Revision Date Author Description of change Jun13 Mark Benton Removed Admin. Manager from approval

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2 Page 2 of 15 Document Revision History Revision Date Author Description of change 10 07Jun13 Mark Benton Removed Admin. Manager from approval 12Feb13 Mark Benton 08 01Oct12 Mark Benton 07 8/30/2012 Refer to CO Updated approval block and org chart to add the President position. Added Finance Director to the approval block. Adjusted page breaks due to the new org. chart Partially recreated from the pdf version, updated to the new document template, corrected typos and grammatical errors, and removed exclusionary statements from the body of the document because it is redundant with the scope. Changed to the new document numbering system. Updated to reflect company logo change, updated Signature page, updated Organizational Chart. 06 4/17/2012 Refer to CO Updated to reflect company name change 05 9/6/2011 Refer to CO Updated to ISO 13485:2003 requirements 04 8/1/2010 Refer to CO Updated to ISO 9001:2008 requirements 03 12/15/20 Refer to CO 02 8/1/2003 Refer to CO Updated all references to ISO 9000:2000 to reflect ISO 9001:2008, Released to ISO 9001:2008 Added Scope and exclusions to 7.3 Design & development, Changed continuous to continual in policy. Change Customer Satisfaction to Monitoring and Measurement in table of contents, Added Appendix C procedure matrix 01 3/7/2003 Refer to CO Released to ISO 9001:2000 Reference Documents BSI British Standards BS EN ISO 9001:2008 BSI Americas, BSI Management Systems America Inc., 16/10/20 15:05 BSI British Standards BS EN ISO 13485:2003 BSI Americas, BSI Management Systems America Inc., 15/10/20 14:53

3 Page 3 of Scope 1.1 Polymer Technology has adopted the Quality Management System described within this Quality Systems Manual to manufacture precision injection molded plastic products. 1.2 Polymer Technology will use the ISO13485:2003 Quality Management System only on product which is considered Medical Products. 1.3 Since Polymer Technology is a manufacturer of precision injection molded plastic products and does not perform any Design and Development, Installation or Servicing Activities, Sterilization or produce any Active Implantable or Implantable Medical Device the following sections have been excluded from the Polymer Technology Quality Management System: Design and Development (ISO 9001:2008, ISO 13485:2003) Production and Service provision subsection Installation activities. (ISO 13485:2003) Production and Service provision subsection Servicing activities. (ISO 13485:2003) Production and Service provision subsections and Particular requirements for sterile medical devices. (ISO 13485:2003) Production and Service provision subsection Particular requirements for active implantable medical devices and implantable medical devices. (ISO 13485:2003) Monitoring and measurement sub section Particular requirement for active implantable medical devices and implantable medical devices. (ISO 13485:2003) 2.0 Polymer Technology Quality Policy 2.1 Polymer Technology, using the ISO 9001:2008 & ISO 13485:2003 Quality Management Systems, is dedicated to providing our customers with the finest service for the accelerated development, engineering, and manufacturing of plastic injection molded product. We will provide this service through continual improvement and innovation. 2.2 With our Zero Defect, Zero Return philosophy, we will strive to exceed our customer s expectations. 2.3 The entire staff at Polymer Technology will collaborate to form a team to assure the preservation and development of our customer relationships.

4 Page 4 of Polymer Technology Quality Management System Process Flow 4.0 Quality Management System 4.1 General Requirements Polymer Technology will establish, implement, maintain, and document a Quality Management System as a means to ensure its products and services conform to the requirements of ISO 9001:2008 and ISO 13485:2003. Polymer Technology will continually strive to improve the effectiveness of its Quality Management System Polymer Technology, in accordance to ISO 9001:2008 and ISO 13485:2003, will: Determine processes, which require the application of the Quality Management System throughout Polymer Technology Determine the required steps and interactions of these processes Select criteria and methods of operation and control of these processes to demonstrate their effectiveness Supply the resources and information needed for the operation and monitoring of these processes Monitor and measure where applicable; and analyze data collected from these processes Perform actions necessary to achieve the desired results and incorporate methods for the continual improvement of these processes Polymer Technology will ensure control over outsourced processes and will be responsible for conformity to customer requirements.

