I will prepare qms I ems I osha documentation and audits
ISO 13485, MDR 2017 745, FDA Regulatory Affairs, Medical Device QMS Expert
Level 2
Has met high performance criteria and has a proven track record for meeting client expectations.
About this Gig
I bring over 25 years of extensive experience in documentation, implementation, auditing, training, and providing support for certifications across a range of compliance standards. These include ISO 9001, ISO 13485, ISO 14001, ISO 45001, US FDA regulations, and cGMP (21 CFR 820).
My services include:
- Outlining the required documentation and a comprehensive list of documents.
- Preparing complete documentation as per the requirements of the relevant standard.
- Development of QMS manuals.
- Drafting procedures and SOPs.
- Defining the scope of the Quality Management System.
- Formulating quality policies and objectives.
- Providing training materials.
- Designing flowcharts for process understanding.
- Conducting risk assessments.
- Preparing forms, formats, and checklists.
- Offering customizable templates.
- Conducting gap assessments.
- Performing internal and external audits.
- Certification assistance and remote audits.
- Supplier audits.
- Preparing QMS requirement overviews.
- Providing training and awareness resources.
Each service is tailored to ensure compliance with relevant standards and to support seamless implementation.
Document type:
User & training manuals
•
Documentation
Industry:
Manufacturing
Language:
English
•
Urdu
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
My Portfolio
FAQ
Do you offer comprehensive solutions for ISO standards documentation and compliance?
Yes, you are at right place and i can provide you complete solutions.

