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Category: QUALITY SYSTEM MANUAL

Doc Description: Medtronic Diabetes Quality System Manual

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This document contains information, which is the property of Medtronic MiniMed. This document may not, in whole or in part, beduplicated, disclosed, or used for design or manufactUring purposes without the prior written permission of Medtronic MiniMed.

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TABLE OF CONTENTS

IN"rRODUCTION .

SCOPE .

NORMATIVE REFERENCES .

TERMS AND DEFINITIONS .

QUALITY MANAGEMENT SySTEM ..4.1 General Requirements4.2 Documentation RequirementsMANAGEMENT RESPONSiBILITY .5.1 Management Commitment5.2 Customer focus5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority & Communication5.6 Management reviewRESOURCE MANAGEMENT .6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work Environment

PRODUCT REALiZATION .7.1 Planning & product Realization7.2 Customer related processes7.3 Design and development7.4 Purchasing7.5 Product and service provision.7.6 Control of monitoring and measurement devicesMEASUREMENT ANALYSIS & IMPROVEMENT .8.1 General8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis and data

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APPENDIX A:

APPENDIX B:

QUALITY MANUAL - QSR CORRELATION CHART .

MEDTRONIC DIABETES SENIOR LEADERSHIP ..

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QUALITY MANUAL

o INTRODUCTION

Medtronic Diabetes also referred to as Medtronic MiniMed, located at 18000 Devonshire Street inNorthridge California, is the diabetes sector of Medtronic, Inc. Medtronic, Inc. is the worldwide leader inmedical technology, providing lifelong solutions for people with chronic disease.

The products manufactured are micro-volume infusion pumps and related accessories and disposableelements designed to deliver small quantities of insulin and other general medications in a controlled,programmable regimen. The pumps utilize the company's proprietary disposable elements consisting ofa reservoir and infusion set. ApproXimately 300,000 people are currently using Medtronic Diabetesproducts.

Other products include a subcutaneous short-term glucose sensor and a monitor for continuousmeasurement of glucose levels and therapy management tools. The ultimate objective is to create an"artificial pancreas" by combining sensors with infusion pumps. Such closed loop systems will controldiabetes and reduce or even eliminate its many associated side effects.

Approximately 4000 employees worldwide are engaged in the design, assembly, sale, market andsupport of our products. In-house production areas of over approximately 125,000 square feet provideenvironmentally controlled clean areas for assembly and servicing of newly developed product lines.Medtronic Puerto Rico Operations Co. - (MPROC), located in Juncos, Puerto Rico manufactures anumber of our devices and maintains its own Quality System. In 2009 our San Antonio, Texas facilitywas established to provide additional helpline support and prepare for the future growth of our business.This facility fully integrates with Northridge call center operations so that calls are routed to the firstavailable representative at either location allowing us to ensure for an exceptional customer experience.Medtronic Diabetes partners with UPS located in Louisville, Kentucky to handle Distribution Operations,who functions under its own Quality System.

We are committed to ensuring the safety and quality of our products and on time delivery to ourcustomers through consistent execution of regulatory and quality system requirements described in thismanual.

1 SCOPE

This Quality Manual describes the scope of the Medtronic Diabetes Quality System and summarizes theoverall quality policies required to meet company business objectives and to comply with the applicablestandards and regulations. The elements of this manual apply to all products and componentsdesigned, manufactured, tested, serviced and distributed by Medtronic Diabetes.

This manual will be revised, as necessary, to document significant changes to the quality program, toensure continued conformance to customer and regulatory requirements and to incorporate changes intechnology or product diversity. This manual shall include justification for any exclusion or nonapplicability of any requirements of the standard.

The purpose of this Quality Manual is to proVide:

• An overview of the company quality management system

• Statement of the quality policy

• Description of the organizational structure

• Description of the interaction between documented policies/procedures and processes of thequality management system

CONFIDENTIAL

This document is for circulation within the company only. It or extracts from it must not be passed orcopied to other companies or persons without written permission of the Senior Vice President andPresident or the Management Representative.


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2 NORMATIVE REFERENCES

• ISO 13485: 2003 Medical Devices-Quality Management Systems-Requirementsfor Regulatory Purposes.

• Council Directive 90/385/EEC Active Implantable Devices (AIMD)

• Council Directive 93/42/EEC Medical Devices (MDD)

• Canadian Medical Device Regulation, SOR/98-282*

• CSA-IS013485: 2003 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes.

• 21 CFR Part 820, Quality System Regulation

• 21 CFR Part 803, Medical Device Reporting

• 21 CFR Part 806, Reports of Corrections and Removals

• J-PAL Japanese Pharmaceutical Affairs Law

• Australian Therapeutic Goods (Medical Devices) Regulations 2002 & TherapeuticGoods Act of 1989

• ISO 14971: 2009/A1: 2009 Risk Management

• ICOP107 Medtronic Diabetes and Medtronic Puerto Rico Operations Center(MPROC) Interface Agreement

• ICOP111 Medtronic Diabetes & UPS SCS Quality/Regulatory Interface Agreement

* Appendix A of this Quality Manual provides a correlation between the Quality Manual sections,IS013485:2003, FDA 21 CFR Part 820, MDD 93/42/EEC, the AIMDD 90/385/EEC, therequirements for combination products and the applicable Medtronic corporate policies.


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3 TERMS AND DEFINITIONS

All terms and definitions specified in ISO 13485, CSA-ISO 13485 and 21 CFR§ 820 also apply for thepurposes of this Quality Manual.

'I' Term Descriptionfl '"

,

Supplier Organization that provides a product to the customer. The supplier may be, for example, theproducer, distriblutor, importer, assembler, or service organization.

Organization Company, corporation, firm, enterprise, or institution, or part thereof, whether incorporated ornot, public or private, that has its own functions and administration.

Active Implantable Medical Active Medical Device which is intended to betotally or partially introduced, surgically orDevice medically, into the human body or by medical intervention into a natural orifice, and which is

intended to remain after the procedure.Active Medical Device Medical device relying for its functioning on a source of electrical energy or any source of

power other than that directly generated by the human body or gravity.Advisory Notice Notice issued by the organization, subsequent to delivery of the medical device, to provide

supplementary information and/or to advise what action should be taken in.Finished Device Any device or accessory to any device that is suitable for use or capable of functioning,

whether or not it is packaged, labeled, or sterilized.Labeling Written, printed, or graphic matter, affixed to a medical device or any of its containers or

wrappers, or accompanying a medical device related to identification, technical description,and use of the medical device, but excluding shipping documents. Labeling includespromotions, literature, and advertising materials.

Manufacturer Any person who designs, manufactures, fabricates, assembles, or processes a finisheddevice. Manufacturer includes but is not limited to those who perform the functions of contractsterilization, installation, re-Iabeling, remanufacturing, repacking, or specification development,and initial distributors of foreign entities performing these functions.

Customer Recipient of a product provided by the supplier.Policy A writing whereby a contract of insurance is made, top level "what must be done."Procedure A logically distinct set of activities that are repeatedly carried out in the same way. Defines

work that should be done, and explains how it should be done, who should do it, and underwhat circumstances.

Process A sequence of activities to transform inputs into outputs.Product An output resulting from a process, including components, manufacturing materials, in-process

devices, finished devices, and returned devices. A result of activities or processes, which mayinclude service.

Quality Plan Defines the quality practices, resources, and activities relevant to devices that are designedand manufactured.

Quality System A network of processes made up of elements that include responsibilities, authorities,relationships, functions, plans, policies, procedures, practices, processes, and resources. Thepurpose of a Quality System is to satisfy quality requirements and to ensure that customersreceive quality products and services.

Regulation Promulgation of the Law; make publicly known; put into action (for example, Code of FederalRegulations).

Standard An expectation, obligation, requirement, or norm. Typically a voluntary choice, unlessprescribed bY' regulation or dire<?tive (e.g., ISO 14971).

Establish Define, document (in writing or electronically), and implement.Combination Product A product comprising two or more regulated components (Le. , drug/device, drug/biologic, or

drug/device/biologic) that are physically, chemically, or otherwise combined and mixed orproduced as a single entity.

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4 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS

A Quality Management System is maintained to ensure that products and services consistently meetor exceed specified requirements by conforming to ISO 13485, FDA Quality System Regulation 21CFR § 820, European Council Directives, relevant Canadian & Japanese requirements and all otherapplicable International regulations. It creates a framework for clearly defining the control of products,processes and verification activities, providing our customers with confidence that products conform tospecified requirements and that the design, manufacture and servicing of products are performed in adefined and controlled environment.

Medtronic Diabetes continually maintains and improves the effectiveness of the QualityManagement System through:

• Adequate resource management,

• Validation of products and processes,

• Continuous monitoring, measurement and analysis of data for process effectivenessand improvement,

• Efficient communication processes,

• Effective Quality Planning, and

• Routine review of the Quality System processes by top management.

4.1.1 Quality Objectives

In order to continually exceed customer requirements, the President and executivemanagement establish a Quality Policy and strategic objectives, including quality objectives, toensure market acceptance. Departmental and individual objectives are established to ensureimplementation of strategic direction.

