Question :
If “Yes”, the audit team shall always include competence for the relevant Technical Areas in Tables A.1.1 – A.1.6 and the “Auditor” requirements in Table B.2. If the answer to all questions is “No”, then the audit team shall satisfy only the “A7:Parts and Services” auditor requirements |
| Is the product a nearly finished and assembled medical device? (i.e., it is intended to be used for a medical purpose and only needs packaging and/or labeling) |
Y
N
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| Is the product intended to be a component/part of a medical device? |
Y
N
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| Is the organization contracted to carry out any activities that are regulated by a medical device regulation (e.g., relabeling, remanufacturing of other medical devices)? |
Y
N
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| Is “Design and Development” in the scope of the ISO 13485 certification? (e.g., when public law permits exclusion of design and development which is the case very often for low-risk medical devices) |
Y
N
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| Is the product (Raw Materials, Parts, Components, Subassemblies, Maintenance Services, or Other Services) intended to support associated medical devices? Note) Refer to the note in Annex A, Table A.1.7, a) as an example |
Y
N
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| Please write the name of products. |
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| Please write the technical characteristics of the product |
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Considering the process, check whether the following requirements are applied and if not, please tick the box.
6.4.2 Contamination control : Our products are excluded from this because they can be produced in a general manufacturing environment.
7.2.1 Determination of requirements related to product : We only manufacture.
7.3 Design and development : We do not perform design/development activities.
7.4.3 Verification of purchased product : We do not purchase raw materials, components, or parts.
7.5.2 Cleanliness of product : We do not manufacture sterile products or products requiring a clean environment.
7.5.3 Installation activities : We do not perform installation activities for medical devices.
7.5.4 Servicing activities : We do not provide after-sales maintenance, repairs, or other services.
7.5.5 Particular requirements for sterile medical devices : We do not perform special processes such as sterilization, welding, bonding, or heat treatment during the production process.
7.5.7 Sterilization and sterile packaging processes : We do not manufacture sterile medical devices.
7.5.10 Customer property : We do not handle assets provided by customers (design data, molds, software, devices, personal information, etc.).
7.6 Control of monitoring and measuring equipment : We do not use measuring equipment.
8.3.4 Rework : We do not perform rework activities.
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| Please indicate relevant technical and legal requirements (licensing documents). |
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| If it is an integrated management system, which management system is it integrated with? |
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| Software validation |
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| Function/User/Bio-compatibility test if applicable |
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