirements that the organization must follow. this "extra" requirements are presented as sub paragraphs to the original as you may see for your self: Paragraph 7.5.1 (the ISO 9001 Standard) - Control of production and service provision Paragraph 7.5.1.1 (the ISO 13485 Standard) - Control of production and service provision – general requirements |
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ISO 13485 Standard Validation of processes for production and service provision requirements |
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The organization is required to validate all processes that are related to the medical device or other services provided, where the organization cannot measure and monitor the results of the processes or the services throughout the realization processes. It is applicable on medical devices (or services) where defects are revealed only after they are already delivered or provided. The organization is required to identify these certain processes required to be validated. The validation (of these "special" processes) shall indicate how these processes achieved the required results. While planning the validation, the organization shall describe the methods of conducting the process validation. Methods such as tests, evidences of process ability and of course the results of the validation. While planning the validation of processes, the organization shall refer to the next issues: |
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ISO 13485 Preservation of Product requirements |
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The organization is required to preserve the product and its conformity during all the time that it has responsibility over the product. The organization is required to ensure that no changes will occur during the internal processes that the products are subjected to. |
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ISO 13485 Customer property requirements |
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Be careful and do not hide anything from your customers. These are the bottom lines of paragraph 7.5.4 – customer property. When the organization makes any use of customer's property, it shall exercise it with care. Customer's property may be used for combination or corporation into the product. |
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