The objectives for quality are achieved through meeting the requirements of the documentedquality system. Medtronic Diabetes is further committed to a philosophy of continuous qualityimprovement. Three primary continuous quality improvement goals have been established:

• Meet production goals consistent with customer schedule requirements.

• Continuously improve product quality to consistently meet or exceed customer'srequired product quality standards.

• Continuously improve the processes and methods used in our manufacturing,assembly, quality control, and support functions.

4.1.2 Quality efforts are guided by the following quality objectives:

• Commitment to Regulatory Requirements: implement and maintain the effectiveness ofa Quality Management System that complies with applicable regulatory requirements.

• Commitment to Customer & Patient Focus: focus on the customers and the patients toensure that their needs and expectations are consistently satisfied with the quality ofour products.

• Continuous Improvement: pursue a planned program of continuous improvement toenhance the quality of the products and the services provided to customers andpatients.


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• Training: Properly enlist, educate and train personnel on the Quality ManagementSystem to ensure competence and dedication and to maximize their contribution toquality and productivity.

• Problem Prevention: concentrate on problem prevention to increase customersatisfaction and reduce cost.

• Technology: consolidate state-of-the-art technology to enhance the quality of productsand processes.

4.1.3 Organizational Communication

Communication plays a critical role in the management of the effectiveness of the QualitySystem including interactions with inter-corporate manufacturing sites.

Communication occurs at various levels throughout the organization and on a continual basisthrough Corporate driven initiatives, Management Reviews, Staff meetings, cross-departmentalreviews, email notifications and postings on the organizations intranet site.

For remote operations sites the methods of communication include, but are not limited toemails, conference calls, telecommunication, site visits and implementation of applicableIntercorporate Operating Procedures (lCOP).

Company personnel receive notifications for organizational changes, new and/or revised QualitySystem Regulations and International Standards, Corporate Policies, internal documentationand any other information pertinent to the business as appropriate.

4.1.4 Interaction of Processes of the Quality Management System

Process management is the foundation of the Quality System. The key processes at MedtronicDiabetes are formally described in process documents. These documents, supplemented bycorporate policies and procedures, describe in detail the operation of the Quality ManagementSystem. The Process Map on the following page as well as the corresponding verbiageprovides details of the interrelation of our Quality Management System processes.


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•

Continuous Improvement

Legal

RegulatoryAffairs

;--------------PostAiarketc:yCle--------------:, ,: Service & Repair Customer Care: • Analyze retums • Customer Sur:veysI • Repair product • 24 Hrs Help In-.eI • Perform product updates • Education

• Trouble Shooting• Return authorization

BusinessReviews

post Release Reylew(Phase 6)• Manufacturing• Field performance• Design• Regulatory &

reimbursement• Marketing

EHS

End of CommercialLife(Phase 7)• End of sales life• Descontinue product

support• Customer communication

IT

CAPASystem

Facilities• P1ant &

EquipmentMaintenance

------------------------ ------------- ------~--~---

~~

DocumentControl

- ------------------------Sujiply-Chain-Cycie-----------------------------------:;------------OrderFuimIrnenic:ycle------------:Planning( ~ Material Warehouse Production i: Order Processing roi~i';;;ti;;'(uPS> .. :Scheduling Procurement . Mat~l ~rage • Assem~y& Test. :: • R~ve Oders •• Product Storage• D6mand Forecast • Supplier Management • Identification • Pac~aglngl Labeling I I • Clanfy Requirements • Handling• Production Scheduling • Receiving Inspection • Handllng . • S~enlizatlon (Outsourced) I I • Obtain documents (e.g. Rx) • Control of nonconforming

