What the package contains: procedures
Procedures explain how your establishment carries out its quality system processes.
| Activity | Core documents | Procedures | Forms and records | Total |
|---|---|---|---|---|
| Importer and distributor | 8 | 15 | 60 | 83 |
| Warehouse | 10 | 28 | 75 | 113 |
| Authorized representative | 10 | 28 | 74 | 112 |
| Local manufacturer | 10 | 23 | 79 | 112 |
The counts follow the establishment's activity and its answers.
The short answer: procedures describe how your establishment carries out each process the quality management system requires and SFDA requires for your activity, from document control to receiving, storage, traceability and reporting. Every establishment has 15 shared procedures, plus its activity's own.
You receive your documents as Word files in your establishment's name, and you review and approve them your own way before submission; the 'Start here' guide inside the package explains the approval steps.
Shared procedures (15)
| Code | Procedure |
|---|---|
| P-01 | Control of documents and records |
| P-02 | Management review |
| P-03 | Competence, training and awareness |
| P-04 | Infrastructure, work environment and storage-condition monitoring |
| P-05 | Purchasing, supplier evaluation and approval |
| P-06 | Receiving, inspection, storage, handling and transport |
| P-07 | Identification, traceability and recall |
| P-08 | Feedback, complaints and incident reporting |
| P-09 | Control of nonconforming product, returns and destruction |
| P-10 | Corrective and preventive action |
| P-11 | Internal audit |
| P-12 | Process monitoring, measurement and data analysis |
| P-13 | Control of monitoring and measuring equipment |
| P-14 | Risk management |
| P-15 | Customer order review, sales and delivery |
Activity procedures
| Activity | Procedures | The activity's own |
|---|---|---|
| Importer and distributor | 15 | The shared procedures cover the activity, including P-04 and P-06, on which the transport and storage undertaking submitted to SFDA rests. |
| Warehouse | 28 | P-50 to P-62: licensing, the zone register, temperature mapping, monitoring and calibration, receipt and release, traceability and inventory, recall, destruction, shipping, third-party storage, staff, the written procedure, and the contingency plan. |
| Authorized representative | 28 | P-70 to P-82: licensing, the agreement, exclusivity, documented evidence, the manufacturer channel, SFDA requests, reporting, overseas incidents, post-market surveillance, UDI, the yearly confirmation, representation transfer, and inspection. |
| Local manufacturer | 23 | P-40 to P-48: licensing, the two managers, design and development, incoming materials, process validation, sterilization (P-45, added for factories that supply sterile devices), the batch, release, and the technical file. |
The counts follow the establishment's activity and its answers.
Why written procedures?
- Transport and storage: the establishment must hold documented procedures for transporting and storing devices per the manufacturer's instructions.
- Traceability and reporting: effective traceability procedures are provided and applied, and written procedures for following up device reports and safety alerts are documented and activated.
- Undertakings: importers and distributors undertake, with their licence application, to apply the documented transport and storage and traceability procedures.
How to read a procedure
Each procedure opens with its purpose, scope and responsibilities, then definitions where needed, then the procedure details step by step, and closes with the forms and records where the result is entered.