Quality System Services
Engineered Datalytics delivers complete and tailored quality system documentation and training to get your customer centric quality system up and running fast. We offer complete standard operating procedures (SOPs) that cover all required aspects of ISO 9001 and ISO 13485 (21 CFR 820) compliant quality systems. We will help you tailor the SOPs to your specific company needs and culture and help you launch your quality system with on-site instructor lead training courses.
WHAT WE OFFER...
- Ready-Made and Customizable Standard Operating Procedures
- ISO 9001-2013 Quality System Development -- Customizable SOP Package
- ISO 13485-2013 | FDA 21 CFR 820 Quality System Development -- Customizable SOP Package
- ISO 14977 Risk Management Development -- Customizable SOP Package
- Instructor Led On-Site Engineering Courses (Remote Course Delivery Available)
- Instructor Led -- Developing Engineering Inputs for Success
- Learn to Write Inputs That Will Facilitate Success
- Instructor Led -- Developing Verification/Validation Strategies for Success
- Learn to Write Verification/Validation Plans That Will Facilitate Success
- Instructor Led -- ISO 9001 Design Control
- Learn How to Navigate the Requirements of ISO 9001 Based Product Development
- Instructor Led -- ISO 13485 | FDA 21 CFR 820 Design Control
- Learn How to Navigate the Requirements of ISO 13845 and 21 CFR 820 Based Product Development
Benefits of an Effective Quality System:
- Shorter Development Times
- Fewer Engineering Changes (reduced development time and costs and product sustaining time and costs)
- Reduce Product Introduction Costs (higher initial quality with less scrap)
- Higher Levels of Customer Satisfaction (deliver what the customer wanted the first time)
- Improved Communication (internal and external)
- Development of a Product Legacy to Ensure Improved Future Product Development and Product Quality
- Greater Profits and Market Share