Transcription

1

2

3

4

5

6 ZOLL Document Number: 90E0021 Page 6 of 50 QUALITY SYSTEM MANUAL

7 ZOLL Document Number: 90E0021 Page 7 of 50 1 EXECUTIVE MANAGEMENT APPROVAL INTRODUCTION QUALITY SYSTEM QUALITY SYSTEM STRUCTURE ISO 13485:2012 PROCESS INTERACTION OVERVIEW NON-APPLICABILITY OF CERTAIN ISO 13485:2012 CLAUSES QUALITY PLAN CONSEQUENCES OF NON-COMPLIANCE WITH RDC 16/ MANAGEMENT RESPONSIBILITY QUALITY POLICY ORGANIZATION RESOURCES MANAGEMENT REPRESENTATIVE MANAGEMENT REVIEW RISK MANAGEMENT QUALITY AUDITS AUDIT RECORDS PERSONNEL GENERAL ORIENTATION AND TRAINING CONTRACT REVIEW DESIGN CONTROLS GENERAL DESIGN AND DEVELOPMENT PLANNING DESIGN INPUT DESIGN VERIFICATION DESIGN REVIEW DESIGN OUTPUT DESIGN VALIDATION DESIGN TRANSFER DESIGN RELEASE DESIGN CHANGES DESIGN HISTORY FILE DOCUMENT AND RECORD CONTROLS DOCUMENT APPROVAL AND ISSUE DOCUMENT DISTRIBUTION DOCUMENT CHANGES DOCUMENTATION CHANGE RECORDS PURCHASING CONTROLS EVALUATION OF SUPPLIERS PURCHASING DATA VERIFICATION AT SUPPLIER S PREMISES IDENTIFICATION AND TRACEABILITY... 26

8 ZOLL Document Number: 90E0021 Page 8 of COMPONENTS AND DEVICES TRACEABILITY MEDICAL DEVICE TRACKING PRODUCTION AND PROCESS CONTROLS GENERAL ENVIRONMENTAL CONTROL CLEANING AND SANITATION PERSONNEL HEALTH AND CLEANLINESS CONTAMINATION CONTROL SEWAGE AND REFUSE DISPOSAL EQUIPMENT AUTOMATED PROCESSES SPECIAL PROCESSES INSPECTION AND TESTING GENERAL INCOMING INSPECTION AND TESTING IN-PROCESS INSPECTION AND TESTING FINAL INSPECTION AND TESTING INSPECTION AND TEST RECORDS INSPECTION, MEASURING, AND TEST EQUIPMENT CALIBRATION CALIBRATION STANDARDS CALIBRATION RECORDS MAINTENANCE SAFEGUARDED FROM ADJUSTMENT INSPECTION AND TEST STATUS NONCONFORMING COMPONENTS AND DEVICES CONTROL OF NONCONFORMING COMPONENTS AND DEVICES NONCONFORMITY REVIEW AND DISPOSITION CORRECTIVE AND PREVENTIVE ACTION CORRECTIVE AND PREVENTIVE ACTION COMPLAINT FILES HANDLING, STORAGE, DISTRIBUTION & INSTALLATION HANDLING STORAGE DISTRIBUTION INSTALLATION PACKAGING AND LABELING DEVICE PACKAGING PACKAGE LABELING PRODUCT LABELING RECORDS GENERAL REQUIREMENTS DEVICE MASTER RECORD (DMR) DEVICE HISTORY RECORD (DHR) TECHNICAL FILE QUALITY SYSTEM RECORD... 39

9 ZOLL Document Number: 90E0021 Page 9 of SERVICING GENERAL REQUIREMENTS SERVICE RECORDS SERVICE RECORD EVALUATION STATISTICAL TECHNIQUES CUSTOMER PROPERTY APPENDIX 1: SUPPORTING SOP INDEX APPENDIX 2: QUALITY SYSTEM COMPLIANCE MATRIX... 47

10 ZOLL Document Number: 90E0021 Page 10 of 50 1 EXECUTIVE MANAGEMENT APPROVAL The executive management of ZOLL Manufacturing Corporation (ZOLL) fully endorses and supports the Quality Policy and quality system elements within this manual. The executive management is committed to promoting an environment where quality will not be compromised and a culture where each employee assumes responsibility for the quality of his or her own work. Executive Management approval signatures appear on the cover page of this document.

11 ZOLL Document Number: 90E0021 Page 11 of 50 2 INTRODUCTION This manual describes the Quality System instituted at ZOLL. The Quality system has been designed to comply with requirements set forth by various regulatory standards and bodies including, but not limited to: - Food and Drug Administration, Quality System Regulation (21CFR Part 820) - ISO 13485:2012, Medical devices Quality management systems Requirements for regulatory purposes - Medical Device Directive, Council Directive 93/42/EEC (as amended by Directive EC) - Canadian Medical Devices Regulations, SOR/ (with amendments) - ANVISA, Resolution RDC 16/2013 This is controlled and implemented within the change order system. The is distributed to Executive Management as well as all functional department managers and supervisors. Functional department managers and supervisors are responsible for making this manual available to all employees. Changes to the manual are distributed to all manual holders. All employees shall be trained to applicable portions of the. The functional department managers and supervisors are responsible for identifying the type of training relevant to their group or department. A title or job function may be identified within a policy or Standard Operating Procedure (SOP). Any person with equal or greater authority within that department may assume the stated responsibility. Additionally, a designate may be identified by written memorandum in cases where the designate is from a different department or is a person of lesser authority from the same department.