• MRS • ~~~~~~IOf Nonconforming : ~~~ Release product

I· Ship Product• Confirm shipping1 _

HumanResources• Training

~~~~~~ --, ,------------------------------------------------ -----FiVd"'i;;";.~",c"'"--------------~-- :Product Needs Product Concept Product Proposal Product Planning Design & "O::-.'-'S"19-'n::::;;Y"'.=;rlfj;;"""C"at""iO"n-:&,--,::;-rD=-e-s""'i-g-n-T=-ra=n=sf=:e::::....r----, :

~:~:~::us G<oups (Phase 0) (Phase 1) (Phase 2) Development .YAUs!lI1l2n (Phase 5) :

: ~~:;~Advisory Boards : ~::~:SO~~:~~7; :~~:~::~~an : g:S~~R~~~=:~~~ ~~~~~;~2uct ~~r~U~~T~ting : ~::~~~a~~a:~~ion i• Analysis of Competitive • FinancIal Analysis • Risk Management Plan • Conduct Design Reviews • Final design review Execittve Steering :

Products Legal review ~:~~'::~I:~1 ::::wA:proval Board Phase Approval Board Phase Approval Board Committee Review 5 I

• Feasibility Studies Review 3 Review 4 :

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4.1.4.1 Support Functions and Continuous Improvement

The outer lying areas of the diagram are considered "support functions". Each serves the purpose ofproviding a specific support either directly or indirectly to the Quality Management System. HumanResources, Facilities, Environmental Health and Safety (EHS), Information Technology (IT) providefor management of resources; specifically, personnel, equipment, tools, technologies, infrastructureand work environment necessary for implementing the quality system, maintaining its effectivenessand meeting Regulatory and customer requirements. Document control ensures that the supportingdocumentation and maintenance of such documents for organizational and regulatory requirementsare handled accordingly.

The Continuous Improvement System encompasses Risk Management, CAPA, ManagementReviews of the quality system, Training, Internal Quality Audits and Business Reviews. Similar tosupport functions, each provide a specific contribution to the overall improvement of the qualitysystem through consistent management and prioritization of quality issues. This system isestablished to identify, manage, correct and prevent customer related, in-house product related andfield related deficiencies. Contributions from each element help to ensure that necessary actions arebeing taken to continuously improve the products and services we provide as well as to strengthenthe overall quality management system. Business reviews provide the lines of communicationnecessary for Executive Management to build awareness, stay abreast of issues, make strategicdecisions and ensure that the organization is aligning its goals and objectives.

4.1.4.2 Customer Requirements and the Product Development Cycle

Customer needs and requirements are obtained through various sources and means of datacollection. We utilize these sources and the information we receive from them throughout theproduct development cycle. We use detailed processes to translate customer responses intorequirements and make considerations for new products and improvements to existing productsbased on their feedback. Being aware of these requirements allows us to make strategicdeterminations regarding feasibility, market acceptance and other factors relating to productdevelopment prior to the organizations commitments to supply product to our customers.

4.1.4.3 Product Development and Supply Chain

The interaction between the Product Development cycle and the Supply Chain cycle begins at Phase3 of Design and Development, where lines of communication are established between the twoprocesses to ensure that materials are available to support product development activities.Communication is also established during Phase 5 Design Transfer for Planning, scheduling andprocurement of materials needed for production build.

4.1.4.4 Material Procurement and Production

Forecasting is conducted and communicated to the planners and schedulers within the supply chaincycle. Supplier Quality Assurance evaluates suppliers, approves them based on our requirementsand builds quality relationships with them in order to ensure that the products they provide meet ourpredetermined specifications. All incoming material goes through receiving inspection to ensure thatonly those materials which have passed inspection are made available for production. Whenprocesses that affect product conformity are outsourced, controls are implemented to ensure thatthese processes meet specified requirements.

Manufacturing receives inspected and approved materials through the material procurement processand begins production build based on supply and demand. Before being released for distribution, allfinished devices are inspected to ensure that quality specifications have been met.

4.1.4.5 Supply Chain Cycle and Order Fulfillment


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Once final product is released, it is stored in "finished goods" pending sales orders. Once received,orders are processed and applicable customer information is verified. Upon confirmation ofverification, the distribution center receives notification to ship products via our automated SAPsystem. Distribution records are maintained.

4.1.4.6 Order Fulfillment and Customer Services (post market)

Once product has been shipped to customers, we want to ensure their continued satisfaction. Thecustomer service representatives of our Helpline provide 24 hour educational and trouble-shootingsupport as well authorization for product that is to be returned. If it is necessary for a product to bereturned, our Failure Analysis group conducts analysis and the Technical Services group performsany upgrades or repairs as necessary in order to ensure that customer product conforms to itsspecified requirements. The main objectives of our Consumer Experience Excellence program are toensure customer satisfaction and solidify each customer relationship with our company. We utilizethe information collected from customer communications as feedback into our CAPA system. Thisinformation is reviewed and used to make regulatory determinations such as MDRlVigilancereporting as well as trended, presented and used to make decisions related to critical issues.

4.2 DOCUMENTATION REQUIREMENTS

Documents and data can be in the form of any media, such as hard copy or electronic media. All documentsand data are reviewed and approved for adequacy prior to release. Pertinent issues of appropriatedocuments are furnished at their designated locations.

Establishment, release and control of documentation, procedures and policies are the responsibility of theDocument Control department. Change Boards and/or Product Quality Review Board are established forthis function. Document and Data Control responsibilities are specified in applicable quality procedures.

A master list and an equivalent control procedure identifying the current version status of documents isestablished, maintained and readily available to preclude the use of invalid and/or obsolete documents.Obsolete and previous versions of documents are identified, removed and retained per their pre-determinedretention period for the following purposes:

• Preservation of knowledge,

• Legal reasons,

• To ensure that pertinent issues of appropriate documents are available at all locations where operationsessential to the effective functioning of the Quality System are performed,

• To ensure that Invalid and/or obsolete documents are promptly removed from all points of issue or use,or otherwise assured against unintended use, and

• To ensure that specifications to which products have been manufactured are available for at least thelifetime of the product.

In conformance with the provisions of the MDD and AIMDD requirements, the retention period shall be asdescribed in Annex II, 6.1 and Annex V, 5.1, for the following documents:

• Declaration of conformity

• Documentation of the quality system

• Decisions of the notifying body

• Design dossier/technical documentation

4.2.1 Document and Data Changes

Document changes are reviewed and approved by the same functions that approved the originaldocument prior to any formal versions. The designated functions/organizations have access to

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pertinent background information upon which to base their review and approval. The documentreview shall include a determination for any verification or validation activities, if appropriate.

Records of changes shall be maintained. The change records shall include a description of thechange, identification of the affected documents, the signature of the approving person(s), theapproval date and when the change becomes effective. Approved changes are communicated to theappropriate personnel and/or furnished in designated locations in a timely manner.

4.2.2 Documentation and Structure

The Medtronic Diabetes Quality Management System (QMS) is defined in the following documentsand illustrated in Figure I below:

• Quality Manual (Level I document)

• Standard Operational Procedures (Level II documents)

• ICOP -Intercorporate Operating Procedures (Level II documents)

• Departmental Operational Procedures & Work Instructions (Level III documents)

• Drawings, product and engineering specifications (Level III documents)

• Standards and other technical reference materials (Level IV documents)

• Records & Forms (Level IV documents)

• Any other documentation specified by national or regional regulation where our product isdistributed.

FIGURE 1: Quality Management System Documentation Structure

/'...

Quality Manual

/' ""-

Standard Operating Procedures (SOP)Intercorporate Operating Procedures (ICOP)

/' ""-

Department Product SpecificationsO~ratingProcedures En~ineeringSpecifications& ork Instructions & rawi~(OOPs, DIMs, DAPs) (BOM, D ,DWG, DT, DMP)/' ..........

Standards Reference Forms RecordsMil-Hdbks Materials . (OTRs. W/Os, (Completed forms,Mil-Stds (Ers, tech. ref.) Sales Order Forms DTRs, Work Orders)

~/ IPC-Stds, etc. RMRs)

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Normative references andStandards (ISO, MODAIMDD, Etc.) andCorporate Policies

4.2.3 Quality Manual

This Quality Manual is a Level I document, which briefly describes the activities that support andmaintain the Quality System. Standard Operating Procedures (SOPs) support each of the sections ofthis manual and contain the working detail of the sections to which they apply. Managementperforms periodic reviews of this manual and all quality system documentation to ensure compliance.The Management Representative reviews the Quality System Manual at least annually. Suchdocuments are revised as necessary to meet FDA and international requirements.

4.2.3.1 Amendment, Approval, Issuing Authority and Control

The Quality manual is prepared and revised by a designee under the direction of thePresident and/or the Management Representative. Revisions and proposed amendmentsto this manual are issued and approved under their authority. Such amendments will beconsolidated in a revised issue.

Control shall be by replacement with a properly authorized version of the manual only.The version number, which appears on the bottom right hand corner of each page of themanual, indicates the current version status. The recipient is responsible for insuring thatthey are working from the latest version of manual and all QMS documents.

The Document Control department is responsible for distributing versions andreplacements of the Quality manual. Internal copies are made available to all employees.

4.2.4 Quality System Procedures

Quality Procedures (level II & III documents) are maintained to prOVide system activities andinstructions, and to assign specific authorities and responsibilities for functional units to implementthe Quality Management System elements.

• Standard Operating Procedure (SOP): Written Quality procedures that support the QualityManual. These procedures detail instructions and assign specific authorities and responsibilitiesand define arrangements for carrying out all activities comprising the Quality ManagementSystem as stated in this Quality Manual.

• Departmental Operating Procedures (DOP): Department Operating Procedures and WorkInstructions are detailed procedures and instructions defined to guide personnel in performingspecific tasks which are applicable to individual departments and are often extensions of arequirement in a Standard Operating Procedure.

• Work Instructions: Documents which specify the requirements for raw materials, componentparts, subassemblies, production processes, finished products, and servicing. Typically, thesewould include:

• purchasing specifications

• drawings

• manufacturing procedures and specifications

• packaging and labeling specifications

• inspection procedures, test methods, and criteria for acceptance/rejection

• servicing procedures

4.2.5 Quality Records

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Quality records are established and maintained to demonstrate conformance to specifiedrequirements and effectiveness of the Quality Management System. All Quality records are legibleand are identifiable to a specific product and the person or the event to which they pertain.