5 Page 5 of Documentation Requirements General Requirements Polymer Technology shall document its Quality Policy, its Quality Objectives, and maintain a Quality Manual. In addition, documented procedures and records required by ISO 9001:2008 & ISO 13485:2003 and documentation specified by national of regional regulations shall be organized and controlled to ensure the effective planning, operation, and control of the Polymer Technology Quality Management System For medical device customers a file will be maintained containing documents defining product specifications, quality management system requirements, and define the manufacturing process for each medical device product The Quality Manual The Quality Manual has been established and shall continue to be maintained in order to provide: The scope of Polymer Technology s quality management system Documented procedures referencing the quality management system. These documents are listed in the Procedure Matrix in appendix C of this manual Procedures referenced in the quality manual will reference forms and quality records used in the Polymer Technology s Quality Management System A description of the interaction between the processes, which make up the Polymer Technology s Quality Management System Control of Documents Quality Management System documents will be controlled. A procedure will document the controls: To review and approve documents for adequacy prior to use To review and update as necessary to re-approve documents To ensure the changes and the current revision status of documents are identified To ensure that relevant versions of applicable documents are available at points of use To ensure that documents remain legible and identifiable To ensure that documents of external origin, determined to be necessary, are identified and their distribution controlled To prevent the unintended use of obsolete documents, and to identify them if they are retained for knowledge preservation purposes For medical customers at least one copy of an obsolete document will be retained for the life of the product but not less than two years from the date of product release at a minimum All quality related documentation, as required by contract, shall be made available to the customer for review and evaluation upon request.

6 Page 6 of Control of Records 5.0 Management Commitment 5.1 General Requirements Quality records pertain to all records prepared for, or required, by the quality management system that provides evidence of conformity to requirements and the effective operation of the quality management system will be controlled All quality records shall be legible, readily identifiable and retrievable. Within the Quality Management System Procedure identification and the methods of storage, protection, retrieval, retention time and disposal of quality records shall be documented For medical customers documents will be retained for the life of the product but not less than two years from the date of product release at a minimum Polymer Technology Management is committed to the development, implementation, and continuous improvement of an effective Quality Management System by the following sections. 5.2 Communicating the importance of customer requirements as well as statutory and regulatory requirements to the organization Polymer Technology Management ensures that customer requirements are determined and achieved. Polymer Technology is committed to the preservation and development of customer relations. 5.3 Establishing a Quality Policy The Polymer Technology Quality Policy will be appropriate to the organization and will communicate to the organization the commitment to the requirements and continual improvement of the quality management system, provide and review quality objectives, and be reviewed for suitability. 5.4 Establishing and maintaining Quality Objectives Quality Objectives Polymer Technology Management will ensure that measurable quality objectives, including product realization requirements, will be consistent with the quality policy established at relevant functions and levels Quality Management System Planning Polymer Technology Management will plan and meet the requirements of the Quality Management System and the stated quality objectives. When changes to the Quality Management System are planned and implemented, the integrity of the Quality Management System will not be compromised. 5.5 Responsibility, Authority, Communication Responsibility and Authority Top Management will ensure that the responsibilities and authorities are defined and communicated within the organization.

7 Page 7 of Organization Chart Management Representative Polymer Technology has a Quality Systems Manager, who is appointed as the management representative. The Quality Systems Manager will have the authority and responsibility for ensuring that the processes of the Quality Management System are established, implemented, maintained, and improved. The Quality Systems Manager will update the management as to the performance of and the improvements made to the Quality System The Quality Systems Manager will promote the awareness of customer specific requirements throughout the organization The Quality Systems Manager may work with external groups on matters of the Polymer Technology quality system The Operations Manager will act as the Deputy Management Representative to BSI in the absence of the Quality Manager.