12 ZOLL Document Number: 90E0021 Page 12 of 50 3 QUALITY SYSTEM ZOLL operates a Quality System for designing, manufacturing, and servicing products as described in this manual. The intent of this system is to ensure that desired product and service quality is being achieved and to provide a consistent development method for products and services that meet customers requirements. This defines ZOLL s Quality System, identifies its elements, and conveys its intent. 3.1 Quality System Structure ZOLL s Quality System consists of three parts: 1. This, which establishes the Quality System and references the elements of ISO 13485:2012, the FDA s Quality System Regulation, Health Canada s Medical Devices Regulations, and ANVISA s RDC 16/2013. The Quality System Compliance Matrix (Appendix #2) correlates all of the various quality system requirements. 2. Department Procedures, which are made up of Standard Operating Procedures (SOPs), detailed Work Instructions and Workmanship Standards. 3. Quality Records. Appendix #1, Supporting SOP Index, lists all SOPs referenced within the. These SOPs are reviewed annually to ensure accuracy and appropriateness.

13 ZOLL Document Number: 90E0021 Page 13 of ISO 13485:2012 Process Interaction Overview The following diagram provides a broad overview of the quality system process interactions. information Management Responsibility Clause5 Customer and Regulatory Requirements Resource Management Clause6 Quality Management System Clause4 Measurement, Monitoring, Analysis, & Improvement Clause8 information Customer and Regulatory FedBack input Product Realization Clause7 Medical Device output The following documents are detailed process interaction diagrams for clauses 4 through 8 of ISO 13485:2012: 90E0021-A01 Clause 4 Quality Management System 90E0021-A02 Clause 5 Management Responsibility 90E0021-A03 Clause 6 Resource Management 90E0021-A04 Clause 7.1 Planning of Product Realization 90E0021-A05 Clause 7.2 Customer-Related Processes 90E0021-A06 Clause 7.3 Design and Development 90E0021-A07 Clause 7.4 Purchasing 90E0021-A08 Clause 7.5 Production Provision 90E0021-A09 Clause 7.5 Service Provision 90E0021-A10 Clause 7.6 Control of Monitoring & Measuring Devices 90E0021-A11 Clause Monitoring, Measuring, & Analysis 90E0021-A12 Clause 8.5 Improvement

14 ZOLL Document Number: 90E0021 Page 14 of Non-applicability of certain ISO 13485:2012 clauses Sections and of ISO 13485:2012 are not applicable to ZOLL s quality system. Sterilization is not required for any devices produced by ZOLL. Section of ISO 13485:2012 is not applicable to ZOLL. ZOLL sells its products to distributors. ZOLL provides installation instructions, but does not perform installation of devices. Section is not applicable to ZOLL s quality system. ZOLL does not produce implantable medical devices. 3.4 Quality Plan This, along with supporting SOP s, acts as the quality plan for the medical devices produced at ZOLL. 3.5 Consequences of Non-Compliance with RDC 16/2013 The device is also considered to be non-compliant with RDC 16/2013 for refusal to schedule an inspection with ANVISA.

15 ZOLL Document Number: 90E0021 Page 15 of 50 4 MANAGEMENT RESPONSIBILITY 4.1 Quality Policy Quality is the overall responsibility of every employee at ZOLL. ZOLL has empowered its employees with the knowledge and necessary authority designed to produce and service safe, efficacious, and reliable medical devices. ZOLL s Quality Policy is: We will continually strive to do the right thing right the first time in delivering patient-driven-quality devices and customer service. 4.2 Organization The President is chartered with the responsibility for ensuring that the ZOLL Quality System is adequately defined in this manual and effectively implemented. The interrelations of personnel, who manage, perform and verify work affecting quality are defined and documented in the ZOLL Organization charts. The general organizational structure of ZOLL is shown in Figure 1. An expanded organizational chart is maintained by ZLH. 4.3 Resources Management is responsible for identifying and making available the resources necessary to meet the requirements of the quality system. These resources include adequate equipment, facilities and trained personnel. Adequate resources also include providing for adequate verification activities to monitor the quality system. Verification activities are accomplished by properly educated/trained personnel in the following manner: 1. Verification of the quality system is accomplished by scheduled formal audits. The Quality Assurance Manager is responsible for the administration of the audit program. 2. The development of all ZOLL products will follow the Product Development SOP - 90A0004. This procedure has been developed to facilitate the definition, communication, and implementation of a product development process that will yield products of the highest quality. According to the Product Development SOP: Prior to actual patient use, ZOLL products will undergo extensive bench testing, verification, validation and simulated use testing. Manufacturing has responsibility for assembled product testing and verification. QA has responsibility for inspection and process audits.

