QUALITY SYSTEM MANUAL - Exsurco

1 QM-1_00001 CONFIDENTIAL REVISION 01 QUALITY SYSTEM MANUAL ISO 13485 QSR (21 CFR 820) Exsurco MEDICAL 10804 GREEN ROAD BIRMINGHAM OH, 44889 QUALITY SYSTEM MANUAL Page 1 of 26 INTRODUCTION Exsurco Medical Inc., developed and implemented a QUALITY Management SYSTEM in order to document the company s best business practices, better satisfy the requirements and expectations of its customers and improve the overall management and performance of the company. The QUALITY Management SYSTEM of Exsurco meets the requirements of the international standards ISO 13485 and (21 CFR 820). This SYSTEM addresses the design, development, production, installation, and servicing of the company s product(s).

2 The MANUAL is divided into eight sections that correlate to the QUALITY Management SYSTEM sections of ISO 13485 and (21 CFR 820). Each section begins with a statement outlining Exsurco s commitment to implement the basic requirements of the referenced QUALITY Management SYSTEM section. Each statement is followed by specific information pertaining to the procedures that describe the methods used to implement the necessary requirements. In Appendix C a list of all procedures is referenced. This MANUAL describes the QUALITY Management SYSTEM , delineates authorities, inter-relationships and responsibilities of the personnel responsible for performing within the SYSTEM .

3 The MANUAL also provides procedures or references for all activities comprising the QUALITY Management SYSTEM to ensure compliance to the necessary requirements of the standard. This MANUAL is used internally to guide the company s employees through the various requirements of the ISO and US QSR standards that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force. This MANUAL is used externally to introduce our QUALITY Management SYSTEM to our customers and other external organizations or individuals. The MANUAL is used to familiarize them with the controls that have been implemented and to assure them that the integrity of the QUALITY Management SYSTEM is maintained and focused on customer satisfaction and continuous improvement.

4 _____ _____ Sara Ann MacKinlay, General Manager Date _____ _____ Swasita Saigal, Regulatory Affairs Manager Date _____ _____ Kayli Camp, Associate QUALITY Manager Date QUALITY SYSTEM MANUAL Page 2 of 26 COMPANY PROFILE Exsurco Medical is a leading-edge equipment manufacturer for tissue bank and surgical applications committed to improving excision results by providing devices for tissue recovery and Its products have been designed to meet the applicable regulatory requirements and the requirements of its customers, but are propriety in design, not designed to customer specifications. Exsurco Medical is located at 10804 Green Road Birmingham, OH 44889 (corporate location).

5 QUALITY POLICY As a responsible company, Exsurco Medical will conduct business with integrity and our commitment is based on QUALITY without Compromise . Our policy is as follows: QUALITY SYSTEM MANUAL Page 3 of 26 TABLE OF CONTENTS Company Profile .. 2 QUALITY Policy .. 2 Table of Contents .. 3 Scope .. 4 References .. 4 Terms and Definitions .. 4 QUALITY Management SYSTEM .. 4 QUALITY Management SYSTEM Continued .. 5 Management Responsibility .. 5 Management Responsibility Continued .. 6 Resource Management .. 7 Resource Management Continued .. 8 Product Realization .. 9 Measurement, Analysis and Improvement .. 17 Appendix A: QUALITY Mangement SYSTEM Process.

6 22 Appendix B: Organizational Chart .. 23 Appendix C : List of procedures for Reference .. 24 QUALITY SYSTEM MANUAL Page 4 of 26 SCOPE GENERAL The QUALITY SYSTEM defined in this MANUAL is designed to meet the needs of Exsurco Medical in the operation of its business, and has been developed from the business principles expressed in the Mission Statement, and the QUALITY Policy. APPLICATION This QUALITY SYSTEM MANUAL (QSM) outlines the overall structure and content of the QUALITY SYSTEM developed by and for the use of Exsurco Medical. REFERENCES GENERAL The Exsurco Medical QUALITY Management SYSTEM has been developed to be in compliance with the applicable requirements and most recent revision of the ISO 13485 and QSR (21 CFR 820).

7 TERMS AND DEFINITIONS GENERAL For the purposes of this document, the terms and definitions given in ISO 13485 and QSR (21 CFR 820) apply. QUALITY MANAGEMENT SYSTEM GENERAL Exsurco Medical has established, documented, implemented and maintained a QUALITY Management SYSTEM (QMS) in accordance with the requirements of ISO 13485 and (21 CFR 820). The effectiveness of the QMS is maintained and the SYSTEM continually improved through the use of the QUALITY policy, QUALITY objectives, audit results, analysis of data, corrective and preventive action and management review. To design and implement the QMS Exsurco Medical has: Identified the processes needed for the QMS and their application throughout the organization.

8 Determined the sequence and interaction of these processes. Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in QUALITY plans and work instructions. Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes. Ensured that Exsurco employees are trained to understand our QUALITY procedures and their application. Established systems to monitor, measure and analyze these processes. Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes.

9 QUALITY SYSTEM MANUAL Page 5 of 26 QUALITY MANAGEMENT SYSTEM CONTINUED DOCUMENTATION REQUIREMENTS The QMS documentation includes: A documented QUALITY Policy QUALITY Objectives This QUALITY MANUAL Documented procedures , Work Instructions and Forms. Documents identified as needed for the effective planning, operation and control of our processes, QUALITY Records Any other documentation specified by national or regional regulations. Each procedure, activity or special arrangement that has been documented is also implemented and maintained. control OF procedures AND RECORDS procedures to control the development, release and revision of documents have been established (See Appendix C for reference).

10 MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT Executive management has been actively involved in implementing the QUALITY management SYSTEM (QMS). It has provided the vision and strategic direction for the growth of the QMS, and established QUALITY objectives and the QUALITY policy. The procedure covering Management Responsibility (See Appendix C for reference) is established and maintained. Executive management provides evidence of its commitment to meeting requirements for the design, manufacture, distribution, and support of safe and effective medical devices through the QUALITY management SYSTEM and maintaining its effectiveness by: Communicating the importance of meeting customer, statutory, and regulatory requirements throughout the organization.