Procedures and methods are defined in all operational units for the identification, collection, indexing,filing, storage, maintenance and disposition of Quality records, including electronic data. Pertinentquality records from suppliers form an element of this data. A record is established and maintainedfor each uniUbatch of medical devices that provides traceability and identifies the quantitymanufactured and the quantity released for distribution. These records are verified and approvedprior to distribution.

Quality Records are retained indefinitely, unless otherwise specified in Departmental Procedures orWork Instructions and are stored in such a way that they are readily retrievable in facilities thatprovide a suitable environment to prevent damage deterioration and loss. Retention times of qualityrecords are established and recorded.

4.2.5.1 Device Master Record (DMR)

A DMR is established and maintained for each product including or referring to the locationof the following:

• Device specifications

• Manufacturing specifications

• Quality Assurance specifications

• Packaging and Labeling specifications

• Maintenance and servicing procedures and methods

4.2.5.2 Device History Record fDHR)

DHR is established and maintained for each batch, lot, or unit, including or referring to thelocation of the following information:

• The dates of manufacture

• Quantity manufactured and released

• Acceptance records that demonstrate compliance to the DMR, including identificationof person(s) who performed the operation and components used and consumed

• The primary identification label and labeling used (for each unit, lot and batch) or themaster data used to generate the labeling

• Device identification and control numbers used

4.2.5.3 Complaint Files

Complaint files are created and maintained to include the following information:

• Name of device

• Date the complaint was received

• Device identification or control number

• Name, address and phone number of complainant, including any associatedcorrespondence

• Nature and details of the complaint

• Dates and results of the investigation

• Any corrective action taken


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• Any reply to the complainant

4.2.5.4 Distribution Records

Distribution records include:

• Name and address of consignee

• Quantity and date dispatched

• Specific product identification, including traceability requirements (lot number or serialnumber)

4.2.5.5 Other Quality Records

Other Quality Records include records maintained to demonstrate quality system compliancefrom the following areas:

• Management Review

• Contract Review

• Design Control

• Document Control

• Purchasing

• Process Control

• Inspection and Testing

• Inspection, Measuring and Test Equipment

• Non-Conforming Product

• Corrective and Preventive Actions

• Internal Audit

• Training

4.2.6 DHF & Technical Files/Design Dossier

4.2.6.1 Drawings and product engineering specifications define the design, formulation,specifications, manufacturing, quality assurance and labeling requirement for eachproduct. Standards and other technical reference materials are maintained to support thedesign and quafification of products. Records are maintained to demonstrate achievementof quality requirements and the effective operation of the quality system.

4.2.6.2 Product technical files will be prepared to allow assessment of the conformity of productswith requirements of the Medical Device Directive 93/42/EEC, Annex VII and otherapplicable medical device regulations.



5 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITTMENT

Medtronic Diabetes executive management is committed to ensuring that the Quality Management Systemand Quality Policy are implemented, understood and maintained at all levels within the organization and toestablishing, implementing, and maintaining a documented Quality System based on a process approach.

We are committed to:

• ensuring that the quality policy is established, documented, communicated, understood, implementedand maintained at all levels of the organization

• initiating, managing and following up on the implementation of the quality policy and the QualityManagement System to ensure continuing effectiveness and compliance with all applicable requirements

• ensuring that departmental and individual objectives are established and are consistent with theCompany's overall objectives

• providing adequate resources and training to support Quality Management System development andimplementation

5.2 CUSTOMER FOCUS

We are responsible for and committed to collecting, analyzing and reacting to customer feedback andincorporating that feedback into product requirements in order to meet or exceed their requests. We arecommitted to building quality relationships with customers' and fulfilling their needs and expectations by providingthem with safe and effective products and exceptional services.

The Quality Management System is designed and implemented to ensure that customer requirements areconsistently fulfilled. Customer focused programs are implemented within the Quality System in order toensure that the voice of the customer is heard and reacted upon as well as to provide a proactive means ofaddressing potential customer issues. Management routinely monitors and reviews customer feedback andother pertinent product information to ensure that we are addressing each and every issue that may be ofcustomer concern.

5.3 PLANNING

Quality plans are established and maintained to define the quality practices, resources and activitiesimplemented to ensure that products conform to specified requirements and to customer's need andexpectations. These plans are aligned with quality objectives determined to support the quality policy.

5.4 QUALITY POLICY

The Quality Policy is implemented and maintained at all levels of the organization by operating a qualitysystem that complies with the quality standards and regulations referenced in Section 2.



Medtronic Quality Policy

We will exceed our customers'expectations by striving without reserve

for unsurpassed product quality,reliability, and patient safety through

effective, agile and compliant processes.

We will continuously improve our qualitymanagement systems, comply with all

applicable regulatory requirements, anddeliver excellence to customers throughour products, processes, services, and

relationships.



5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

The President and the Management Representative have the responsibility for the organization's adherenceto the quality assurance requirements described in this Quality System Manual and the Quality Procedures.

The organizational chart (Appendix B) identifies Senior Leadership whose organizations manage, performand verify work affecting the Quality Management System.

Specific executive responsibilities include:• Formulating a quality policy and quality objectives.• Defining the organizational structure.• Assigning authorities and responsibilities.• Appointing a management representative.• Establishing a quality plan and quality system procedures and instructions.• Reviewing the quality management system.• Ensuring that necessary resources are available to maintain the quality management system.

5.5.1 Authorized Representative

Medtronic Diabetes has designated the following organization to serve as our authorizedrepresentative responsible for marketing our products in the European Union as definedin Council Directive 93/42/EEC, Article 14:

Medtronic BVEarl Bakkenstraat 10

6422 PJ HeerlenThe Netherlands

5.6 MANAGEMENT REVIEW

The Quality Management System is reviewed by management with executive responsibility on apredetermined periodic basis to ensure its continued suitability, adequacy and effectiveness in satisfying therequirements of all applicable regulatory requirements, corporate policies, and the stated quality policy andobjectives. Records of all such reviews are maintained.

5.6.1 Management Representative

The VP of Quality is the appointed Management Representative and has the authority to definequality problems and initiate preventive measures against possible nonconformities in product,process, quality or system, as well as to define or to initiate corrective action. The ManagementRepresentative also has the authority and responsibility for the following:

• Ensuring that a quality system that meets the requirements of the quality standards cited insection 2 is established, implemented and effectively maintained.

• Reporting on the performance of the quality system at Management Review meetings as a basisfor communication and continual improvement of the quality system.

• Recording all reviews of the Quality System and maintaining the records of all such reviews.

• Ensuring the promotion of awareness of regulatory and customer requirements throughout theorganization.


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6 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES

Medtronic Diabetes shall determine and provide the resources necessary to implement the quality systemand to maintain its effectiveness in meeting regulatory and customer requirements.

Department managers are responsible for determining personnel, equipment and training requirements foremployees of their respective departments, developing and scheduling training sessions as needed tomaintain the quality system, establishing departmental training programs outside the realm of the QualitySystem and ensuring maintenance of all training files. Budgetary recommendations and requests aresubmitted to the President for review and approval.

6.2 HUMAN RESOURCES

Human Resources coordinates and provides specific training such as general orientation, rules andregulations and other company-wide trainings and core competencies identified by functional managementor as mandated by an outside authority. The Quality policy and supporting quality objectives areemphasized in training to ensure employee understanding and awareness of how their activities contribute tothe achievement of these objectives.

All records of personnel qualifications and training are maintained. Personnel assigned to perform specifictasks will be qualified on the basis of appropriate education, training, and/or experience.

As a minimum, the orientation training comprises the following topics:

• The Quality Policy

• Quality System & the employees role in maintaining and improving its efficiency

• Product Orientation with emphasis on quality characteristics

• Specific employee requirements for performing their job functions as they pertain to quality standards

• Department structure as it pertains to reporting status for training/certification purposes

• Safety training

Quality Assurance provides education on regulations and standards and ensures that training on qualityprocedures is conducted in respective departments for all employees (contract, temp and regular).

The Human Resources and Quality Departments maintain records of training and effectiveness evaluationsfor which they are responsible.

6.2.1 Quality and Compliance Training

A procedure has been established and implemented to describe the Training program used toensure compliance with Quality System standards and effectiveness of employees performingactivities affecting quality. Verification of training effectiveness is conducted and documented asnecessary through assessments, the certification program, training file reviews, audits and qualitydata evaluations.

Personnel working under special environmental conditions or performing special processes orfunctions are appropriately trained or supervised by a trained person. Special training on health,cleanliness and clothing is provided to all personnel working in clean rooms.

All personnel, including those who perform verification and validation, are made aware of defectsand errors which may occur from the improper performance of their jobs, and which can affectproduct quality and the achievement of quality objectives.



Quality Assurance personnel conduct audits on Training Records for accuracy, completeness andcompliance with regulations and internal documented procedures.

6.3 INFRASTRUCTURE

Medtronic Diabetes has established and implemented procedures for maintenance activities of the applicableinfrastructure (building, workspace, associated utilities, process equipment, etc.) to assure product quality isnot affected.

Management is responsible for assuring that the infrastructure and the work environment are adequate toachieve the planned quality objectives and product requirements. Planning of new and/or modification ofexisting infrastructure and facilities is conducted to improve productivity and/or quality, or to improve the workenvironment. Evaluations are conducted during product or process changes, capacity and/or work forceexpansions, and other such events to determine adequacy of infrastructure and/or the work environment.

Plant management ensures a suitable working environment for personnel. This is to include both human andphysical factors.

6.4 WORK ENVIRONMENT

