SUPPLIER QUALITY EXCELLENCE MANUAL - Medtronic

1 SUPPLIER . QUALITY . EXCELLENCE . MANUAL . Creating a predictable supply through unwavering commitment to QUALITY WE WILL. INNOVATE IN. NEW WAYS AND. COLLABORATE. WITH NEW. STAKEHOLDERS. TO TAKE. HEALTHCARE. FURTHER, TOGETHER. TABLE OF CONTENTS. Introduction .. Management Responsibilities .. How to Use This MANUAL .. Management Commitment .. Purpose and Scope .. Customer Focus .. Code of Conduct .. QUALITY Policy .. Medtronic Mission .. QUALITY Planning .. Medtronic Businesses .. Responsibility, Authority and Communication .. SUPPLIER Diversity .. Management Review .. Environmental/Social Obligations .. Continuous Improvement .. Resource Management .. Key Roles and Responsibilities .. Product Realization .. Medtronic Sourcing .. Planning of Product Realization .. SUPPLIER Organization .. Customer Expectations .. Design and Development .. Overview of SUPPLIER Expectations.

2 Purchasing .. QUALITY Agreements .. Identification and Traceability .. Non-Disclosure Agreements .. Environmental Compliance .. Control of Monitoring and Measuring Devices .. Declaration of Raw Materials Used .. Import Compliance .. Measurement, Analysis, and Improvement .. Business Continuity .. General .. Change Management .. Production and Process Control .. Sub-Tier SUPPLIER Control .. Audits & Inspections .. Measurement System Analysis (MSA) .. Monitoring and Measurement .. Process Capability .. Control of Nonconforming Product .. Control Plans .. Corrective and Preventive Action (CAPA) System .. Cost of Poor QUALITY (COPQ) .. Appendix A: Acronyms .. QUALITY Management System .. Expectations .. Appendix B: Terms and Definitions .. Documentation .. Complaints and Adverse Events Reporting .. Appendix C: Control Plan Template .. Field Corrective Actions.

3 Appendix D: Standards .. 019-G034 Rev 5 Medtronic CONFIDIENTIAL 1. FORWARD. An important building block for a successful SUPPLIER -Customer partnership is communication. The MANUAL provides an overview of Medtronic 's expectations to its Suppliers. Its purpose is to give our Suppliers and potential Suppliers the information required for securing business and maintaining a successful partnership. 2 SUPPLIER QUALITY EXCELLENCE MANUAL 019-G034 Rev 5. INTRODUCTION. HOW TO USE THIS MANUAL . The first three sections of this document provide an overview of Medtronic , the key roles in the sourcing organization, and an overview of Medtronic 's expectations. The remaining sections provide more detailed expectations. The MANUAL aligns with the content of ISO13485 Medical Devices QUALITY Management Systems Requirements for Regulatory Purposes; however, it is not intended to take the place of the standard itself.

4 We recognize that Medtronic has a wide variety of Suppliers and technologies; the expectations stated in this MANUAL may apply in different ways, depending on the Product or Service supplied. Terms and definitions used in this MANUAL are listed in Appendix B. Medtronic welcomes any questions regarding the content of the SUPPLIER QUALITY EXCELLENCE MANUAL . Please send feedback to: 019-G034 Rev 5 Medtronic CONFIDIENTIAL 3. PURPOSE AND SCOPE Medtronic MISSION. The purpose of this SUPPLIER QUALITY EXCELLENCE MANUAL is to The Medtronic mission is very important to us as a company. clearly communicate Medtronic 's QUALITY expectations to all First and foremost, our mission is to alleviate pain, restore health, new and existing external Suppliers. These QUALITY expectations and extend life. We at Medtronic are committed to fulfilling this apply to the development, manufacture, and delivery of all mission and expect the same commitment from our Suppliers.

5 Products and Services supplied to Medtronic . Suppliers have Please take time to review and understand the Medtronic a direct impact to Medtronic delivering high- QUALITY Product mission: to our customers. Therefore it is important to understand n To contribute to human welfare by application of biomedical expectations, identify gaps and track progress to gap resolution. engineering in the research, design, manufacture, and sale of Medtronic establishes long-term partnerships with Suppliers instruments or applications that alleviate pain, restore health, who strive to meet performance expectations and comply with and extend life. regulatory requirements. n To direct our growth in the areas of biomedical engineering QUALITY requirements and expectations may take the form of where we display maximum strength and ability; to gather an agreement or specification.

