QMS rearrangement example collection
Updated: July 2024, 3
As we continue to develop and develop new businesses or new businesses, we have also established a QMS system and established a QMS system that provides a license for manufacturing medical equipment.
If there are any problems in the perfect QMS operation, please let us know.
Up until now, this is a collection of guideline reform examples of QMS tools for general management.
| Article 4: | Scope of application |
| Article XNUMX | Systematic documentation of quality management |
| Article XNUMX | Quality management system standard book |
| Article XNUMX | Literature management |
| Article XNUMX | Record management |
| Article XNUMX | Management advisor |
| Article XNUMX | Importance of product receivers |
| Article XNUMX | quality policy |
| Article XNUMX | Quality index |
| Article XNUMX | Planning and establishment of quality management system |
| Article XNUMX | Responsibility and limitations |
| Article XNUMX | person in charge of management |
| Article XNUMX | Internal information |
| Article XNUMX | Management director core |
| Article 19 | Information on importing the process of management and supervisory personnel |
| Article 20 | Management supervisor personnel information related to the process export |
| Article 21 | source security |
| Article 22 | Quality personnel ability |
| Article 23 | Ability, recognition and educational cultivation |
| Article 24 | Basics of business operations |
| Article 25 | work environment |
| Article 26 | Product production accounting |
| Article 27 | Clarification of product requirements |
| Article 28 | Core requirements for goods |
| Article 29 | Exchange of information between the goods and the recipients |
| Article 30 | design development planning |
| Article 31 | Design and development process import information |
| Article 32 | Design and development process export information |
| Article 33 | Design development core |
| Article 34 | Design development test |
| Article 35 | Design opening test |
| Article 36 | Design development change management |
| Article 37 | Purchase process |
| Article 38 | Purchase information |
| Article 39 | Confirmation of purchased goods |
| Article 40 | Confirmation of purchased goods |
| Article 41 | |
| Article 42 | installation business |
| Article 43 | Additional clothing service |
| Article 44 | Special requirements for production management of sterilization products |
| Article 45 | Proof of manufacturing process etc. |
| Article 46 | Confirmation of the process of pyrolysis |
| Article 47 | Identify |
| Article 48 | Securing the possibility of being pursued |
| Article 49 | Possibility of disappearance of specific medical equipment related products |
| Article 50 | Product status identification |
| Article 51 | Goods for recipients, etc. |
| Article 52 | maintenance of goods |
| Article 53 | equipment and instrumental management |
| Article 54 | Measurement, analysis sum improvement |
| Article 55 | Product receiver's opinion |
| Article 56 | Internal cabinet |
| Article 57 | Engineering control and measurement |
| Article 58 | Product inventory and measurement |
| Article 59 | Specific requirements for specific medical equipment |
| Article 60 | Non-conforming requirements product management |
| Article 61 | Data Analysis |
| Article 62 | improvement |
| Article 63 | Amendment measures |
| Article 64 | Precaution |
| Article 65 | Quality control system for manufacturing facilities |
| Article 66 | Additional requirements for quality management system interaction |
| Article 67 | Literary storage period |
| Article 68 | Record storage period |
| Article 69 | Notice of termination |
| Article 70 | Standard system for safety management after Japanese manufacturing |
| Article 71 | Manufacture of medical equipment, etc. |
| Article 72 | Japanese Domestic Quality Management Person |
| Article 72-2 | Other compliance matters |
| Article 72-3 | Selected foreign manufacturers of medical equipment, etc. |
