Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 1 of 32 Confluent Medical Technologies Quality Manual 1 Introduction to Confluent Medical Technologies 1.1 About Confluent Medical Technologies Confluent Medical Technologies is a developer and manufacturer of components for both medical and commercial applications. Confluent Medical Technologies is also a manufacturer of medical devices. Confluent Medical Technologies’ Headquarters is located in Fremont, California. 1.1.1 NDC has filed a “fictitious name” of Confluent Medical Technologies for use in sales related literature 1.1.2 NDC has purchased Interface Catheter Solutions Inc (ICS), making ICS a wholly owned subsidiary 1.1.3 Both organizations continue to run under previously established ISO registration certificates with business centered quality systems 1.1.4 Some quality system elements are shared across organizations. Such sharing is defined in organization specific procedures. 1.1.5 When referring to information that is common to BOTH organizations, the term “Confluent” will be applied, since Confluent is the joint legal entity and intended marketing brand of the future. When referring to specific information about each organization, the affected organization abbreviation (NDC or ICS) will be applied. . 1.2 Registrations • ISO 13485: 2003 BSI # FM 539571, NDC, Fremont, Ca • ISO 13485: 2003 BSI # FM 517760, ICS, Laguna Niguel, Ca • US FDA Registration # 3007635982: NDC, Fremont, Ca • US FDA Registration # 3009018440: Nitinol Devices and Components, Costa Rica, S.R.L., Coyol Free Zone B15 • State of California DHS # 51960: NDC, Fremont, Ca • State of California DHS # 48859: ICS, Laguna Niguel, Ca • Canadian Medical Devices Registration – 81459 Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 2 of 32 1.3 References • ISO 13485(Current Revision) Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes • ISO 14971:2012, Medical Devices - Application of risk management to medical devices • Title 21 CFR Part 820, Food and Drug Administration, “Quality System Regulation” • Title 21 CFR Part 11, Food and Drug Administration, “Electronic Records; Electronic Signatures” • Medical Device Regulations SOR/98-282 (Promulgated 1998. Latest Consolidated Version) • Medical Device Directives (MDD, 93/42/EEC, as amended) • Ministerial Ordinance #169 (Pharmaceutical Affairs Law) • Council Directive 93/42/EEC of 14 June 1993 (Consolidated 2007) 2 Scope 2.1 Application 2.1.1 Confluent Medical designs, develops and manufactures medical devices, medical device components, raw materials (for both medical and non-medical uses) and provides analytical services/consulting. Finished medical devices are manufactured in an ISO class 8 cleanroom. 2.1.2 Confluent Medical has 3 locations of business; California (Fremont and Laguna Niguel) and Costa Rica 2.1.2.1 Fremont California performs all applications listed above. 2.1.2.2 Laguna Niguel carries an exclusion for design activities, but performs all other activities. 2.1.2.3 Costa Rica is a manufacturing site. 2.1.3 Confluent Medical Technologies manages an inspection operation in Juarez Mexico, which is staffed by customer personnel in a customer owned building. This operation follows Confluent Medical Technologies procedures, but official registrations are maintained by the customer. 2.2 Exclusions - the Laguna Niguel (ICS) organization carries an exclusion for Design Control. 2.3 Non-Applicable -The Company does not provide installation or servicing for the customers. The installation and servicing requirements of ISO 13485 Sections 7.5.1.2.2, Installation Activities, and 7.5.1.2.3, Servicing Activities, are non-applicable in this quality system. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 3 of 32 3 Quality System Overview 3.1 Confluent Medical Quality Policy (translated in Spanish) (Política de Calidad de Confluent Medical) Confluent Medical Technologies is focused on high quality products and satisfied customer-partners. This is accomplished by establishing a culture of teamwork, personal responsibility for work, creativity and integrity. (Confluent Medical Technologies está enfocado en productos de alta calidad y clientes- socios satisfechos. Esto se logra estableciendo una cultura de trabajo en equipo, responsabilidad personal por el trabajo, creatividad e integridad). Confluent Medical Technologies will achieve this commitment by: (Confluent Medical Technologies alcanzará este compromiso mediante:) • Continuously improving the effectiveness of our Quality Management System, our products and our services. (Mejoramiento continuo de la efectividad de nuestro Sistema de Calidad, nuestros productos y nuestros servicios.) • Meeting regulatory requirements and satisfying the needs of our customers and partners. iCumplimiento de requisitos regulatorios y satisfacer las necesidades de nuestros clientes y socios.) • Striving to deliver high quality products with on-time delivery and superior services to achieve total customer satisfaction (Esfuerzo por entregar productos de alta calidad con entregas a tiempo y servicios superiores para alcanzar la satisfacción total del cliente.) 