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ISO 13485: A Complete Guide to Quality Management in the by Itay Abuhav

By Itay Abuhav

Even though advanced and long, the method of certification for the ISO 13485 might be simply mastered utilizing the straightforward technique defined in ISO 13485: an entire advisor to caliber administration within the scientific gadget undefined. Written through an skilled specialist, this functional ebook offers an entire consultant to the ISO 13485 ordinary certification for clinical machine production. jam-packed with examples drawn from the author’s adventure and spanning varied sectors and fields of the scientific machine undefined, the publication interprets the additional usual standards and targets of the normal into possible actions and initiatives. The ebook presents a whole research of every clause and sub clause via caliber views: the results on a company, its approaches, administration, human assets, infrastructures, paintings surroundings, keep watch over and effectiveness, documentations and files. The ebook is geared up just like the typical itself — the desk of contents is the same to the ISO 13485 Standard’s desk of contents — making it consumer pleasant, favourite, and unintimidating. you should use the e-book as a consulting consultation — learn it, discover it ,extract principles — and draw at the details and data that fits you and your company, after which observe it successfully on your caliber administration method and tactics.

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ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry

Even supposing complicated and long, the method of certification for the ISO 13485 should be simply mastered utilizing the straightforward technique defined in ISO 13485: an entire consultant to caliber administration within the scientific equipment undefined. Written by way of an skilled specialist, this sensible booklet presents a whole advisor to the ISO 13485 usual certification for clinical gadget production.

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Extra info for ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry

Example text

In other words, the documentation is the statement of defense (and let us hope that we will never have to use it). But, if tomorrow morning we find ourselves in a certain situation or if any question arises, the records will be our savior. Documented Procedure A documented procedure defining the control of the records is required. The procedure will describe the methods, activities, and technologies used to implement the control of the records and the required evidence. 3 (Control of Documents).

It is necessary to define what is to be done with old versions that are not updated, how one handles them, and whether they are to be disposed of or archived. Invalid documents that are not disposed of are to be indicated or marked. The mark will ensure beyond any doubt that no one will use them. If you print out several documents and they are now invalid, you have two options: destroy them or mark each one with a stamp. If the documents are saved on the company’s server, an authority will be appointed for deleting or archiving the obsolete ones and replacing them with updated ones.

Prepare a chart or a diagram presenting the relations between the various documentations: procedures relating to work instructions, checklists, routing cards. • Plan a table or a matrix specifying the documents according to subject, issue or range of activities; realization processes, packaging activities, handling customer’s complaints. Each subject will include the documents that are relevant to it. 4). Interaction between the Processes and the Quality Management System The objectives are as follows: • To present the relations and interactions between the core business processes of the organization and its QMS processes • To help people associate themselves with the structure of the QMS This is the link to the list of processes mentioned above, explaining the relation between the different processes and activities, and the quality management processes.

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