16 ZOLL Document Number: 90E0021 Page 16 of Management Representative The Director of Quality Assurance and Regulatory Affairs is designated by the President as the Management Representative. The Management Representative has the authority over, and the responsibility for ensuring that, the quality system requirements established by this manual are continually met. The Director of QA/RA reports on the performance and implementation of the quality system to the Corporate Quality Council. 4.5 Management Review The Corporate Quality Council (CQC) comprised of members of executive management, meets at regular intervals to review the effectiveness of the quality system, specifically reviewing the following: 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 The resultant meeting minutes will include any decisions and actions related to: Improvements needed to maintain the effectiveness of the quality management system and its processes Improvement of product related to customer requirements Resource needs The Corporate Quality Council SOP - 90E0492 outlines in detail the responsibilities of the CQC. 4.6 Risk Management Executive management establishes the risk management process in Risk Management 90C0052. Activities to support the process are carried out in accordance with the Failure Modes, Effects, and Criticality Analysis Procedure 90C0014 and

17 ZOLL Document Number: 90E0021 Page 17 of 50 Usability Engineering Procedure 90G0868. ZOLL s policy for risk acceptability is that the risk level of all failure modes shall be reduced to the greatest extent possible. Figure 1 - ZOLL Organizational Chart President VP Operations VP Engineering Quality Assurance Hardware Engineering Regulatory Affairs Software Engineering Manufacturing Web App Development Service Engineering Services Supply Chain Packaging & Integration Operations Engineering Software Test Facilities

18 ZOLL Document Number: 90E0021 Page 18 of 50 5 QUALITY AUDITS Regularly scheduled quality audits are conducted to verify the quality system is in compliance with the requirements established in this manual. The Quality Assurance Manager is responsible for the administration of the audit program by assigning qualified auditors, and scheduling and planning internal audits. The responsible manager reviews the documented results of each audit. Follow-up corrective action is required for deficient matters noted during audits. Internal quality audits are performed in accordance with the Quality Audits SOP - 90E0002. Auditors are trained and qualified in accordance with Qualification of Quality Auditors SOP - 90E Audit Records Audit records are maintained in accordance with the Quality Audits SOP - 90E0002. Upon request, the Quality Assurance Manager will certify in writing that the required internal audits have been performed and documented and that any required corrective actions have been taken.

19 ZOLL Document Number: 90E0021 Page 19 of 50 6 PERSONNEL It is the policy of ZOLL to ensure all aspects of design, manufacture, service, and maintenance of its medical devices are performed by qualified personnel. To provide this assurance, ZOLL has implemented the following elements of control: 6.1 General It is the policy of ZOLL to ensure there is sufficient personnel with the necessary education, background, training and experience to perform all activities correctly and in accordance with applicable government regulations. Prospective employees, temporary employees, and contractors will be judged as qualified based upon background, education, training and experience. ZOLL LifeVest Holdings, LLC (ZLH) provides administrative services that include assisting managers with the recruitment and onboarding of qualified individuals, the development and coordination of the orientation program covering corporate history, philosophy, policies, benefits and new employee files and documentation, and administration of the on-line training portal. Qualification requirements are defined within each job description. 6.2 Orientation and Training It is the policy of the company to provide orientation programs for new employees and to conduct or support training programs as deemed appropriate. Each department manager or supervisor is responsible for orientation as it applies to introducing the new employee or contractor to the specific job and department and may select a co-worker to serve as a sponsor to facilitate the new employee or contractor s transition. Each department manager or supervisor whose personnel perform activities affecting product quality is responsible for defining, planning, conducting and documenting training for personnel within their department. The department manager or supervisor ensures that all personnel are trained adequately to perform their assigned responsibilities. Training is conducted in accordance with established procedures by qualified individuals to ensure that employees have a thorough understanding of their current job function and quality requirements. As part of their training, all employees are made aware of any device defects, which may occur from the improper performance of their specific jobs. All employee training is documented and maintained in accordance with Training SOP - 90A0032.

20 ZOLL Document Number: 90E0021 Page 20 of 50 7 CONTRACT REVIEW Contract/Sales Order requirements for international orders are reviewed by the Materials Department for completeness, clarity and delivery requirements. Any discrepancies are resolved by the Materials Department in conjunction with the sales order originator. Changes to sales orders are maintained via a change order in the sales order entry software. Contract review and sales order entry is performed in accordance with Sales Order Entry - 90P0012.