3.2 NDC Quality Objectives NDC considers the safety, efficacy and quality of our products to be of utmost importance. These high-level quality objectives are derived from the Quality Policy and are the foundation from which all quality goals and activities are developed. The Quality Objectives and goals or changes to them are generated during the Management Review meetings and recorded on management review meeting notes. In general, the Quality Objectives include Product Performance, Customer Communication (Complaints, returns, delivery performance), Supplier management, Training, and Corrective and Preventive Actions, and others. 3.3 ICS Quality Objectives Based upon the Quality Policy, ICS establishes quality objectives, which are clear and measurable. The objectives may include customer, product and Quality System goals that support maintaining the suitability and effectiveness of ICS QMS and products. Quality objectives are discussed, established, monitored and reported during management review meetings and departmental staff meetings. 3.4 Organizational Structures The NDC/ICS organizational structures are maintained as separate documents. Approved copies are maintained by the Quality Assurance departments. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 4 of 32 3.5 Quality System Effectiveness Quality system effectiveness is documented and monitored through periodic review of the Quality Objectives. If Quality Objectives are not sufficiently achieved, action is taken and documented via the appropriate quality systems. 3.6 Shared Quality System Elements/Documents The Confluent Medical Technologies Quality Management System shares resources across all sites in many cases, including elements involved in supplier management, document control, customer complaints, internal audits, purchasing, materials management, training and CAPA. While there may be local procedures describing the various interactions with these elements, testing and validation of such systems are considered to be applicable to all sites due to the nature of the systems. In many cases, manufacturing processes may have been validated at one site, or have instructions authored at the origin site. When moved to another site, the moving team will review the previous activity to determine its adequacy for the updated location and needs. Many documents authored prior to the acquisition of Interface Catheter Solutions will retain the original company logos until their next revision. 4 Quality Management System 4.1 General Requirements The Confluent Medical Technologies Quality Management System is customized to the business needs of customers specific to each entity. The NDC Quality Management System is established to implement the requirements of ISO 13485:2003, USFDA 21 CFR Part 820, Quality System Regulation, Canadian Medical Device Regulation (CMDR) and other standards, and to establish policies and procedures that support the objectives of the company. The ICS Quality Management System is established to implement the requirements of ISO 13485:2003, USFDA 21 CFR Part 820, Quality System Regulation and other standards, and to establish policies and procedures that support the objectives of the company. The Management with Executive Responsibility approves initial release and changes to this document through the Engineering Change Order (ECO/ECR) process. The process needed for the management of the QMS consist of: • Product Realization, where new product is developed based on customer needs and transferred to manufacturing, • Delivery to customers and • Using customer feedback to make improvements to the Product Realization process. • The customer feedback and communications processes include procedures to define the review of experience gained from devices in the post-production phase. In addition, Internal Audits and Management Review processes are used to evaluate the effectiveness of quality system and drive improvement by monitoring and measuring the outcome of these processes. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 5 of 32 Management Review also ensures availability of adequate resources and technology to support the QMS. This Quality Manual provides policy and other top-level guidance (Level I), and makes reference to Operating Procedures and Standard Operating Procedures for detailed procedures on the operation of the System (Level II). Detailed procedures for manufacturing and supporting activities are found in Travelers, Work Instructions, Inspection Plans and other Level III documents. The authority to perform the tasks identified in this document and other Quality System documents may not be delegated unless specifically stated otherwise. Such delegation is to be in writing, and the overall responsibility for proper performance of the task remains with the individual referred to in the documentation. The scope of the NDC quality system covers production of standard product, provision of analytical/design services, new product design/development and all supporting activities. The scope of the ICS quality system covers production of standard product and all supporting activities. The responsibility for the Confluent Medical