Controlled manufacturing areas are validated and suitable for the class of the device and any associatedrisk. Personnel working in controlled manufacturing areas are trained in established requirements for health,cleanliness and clothing to assure product quality is not adversely affected. Personnel who are required towork temporarily under special environmental conditions are trained or supervised by a trained person.

Production, Quality and Engineering are responsible for identifying those operations where extremeenvironmental conditions could impact directly or indirectly the quality of the product resulting innonconformities. Work environment conditions are defined, monitored and controlled to assure compliancewith established requirements and product conformity to specifications.

Contaminated or potentially contaminated product is segregated as per Non-Conforming Product proceduresto prevent contamination of other product, the work environment and/or personnel.



7 PRODUCT REALIZATION

7.1 PLANNING AND PRODUCT REALIZATION

Planning product realization includes identification of quality objectives, product specifications and therelevant quality system requirements and related policies and procedures (levels I, II and III documents),which describe all activities to be carried out, including verification, validation, monitoring, inspection, testactivities, criteria for product acceptance and records used in the design, purchasing, manufacturing anddistribution of product.

Consideration is given to the following activities, as appropriate, in meeting specified requirements:

• Preparation of quality plans (e.g., during design control activities, by operation of quality improvementteams, and by preparation of project plans for CE marking).

• Identifying and defining the interrelation of processes throughout the organization.

• Identification and acquisition of any controls, processes, equipment (including inspection and testequipment), fixtures, resources and skills needed to achieve the required quality.

• Ensuring compatibility with the design, production process, servicing and inspection, personnel trainingrequirements, test procedures and applicable documentation.

• Updating, as necessary, quality control, inspection and testing techniques, including the development ofnew instruments.

• Identification of any measurement requirement involving capability that exceeds the known state of theart. Sufficient time is given to develop the needed capability.

• Identification of suitable verification at appropriate stages of product development.

• Clarification of standards of acceptability for all features and requirements, including those that contain asubjective element.

• Identification and preparation of quality records.

• Establish documented requirements for risk management throughout product-realization. Recordsarising from risk management shall be maintained.

7.2 CUSTOMER RELATED PROCESSES

The organization shall determine and implement effective arrangements for communicating with customersin relation to product information, inquiries, contracts or order handling.

7.2.1 Contract Review

The organization shall review all contracts and orders to assess if they are adequately defined,understood and documented and if the company has the capacity to meet contract or orderrequirements.

Records of contract reviews and actions arising from the review are maintained in accordance withthe Quality Records procedure.

7.2.2 Customer Orders

Customer orders, including orders for sales demo units, are received only for products that havebeen released for distribution.



Purchase orders and associated information (product ordered, pricing, terms, and delivery) arereviewed for accuracy. Any anomalies are resolved prior to accepting the order for furtherprocessing.

Customer information is established and maintained in a computer database, and is referencedduring order processing.

Accepted orders are then released for order picking and distribution.

7.2.3 Distributor Contracts

All distributor contracts are initiated, reviewed and approved by appropriate personnel.

Amendments to customer orders and distributor contracts are handled using the same systems usedfor initial contract review. Changes made to the original contract are communicated to the affectedfunctions.

7.3 DESIGN AND DEVELOPMENT

7.3.1 Design Control

The organization is responsible for defining specifications, and where applicable, the design anddevelopment of its products. Specifications and procedures are established and maintained toensure that product conforms to specified requirements. The Risk Management Process isperformed as part of the design control process.

A primary contact for commercial release activities will be established. For the business unit, thiscan be a project manager for product specific information or a person with overall responsibility forthe commercial release process. The business unit shall comply with .the requirements of theCommercial Release process.

7.3.2 Design and Development Planning

Written product proposal is reviewed, prioritized and approved prior to commitment of resources andproject planning.

A Project plan is prepared for design and development activities, and is assigned to qualifiedpersonnel. The plans describe or reference these activities, and define the responsibility for theirimplementation. Design and development activities are assigned to qualified personnel equippedwith adequate resources.

Project plans and product specifications are reviewed and approved prior to implementation. Theyshall include review, verification, validation and design transfer activities that are appropriate at eachdesign and development stage. It shall be reviewed, updated, and approved as design anddevelopment evolves.

Planning output s shall be documented and updated as appropriate, as design and developmentprogresses.

7.3.3 Organizational and Technical Interfaces

Project plan defines the interfaces with different groups or activities that provide input to the designand development process. Key information is documented, transmitted and reviewed regularly.

7.3.4 Design Input

Design input requirements are identified in Product Specifications. This document includes theintended use of the product, the need of the user and patient, performance features,limits/tolerances, hazard/risk, analysis, toxicity and biocompatibility, electromagnetic compatibility,compatibility with accessories/auxiliary devices, compatibility with the environment of intended use,human factors, physical/chemical characteristics, packaging and labeling, voluntary standards,


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manufacturing processes, sterility, MDRIcomplaints/failures and other historical data, previousdesign history files, device and industry standards, reimbursement strategy, environmentalrequirements, applicable statutory and regulatory requirements (AIMDD & MDD), and product safetyand reliability requirements.

Environment, Health and Safety evaluations are conducted to identify and document EHSrequirements and opportunities regarding the process, product & packaging (reference the EHSProduct Design/Manufacturing Evaluation Plan).

Incomplete, ambiguous or conflicting requirements are resolved with those responsible for imposingthe requirements before release. Discrepancies in designs are resolved with the responsiblegroup(s). Input includes device classification and compliance with the MDD Essential Requirements,Annex II. Requirements related to the safety of the medical device are identified and included asdesign input data.

7.3.5 Design Output

Design output is expressed and maintained in terms that allow an adequate evaluation ofconformance to design input requirements that can be verified and validated against. This Includesthe Essential Requirements Checklist and Risk Management File as part of the technical filesdocumentation. Design outputs are documented, reviewed, approved before release, and verified atappropriate stages of the design and development process.

Design output documentation must:

• Meet the design input requirements.

• Contain or make reference to acceptance criteria.

• Identify those characteristics of the design that are crucial to the safe and proper functioning ofthe product (e.g., operating, storage, handling, maintenance, service provisions and disposalrequirements).

7.3.6 Design Review

Formal design reviews are planned and conducted at appropriate stages of the design anddevelopment process. Participants include representatives of all functions concerned with the designstage being reviewed, as well as other specialist personnel. The purpose of design review is to verifythat design output meets design inputs, and to identify problems and possible solutions.

As a minimum, a final design review is conducted for each project. Design reviews are conductedaccording to internal guidelines. The results of design review are documented in the Design HistoryFile (DHF).

7.3.7 Design Verification

In addition to design reviews, verification activities are conducted at appropriate design stages.These activities are performed to ensure design stage output meets design stage inputrequirements. Such activities include functional testing, comparative testing, biocompatibility testing,electrical safety testing, electromagnetic compatibility testing, etc. and are identified in the projectplan.

Verification results are documented in the DHF.

7.3.8 Design Validation

Design validation is performed under defined operating conditions on initial production units, lot s orbatches. The purpose of design validation is to ensure that product conforms to defined user needsand intended use. Design validation also includes software validation and risk analysis. Validationshall be completed prior to release of products for commercial distribution.

Where data is needed to support a regulatory submission, formal clinical trials are conductedaccording to appropriate standards, regulations and internal documented procedures.


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Results of validation activities are documented and maintained in the DHF.

7.3.9 Design Changes

Design Changes are reviewed, verified and/or validated, and approved prior to implementation.

The impact of design changes on conformity with essential requirements under AIMDD and MDD,qualification status, design dossiers, risk management process or type examination certificates, isaddressed during change review.

Rationale for not conducting verification and validation for design changes shall be documented.

Design changes are documented in the device master record (DMR).

7.3.10 Market Release Activities

Ensure that all Corporate Commercial Release deliverables are addressed per applicable procedure.

7.3.11 Design Transfer

The design is transferred to manufacturing upon successful completion of the following:

• Design verification

• Design validation

• Design specifications are successfully translated into manufacturing specifications

Technology/Facility Transfer: To ensure that the process and technology have been appropriatelytransferred, devices taken from production lots shall be tested to the same Product Verification(Qualification) criteria.

7.3.12 Design History File

A DHF is established and maintained for each product. The DHF contains or references the recordsnecessary to demonstrate that the design was developed in accordance with the approved designand development plan.

All records that illustrate the execution of the design activities are considered design history record.Those used in the manufacturing of the products are referred to as Device Master Records. Otherrelated information that is not part of DMR will be placed in the DHF.

7.4 PURCHASING

Medtronic Diabetes reviews, evaluates and qualifies its suppliers, including consultants and will purchaseonly from those that can satisfy the specified quality requirements. Supplier performance is regularlymonitored.

7.4.1 Evaluation of Suppliers and Consultants

All suppliers, including those responsible for performing outsourced processes are evaluated andselected on the basis of their ability to meet specified/contract requirements.

All suppliers are approved based on an assessment of their quality system and one or more of thefollowing criteria:

• Capability and performance history

• First article inspection

~MedtronicSave Date Type Document Sheet Ver.


• Review and approval by the Supplier Management Review Team

• Qualification test results

Supplier performance is monitored, documented, and periodically evaluated to ensure continuedability to fulfill requirements. Quality records of acceptable suppliers are established and maintained.

Written procedures are established and maintained for planning and implementing supplier audits toverify whether quality activities and related results comply with the requirements and specificationsof Medtronic Diabetes.

Supplier audits apply to, but are not limited to, processes, products, services, and quality systems orelements thereof and may be performed depending on the nature of the services, materials,components or products provided. Supplier audits are carried out by trained and qualifiedpersonnel.