21 ZOLL Document Number: 90E0021 Page 21 of 50 8 DESIGN CONTROLS 8.1 General The control and verification of product design is ensured by the Product Development SOP - 90A0004 and the Software Development Standards and Practices SOP - 90C0006. These SOPs require the definition, communication, and implementation of the product development process that yields products of the highest quality and effectiveness. Engineering is responsible for establishing and maintaining an effective design control system to verify that specific design requirements are met. Prior to release to production, all new designs and/or any changes to existing designs are tested and validated in order to establish their safety and efficacy for their designated use. Design results shall be evaluated at appropriate points during each development effort to assure they meet design stage input requirements. Criteria are established that must be met before the development process may proceed to the next phase. 8.2 Design and Development Planning A project plan is developed in the form of a comprehensive schedule defining major project milestones and assigning responsibilities and interfaces. This schedule is approved by management and reviewed for compatibility with the Product Development SOP - 90A0004, Software Development Standards and Practices SOP - 90C0006 and the. 8.3 Design Input The first step in the design phase is to develop product design input requirements. Design input requirements are developed according to - 90C0013 Design Input Requirements Document Procedure. A cross functional review is used to reinforce corporate-wide agreement with the new input requirements, to verify that the input requirements are appropriate and address the intended use of the device including the needs of the patient, prior to the start of design. Peer review meetings evaluate the technical merit of the design as well as compliance to regulatory and voluntary standards. R&D team members, each focused around his/her particular area of expertise, thoroughly analyze the input requirements and develop subsequent detailed design specifications. 8.4 Design Verification Every design or design change is verified by an appropriate combination of formally conducted and documented design reviews and tests. Verification of ZOLL s product ensures that the design output meets the design input requirements as defined in the individual module requirements. Verification tests are conducted using approved protocols in accordance with the Format for Engineering Protocols, Reports and Test Reports SOP - 90C0009. The

22 ZOLL Document Number: 90E0021 Page 22 of 50 product and design are subjected to a number of reviews and tests as specified in the Product Development SOP - 90A0004 and Software Development Standards and Practices SOP - 90C Design Review Design Reviews are conducted to confirm the integrity of the product s design. Evaluations are performed by a cross functional group, which includes persons other than the original product development engineers. This maximizes protection against oversights that might adversely affect product quality, safety, and efficacy and ensures that the design reviews are conducted and documented in accordance with the requirements in the Design Review SOP - 90A Design Output Documents produced by development projects conform to the Product Development SOP - 90A0004 and Software Development Standards and Practices SOP - 90C0006. Design output documents such as detailed design drawings, bills of material, software design, and manufacturing instructions are reviewed and released into the documentation control system through the Documentation Control SOP - 90A0001. These documents are considered the design output and shall meet documented design input requirements, identify or reference design acceptance criteria, and identify characteristics, which are crucial to the safe and effective operation of the device. Configuration control of documentation during the engineering prototype stage, prior to formal review and approval, is controlled via the Prototype Documentation SOP - 90A Design Validation Prior to release to production, all new products or product design changes shall be validated to ensure that the design conforms (or continues to conform) to defined user needs and/or requirements at the system level. Simulated use testing is performed in accordance with the Product Development SOP - 90A0004 to verify that the device performs according to product specification. Validation efforts follow successful completion of design verification activities and are performed on devices representative of the final product. 8.8 Design Transfer A design is transferred to pilot production by translating design documentation into production specifications. The production specifications are reviewed by a cross functional group. This review assures that the device and its components have been correctly transferred into production specifications.

23 ZOLL Document Number: 90E0021 Page 23 of Design Release Designs are released to full production via the successful completion of the Design Transfer Review. The design releases, including the date and signature of the individual(s) approving the release, are documented per Documentation Control SOP - 90A Design Changes Design changes are requested, approved and documented through the Change Request/Change Order (CR/CO) process. CR/COs are documented, reviewed, and approved by members of the Engineering Change Board (ECB) per the requirements of the Documentation Control SOP - 90A0001 and Change Requests and Change Orders SOP - 90A0023 prior to implementation. All approved changes are made known to all appropriate ZOLL personnel. Any change to a configured product is verified and validated to the extent necessary Design History File A design history file is established to record all design data per the Design History File SOP - 90G0100. This file is reviewed to assure that the file is correct and that the final design is consistent with the approved design plan prior to releasing the design to full production. The design releases, including the date and signature of the individual(s) approving the release, are documented per Documentation Control SOP - 90A0001.

24 ZOLL Document Number: 90E0021 Page 24 of 50 9 DOCUMENT AND RECORD CONTROLS Documentation Control is responsible for creating and maintaining a Documentation Control System for controlling documented information describing the design and manufacture of products. Documentation Control is also responsible for maintaining proper in-house record keeping, and contributing to the efficiency of product development, manufacturing, distribution, and service. 9.1 Document Approval and Issue All documents put under documentation control shall be reviewed for adequacy and approved by authorized personnel prior to their issue. Individuals required to review, approve, and issue ZOLL documents are defined in the Documentation Control SOP - 90A Document Distribution All documents shall be current and distributed per the requirements of Documentation Control SOP - 90A0001. A master listing of all revision controlled documents is maintained by Documentation Control. This listing shall be posted as well as filed on line and is available for viewing by those functions needing access to the information in order to preclude the use of invalid and/or obsolete documents. 9.3 Document Changes All changes to controlled documents are requested, documented, reviewed, and approved per the requirements of the Documentation Control SOP - 90A0001 and the Change Requests and Change Orders SOP - 90A0023. All CR/COs must be reviewed by the Engineering Change Board (ECB). All approved changes are then made known to all appropriate ZOLL personnel. Any change to configured product is verified to the extent necessary. Obsolete master documents are retained by documentation control. Documents are made obsolete by the CR/CO process only. 9.4 Documentation Change Records The ZOLL Change Order database identifies the Change Order used to make the change, the documents affected by the change, the approval dates, and the change implementation date. All approval signatures and changes are recorded on the CR/CO form, which is filed using sequential tracking numbers.

