Medical device quality
A quality manual, policies, procedures and forms for an ISO 13485 quality management system, tailored to importers and distributors, warehouses, authorized representatives and local manufacturers, in Arabic, English or both.
Edition ISO 13485:2016
Package contents
Your sector and answers determine your package contents.
- Quality manual8 chapters
- Policies and procedures51 documents
- Forms and registers93 forms and registers
Sectors
Choose your organisation’s sector, then answer questions about its activities to determine the package contents.
About the ISO 13485 package
Which documents are included in the medical device package?
A quality manual, policy, procedures and forms according to the organisation’s importing and distribution, warehousing, authorised representation or local manufacturing activities.
What is the price of the medical device package?
The standalone package price is SAR 2,490, including VAT.