7.4.2 Remote Operation Sites

Inter-Corporate Operating Procedures (ICOPs) and/or Quality Agreements are established to identifythe roles and responsibilities and to define the interactions and relationships between operatinglocations, including Medtronic Business units.

7.4.3 Purchasing Data

Purchase Orders and/or contracts are used to define and reference the product or service orderedand applicable requirements. Requirements include product identification, specifications or drawingscontaining all relevant technical data, processing and/or inspection instructions. Purchasingdocuments are reviewed and approved prior to release and communication to suppliers.

All Purchase Orders are reviewed to ensure that the requirements are adequately defined and thatthe supplier has the capability to meet contractual requirements. Purchasing documents include,where appropriate, an agreement that suppliers notify Medtronic Diabetes of changes in theproducts, processes or services they provide to the organization. Purchasing records are maintainedas part of Quality Records in accordance with established procedures.

Copies of purchasing documents are retained to the extent required by the particular requirementsfor traceability.

7.4.4 Verification of Purchased Product

All materials/products used for the development and manufacturing are inspected or otherwiseverified in accordance with specified requirements.

Where verification of purchased products or materials is necessary at a supplier's facility, theverification arrangements, verification procedure and the methods of product release are included inthe material/product specification or the Purchase Order. Records of verification are maintained.

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 Process Controls

Procedures are established and maintained to control environmental conditions, personnelrequirements, manufacturing material and contamination. Buildings are of suitable design toassure orderly handling and to prevent mix-ups. Equipment used in the manufacturing process isreviewed and is appropriately designed, constructed and installed to facilitate maintenance,adjustment, cleaning, and use. Automated and special processes are validated and controlledaccording to established procedures.


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7.5.2 Production Processes

Assembly Procedures, Work Instructions and Operating Procedures are established to define andcontrol the production processes. Specific requirements for personnel, material, equipment,methods, and quality criteria are included in these documents.

Production processes are reviewed and approved according to established procedures prior toimplementation. Changes are verified, or where appropriate, validated according to establishedprocedures prior to release.

Production processes are planned and documented and carried out under controlled conditions toensure that Medtronic Diabetes products conform to specifications.

These conditions include the following:

• Use of suitable production and servicing equipment, and a suitable working environment.

• Compliance with reference standards/codes, quality plans and/or documented procedures.

• Monitoring and control of suitable process parameters and product characteristics.

• The approval of processes and equipment, as appropriate.

• Criteria for workmanship, which are stipulated in the clearest practical manner.

• Special processes are identified and qualified.

This includes a process, which cannot be fully verified by subsequent inspection and testing of theproduct and where, for example, processing deficiencies may become apparent only after theproduct is in use. Qualified operators carry out the processes and parameters are continuouslymonitored and controlled to ensure that the specified requirements are met.

The requirements for any qualification of process operations, including associated equipment andpersonnel, are specified.

Records are maintained for qualified processes, equipment and personnel as appropriate. Thequality records shall identify the follOWing:

• The process used.

• The date the process was performed.

• The identity of the operator performing the process.

7.5.3 Personnel

Personnel requirements such as health, cleanliness, personal practices, and clothing are definedand documented in the appropriate quality system plans, policies and procedures. The requirementsfor health, cleanliness, and clothing of personnel, if contact between such personnel and product orenvironment could adversely affect the product, are established, documented, and maintained.Personnel are properly trained on these requirements.

7.5.4 Building and Environmental Control

Buildings are of suitable design and contain sufficient space and associated utilities to performnecessary operations, prevent mix-ups, and assure orderly handling.

Procedures are established as part of the quality plan to control environmental conditions andsystems, which may have an adverse effect on product quality. Environmental control systems,including the equipment, are periodically inspected to verify proper operation.



7.5.5 Cleanliness of Product

Procedures are defined to prevent contamination of equipment or product by substances that mayhave an adverse effect on product quality, including manufacturing material. The requirements forcleanliness of product are established, documented and maintained.

7.5.6 Equipment and Maintenance

Equipment used for production is reviewed to ensure that it meets specified requirements and isappropriately designed or fabricated, and installed to facilitate maintenance, adjustment, cleaning,and use.

The Preventative Maintenance of Equipment procedure delineates responsibility and establishes themanner in which preventative maintenance operations will be performed on all Medtronic Diabetesequipment utilized in the development and the production of Medtronic Diabetes devices, and howmodifications and repairs are to be recorded. In addition, it establishes that regular maintenance isperformed on production equipment to ensure continued process capabilities.

7.5.7 Automated and Special Processes

When automated processes or computer software are used as part of production or the qualitysystem, they are validated for the intended use according to established procedures. All changesare verified or validated before final implementation.

Special processes (sterilization, packaging, and other processes where the results cannot be fullyverified by subsequent inspection and test) are validated and documented according to approvedprocedures. Procedures for monitoring and controlling process parameters are established andmaintained. Changes are reviewed, evaluated, and documented.

7.5.8 Servicing Activities

Service is provided to product during and beyond the warranty periods. Procedures are defined fordesignated functions involving customer service and product repair.

Customer services, including customer complaints, are provided for distributed products inaccordance with their specific contract provisions and/or warranty.

Returned product is received, analyzed, serviced and/or upgraded by designated functional unitaccording to established procedures.

All quality standards used in the repair/upgrade process are equivalent to the correspondingactivities in manufacturing to ensure that the serviced product meets its current specification.

Service reports are maintained to include:

• The name of the device

• Device identification and/or control number

• Service date

• Individual servicing the device

• The service(s) performed and component replacement if any

• The test and inspection data

Service reports are analyzed with appropriate statistical methodology to provide trending of fieldexperience and product failure. Information is used to identify any potential corrective action.

7.5.9 Identification and Traceability

Procedures are established and maintained for identifying product during all stages of receipt,production, storage, distribution and services. Production records, distribution records and implantrecords are established and maintained with required traceability information to facilitate correctiveaction.



7.5.9.1 Product Identification

Product is identified with a part number correlating to corresponding drawings, specificationsor other technical documents. This part number is established and controlled throughout themanufacturing process.

At time of receipt a tracking number is assigned to all products (including components,materials and finished products) used in development, manufacturing and service. Uniqueserial numbers are assigned to finished instruments. Lot numbers are assigned to finisheddisposables.

Materials, in-process and finished products are identified and segregated throughoutproduction to ensure that there are no mix-ups between conforming and non-conformingproducts, and between approved and quarantined products.

7.5.9.2 Product Traceability

Batch numbers are assigned to all components, materials and products upon receipt. Theintegrity of product identification and traceability is maintained throughout the manufacturingprocess.

Lot numbers or serial numbers are assigned to finished products for device trackingpurposes. Production records are established and maintained to include date ofperformance, personnel, operations performed, materials used and their tracking numbers,equipment, and inspection and test results.

For Implantable products, the extent of traceability includes records of the specifiedenvironmental conditions.

Distribution records are maintained for direct distributed product, including returned and redistributed product. Medtronic Diabetes distributors are required to maintain their respectivedistribution records.

Implantation records are maintained for all implanted product.

7.5.10 Customer Property

Medtronic Diabetes will maintain adequate procedures to ensure the proper handling of all customerproperty when it is under the organization's control, or being used by the organization.

Medtronic Diabetes will comply with all USA HIPAA (Health Insurance Portability and AccountabilityAct) Regulations. Policies to protect customer's confidential health information have been adopted.

7.5.11 Preservation of Product

Methods for product handling, preservation, storage, packaging and delivery of product are definedfor affected functional areas. Procedures are established and maintained for the control of productwith a limited shelf life.

The environment for product storage is controlled. Returned products are properly segregated anddisinfected to prevent contamination of other products, the manufacturing environment andpersonnel. Product packaging is designed and constructed for its intended use. Procedures aredefined for the control and distribution of finished devices, including all labeling activities.

All received materials, components, and products are properly labeled and controlled with part andlot numbers. All materials and components to be used in manufacturing processes are received,controlled, and stored in such a manner as to be protected from misidentification, misuse andcontamination by substances that could adversely affect device safety or effectiveness.

All areas where materials are stored and used are clean, sanitary and organized in a manner as toprevent misidentification or misuse or contamination that could have an adverse effect on devicequality.

~MallronicSave Date Type Document Sheet Ver.


7.5.11.1 Handling

Materials and products are handled according to requirements specified in proceduresand work instructions.

Containers holding product are suitably selected for the intended use. Equipment usedfor internal transportation of product is maintained.

Anti-static wrist straps, glove and protective clothing are provided to prevent damage,deterioration or contamination of product.

Written procedures are established and maintained for the control of products, whichrequire special storage conditions. Such special storage conditions are controlled andrecorded.

When product is returned to Medtronic Diabetes or its distribution centers and itsshipping parameters can be inspected without removal from packaging (e.g. Sensor andDisposables) it shall be re-inspected to labeling and product requirements prior to beingrestocked. Product that can be affected by environmental factors (e.g. temperature)shall have procedures established to determine suitability of the product prior torestocking.

7.5.11.2 Storage

Product is stored and preserved in controlled, restricted areas.

Product with limited shelf life and/or expiration requirements is periodically monitored.

Procedures are established for the control of stockrooms &storage areas, includingmethods for authorizing receipt from & dispatch to these areas.

7.5.11 .3 Packaging & Labeling

Packaging is designed and specified to provide adequate protection against damageand/or contamination. Where applicable, the packaging is designed to maintain sterility.