8 Page 8 of Internal Communications Polymer Technology Management ensures that appropriate communications are established. These communications take place during the daily production meetings and MRB meetings. 5.6 Conducting Management Reviews General Requirements Polymer Technology management will, at a minimum, annually review its quality management system. This review will evaluate the stability, adequacy and effectiveness of the entire Quality Management System and will look for opportunities for improvement and needs for change of the Quality Management System including changes to the Quality Policy and Quality Objectives Inputs to the Management Review will include: Results of audits Customer Feedback Process performance and product conformity Status of preventive and corrective actions Follow up actions from previous management reviews Changes that could affect the Quality Management System Recommendations for improvement New or revised regulatory requirements Output of the Management review will include decision and actions to: Improvements to maintain the effectiveness the Quality Management System and its processes Improvements to product related customer requirements Resource needs 5.7 Ensuring the availability of resources 6.0 Resource Management 6.1 Provisions of Resources During Management Reviews and or Product Realization meetings, Polymer Technology will review and provide the resources needed to implement, maintain and improve the Quality Management System and will review and provide the resources required to meet regulatory and customer requirements and to increase customer satisfaction. 6.2 Human Resources General Requirements Polymer Technology will maintain competent personnel, based on education, training, skills and experience, performing work affecting the product requirements produced Competence, Training and Awareness Polymer Technology will ensure that personnel are aware of the relevance and importance of the processes they perform and how their activities affect the outcome of the product requirements.

9 Page 9 of Infrastructure Polymer Technology will determine the required competency of personnel performing work that affects product quality and, if necessary, will provide and evaluate the effectiveness of the training Records of education, training, skills, and experience will be maintained If required by National or regional regulations, procedures for identifying training needs will be documented Polymer Technology will determine and provide the necessary building, workspace, utilities, process equipment, and support services needed to produce product that conforms to customer specifications Preventive Maintenance activities including their frequency will be documented. 6.4 Work Environment 7.0 Product realization Polymer Technology will determine and manage the work environment necessary to provide product that meets customer requirements Polymer Technology will document requirements for health, cleanliness and personnel, if contact between the personnel and the product or work environment could adversely affect the quality of the product If the work environment conditions have an adverse effect on the quality of the product Polymer Technology will document required conditions, and monitor and control these conditions Polymer Technology will ensure that all personnel temporarily working in special environmental conditions are trained or supervised by a trained person If appropriate, arrangements will be documented for the control of contaminated or potentially contaminated product, to prevent contamination of other product, the work environment or personnel. 7.1 Planning of Product Realization Polymer Technology will develop and plan the processes needed for product realization as defined by the quality management system requirements The planning of product realization will determine and document, with the control plan and traveler, the following: Quality objective and requirement for the product The processes, documents, and resources specific to the product The verification, validation, monitoring, measurement, inspection and test, and product appearance specifications required to meet customer requirements Records needed to provide evidence that the realization process and product meets requirements For medical device product, Polymer Technology will conduct Risk Management procedures throughout Product Realization. Records of Risk Management will be maintained Input from the customer s design and development may be used by Polymer Technology during Product Realization 7.2 Customer-Related Processes Determination of requirements related to the product.

10 Page 10 of Polymer Technology will determine: Requirements specified by the customer including delivery and post delivery activities Requirements not stated by the customer but necessary for the realization of the product, where known Statutory and regulatory requirements applicable to the product Any additional requirements considered necessary by Polymer Technology Review of requirements related to the product Polymer Technology will review and document the requirements related to a product prior to accepting a customer order or contract. The review will verify that product requirements are defined, changes to previous contract or order changes are resolved, and that Polymer Technology had the resources to fulfill its obligation to the customer order or contract Records of the review and any issues arising from the review will be maintained Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by Polymer Technology before accepting the customer order or contract When changes have been made to product specification, all relevant documentation will be changed and personnel will be made aware of the changes Customer Communication Polymer Technology will determine and implement effective communications for the transfer of information regarding product information, enquires, contracts and order processing including amendments, customer feedback including customer complaints and advisory notices with its customers. 7.3 Design and Development Excluded 7.4 Purchasing Information General Requirements Polymer Technology will maintain documented procedures to ensure that product being purchased will conform to specific purchase requirements. The type and amount of control applied to the supplier and the product will depend on the effect of the product on the subsequent product realization or final product Criteria for selection, evaluating, and re-evaluating suppliers will be established and records of the evaluations and any necessary actions will be maintained. Polymer Technology will select suppliers based on the supplier s ability to provide product in accordance with Polymer Technology s requirements Purchasing Information Purchasing information will include a description of the product and when appropriate: Requirements for the approval of product, procedures, processes or equipment Requirements for qualification of personnel Requirements for the supplier s quality system

