DOOOQSBeta العربية

Prepare for SFDA requirements with quality documentation tailored to your establishment.

A quality management system package to ISO 13485 and SFDA requirements, built from your establishment's data and delivered in Word, in Arabic and English.

Buy package

Choose your establishment category and buy the package, then complete your details and applicability questions to prepare your documents.

Your establishment's data becomes its documents A form with the establishment's name, activity and document code; lines run from it into a quality-manual page in the establishment's name, then to a package in Arabic and English. Establishment name Al-Shifa Medical Trading Est. Activity Import and distribution Document code IMP Al-Shifa Medical Trading Est. Quality management system — ISO 13485 IMP-QM-00 Quality Manual 1. Scope of the quality management system 2. Responsibilities and authorities Prepared · Reviewed · Approved Completed by the establishment after review دليل الجودة ١. نطاق نظام إدارة الجودة ٢. المسؤوليات والصلاحيات الإعداد · المراجعة · الاعتماد تُملأ من المنشأة بعد المراجعة Your package is ready AR · EN — 83 documents per language

What you receive

  • Quality manual and policyYour establishment's system, its scope and your team's responsibilities.
  • ProceduresPurchasing, storage, traceability, complaints and whatever your activity needs.
  • Forms and recordsReady for documenting daily work.
  • About 83 documents per language for an importer and distributor, and more for a manufacturer, a warehouse and an authorized representative.
Part of a quality-manual page for a fictitious establishment as it leaves the platform: the establishment-definition table with its data, then the nature-of-business paragraph.
From the quality manual of a fictitious establishment: its definition table, as it leaves the platform.

How it works

Choose your activity and buy the packageBrowse contents and the price, then create your account and complete your purchase.
Enter your establishment's dataAfter purchase, enter your establishment details and answer applicability questions to personalize the documents.
Download your packagePreview the documents and confirm your details, then generate and download the package: Arabic and English folders in one file.

Before you start

Can I edit the files?

Yes. You receive them in Word and edit them as you wish.

When do I pay?

Choose your activity and review its price, then buy the package before entering personalization details and answering applicability questions.

Which languages?

Arabic and English: a folder for each language in the same file.

How do I approve my documents?

You review and approve them your own way before submission; the 'Start here' guide inside the package explains the approval steps.

Does it fit my activity?

Importer and distributor, warehouse, authorized representative, and local manufacturer.