I will prepare qms I ems I osha documentation and audits

Pakistan

I speak English

127 orders completed

ISO 13485, MDR 2017 745, FDA Regulatory Affairs, Medical Device QMS Expert

Hi, Greetings! I am a Medical Device Regulatory and QMS expert with over 20 years of experience in regulated industries. I am an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016 and speci...

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

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