11 Page 11 of Polymer Technology will verify the adequacy of the purchasing requirements prior to selection of a supplier For medical device product, Polymer Technology will maintain relevant purchasing documents for traceability per Section Traceability of ISO 13485: Verification of Purchased Product Polymer Technology will establish activities and/or inspections to ensure that purchased product meets purchasing requirements. If Polymer Technology or its customer intends to perform the verification of purchased product at the supplier s premises; the verification logistics and methods will be stated in the purchasing information Records of the verification will be maintained. 7.5 Production and Service Provision Control of production and service provisions Polymer Technology will plan and perform production and services under controlled conditions. Controlled conditions where applicable will include: The information that describes the characteristics of the product Work instructions, Documented Procedures and Requirements as necessary For medical device product, Polymer Technology will maintain a batch file for each batch of medical product. The batch file will provide traceability and identify the amount of manufactured and amount of product approved for distribution. The batch file will be verified and approved Reference Materials and measurement procedures as necessary Suitable equipment The use and implementation of monitoring and measuring equipment for monitoring and measurement of product The implementation of product release, delivery and post delivery activities Control of production and serviced provision-specific requirements Polymer Technology will document procedures for cleanliness of the product if: The product is cleaned by Polymer Technology prior to sterilization and/or its use The product is supplied non-sterile to be subject to a cleaning process prior to sterilization and/or its use Product is supplied to be used non-sterile and its cleanliness is of significance in use Process agents are to be removed from product during manufacture Validations of processes for production and service provisions

12 Page 12 of Polymer Technology will validate any processes for production where the product cannot be verified by monitoring or measurement and, as a consequence, a defect results only after the product is in use Polymer Technology will setup validation processes which include, where applicable, the definition of criteria for the review and approval of processes, the approval of equipment and qualification of personnel, the use of specific methods and procedures, and the required record keeping and revalidation Identification and Traceability Identification Polymer Technology will identify product with a unique control number throughout the product realization process. The status of the product will be identified with respect to monitoring and measurement requirements Traceability Polymer Technology will have documented procedures for traceability of product produced. Where required a unique number will be used to identify product Status Identification Customer Property Polymer Technology will identify product status throughout production and storage of the product. Only product that has passed required inspections will be used or shipped Polymer Technology will identify, verify, protect and safeguard all customer property provided for use or incorporated into the product. Polymer Technology will respect and maintain professionalism in caring for customer property while in Polymer Technology s control. If any customer s property is lost, damaged, or found to be unsuitable for use, the customer will be notified and records of the status of the property will be maintained Preservation of Product Polymer Technology will identify, handle, package, store, protect and maintain the integrity of all product and constituent product from the time materials enter into the facility, through the internal processing, and to the delivery of the product to the desired destination. Documented procedures will be followed for product with limited shelf life or special storage conditions. 7.6 Control of Monitoring and Measuring Equipment Polymer Technology will determine the monitoring and measurement needed to be performed on product, and determine and establish the devices and methods to provide evidence of product conformity to the product requirements Measuring equipment will: Be calibrated at specified intervals, prior to use, or both, against standards traceable to the National Institute of Standards and Technology (NIST). Where no such standard exist, the basis used for calibration or verification will be recorded Be adjusted or re-adjusted as necessary Be identified as to the calibration status Be safeguarded from adjustment that would invalidate the measurement result