6 The expectations and guidance people and facilities that tend to augment these areas; to within this MANUAL are provided as a supplement, not as a continuously build on these areas through education and replacement for or altering of the terms or conditions with pre- knowledge assimilation; to avoid participation in areas where established agreements, engineering drawings or specifications. we cannot make unique and worthy contributions. n To strive without reserve for the greatest possible reliability If conflicting interpretations of the standards arise, the and QUALITY in our Products; to be the unsurpassed standard of following order of precedence applies unless otherwise noted comparison and to be recognized as a company of dedication, contractually: honesty, integrity, and service. 1. Agreements ( QUALITY , Supply, etc.). n To make a fair profit on current operations to meet our 2.

7 Specification Requirements obligations, sustain our growth, and reach our goals. 3. Medtronic Purchase Orders n To recognize the personal worth of employees by providing an 4. SUPPLIER QUALITY EXCELLENCE MANUAL employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. CODE OF CONDUCT n To maintain good citizenship as a company. Our relationships with Suppliers are based on lawful, efficient, and fair practices. Medtronic expects our Suppliers and contractors to: Medtronic BUSINESSES. n Abide by applicable laws, rules and regulations of the countries Medtronic understands that our four business groups are in which they operate different in nature and may have unique SUPPLIER QUALITY n Uphold the human rights of workers and treat them with requirements.

8 However, the processes and tools depicted in this dignity and respect MANUAL represent the core Medtronic expectations. n Ensure a safe and healthy working environment For more information about Medtronic Products and the n Practice social and environmental responsibility patients we serve, please visit n Demonstrate the highest standards of business ethics Cardiac and Vascular Group n Medtronic reserves the right to discontinue business relationships with Suppliers that fail to conduct business in a Cardiac Rhythm & Heart Failure Disease Management legal, responsible, and ethical manner. (CRHF): Our CRHF division develops, manufactures and markets Products for the diagnosis, treatment, and management of Appendix D contains a list of regulations and standards that are heart rhythm disorders and heart failure. Our Products include applicable to Medtronic and may be applicable to our Suppliers implantable devices, leads and delivery systems, Products for also.

9 The treatment of atrial fibrillation (AF), Products designed to reduce surgical site infections, information systems for the management of patients with CRHF devices, and an integrated health solutions business. Coronary & Structural Heart Disease Management (CSH): Our CSH division develops, manufactures and markets therapies to treat coronary artery disease (CAD), and heart valve disorders. 4 SUPPLIER QUALITY EXCELLENCE MANUAL 019-G034 Rev 5. Our Products include coronary stents and related delivery Brain Our Brain business develops, manufactures and markets systems, including a broad line of balloon angioplasty catheters, a comprehensive line of medical devices and technologies that guide catheters, guide wires, diagnostic catheters, and treat a wide range of neurological disorders and diseases. Our accessories as well as Products for the repair and replacement solutions focus on treatments for; neurovascular conditions of heart valves, perfusion systems, positioning and stabilization ( Stroke), movement disorders ( Parkinson's disease, systems for beating heart revascularization surgery, and surgical Essential Tremor, and Dystonia), Hydrocephalus, neuro trauma, ablation products.

10 And neuro-oncology. Our Brain business also develops surgical technologies designed to improve the precision and workflow of Aortic & Peripheral Vascular Disease Management (APV): neuro procedures, including surgical navigation, surgical imaging, Our APV division develops, manufactures and markets a Stealth-integrated powered instruments, and MRI-guided laser comprehensive line of Products and therapies to treat aortic ablation. disease (such as aneurysms, dissections, and transections) as well as peripheral vascular disease (PVD). Our Products include Pain Our Pain business develops, manufactures and markets a endovascular stent graft systems, peripheral drug coated comprehensive line of medical devices and procedures that treat balloon, stent and angioplasty systems, and carotid embolic chronic pain as well as pain from cancer and severe spasticity.