What the package contains: core quality management system documents
These core documents define your quality system and its responsibilities.
Reviewed: October 2026
| 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: the core documents define your establishment's quality management system and its responsibilities: the quality manual, the quality policy and objectives, the management representative decision, the organization chart and job descriptions, and the document list with record retention periods. With them comes a "Start here" guide that sets out your first steps to run the system.
You receive your documents as Word files in your establishment's name, and you review and approve them your own way before you submit them — and we guide you step by step to issuing your approved edition.
What this family holds
| Document | What it does for you |
|---|---|
| Start here: first steps to run the quality system | Sets out the first running steps; each step points to a record in the package. |
| Declaration of preparation of the quality management system documents | You sign and stamp it and keep it at the front of the quality system file. |
| Quality manual | Sets your system's scope and exclusions, and points to the procedure for each requirement. |
| Quality policy and objectives | Top management's commitment and measurable objectives. |
| Decision appointing the management representative for the quality system | Names who follows the system for top management. |
| Organization chart and job descriptions | Roles and their responsibilities, including those SFDA requires for your activity. |
| Forms and records | A combined booklet of all the forms, for those who print and fill them by hand. |
| Master document list and record retention periods | Your document codes and revisions, and how long each record is kept. |
| Your two activity documents | For manufacturers, authorized representatives and warehouses: what SFDA requires of your activity, and its records. |
How many core documents do you receive?
| Activity | Core documents |
|---|---|
| Importer and distributor | 8 |
| Warehouse | 10 (8 shared and 2 for the warehouse) |
| Authorized representative | 10 (8 shared and 2 for the authorized representative) |
| Local manufacturer | 10 (8 shared and 2 for the factory) |
The counts follow the establishment's activity and its answers.
Why these documents?
- Certificate or evidence: SFDA asks for a certificate of conformity with a quality management system under SFDA.MD/GSO ISO 13485:2017, or documented evidence of applying it, depending on your activity and category.
- At inspection: the quality manual and the applicable procedures and records are sent when preparing for a factory inspection.
- Archiving: the establishment keeps its data and documents in a database that is easy to retrieve, for at least 5 years.
Where to start
- "Start here": read it first.
- The declaration: sign and stamp it, and keep it at the front of the quality system file.
- The quality manual: check its scope and exclusions against your establishment.
- The document list and retention periods: your document codes and how long to keep your records.
- The forms booklet: print the forms you fill in by hand.
Practical notes
- File names are in English because Windows limits the length of file and folder names; each file's content is in the package's language.
- Font: the documents are designed in IBM Plex Sans Arabic, a free-licence font. Install it so pages look as designed.
- Codes: every document code starts with your establishment's code.
References
| Number | Official name | Link | Last updated |
|---|---|---|---|
| MDS-REQ-009 | Requirements for Licensing of Medical Devices Establishments | https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf | 2025-01-15 |
| MDS-REQ-010 | Requirements for Inspections and Audit of Quality Management System (QMS) on Medical Devices Manufacturers and Establishments | https://www.sfda.gov.sa/sites/default/files/2026-08/MDS-REQ10E.pdf | Not stated |
Browse the package contents and published prices. The Inspection Simulator is a separate product and is not available for purchase.