iso 9001 quality management system

ISO 9001 Quality Management System (QMS) Implementation

E & E Medicals and consulting Quality management Experts have been developing and implementing quality systems including ISO 9001 quality management system in companies attempting their first products approved by the FDA. We help in designing Smart Quality Management Systems that streamline business demands and increase practical time usage on quality management. E & E Medicals and consulting shall implement a complete 21 CFR 820 and ISO 13485:2016 quality management system. Depending on the available resources, Implementation could Paper-based or Electronic based. We shall help in developing Standard Operating Procedures and documentation:

  • Production and Process Control
  • Management Review
  • Quality Manual
  • Design, Purchasing, Document Control
  • Device Master and Device History Records
  • Internal Audits
  • Complaint Handling
  • Corrective and Preventive Action CAPA
  • Risk Management
  • Storage and Distribution
  • Management Review
  • Personnel and Training

E &E Medicals and Consulting works with small companies and startups in achieving ISO Certification in a Simply, Affordably, and Speedy process.


Our Consultants help small businesses achieve ISO 9001 quality management system certification and provide all training tools necessary to sustain certification. Our team of dedicated consultants walks companies through each stage of the ISO certification process. We contribute immensely in developing quality manuals, process documentation, management reviews, and internal audits and training tools for our clients to be ISO 9001: 2015 certified. Understanding that ISO 9001 is the bases used as the quality management standard we insist that most small businesses implement this system so that continuous improvement within business processes and compliance can be met. The certification can be completed within an adequate amount of time in just four simple phases, namely: planning, Implementation, Review, and Certification ISO 9001 is achievable by small businesses with our expert consultants and our online training portal.

1. Achieve ISO Certification with a dedicated, expert consultant guiding you from start to finish
2. Available for multiple standards (ISO 9001, ISO 13485, ISO 14971) Our unique with a dedicated, expert consultant guiding you from start to finish
3. Online training and support options are available

To learn more about our quality management system implementation, contact us today