QM docs was founded to mainly serve companies and Quality Management representatives in their aim to establish a complete and well structured Quality System based on documents for the Drug Product, Medical Device, Drug Substance as well as ISO related business activities.
The development, manufacture and life cycle management of Drug Products, Medical Devices, Drug Substances as well as any other business which is ISO 9000 related is in the scope of our documents. Drug Products and Drug Substances in particular are highly regulated by health authorities such as the FDA or EMA requiring robust and well defined quality systems.
Our document templates and forms will help all companies as well as established businesses to reach this goal with a minimum of effort and resources. Our templates have been developed by a group of international professionals and consultants working in the health and pharmaceutical industry in related consulting functions. We are constantly monitoring the requirements and expectations of the health agencies to deliver state of the art (cGMP) quality system documents.
Please don’t hesitate to contact us if you would like to become a member of our network group and wish to contribute in the establishment of these kinds of quality services and documents.
Compliance Checklist CFR 820
Medical Device Design And Development Plan
Design History File (DHF) SOP
Medical Device Design Control SOP
Standard Operating Procedure Template - SOP Template
Medical Device Human Factor SOP
Medical Device Design Inputs
CAPA Management SOP
Vendor, Supplier and Contractor Audit
Design Transfer SOP
Medical Device Design Outputs
Complaint Handling - Customer Complaints SOP
Training Program SOP
Product Recall Management
Supplier Approval, Qualification and Certification SOP
Deviations and Non-Conformances SOP
Risk Management Process
Medical Device Design Changes SOP
Development Project Initialization And Design Review
Medical Device Design Validation SOP
Medical Device Design Verification SOP
Internal Audit SOP
Quality Product Review / Annual Product Review
Change Control SOP
Clinical Evaluation Medical Devices Development
Management Review for Medical Devices
Hazard Analysis SOP
FMEA Failure Mode And Effect Analysis
CFR 4 Medical Device - Combination Product SOP