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ISO 9001 Quality Management System Implementation

ISO 9001 Quality Management System (QMS) Implementation

ISO 9001 Quality Management System

E & E Medicals and Consulting’s 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 QMS 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 be paper-based or electronic-based.

We shall help in developing Standard Operating Procedures (SOP) 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 Actions (CAPA)
Risk Management
Storage and Distribution
Personnel and Training

Why E & E Medicals and Consulting?

We work with small companies and startups in achieving ISO Certification in a simple, affordable, and speedy process.

Our consultants help small businesses achieve ISO 9001 quality management system (QMS) certification and provide all training tools that are necessary to sustain their certification. We walk companies through each stages of the ISO certification process. We contribute immensely in developing quality manuals, process documentation, management reviews, 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.

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