25 ZOLL Document Number: 90E0021 Page 25 of PURCHASING CONTROLS ZOLL recognizes the importance that purchased material has in the overall quality of a product. These purchasing controls apply to material going directly into the product and tools and equipment used in the production of the product. The Procurement department of ZOLL is responsible for procuring from qualified suppliers and for assuring that purchasing documents adequately describe ordered products or services Evaluation of Suppliers ZOLL purchases material and services from suppliers, contractors, and consultants which meet ZOLL requirements, including their quality systems which specifically apply to purchased items and services. The status of all suppliers, contractors, and consultants is maintained by Procurement in accordance with the Approved Suppliers List SOP - 90P0004 and monitored by Quality Assurance. Supplier Quality is responsible for performing audits and evaluations of suppliers and contractors to evaluate their ability to meet established requirements. The engaging department manager is responsible for evaluating consultants based on their qualifications for performing the intended consultation. Qualified suppliers failing to meet ZOLL s quality requirements will be subject to review and possible disqualification. Evaluation of suppliers, contractors, and consultants, including the criteria used, is defined in the Supplier Evaluation SOP - 90E0016. Ongoing evaluation is based on consistent quality, delivery and cost controls. Records of supplier, contractor, and consultant evaluations are maintained in accordance with the Supplier Evaluation SOP - 90E Purchasing Data Purchasing documents clearly state the item or service ordered and the required specifications and requirements, including quality requirements, quantity ordered, the ZOLL and the manufacturer s part number(s) and revision(s) where applicable, cost, and delivery dates. A standard clause is printed on the face of purchase orders, where possible, which is an agreement that suppliers and contractors notify ZOLL of any changes in the product or service so that ZOLL may determine whether the change affects the quality of a finished device. Purchasing forms are reviewed and approved prior to release. The approval of purchasing documents, including the approval signature, is documented in accordance with the SOP for Generating Purchase Requisitions - 90P0001 and Generating Purchase Orders SOP - 90P Verification at Supplier s Premises If it is determined to be necessary, ZOLL may choose to verify purchased material at the supplier or contractor s facility. Arrangements for this verification and the method of product release/acceptance are clearly specified in the notes section of the purchase order documents.

26 ZOLL Document Number: 90E0021 Page 26 of IDENTIFICATION AND TRACEABILITY ZOLL uses an Enterprise Resource Planning (ERP) and Manufacturing Execution System (MES) to maintain complete identification and traceability of components and devices from receipt through distribution of finished devices in accordance with Identification and Traceability Procedure - 90F0015. Quality Assurance and Production Control are responsible for assigning serial numbers and lot control numbers for components and devices in accordance with Serialization and Lot Control SOP - 90F Components and Devices Traceability Where appropriate, each lot of components and devices is identified with a unique lot control number or serial number for accurate identification and traceability during all stages of storage, production, and distribution. Records of traceability are recorded in the Device History Record (DHR)/shop router in accordance with Procedure - 90A0035. The Shipping Department is responsible for recording the control number of the product to be distributed on the appropriate shipping document Medical Device Tracking Any device manufactured by ZOLL that is subject to the Medical Device Tracking Requirements of 21 CFR Part 821 shall be tracked through the distribution chain to the end user in accordance with Medical Device Tracking SOP - 90C0037.

27 ZOLL Document Number: 90E0021 Page 27 of PRODUCTION AND PROCESS CONTROLS 12.1 General Manufacturing has responsibility for the establishment and maintenance of the production process. The production process at ZOLL provides a system of controls that verifies the manufactured device conforms to specifications. Product and process characteristics are monitored and controlled through Manufacturing Process Flow charts, manufacturing instructions and by appropriate test and inspection instructions. Processes that are new or changed are identified and subject to a process review and potential revalidation. Written manufacturing, test and inspection instructions, operator certifications, and QA audits are used to ensure processes are carried out under controlled conditions in a uniform manner. Sequences are performed by qualified, trained personnel using approved, written procedures, work orders, bills of materials (BOM), and utilizing equipment that has been designed and maintained to meet the requirements of the process. Workmanship standards are conveyed either through written procedures, assembly drawings, or by examples to establish acceptability criteria Environmental Control ZOLL provides a safe and comfortable work environment for its employees. This includes the proper environmental controls to ensure the cleanliness of its products as defined in the Environmental Controls SOP - 90A Cleaning and Sanitation Where required, cleaning instructions are in place to ensure that manufacturing process specifications are being met. Personnel are trained in these instructions. Eating, drinking and smoking is not permitted within the manufacturing area Personnel Health and Cleanliness Personnel are suitably attired in the manufacturing areas with special clothing where necessary. Such clothing may consist of lab coats and safety glasses Contamination Control Caution is used when cleaning equipment in the manufacturing area to prevent contamination of equipment, components, manufacturing materials, and in-process and finished devices by cleaning materials Sewage and Refuse Disposal Sewage, trash, chemical effluents and other refuse is disposed of in an