Procedures are established and maintained to control the following labeling activities:labeling design and changes, labeling review and approval, labeling storage and control,and labeling operations.

Packaging and marking processes (including materials used) are controlled to the extentnecessary to ensure conformance to specified requirements.

For sterile medical devices, written procedures are established and maintained toensure that:

• The medical device is presented in a container, which maintains the sterility of themedical device.

• The medical device is capable of being presented in an aseptic manner, if its useso requires.

• The package clearly reveals when it has been opened.

• The medical device is manufactured and sterilized by an appropriate validatedmethod.

• Medical devices are manufactured in appropriately controlled conditions.

• The labeling of the packaged medical devices distinguishes between identicaland/or similar products sold in both sterile and non-sterile conditions.

• The identity of the person(s) who perform(s) the packaging procedures and thefinal labeling operation is recorded.

~M£dtronicSave Date Type Document Sheet Ver.


7.5.11.4 Preservation

Product is stored and preserved in controlled designated areas to prevent deteriorationand contamination.

Preservation measures include the following: maintenance of sterile conditions ofproduct, maintenance of static free conditions for electro-static sensitive products,protection for fragile products, temperature controls and humidity and clean-roomconditions as specified by requirements.

7.5.11.5 Delivery

Procedures are established in Finished Goods areas for the control and distribution offinished devices, including the review of sales orders and removal of expired product.

Distribution records including the name and address of the shipping consignee aremaintained as Quality Records.

7.5.11.6 Installation

Installation activities are excluded from this manual because they are not applicable toMedtronic Diabetes medical devices.

7.6 CONTROL OF MONITORING AND MEASUREMENT DEVICES

7.6.1 Inspection and Testing

All purchased products, labels/labeling used for manufacturing are subjected to inspection andtesting, or otherwise verified in accordance with defined instructions to ensure conformance tospecified requirements. This shall include determination of applicable methods, including statisticaltechniques and the extent of their use. Inspection, testing and verification activities are conducted atstrategic stages of the product realization development process in accordance with the plannedarrangements and documented procedures.

Acceptance or rejection decisions, including the identity of personnel performing inspection and/ortesting, are documented. Products, labels/labeling are prevented from use and/or shipment until therequired acceptance activities are completed.

7.6.1.1 Receiving Acceptance Activities

Products used for manufacturing are inspected or otherwise verified in accordance withdocumented procedures prior to releasing for manufacturing. Acceptance or rejection isdocumented. Non-conforming products are segregated and prevented from use.

The level of incoming inspection performed is based on the nature of the product, thedependence of finished product quality on the material, the amount of control exercised atthe subcontractor's facility and the recorded evidence of conformance provided.

Product is not used or further processed until compliance to specified requirements is met.

7.6.1.1 In-Process Acceptance Activities

In-process inspections and test activities are performed in accordance with approved WorkInstructions and quality plans. In process acceptance activities are documented.Manufacturing Process Audits may be performed to augment in process inspection activities.

Product will not be processed beyond any established routine operation, unless otherwiseapproved and documented, until all acceptance criteria have been met. Non-conformingproducts are segregated and prevented from use.



Product released to manufacturing prior to proper verification is positively identified to allowimmediate recall and replacement in the event of nonconformity to specified requirements.

7.6.1.2 Final Acceptance Activities

All finished products are subjected to testing, inspection and/or verification according toestablished procedures. Acceptance or rejection is documented.

Finished products include finished instruments, finished disposables and device accessories.Finished devices will not be released for distribution until final acceptance activities havebeen completed and documented.

7.6.1.3 Inspection and Test Records

Acceptance records are maintained in accordance with established procedures. Theserecords are part of the Device History Record (DHR).

7.6.2 Inspection, Measure and test Equipment

All inspection, measuring and test equipment, including automated and software driven testequipment, are reviewed for their intended purpose and capability to produce valid results.Procedures are established and maintained to ensure that equipment is routinely calibrated andmaintained. Calibration procedures will include specific directions and limits for accuracy andprecision. Calibration standards used for inspection, measuring, and test equipment will betraceable to acceptable standards, both national and international. Outside subcontractors used forcalibration of measuring and test equipment will conform to the same requirements.

7.6.2.1 Control of Inspection, Measuring And Test Equipment

Measurements and their required accuracy are evaluated, specified and documented.Equipment is selected and approved to ensure that the required measurements, accuracy,and precision are met. Only approved equipment is used for production purpose.

All equipment used to demonstrate product conformance to specified requirements areroutinely calibrated and maintained. Calibration procedures will include specific directionsand limits for accuracy and precision.

Calibration standards are traceable to National Institute of Standards and Technology orequivalent international standards. Where National or International standards are notavailable, an in-house or an independent reproducible standard may be used.

Calibrated equipment is identified with a control number and a calibration label. Thecalibration label includes the date of last calibration, calibration due date, and theidentification of the person performing the calibration.

Out-of-calibration conditions are reviewed by Quality Assurance to determine what actionneeds to be taken.

The handling, preservation, and storage of inspection, measuring, and test equipment issuch that the accuracy and fitness for use are maintained. Procedures are defined anddocumented to include provisions for handling, preservation, storage, and maintenance ofequipment, to ensure its accuracy and suitability for use.

Software installed in test equipment is verified and validated for its intended use according toestablished procedures. In-house developed software applications are verified andvalidated. For purchased software, validation activities may be waived via a certification froman approved sub-contractor. Software changes are reviewed to determine if validation,verification or certification is required.

The validity of previous inspection and test results is assessed and documented wheninspection, measuring or test equipment is found to be out of calibration.


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Suitable environmental conditions for the calibrations, inspections, measurements, and testsbeing carried out are specified when necessary.

Records pertaining to the selection, control, calibration and maintenance of inspection,measuring, and test equipment are maintained.

7.6.3 Inspection and Test Status

The identification of product status shall be maintained throughout production, storage and servicingof the product to ensure that only product that has passed the required inspections and tests (orreleased under an authorized concession) is dispatched. The authority responsible for the release ofconforming product is defined.

7.6.3.1 Conforming Products

Operator 10, electronic signature, stamps, or initials and date on the Device HistoryRecords verify completion of inspections. Operations may not be performed unlessrecords indicate that all previous operations have been completed.

7.6.3.2 Non Conforming Products

Non-conformities are identified, segregated, and dispositioned according to establishedNon-Conforming Material procedures.

7.6.3.3 Authority to Release Products

Only authorized individuals with the appropriate training have the authority to releasefinished product for distribution.

Procedures are established and maintained to ensure that only those authorizedpersonnel are designated to perform release activities.


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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL

Procedures have been developed and implemented for monitoring, measurement, analysis and improvementactivities to ensure product and process conformity and to maintain the effectiveness of the qualitymanagement system. Each process works together to ensure that all possible improvements are made andpreventive actions taken to ensure the continual maintenance and efficiency of the Quality System.

8.2 MONITORING AND MEASUREMENT

8.2.1 Feedback

Feedback is obtained through various internal and external sources in order to maintain theeffectiveness of the QMS by providing early warnings of quality problems. Sources of feedbackinclude but are not limited to production trends, complaint/return trends, internal audit results,Corporate and third party audit results, post-market surveillance, non-conforming product (incomingand in-process) as well as Management Reviews. Feedback is evaluated and filtered through ourCAPA system. More details about our continuous improvement system are included in section4.1.4.1 of this manual.

8.2.2 Internal Audit

A comprehensive program of planned and documented Quality Management System audits iscarried out. Procedures are established and maintained for planning and implementing internalquality audits to verify that quality activities and results comply with planned arrangements, as wellas to monitor the effectiveness of Quality System.

Audits are scheduled on the basis of the status and the importance of the activity and are conductedby trained and qualified personnel independent of those having direct responsibility for the auditedactivity.

Identified non-conforming conditions are documented and reported to responsible managers.Corrective actions, including a re-audit of findings, are documented.

Each main activity comprising the Quality System will be audited at planned intervals. In addition toscheduled audits, certain activities may be selected for more frequent auditing, depending on theirstatus, importance, and past compliance history.

An internal audit schedule and plan will be developed each year. The plan will list dates, the areasto be audited, the dates audits were completed, and the signature of the internal auditor.

A checklist may be completed by the audit team and used as a tool during audits to evaluate anddetermine whether all the activities corresponding to ISO 13485, MDD and AIMDD requirements,and QSRlGMP including 21 CFR§ 803, comply with the specified requirements.

Management personnel responsible for the audited areas are required to take timely correctiveaction on the deficiencies found during the audit.

Follow-up audit activities are required to verify and record the implementation and effectiveness ofthe corrective action taken. The file shall document audit dates, auditors, and final closure dates.

The results of internal quality audits form an integral part of the input to the management reviewactivities.

Audit files are proprietary and not available to any outside agency without the permission ofCorporate Quality and Regulatory and/or Medtronic Legal Council.

8.2.2.1 Auditing

Audits of the Quality Management System consist of the following activities:

• Selection of lead auditor(s) and auditor(s)


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• Preparation of the audit plan

• Conducting the audit

• Reviewing the audit findings

• Conducting the closing meeting

• Issuing the audit report

• Implementing the corrective action

• Verifying the effectiveness of the corrective action

• Re-audit if necessary

8.3 CONTROL OF NON CONFORMING PRODUCT

Non-conforming product is identified, segregated, quarantined, documented, evaluated and prevented frombeing used or distributed. The Material Review procedure details how the disposition of non-conformingproduct is handled.

8.3.1 Review and Disposition of Non-Conforming Product

All non-conformities are identified and documented according to established procedures. Nonconforming product is segregated or otherwise clearly identified.

Non-conformities are reviewed, evaluated and dispositioned according to established MaterialReview Board procedure.

