QMS point case collection
Updated: July 2024, 9
At Support Administrative Scrivener Corporation, we provide consulting services related to QMS construction for new businesses, companies that are newly entering the market, and companies that already have a license to manufacture and sell medical devices.
If you have any trouble maintaining or operating your QMS, please feel free to contact us.
On this page, we will introduce a collection of case studies that serve as guidelines for preparing QMS procedure manuals.
| Article 4: | Scope of application |
| Article XNUMX | Documentation of quality control supervision system |
| Article XNUMX | Quality control supervision system standards |
| Article XNUMX | Document management |
| Article XNUMX | Control of records |
| Article XNUMX | Supervisor involvement |
| Article XNUMX | Product recipient focus |
| Article XNUMX | Quality Policy |
| Article XNUMX | Quality goal |
| Article XNUMX | Developing a plan for quality control supervision system |
| Article XNUMX | Responsibility and authority |
| Article XNUMX | Chief administrator |
| Article XNUMX | Internal information communication |
| Article XNUMX | Management supervisor review |
| Article 19 | Process input information related to management supervisor review |
| Article 20 | Process output information related to management supervisor review |
| Article 21 | Securing resources |
| Article 22 | Competence of quality workers |
| Article 23 | Competency, awareness and training |
| Article 24 | Business operation infrastructure |
| Article 25 | Work environment |
| Article 26 | Product realization plan |
| Article 27 | Clarification of product requirements |
| Article 28 | Verification of product requirements |
| Article 29 | Exchange of information, etc. with product recipients |
| Article 30 | design development plan |
| Article 31 | Process input information for design and development |
| Article 32 | Process output information from design and development |
| Article 33 | Design development review |
| Article 34 | Verification of design development |
| Article 35 | Design development validation |
| Article 36 | Manage design and development changes |
| Article 37 | Purchasing process |
| Article 38 | Purchasing information |
| Article 39 | Verification of purchased items |
| Article 40 | Verification of purchased items |
| Article 41 | Product cleanliness management |
| Article 42 | Installation work |
| Article 43 | Ancillary service operations |
| Article 44 | Special requirements for manufacturing control of sterile products |
| Article 45 | Validation of manufacturing processes, etc. |
| Article 46 | Sterilization process validation |
| Article 47 | Identify |
| Article 48 | Ensuring traceability |
| Article 49 | Ensuring traceability of products related to specified medical devices |
| Article 50 | Product condition identification |
| Article 51 | Product recipient goods, etc. |
| Article 52 | product retention |
| Article 53 | Management of equipment and equipment |
| Article 54 | Measure, analyze and improve |
| Article 55 | Product recipient opinions |
| Article 56 | Internal audit |
| Article 57 | Process monitoring and measurement |
| Article 58 | Product monitoring and measurement |
| Article 59 | Specific requirements for specific medical devices |
| Article 60 | Management of nonconforming products |
| Article 61 | Analyzing the data |
| Article 62 | improvement |
| Article 63 | Corrective action |
| Article 64 | precautionary measures |
| Article 65 | Quality control supervision system for registered manufacturing facilities |
| Article 66 | Additional requirements for quality control supervision systems |
| Article 67 | Document retention period |
| Article 68 | Records retention period |
| Article 69 | Defect report |
| Article 70 | Relationship with post-marketing safety management standards |
| Article 71 | Duties of general manufacturing and sales manager for medical devices, etc. |
| Article 72 | Domestic quality operations manager |
| Article 72-2 | Other compliance matters |
| Article 72-3 | Appointed foreign-manufactured medical device manufacturers, etc. |
