Efficia Quality | Philips Healthcare

Every Philips solution is designed, manufactured and delivered knowing that patients, their clinicians and their families are counting on quality. From material sourcing and selection through product testing and monitoring, we employ a quality-first philosophy that supports compliance with various worldwide regulations and standards for the design, manufacturing, selling and servicing of medical devices; we apply strict quality and reliability metrics, processes and methodologies across all Philips manufacturing sites; and we install to the standards of the local region we distribute solutions to.

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Philips is dedicated to leading and creating a passion, culture, and accountability for quality and quality system compliance at every level and every place.”

Frans van Houten, President and Chief Executive Officer, Royal Philips

Efficia testing metrics

Meeting standards matters for every solution, in every region. Efficia undergoes rigorous testing for compliance with standards and quality and reliability targets. For example, standards for the Efficia CM Series include:

Quality system is ISO 13485 compliant
Complies with the international standards for countries where available
Mechanical shock test, 3 shocks per direction per axis (18 total)
Mechanical vibration frequency up to 2000 Hz
Humidity up to 90% RH, non-condensing
Electromagnetic compatibility (EMC) compliant within a typical clinical environment

A proven approach to quality and reliability

Philips commitment to quality begins with product and solution design and continues throughout the entire value chain. We focus on quality end-to-end, from the sourcing of material to delivery.

Designed for quality

A multitude of quality and engineering best practices are used throughout the design process to verify, validate and continually improve solution designs, including human factors studies, risk management, and models. Quality and reliability requirements are set at the beginning, enabling the integration of methods and tools; and the installation of control and feedback loops.

Manufactured for quality

Our manufacturing process reflects the same commitment to quality as our design process. We employ industry best practices, such as Six Sigma and Lean Manufacturing, for consistency and reliability; and rigorously test products before shipment, including safety tests, functional tests and environmental stress tests that simulate real-world use. Prior to selection, significant testing is also completed on materials to ensure they are able to withstand the stress demanded during product use.

Monitored for quality

Once the product is in use, equipment malfunctions reported by customers are collected and analyzed using a robust Field Change Order process in conjunction with repair data. Quality surveillance activities include monitoring data from suppliers, manufacturing and customer experience feedback; tracking trends in service activities, field failures and installed base performance; surveying new owners; and investigating returned components and devices using our in-house failure analysis lab.

Verified for quality

Evaluation and feedback checkpoints are integrated and used at every phase of the solution life cycle. Data collection is designed into every product Philips makes using advanced logging schema, which facilitates improved diagnostics for repair and root cause identification. These quality and reliability methodologies facilitate early issue identification and help speed resolution, many times before the product is even distributed.

Quality and reliability are our priority at every step

A systematic approach to quality management

Used across all global sites, Philips’ quality management system is a process designed to help Philips products and solutions meet the high expectations of our customers and be compliant with worldwide regulatory requirements in various countries.

Irrespective of location, Philips follows this systematic closed loop process to embed quality and reliability into our products. In addition, Philips suppliers are held to the same standards and audited regularly so that they meet our stringent requirements.

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Efficia quality you can rely on