13 Page 13 of Be protected from damage and deterioration during handling, maintenance, and storage Polymer Technology will assess and record the validity of previous measurement results when equipment used in measurements are found to be in nonconformance. Polymer Technology will take appropriate action on the equipment and any product affected Records of the results of calibrations and verifications will be maintained When computer software is used in the monitoring and measurement of specific requirements, the software will be confirmed prior to initial use and will be reconfirmed as necessary. 8.0 Measurement, Analysis and Improvement 8.1 General Description To demonstrate conformity to product requirements, ensure conformity of the Quality Management System, and to maintain and continually improve the effectiveness of the Quality Management System, Polymer Technology will implement the monitoring, analysis, and improvement process required Monitoring and Measurement Customer Satisfaction (ISO 9001:2008) & Feedback (ISO 13485:2003) ISO 9001:2008: Polymer Technology will monitor information relating to customer satisfaction as a means to determine whether customer requirements have been met. Customer Satisfaction will be used as a measure of the Quality Management Systems performance ISO 13485:2003: Polymer Technology will document procedures for a feedback system to provide early warning of quality problems and will use this data in the corrective and preventive action processes. As one of the measurements of performance of the Polymer Technology Quality Management System, Polymer Technology will monitor whether customer requirements have been met Internal Audit To ensure the effective implementation and effectiveness of the Quality Management System and its conformance to ISO 9001:2008 and additional requirements set forth in the planning of product realization section 7.1, Polymer Technology, will at planned intervals, conduct internal audits of its Quality Management System The Audit program will take into consideration the previous audit results, and the importance of the processes and areas to be audited. Audit criteria, scope, frequency, and methods will be defined. Auditors shall be objective and impartial of the audit process and will not audit their own work Responsibilities and requirements for planning and conducting audits, and records for reporting results of the audit will be documented Actions are to be taken on any non-conformances and their cause discovered during an audit without undue delay. Action will be taken by the management responsible for the area of the nonconformance. Follow up to the nonconformance discovered will include verifications of the actions and the results of the actions Monitoring and Measurement of the Processes Polymer Technology will monitor and, where applicable, measure the quality management system processes. The methods used will show the ability of the

14 Page 14 of 15 Quality Management System to achieve planned results. If planned results are not achieved, correction and corrective action will be taken as appropriate Monitoring and Measurement of the Product Polymer Technology will monitor and measure characteristics of the product produced to ensure product requirements. The monitoring and measurement will be carried out in accordance to the Control Plan. Records, with the person authorizing the release of product, showing that the product conforms to the Control Plan will be maintained Product will not be released to the customer until all requirements of the quality plan have been completed unless approved by a relevant authority and where applicable by the customer Particular requirements for active implantable and implantable medical devices Excluded 8.3 Control of Nonconforming Product Polymer Technology will maintain a documented procedure to ensure that product which does not meet product requirements is identified and controlled to prevent the unintended use or delivery. The procedure will define the controls and responsibilities and authorities for disposition of the nonconforming product Where applicable, actions taken to correct the nonconforming product will include one or more of the following: Elimination or correction of the detected nonconformity Authorizing its use, release or acceptance under concession by an authority and where applicable by the customer. If the product is accepted by concession, all regulatory requirements must be met and records of the person authorizing concession will be maintained Precluding its original intended use or application When a nonconforming product is corrected, the product will be re-verified to show the product s conformance to its requirements. If the product is reworked, the rework process will be documented in the rework work instruction. The rework work instruction must be authorized and approved. Prior to authorization and approval any adverse effect of the rework must be documented When Nonconforming Material is detected after delivery or use, Polymer Technology will take action to the effects or potential effects of the nonconformity Records of the nonconformity will include the nature of the nonconformity, any concessions obtained, and actions taken to resolve the nonconformity. 8.4 Analysis of Data Polymer Technology will determine, collect, and analyze data to show the effectiveness, stability and the continuous improvement of the Quality Management System. Data to be analyzed will include: Customer Satisfaction, Feedback, Product Conformity to Requirements, Trends of Processes and Product including opportunities for preventive actions, and Supplier Performance. 8.5 Improvement Continual Improvement / General Polymer Technology will strive to continually improve and maintain stability of the effectiveness of its Quality Management System by using quality policies,

15 Page 15 of 15 quality objectives, audit results, analysis of data, corrective and preventative actions, and management reviews Polymer Technology will have documented procedures for the issue and implementation of advisory notices Records of all customer complaints investigations will be maintained. If the complaint is determined to be due to activities of an outside source, information will be exchanged between the organizations. If a complaint is not followed by a corrective and or preventative action the reason will be authorized and documented Corrective Actions Polymer Technology will be decisive in eliminating the cause of nonconformances A documented procedure will: Preventive Action Review nonconformities including customer complaints Determine causes of nonconformities Evaluate actions needed to eliminate the reoccurrences of nonconformities Determine and implement actions need Record the results of the actions taken Review the effectiveness of the corrective action taken Polymer Technology will eliminate the cause of potential nonconformities with the use of appropriate preventive actions Documented procedures will be established to define: The determination and causes of potential nonconformities Evaluating the need for action Determining and implementing actions needed Recording results of actions taken Review the effectiveness of the preventive actions taken