28 ZOLL Document Number: 90E0021 Page 28 of 50 environmentally safe, timely and sanitary manner Equipment Equipment used to evaluate or control product or process characteristics is inspected and calibrated to applicable standards at scheduled intervals in accordance with the Calibration SOP 90E0010 and the Equipment Maintenance Schedule as defined by the Equipment Maintenance SOP - 90A0036. This assures that the equipment is precise and accurate and therefore yields reliable data within limits commensurate with product or process characteristics being measured Automated Processes All software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of ZOLL s quality system shall be validated as appropriate for its intended use in accordance with the Automated Process Software Validation SOP - 90F Special Processes Special processes are those processes, the results of which cannot be fully verified by subsequent inspection and testing. These processes are performed in accordance with written procedures. The operators are trained, process validation studies are performed in accordance with the Production Process Validation SOP - 90F0068, and the process is monitored when appropriate. Records of these activities are maintained in accordance with the Maintenance of Quality Records SOP - 90E0004.

29 ZOLL Document Number: 90E0021 Page 29 of INSPECTION AND TESTING 13.1 General ZOLL maintains an effective Inspection and Test system to ensure the conformance to specifications of all incoming material, in-process, and finished devices. Inspections and tests are performed throughout the production cycle by qualified designated individuals. The results of all inspections and tests are documented, including the signature of the individual performing the inspection or test Incoming Inspection and Testing All material used in the manufacture of a device is received and routed through Incoming Inspection. Incoming material is held until determined to be conforming to specified requirements. Incoming Inspection and Test is performed and documented in accordance with Procedure 90F0029. Quality Assurance is responsible for designating qualified individuals to perform Incoming Inspection and Test. Material determined to be nonconforming is rejected in accordance with Nonconforming Material SOP - 90F In-process Inspection and Testing All devices undergo inspection and testing as defined in the Manufacturing Process Flowcharts and Manufacturing/Inspection Instructions, which are approved by Quality and Manufacturing and are under change control. Devices are held from further processing until the required verifications have been made and documented. ZOLL utilizes trained operators, technicians, and inspectors to verify in-process conformance to specifications Final Inspection and Testing Final inspection and testing is performed on each lot or batch of finished devices to ensure the devices meet all device specifications in accordance with the Device Master Record. Quality Assurance is responsible for designating qualified individuals to perform final inspection and testing. Finished devices are not released until all required activities specified in the Device Master Record (DMR) have been completed, and the associated Device History Record (DHR) data and documentation are reviewed to ensure all acceptance criteria have been met. Devices are not available for release until they successfully pass all indicated final inspections and test. Finished device release is documented, including the signature of the designated Quality Assurance individual, in accordance with the Device Release SOP - 90F0069.

30 ZOLL Document Number: 90E0021 Page 30 of Inspection and Test Records Records of all inspections and tests performed, which include the acceptance criteria; inspection checks performed; the results of the inspection or test; equipment used; and the date and signature of the individual performing the inspection or test, are maintained in accordance with the Maintenance of Quality Records SOP - 90E0004.

31 ZOLL Document Number: 90E0021 Page 31 of INSPECTION, MEASURING, AND TEST EQUIPMENT 14.1 Calibration All Inspection, Measuring, and Test Equipment (IM&TE) used to determine an item s conformance to specified requirements is calibrated and maintained on a scheduled basis. The calibration of equipment and the maintenance of records are governed by the Calibration SOP - 90E0010. Manufacturing Engineering maintains a computerized recall system to track due dates for all equipment requiring calibration. Each department using IM&TE is responsible for ensuring that only appropriately calibrated equipment is used Calibration Standards All standards used for calibration of inspection, measurement, and test equipment are traceable to the National Institute of Standards and Technology (NIST) or international standards where practical and available. Outside laboratories are used to calibrate IM&TE. The performance of outside laboratories is monitored in accordance with the Supplier Evaluation SOP - 90E Calibration Records Manufacturing Engineering maintains a calibration database/mes that includes past calibration dates and the next scheduled calibration date for each piece of equipment. Calibrated equipment are clearly identified with a CALIBRATED label which identifies the organization and technician performing the calibration, the date the next calibration is scheduled, and the date of calibration. Only equipment identified with an appropriate label shall be used for carrying out the measurement, inspection or test Maintenance IM&TE is handled and stored to ensure the accuracy and fitness-for-use is maintained. Each department is responsible for the appropriate maintenance and handling of their IM&TE Safeguarded From Adjustment Once calibrated, equipment is secured by label stickers or other suitable means to prevent unauthorized personnel from tampering with the calibration. Software is to be protected by passwords or a hardware key. Only authorized personnel are to remove label stickers, or to have access to hardware keys or to be issued passwords.

32 ZOLL Document Number: 90E0021 Page 32 of INSPECTION AND TEST STATUS The Inspection and Test Status of all components, materials, and finished devices is readily visible from either the documentation accompanying the material or by tags, labels or markings on the material or location. The inspection and test status of all components, materials, and finished devices is maintained, as necessary, throughout component acceptance, manufacturing, distribution, and servicing to ensure that only components, manufacturing materials, and finished devices which have passed the required inspections and tests are distributed.. The inspection and test status of components, manufacturing material, and finished devices is readily established by examining accompanying documentation and/or attached labels indicating the conformance or nonconformance with respect to its established acceptance criteria in accordance with the Indication of Inspection and Test Status SOP - 90F0032. Only conforming material is accepted into the stockroom. Material to be used for production is accepted only from the stockroom.

