QMS SYSTEM

• MPS operates under one Quality Management System (QMS), focused on meeting or exceeding regulatory and customer requirements, as well as continuous improvement. Our Quality Management System supports the business objective of providing “quality products/services, on time and within budget” to our customers.
• The use of advanced engineering, manufacturing, and information technology is the engine driving us towards our quality goals. Only by a commitment from the whole company to continually improve our business and the way we serve customers, will we fulfill our strategic objectives.

MPS has detailed quality policies and procedures that define requirements and responsibilities for identification and control of quality records. Quality records are maintained to demonstrate conformance to specified requirements and the effective operation of the quality management system. Pertinent supplier records are also maintained.

MPS Medical, Inc. is committed to discovering, developing, and commercializing integrated diagnostic and screening test solutions for virus detection focused on infectious diseases.  We ensure that our products benefit patients in a manner that exemplifies the highest standards of quality at all levels of the organization.

We strive to meet the following four C's:

• Ensure that our Commitment to quality, integrity, safety, and efficiency is understood and implemented throughout the organization.
• Develop, manufacture, and deliver world-class products and services that understand and exceed our Customers' expectations.
• Improve our quality system through monitoring and Continuous improvement.
• Comply with worldwide applicable Regulatory and Quality standards

• MPS has detailed quality policies and procedures for management responsibility and authority that define requirements and responsibilities. The organization and the interrelation of personnel who manage, perform, and verify work affecting quality within each facility are defined in the quality policies and procedures. Ultimately, the President of MPS Medical is responsible for establishing, implementing, and maintaining the company-wide quality management system. The President is also responsible for appointing the Management Representative. The Management Representative reviews compliance to the MPS Medical Quality Management System at Management Review Meetings and maintains the records of the reviews.
• MPS Medical is committed to continuous improvement. MPS Medical company-wide metrics include Quality Objectives and are defined in company-wide quality policies and procedures. Regular metrics performance review meetings are held to drive process improvement efforts. Annual improvement goals are established with corresponding process improvement plans as a part of Management Review Meetings.
• A quality function has been established and is maintained under the direct supervision of QA/RA to perform the quality management system activities outlined in the MPS Medical Quality Manual and company-wide and/or facility quality procedures.

MPS will determine and provide the resources needed to implement the quality management system, maintain its effectiveness, and, where necessary, improve the quality management system. Resources include personnel, information, infrastructure, work environment and financial resources. Management throughout the organization has the authority and responsibility to determine and ensure the appropriate resources are available for inspection, testing and monitoring of the design, production, and the servicing of the product, to implement and maintain the quality management system, and to meet customer and regulatory requirements.

• MPS provides sufficient suitably designed buildings, equipment, and supporting services such as IT, PM, etc., to perform all operations necessary to meet product requirements and prevent unintended uses.
• Planning of new, and/or modification of existing infrastructure and facilities are usually conducted in conjunction with product or process changes, capacity and/or workforce expansion, and other such events. Facilities may be expanded or modified to improve the ease of maintenance, product quality, process efficiency, or the work environment.
• Maintenance of building, facilities, and equipment is performed on a routine basis. This includes regularly scheduled maintenance of production equipment, lighting systems, air conditioning and heating systems, landscaping, and cleaning. Repairs of buildings, equipment, and other facilities maintenance may be contracted to outside service providers.
• Records of maintenance activities, including inspections to assure adherence to maintenance schedules, are maintained.
• Controlled environmental requirements for manufacturing areas are suitable for the class of risk of devices being manufactured.

MPS has detailed quality policies and procedures for the control of inspection, measuring, and test equipment that delineate requirements and responsibilities. This includes customer supplied equipment. Calibration may be performed by an approved subcontractor qualified to perform equipment calibration. Where necessary to ensure valid results, measuring equipment will:

• Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification will be recorded.
• Be identified to enable the calibration status to be determined.
• Be safeguarded from adjustments that would invalidate the measurement result.
• Be protected from damage and deterioration during handling, maintenance, and storage.

• MPS Medical has detailed quality policies and procedures for control of nonconforming products that delineate requirements and responsibilities. Nonconforming products are controlled to ensure that product that does not conform to specified requirements is prevented from unintended use or sale. This control provides for the identification, documentation, evaluation, segregation, and disposition of nonconforming product. Functions affected by nonconforming products are identified and notified.
• Records of the nature of nonconformities and any subsequent actions taken will be maintained.

MPS Medical will apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods will demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action will be taken as appropriate to ensure conformity of the product.

• Inspection and testing activities are performed to verify that the specified product requirements are met. MPS Medical has detailed quality policies and procedures for inspection and testing that delineate requirements and responsibilities. Inspection and test requirements, and associated records, are specified in quality plans and quality procedures.
• Incoming product is not used or processed until inspected, tested, or otherwise verified, and it has been determined that the product meets specified requirements. Receiving inspection requirements are based, in part, on the amount of control exercised by the subcontractor and the inspection records provided. Product may not be shipped until all required inspections have been completed.
• In-process inspections are performed in accordance with established quality plans and procedures. Product is held until required inspections and tests have been performed and recorded, except when urgently needed for production and conditional release is required.
• Final inspection and testing are performed in accordance with established quality plans and procedures to verify that the finished product meets specified requirements. All inspection and testing requirements are completed, documented, and acceptable prior to authorization of release of product for shipment.
• Records of inspections and tests performed, test results, identification of person(s) performing inspections and tests, and any non-conformances detected are maintained as specified in quality procedures.

MPS Medical has detailed quality policies and procedures for planning and implementation of internal quality audits that delineate requirements and responsibilities. Internal quality audits are conducted to determine the effectiveness of the quality management system. Procedures are maintained for conducting and recording the results of audits of process and operations within the facility. In addition to internal audits, audits may be carried out by qualified personnel from outside the organization to ensure auditor independence and identification of best practices. Corrective actions are issued to the appropriate managers for any deficiencies detected during audits. Follow-up audits are conducted to verify the effectiveness of the corrective actions. Internal quality audit results, deficiencies, corrective actions, and follow-up activities are an integral part of the management review process.

• MPS has detailed quality policies and procedures for the measurement and monitoring activities required to ensure product conformity, to facilitate continuous improvement to processes and the quality management system, and to assure continued effectiveness of the quality management system.
• Sampling plans must utilize appropriate statistical methodologies. When changes occur to products or processes, sampling plans will be reviewed.
• Measurement and monitoring activities to ensure and verify product conformity are defined in engineering specifications and drawings, work instructions, inspection and testing procedures, and process control procedures.
• MPS Medical will include review of monitoring, measurement, and analysis data of Quality Indicators; Non-Conformance, Returned Goods Authorization, Customer complaints; Internal/External audit observations, Corrective and Preventive actions; Calibration Out of Tolerance and will perform a risk analysis to identify the risk and take action to mitigate the issue.

• MPS Medical deploys a continual improvement philosophy throughout the organization, and the efforts are focused on the goals in the quality objectives and quality policy. Improvement opportunities are identified by analyzing quality performance data and information. Improvement projects are defined and implemented through the system of corrective and preventive action and management review.
• Corrective and preventive actions taken are recorded and followed to ensure they have been properly implemented and are effective.
• If a customer complaint is not followed by corrective and/or preventive action, the reason will be authorized and recorded.