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Sample Pages - Quality Coach

Sample Pages - Quality Coach

What can you do to 3.5

What can you do to 3.5 prepare for the audit Make a list of all controlled documents that can be found in your work area, including those that may only be passing through. These can be procedures, work instructions, drawings, bills of materials, parts lists, work orders (travelers), etc. Now that you know what the requirements are and how auditors work, you can prepare for the audit. This is your personal list that applies only to you and your immediate work area. Managers responsible for preparing the whole company for the audit will be doing much more. Know the company’s quality policy ❑ The standard requires that the quality policy be understood by everyone in the company. If it is long, you do not need to learn it by heart. But you should be able to explain what it says and how you understand it. It is helpful to have the policy posted in conspicuous locations throughout the company. Check your documents and records Make a list of all records that can be found in your work area, including those that may only be passing through. These can be travelers, as-build marked-up drawings, inspection and testing reports and certificates, nonconforming product reports, workmanship standards, calibration certificates, etc. ❑ If you are on a distribution list for any document, make sure that you have this document and can quickly locate it, and that you have ONLY the latest revision. ❑ If you normally have any procedures, specifications, drawings, etc. in your files, review those files to make sure you have a complete set and that everything is the latest revision. Remove superceded and/or obsolete documents from your files. ❑ Check that your documents do not have unauthorized changes. ❑ Look at the machines, work stations, walls, etc. and make sure that there are no unauthorized work instructions posted. ❑ If you establish or file records, check that all your records are in order, are properly indexed, and are easy to find. Sample pages from “ISO 13485 In Our Company” by Jack Kanholm Learn More and Buy this ISO 13485 Self-Study Course at: http://www.qualitycoach.net/shop/shopexd.asp?id=1964 23

❑ Organize and index your files, and label your folders and filing cabinets. ❑ Whether or not you normally deal with documents, look around you and pick up all documents you can find on workbenches, desks, tops of cabinets, floors, etc. Examine each such document, and place it where it belongs or throw it away. Read again this section together with Section 3.3, 3.4 and 3.5 and write down a list of things YOU need to do to prepare for the registration audit. Clean up your work area ❑ If your job is processing paperwork, this is a good time to throw away anything that you do not need and to organize what is left. When auditors come into your office, you should be able to explain the purpose and status of every document that is out. ❑ Get scrap and trash out of your work area. Do not accumulate broken equipment, tooling, half-used supplies and other such “maybe-we-could-use-it-someday” items in your work area. Designate a special storage for those items — if you want to keep them at all. Prepare to answer questions ❑ Be prepared to answer questions. Not everyone will be asked, but do not take chances. The questions may be about the quality policy, quality system, or your specific work and responsibilities. ❑ Answer truthfully but do not elaborate. If it is possible to answer yes or no, do just that and stop. Answer only to the point of the question. Do not volunteer any information that is not directly requested. While being brief, try nonetheless to convey the impression of being forthcoming and cooperative. 24 Sample pages from “ISO 13485 In Our Company” by Jack Kanholm Learn More and Buy this ISO 13485 Self-Study Course at: http://www.qualitycoach.net/shop/shopexd.asp?id=1964

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