33 ZOLL Document Number: 90E0021 Page 33 of NONCONFORMING COMPONENTS AND DEVICES 16.1 Control of Nonconforming Components and Devices Nonconforming components, manufacturing material and devices are clearly identified, tagged, segregated, and held in accordance with Nonconforming Material SOP - 90F0030 to prevent their inadvertent use or distribution. The organization or persons responsible for the nonconformance are promptly notified so that immediate and effective corrective action can be implemented to prevent recurrence of the nonconformance Nonconformity Review and Disposition The Material Review Board (MRB) of ZOLL is responsible for the review and disposition of nonconforming material in accordance with Nonconforming Material SOP - 90F0030. The MRB is responsible for determining the need for, and assigning corrective action to the organization or persons responsible for the nonconformance. When the MRB determines the disposition of the material, the specific reprocessing, re-testing, and re-inspection procedures are identified as part of the disposition. These reprocessing procedures are contained or referenced in the Device History Record (DHR). Components and devices which have been reprocessed are clearly identified as reprocessed, and the reprocessing, re-testing, and re-inspection results are recorded in the Device History Record (DHR). When there is repeated reprocessing of a component or device, the MRB determines the effect of the reprocessing on the component or device, and this determination is documented in the DHR. Nonconforming material dispositioned for a downgraded or alternate use is processed in accordance with Control of Special Purpose Material SOP - 90F0374. When additional testing is needed, or insufficient data exists, for the proper disposition of nonconforming material, this material is identified, segregated and held in accordance with the Quarantining Material SOP - 90E0490.

34 ZOLL Document Number: 90E0021 Page 34 of CORRECTIVE AND PREVENTIVE ACTION 17.1 Corrective and Preventive Action ZOLL maintains a formal, closed loop, documented corrective action system to obtain prompt, effective corrective action on identified quality problems and to determine any steps necessary to deal with problems requiring preventive action. Corrective action and preventive action may be initiated through any of four methods: (Internal) Corrective Action Request, Supplier Corrective Action Request, Complaint Reports, and Internal Audits. Inherent in each system are provisions for follow-up through increasing levels of management to ensure effectiveness. Control of the corrective action and preventive action system is the responsibility of Quality Assurance in accordance with the Corrective and Preventive Action SOP - 90C0010. The quality system is designed to minimize the need for corrective actions by preventing non-conformances from occurring in the first place. Internal Corrective Action is initiated when an internal audit, review of quality records (including trend analysis), or observation identifies the need for investigation and corrective action. Each ZOLL employee has authority to, and responsibility for initiating a Corrective Action Request through QA when a quality problem, or potential quality problem is identified. Supplier Corrective Action is initiated when a nonconformance or observation of a quality problem is determined to be the responsibility of a supplier or contractor. Complaint Report Forms are initiated in accordance with the Complaint Handling SOP - 90E0012 when a returned product or customer complaint is received, or when a distributed device fails to meet specifications. Audit Reports are initiated when a quality audit identifies deficiencies or areas for improvement. When corrective action involves a product recall or the issuance of an Advisory Notice, these actions shall be performed in accordance with the Device Recall Procedure - 90C Complaint Files All complaints and malfunctions of a distributed device are documented via the Receipt and Evaluation of Product Complaints SOP - 90E0012. The Complaint Review Unit (CRU) of ZOLL is responsible for reviewing, evaluating, and investigating complaints and maintaining complaint files. The CRU ensures that complaints are processed in a uniform and timely manner. Regulatory Affairs determines whether the complaint represents an event that is required to be reported to a regulatory agency. Requirements for reportable events are established by the Food and Drug Administration (FDA) under the medical device reporting (MDR)

35 ZOLL Document Number: 90E0021 Page 35 of 50 requirements of Chapter 21, part 803 of the Code of Federal Regulations, the European Competent Authority under the guidelines for medical device reporting, MEDDEV 2.12/1, the Canadian Department of Justice under Part 1 of the Canadian Medical Devices Regulations, and the National Sanitary Surveillance System (SNVS) under the technical surveillance standards, Resolution RDC 67/2009. Events which are required to be reported are processed in accordance with MDR / Vigilance / MPR Reporting / Mandatory Notification Procedure - 90E0549. Oral complaints are documented upon receipt, and all complaints are reviewed to determine if an investigation is necessary. When the CRU determines no investigation is necessary, the reason for no investigation, and the individual responsible for the decision not to investigate is recorded in the complaint file. All complaints involving the failure of a device, labeling, or packaging to meet specifications are investigated. Any complaint pertaining to death, injury, or any hazard to safety is immediately reviewed, evaluated, and investigated by the CRU and is maintained in a separate portion of the complaint files. These complaints are reported to the FDA, Competent Authority, Health Canada, and/or SNVS in accordance with MDR / Vigilance / MPR Reporting /Mandatory Notification- 90E0549. Documented records of each investigation are maintained by the CRU and include the following information: - The name of the device. - The date the complaint was received. - Any control number used. - The name, address, and phone number of the complainant. - The nature of the complaint. The results of the investigation, including the corrective action taken, the dates of the investigation, the details of the complaint, and the reply to the complainant. ZOLL s policy is to not reply to the complainant after completion of the complaint investigation unless specifically requested.