When rework activities are required, the procedure is reviewed and approved by the same functionsthat approved the original Work Instructions and will include repair, retest, and/or re-inspectionrequirements. Prior to authorization and approval of the work instruction, a determination of anyadverse effect of the rework upon product shall be made and documented.

Regulatory Affairs department is responsible for verifying that non-conforming product is accepted byconcession only if regulatory requirements have been met. Records of the identity of the person(s)authorizing the concession shall be maintained.

Determination of the disposition, including notification of other functions and/or departments affectedby the non-conformity, is documented.

8.4 ANALYSIS AND DATA

Where appropriate, procedures are defined to identify the required statistical techniques for establishing,controlling, and verifying the acceptability of process capability and product characteristics. Techniques aredefined based on valid statistical rationale.

8.4.1 Identification of Need

The need for the use of statistical techniques is identified. Statistical techniques may be needed inguiding the design and modification of products, evaluating product performance, controllingproduction processes, establishing inspection and sampling procedures and in the trend analysis ofdevice non-conformities. The appropriate statistical personnel review the choice of techniques.

8.4.2 Procedure

Statistical procedures will reference the recognized source for each technique, or otherwise theassumptions supporting its use.

Procedures are defined to ensure that statistical techniques are regularly reviewed for conformity toassumptions and appropriateness of purpose using applicable information and feedback from nonconforming products and audit reports.


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8.5 IMPROVEMENT

The causes of observed or potential non-conformities are investigated, and corrective or preventive action isdetermined and implemented, to eliminate or minimize recurrences. Actions taken are to a degreeappropriate to the magnitude of problems and commensurate with the risks encountered.

Non-conformities from processes, work operations, quality records, internal audit reports, technical servicereports, clinical service reports including customer complaints, and failure analysis reports are investigated toidentify the source of non-conformity.

Appropriate measures and statistical methods are used as needed to evaluate the effectiveness of theCorrective and Preventative Action (CAPA) system and to identify trends and opportunities for preventiveaction.

Personnel within the organization are aware of and trained in the appropriate use of this process.

All records regarding preventive and corrective actions are maintained as Quality Records.

8.5.1 Improvements

The organization shall identify and implement any changes necessary to ensure and maintain thecontinued suitability and effectiveness of the quality management system through the use of theQuality Policy, quality objectives, audit results, analysis of data, corrective and preventive actionsand management reviews.

8.5.2 Corrective Action

Corrective action may be initiated as the result of:

• Identification of product non-conformity.

• Accumulation of minor product nonconformities of a similar character.

• Identification of process or operation non-conformity.

• Recurring problem with a process or )Nork operation.

• Non-conformances observed during internal audits.

• A noncompliance observed during an internal, customer, or third-party audit.

• Customer complaints, failure analysis and service reports.

• Non-conformance of procured material.

• Regulatory Affairs review of Medical Device Reports.

• Post-Market feedback, including information received through the Medical Vigilance process,product complaints, and field performance problems reported by servicing, literature review,reported experiences with similar products, and other information from customers.

• Other conditions that do not comply with the documented quality system and/or FDA cGMP's,15013485 or MDD requirements.

• Appropriate analytical and statistical tools are used to generate accurate and timely informationfor making decisions involving product/process quality, reliability or regulatory compliance.

Corrective action procedures include:

• Effective handling of customer complaints and reports of product non-conformities.

• Investigating the root cause of non-conformities.

• Identifying the action(s) needed to correct re-occurrence of non-eonformance and if appropriate,updating documents. .



• Application of controls to insure that corrective action is taken and is effective.

• Recording the results of any investigation(s) and/or action(s) taken.

• Implementing and recording changes in design and process.

• Ensuring that information related to the non-conformity is communicated to appropriatepersonnel, including management with executive responsibility.

• When required, reporting the necessary information to the appropriate regulatory entities.

8.5.3 Field Corrective Action Policy

When product quality issues are identified that require a communication to customers, or a correctiveaction when a product quality issue is identified, a Field Corrective Action Plan is developed andapproved by the responsible senior management, Corporate Quality and applicable seniorgeography management or their designee.

8.5.4 Preventative Action

Preventive actions are initiated by utilizing the information from:

• Product non-conformity.

• Process or operation non-conformity.

• Non-conformances observed from internal audits.

• Customer complaints, failure analysis and service reports.

• Non-conformance of procured material.

• Regulatory Affairs review of Medical Device Reports.

• Risk analysis results.

Preventive action procedures include:

• Identifying the action(s) needed to prevent re-occurrence of non-conformance.

• Determination of the steps needed to deal with any problems requiring preventive action.

• Application of controls to insure that preventive action is taken and is effective.

• Recording the results of any investigation(s) and of action(s) taken.

• Implementing and recording changes in design and process.

• Ensuring that relevant information on actions taken is communicated to the appropriatepersonnel, including management with executive responsibility to be submitted for managementreview.

Appropriate sources of information such as processes and work operations which affect productquality, concessions, audit results, quality records, service reports and customer complaints areused to detect, analyze and eliminate potential causes of nonconformities.

A documented feedback system is used for input into the corrective and preventative action systemand is maintained to provide early warnings of quality problems for products and includesinformation obtained on quality problems from similar products.



APPENDIX ACorrelation between the Quality Manual sections, ISO 13485:2003, FDA 21 CFR Part 820,

MDD 93/42/EEC, the AIMD 90/385/EEC, the requirements for combination products and the aoolicable Medtronic Diabetes Policies and Procedures

.Quality·:.aanua1',lYJ .

Section

Section 0Section 1Section 2Section 3

Section 4

Section 5

150 13485: 2003 QualityS,ystem. Element

o Introduction1 Scope2 Normative References3 Terms and Definitions

4 Quality Management System4.1 General Requirements4.2 Documentation Requirements

5 Management Responsibility5.1 Management Commitment5.2 Customer focus5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority &Communication5.6 Management review

QSR21 CFR 8~0

Subpart A-General Provisions820.1 -Scope820.3 -Definitions

820.5 Quality SystemSubpart D -- Document Controls820.40 -Document ControlsSubpart M--Records820.186 Quality System records

SUbpart S--Quality System Requirement820.20 Management Responsibility

·tORCPolicies

029 Regulatory and Enforcement ActionPolicy

001 Corporate Documentation Structurefor Quality, Regulatory and ClinicalResearch

028 Quality Records and DocumentControl

007 Electronic Records and Signatures

022 Quality System ManagementResponsibility

050 Quality Management Reviews

053 Quality Policy

Medtronic mab~tes

SOP{si .

SOP101-02Regulatory Inspection

D9195331 Quality ManualSOP102-01 Quality ManagementSystemSOP105-01 Document/Data ControlSOP105-02 Documentation,GeneralSOP105-03 Document Types,Formats, Numbering and ApprovalSOP105-05 Change Control &PQRSSOP105-06 ECOIECR ProcessSOP105-13 Diabetes EDMS(Electronic Document Mgt. Sys.)SOP116-D1 Quality RecordsSOP116-02 Retention,Maintenance, Indexing, Filing andStoring

SOP101-01 ManagementResponsibility & Management·Review



--- -,-

-Quality.- ... J., ·.... 'A • -:::-

-15013485: 20:03 QuaUty-,-'

QSR. Medtronic Oi;abet~s;

:Manual CQRCSection System 'E1el1le-nt - ~1 CFR'8!O Policies' SOP(s)

Section 66 Resource Management 820,25 -Personnel 020 Personnel Training SOP118-01 Training6.1 Provision of resources6.2 Human resources SOP109-01 Process Control6.3 Infrastructure SOP109-13 Gowning, Mfg Areas6.4 Work Environment

7 Product Realization Subpart C--Design Controls 014 Design Controls SOP103-01 Contract/Sales Order820.30 - Design Controls ReviewSection 7 7.1 Planning & Product Realization820.181 Device Master record SOP104-01 Design Control7.2 Customer related processes820.184 Device History record SOP104-08 Product Risk Mgt.7.3 Design and development

SOP106-01 Supplier Evaluation7.4 Purchasing Subpart F--ID & Traceability 017 Product ID & Traceability Policy SOP106-02 Purchasing7.5 Product and service provision 820.60/65 -ID & TraceabilitySOP109-01 Process Control7.6 Control of monitoring and measurement

Subpart K-Labeling & Packaging 021 Labeling & Packaging Control SOP110-01 Inspection & Testingdevices820.120/130 Device Packaging & Label SOP111-01 Inspection, Test &

Measuring Equip.Subpart G--Production & Process 024 Production & Process Control SOP115-01 Product Handling &820.70 -Production and Process 003 Manufacturing Process Validation Preservation820.75 Process Validation 034 Product Safety Risk Management SOP115-02 Storage820.72 Inspection/MeasurelTest Equip. 041 Product Software Lifecycle SOP115-03 Packaging & Delivery

047 Mfg. implementation &Transfer SOP115-04 Label ControlSubpart E--Purchasing Controls 043 Product Change Control SOP115-05 Regulatory Specs for820.50 Purchasing Controls

019 Purchasing Controlslabeling a medical deviceSOP119-01 Servicing

040 Quality Rqts. for Outsourcing ofProduct Development or Mfg. of FinishedDevices, Drugs or Biologics

045 OEM Policy002 Commercial Release Policy

Subpart N-Servicing 012 Service Requirements820.200 Servicing 016 Handling, Storage, Distribution &

Subpart L-Handling/Storage/DistributionlDevice Installation Policy018 Product Distribution Release

Installation Authorization820.140 Handling820.150 Storage820.160 Distribution820.170 Installation



QlJanly.Manual

,;Section

Section 8

l~O q3485: 2.003 'Quality. System'i:lem;nt

.....

8 Measurement Analysis &Improvement8.1 General8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis and data

QSR2fcFR 820

:",

Subpart O--Statistical Techniques820,50 -Statistical Techniques820.22 Quality AuditSubpart H--Acceptance Activities820.80 Receiving, in-process, & finisheddevice acceptance820.86 Acceptance StatusSubpart I Nonconforming Product820.90 Nonconforming ProductSubpart J --Corrective and PreventiveAction820.100 -Corrective and preventive Action820.198 Complaints

CQRCPolicies

030 Corrective and Preventive Action027 Complaint Handling and Reporting023 Control of Nonconforming Product006 Product Hold Order004 Field Corrective Action026 MDT Quality &Compliance Audit013 Product Acceptance Activities

Medtronie Dhl'betesSOP(s)

SOP114-01 CAPASystemSOP114-02 Complaint HandlingSystemSOP114-03 Product Correctionsand RemovalsSOP114-05 ContinuousImprovement SystemSOP114-06 Quality ImprovementSystemSOP114-16 GCAPA TrackWiseSystemSOP113-01 Control ofNonconforming ProductSOP113-04 Material PurgeProcedureSOP114-10 Product HoldsSOP117-01 Internal Quality AuditsSOP120-01 Statistical Techniques

CombinationProduct

,".,' c,,',

,.

N/A

" ;-

>. ~OM$tNATION.:PRC?DUC1"I·

21 CFR Parts: N/A• 210 Current Good Manufacturing

Practice in Manufacturing,Processing, Packaging, or Holding ofDrugs; General

• 211 Current Good ManufacturingPractice for Finished Pharmaceuticals

SOP402-03 Combination Products,Guidelines and Responsibilities ofthe Quality Unit

Note 1: Not all corporate policies are included in Appendix A, however a full list can be accessed at http://sitebuilder2/sites/CorpPD/default.htm.

Note 2: For Combination Products the relevant sections of 21 CFR 210/211 apply.


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APPENDIX B: MEDTRONIC DIABETES SENIOR LEADERSHIP

Senior Vice President &President, Diabetes

*vp VPQuality Operations

VPVP/GM Patient Financial

CGMBU Services &InformationTechnology

VP VPUS Sales Human Resources

,

VP VPPump Marketing & Legal

GlobalReimbursement

CMO Sr. DirectorGlobal Med Affairs. ProgramClinical, Education Management

VPVPR&D Finance

Pumps & ClosedLoop

IVP/GMDeveloped &

EmergingMarkets

* DENOTES THE MANAGEMENT REPRESENTATIVE


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