QUALITY POLICY
Medis Technologies' quality policy covers all aspects and levels of our work. Our quality goal is to design and produce products that consistently meet or exceed consumer expectations. Being customer driven, our Quality Management Systems (QMS) and state-of-the-art engineering design spearhead our production process.

Our commitment is to meet and exceed all requirements in manufacturing and supplying of our products. We will strive to improve the reliability, efficiency and effectiveness of operations and processes, through the continual improvement of our quality management system by measuring progress toward established objectives. We will work to be the very best by creating and enhancing customer value.

More Energy is ISO 9001:2000 certified.

Power Pack Quality
The Medis Power Pack product is based on new technology and its high-volume production utilizes equipment and technology designed specifically to meet the most stringent performance and quality standards.

Medis’ performance standard is zero defects. We expect all quality requirements to be met 100% of the time. All materials and components are held to well-defined specifications and quality requirements.

Managing quality effectively mandates a proactive rather than a reactive system and because of this Statistical Process Control (SPC) is a critical tool used in our production. SPC is used to assure and confirm the product quality by continuously measuring and improving assembly processes at each step of the assembly operation rather than simply the final product. It stresses the prevention of problems as opposed to detection.

From the first design stages, Medis’ high volume production line was built with product quality and traceability as the key target. Key attributes built into our high volume production line include:
• The production line was designed for full automation to remove the human element.

• All equipment used in the construction of the assembly line was from well established, qualified vendors.

• The production line was validated to a level of rigor normally reserved only for medical device products (an IQ/OQ/PQ process).

• The production team operating the line is an experienced, well established team from Celestica, with over 15 years and 100s of millions of units’ worth of world-class assembly production experience.

• The traceability and data collection used is above the requirements needed medical devices. Each Power Pack has its own serial number and full traceability for each unit is kept.

• SPC is used at every step of the assembly operation. The assembly process is controlled at every step and process parameters are measured, analyzed and recorded.

• Each assembly step is followed by at least one automated confirmation step and all data for the confirmation is recorded as well. All these data are kept in the traceability system and connected to the specify Power Pack serial number.

• Components are made using the same rigorous quality methods as our assembly. Our high volume component production is fully automated with full online quality assurance and traceability.

Below is a brief overview of the product quality assurance and control tests built into our high volume manufacturing processes:
• Incoming material:

- Each supplier under goes a rigorous qualification and
ongoing monitoring process

- All critical dimensions are checked on incoming
components prior to loading on the production line

• In-process testing:

- Full SPC, including data feedback for all process
parametric data

- 100% automated in-process quality systems
include multiple:

- Vision defect check systems
- Automated leak test processes
- Electrical tests
- Weight checks
- Dimensional tests to ensure part alignment
- Sensors to detect product integrity
- Full traceability control systems

• Final product and off-line testing include numerous:

- In-process audit check stations

- Final product performance tests

- Key environmental tests required by UL

- Chemical quality tests

• Full traceability from raw material to finished Power Pack for each component:

- Raw material down to batch, date of manufacture, &
molding cavity number

- Complete history of the Power Pack as it travels through the processes:

- Time assembly enters & leaves each station
- Process station number for steps with multiple stations
- Key parametric or test data

In addition to the quality assurance and control testing listed above, other aspects of our quality system include:
• Manufacturing in accordance with ISO 9001 and ISO 14000 standards

• A QC team consisting of:

- Support team of 11 quality engineers, 8 quality technicians and 20 quality inspectors
- Dedicated performance, environmental and chemical test laboratories on the production floor
- Dedicated quality support for each supplier including regular auditing
- Dedicated training support and regularly scheduled operator & technician training

• Full documentation control including:

- Agile document control system
- Full control of change management processes
- Electronic approval processes