36 ZOLL Document Number: 90E0021 Page 36 of HANDLING, STORAGE, DISTRIBUTION & INSTALLATION 18.1 Handling Components, manufacturing materials, work in process, and finished devices are handled and transported in accordance with the Handling, Storage and Distribution SOP - 90P0006 to prevent damage, deterioration, mix-ups, or other adverse effects. Electrostatic Discharge Sensitive (ESDS) components and devices have additional handling requirements as defined in ESD Protection Procedure - 90E0015. Anyone handling ESD sensitive material must practice appropriate ESD precautions. Finished product that were used by patients have additional handling requirements as defined in the Safe Handling and Cleaning Procedures for Serviceable WCD System Hardware - 90F Storage Material Control is responsible for the control of storage areas and stockrooms for components, manufacturing materials, and finished devices in accordance with Handling, Storage and Distribution SOP - 90P0006. ZOLL utilizes its ERP and MES system to control all receipts and issues from stockrooms and storage areas in accordance with the SOP for Generating Stock Requisitions - 90P0003. Lot control numbers and/or serial numbers are tracked from receipt of material through distribution of finished devices. Control numbers used are legible and clearly visible. ZOLL utilizes a first-in first-out (FIFO) system for components or devices whose quality deteriorates over time. Deteriorated components, manufacturing material, and devices held in storage are promptly identified, removed, and segregated in accordance with the Limited Life Material Control SOP - 90P0008. Obsolete and rejected components, manufacturing material and devices held in storage are promptly identified, removed and segregated in accordance with the Nonconforming Material SOP - 90F Distribution Material Control is responsible for ensuring that only those devices approved for release are distributed in accordance with Device Release SOP - 90F0069. ZOLL utilizes a FIFO system for finished devices whose quality or fitness for use deteriorates over time. Material Control is responsible for ensuring that expired devices are not distributed. Distribution records of all finished devices which include: the name and address of multiple distributor; the identification and quantity of devices shipped; the date shipped; and any control number used for traceability are maintained per 90E0004 Maintenance of Quality Records and 90C0037 Medical Device Tracking Installation ZOLL products are installed by independent distributors. No installation activities are performed by ZOLL. ZOLL only provides installation

37 ZOLL Document Number: 90E0021 Page 37 of 50 instructions to the distributor. 19 PACKAGING AND LABELING 19.1 Device Packaging Device packaging is provided for parts, sub-assemblies, and products during internal movement and shipment to the customer. Packaging during internal movement is specified in the manufacturing instructions. This packaging protects against damage during storage and handling. Packaging for shipping prevents damage from normal transportation shocks and vibration as defined in the Packaging SOP - 90F0070 and shipping instructions Package Labeling Package labeling processes are controlled. Proper product identification, traceability and shelf life are clearly displayed on each package in accordance with the Labeling SOP - 90F0071. The labeling process assures the design integrity, prevents mix-ups, and facilitates traceability Product Labeling Product Labeling (device labels and instructions for use) is designed, tested, and approved in accordance with the Product Development SOP 90A0004. Approved product labeling is controlled via the Documentation Control SOP 90A0001 and Change Request and Change Orders SOP 90A0023. Product labeling is inspected upon receipt and assigned control numbers for traceability. Accepted labeling is stored in controlled stockrooms. Device labeling operations are performed by trained personnel in accordance with documented work instructions. Device labeling is verified as part of the finished device release process. The names and dates of the individuals performing and verifying labeling operations are recorded.

38 ZOLL Document Number: 90E0021 Page 38 of RECORDS 20.1 General Requirements All records required by the Quality System of ZOLL are legible and stored to prevent loss, allow rapid retrieval, and minimize deterioration in accordance with the Maintenance of Quality Records SOP - 90E0004. Records are maintained at the ZOLL facility or off-site in secured environmentally protect facilities and, where applicable, are available for review and duplication by employees of the Food and Drug Administration (FDA) and the National Health Surveillance Agency (ANVISA). Records deemed confidential by ZOLL are so marked. Records stored in automated data processing systems are backed up at established intervals. At a minimum, Quality Records shall be maintained for a period of 12 years from the date of record creation. Examples of quality records: - Quality System Reviews (Confidential) - Corrective Action Reports - Inspection, Test, and Nonconformance Reports - Audit Reports (Confidential) - Design Review Records - Design History Files - Purchase Orders - Calibration Records - Material Review Board Records - Employee Training Records - Complaint Report Forms 20.2 Device Master Record (DMR) Device Master Records (DMRs) are maintained for each type of device in accordance with the Establishment and Maintenance of the Device Master Record - 90A0100. Manufacturing Engineering is responsible for the formal review and approval of the DMR at the end of the Design Transfer Phase. Each DMR includes, or refers to the location of, the following information: - Complete device specifications including the appropriate drawings,