Technologies quality system has been assigned to Management with Executive Responsibility (MWER). The Senior Vice- President of Quality Assurance has been designated by the President of Confluent Medical to be the Management Representative with full responsibility and authority for establishing and maintaining the quality system in accordance with Quality System requirements. The responsibility for the ICS quality system has been further assigned to the Vice-President of QA/RA for ICS, along with corresponding Management Representative duties. The process depicted below provides an overview of the Confluent Medical Technologies Quality System model. The closed loop process ensures that Confluent Medical Technologies has not only established, but also improves processes and practices on a continuous basis. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 6 of 32 Customer Needs, Customer Centric Quality System 5.0 Management Responsibility (cid:1) Management Requirements (cid:1) Contract Review (cid:1) Other procedures TBD Customer Needs 8.0 Measurement, Analysis Customer RR(EISneeOvgqi,uur oFliarnDetmAome,r eynSnt aatflse)t y, 6(cid:1)(cid:1)(cid:1)(cid:1)(cid:1).0 ROPTSOerrartsahogfoieecanuetrniyr nsip czsPgrea orC tocMiooecanendn tduCrauorhegrlseases rmTtBeDnt M(cid:1)(cid:1)(cid:1)a na4gQDQ.e0ouum caaQulleiiumttnyya etMRl niSteatyy cnCsouotraendlmtsrol (cid:1)(cid:1)(cid:1)(cid:1)(cid:1)(cid:1) INCISOnntaoAtstahennpPterid-ensACr ca t/IpitoCcmli rnoaAoopnlfcomu r MerPdopmdeivrltouatseihncrimngoeetds sseM ssnTeaBttseDrial TSeCacMtohisennfdfoaliulccoetaginloi tens Quality Policy 7.0 Product Realization (cid:1) Contract Review (cid:1) Design Control (cid:1) Supplier Management (cid:1) Product Identification (cid:1) Production Controls Product (cid:1) Inspection Procedures (cid:1) Measurement Systems (cid:1) Inspection Status (cid:1) Handling/Storage3 4.2 Documentation Requirements 4.2.1 General The Confluent Medical Technologies quality policy is stated in this Quality Manual. Top management identifies quality Objectives that meet the requirements of the quality policy annually. The quality objectives are documented in the Management Review meeting minutes. The Confluent Medical Technologies Quality Manual is the top-level document that describes the overall quality system in accordance with the stated quality policy, ISO 13485: 2003, CMDCAS and 21 CFR Part 820. The NDC Operating Procedures (OP) and ICS Standard Operating Procedures (SOP) and Quality Plans are the next level of documentation. Quality Plans provide a summary of all quality activities in support of a product or product line. Ops/SOPs establish company-wide procedures and requirements. They are generally non-technical and may use a variety of formats. Each section of this quality manual is reflected in organization-specific applicable Ops/SOPs. The third level of documentation includes (but not limited to): Departmental operating Procedures (DOP) describes the interdepartmental activities required to accomplish compliance with a Quality System requirement(s). Travelers establish the process flow and processing instructions for items produced in the facility. Verification activities are included or incorporated as steps in the process flow defined by the traveler. Detailed instructions are Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 7 of 32 normally incorporated in Work Instructions, which are referenced on the Traveler. Work Instructions (WI) provide detailed instructions that are too lengthy to be included on a traveler or other document. Work Instructions may also be created for detailed or step-by-step instructions for a process whose policies are described in an OP. Manufacturing Assembly Instructions (MAP) provide detailed work instructions primarily used by Production personnel that describes the procedure(s) used in the assembly process. Process Instructions (PI) provide detailed work instructions used for non-production/QC inspection applications, e.g. Preventative Maintenance. Inspection Plans identify specific inspections or tests to be performed, sampling plans, and the data or other records to be generated. Detailed inspection methods are documented in Work Instructions. Inspection Procedures (IP) provide detailed work instructions primarily used by Quality Assurance/Control personnel that describes the procedure(s) used during the inspection of materials, subassembly and finished devices to ascertain whether they conform to the respective specifications. Test Methods (TM) provide detailed instructions that define the procedure to conduct a specific test and/or operate specific test equipment, e.g. a Tensile tester. Inspection Data Sheets may be developed to record specific measurements or other quality data. Product drawings define company products, including dimensional, material, and functional characteristics. Tooling drawings define key tools, dies, and other production or test/inspection equipment. Product Specifications may be created for products that are not suited for drawings. Purchase Specifications define purchased items or material not appropriate for drawings. Workmanship Standards provide examples of qualitative references. Forms are used to define some activities, record inspection results, production data, or specific measurements.. Run Sheets (RS) are used to record the master process and forming parameters for specific products. Lab Notebooks record design and development activities. Protocols and associated Reports define test and validation plans and their results. Approved Supplier List shows the suppliers that may be used to purchase inventory items and certain key manufacturing materials. The last level of documentation is quality records. These documents serve as evidence of the performance of all activities that impact product quality. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 8 of 32 Device Master Records (DMRs) containing product specifications, procedures for manufacture and inspections consist of the Level III documents and Level IV records (drawings, work instructions, process instructions, inspection procedures, specifications, travelers, forms, etc.). Device History Records (DHR) or Lot History Record (LHR) also known as lot history folders, consist of process/manufacturing/inspection records for each lot. Design History File (DHF) contains design and development history for product, such as product requirements, design and development plan, FMEA/risk analysis, quality plan, design change records, validation documents etc. 4.2.2 Quality Manual The Confluent Medical Technologies Quality Manual (this document) defines the policies, application, scope, exclusions and documentation of the quality management system. 4.2.3 Control of Documents Documents that define products, processes, and the quality system are approved before controlled release and distribution. Documents are available for use in the locations required as well as online. Obsolete documents are removed when superseded. External documents such as industry or agency standards and customer drawings are controlled. Quality Assurance Document Control provides document control services; however, all employees are responsible for using correct documents, at the prescribed revision level, at all times. Obsolete documents are retained for a period specified in the operating company’s local procedure for Quality Records. External documents are controlled and issued to ensure use of correct documents and current revisions. Such documents include external customer documents (such as drawings and specifications) and other external documents, such as industry standards. 4.2.3.1 Approval and issue Controlled Documents are approved by the individuals assigned per local Document Control procedures, using local document control systems. The document control procedure is also available to approve changes in development items. Controlled copies are issued to the individuals or work areas that require them for day-to-day use. Uncontrolled reference copies may also be provided. Control status is indicated by the use of stamps with red ink on hard copies. Indexes are maintained. Documents are also maintained on-line as read only in the document control system. 4.2.3.2 Initial release and changes Initial releases and changes are processed using the local document control processes. The changes are reviewed and approved per local Document Control procedures. Changes to associated documents are initiated as part of the document control approval cycle. A history of changes is maintained for approved documentation. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 9 of 32 4.2.4 Control of Records Quality records are created and maintained to provide documented evidence of the conformance of products and systems to specifications and process requirements. The records are identified, indexed, and stored to prevent deterioration and provide access in a reasonable period of time. Secrecy, Confidentiality, and Nondisclosure Agreements may govern customer access to records. 4.2.4.1 Identification of Quality Records All documents that establish the history of the product and supporting systems are considered quality records. Exclusions include production or inspection tally sheets that are summarized on other records. 4.2.4.2 Filing and Storage For product, quality records are filed with the Lot History File or Work Order File. System records are filed by type. 4.2.4.3 Retention Records on all media will be maintained that (1) are required by law; (2) necessary to support the orderly operation of the Company; or (3) provide the basis for recovery from a disaster. All other records will be destroyed. Retention guidelines are stated in local Quality Record procedures 5 Management Responsibility 5.1 Management Commitment The progress of the business and the effectiveness of the quality system are reviewed on a regular basis by Management with Executive Responsibility. Management with executive responsibility (executive management) is responsible for establishing, implementing, and continuously improving the quality system. Personnel and other necessary resources are provided to accomplish the goals of the quality system. There are several processes by which executive management communicates to the rest of the company regarding customer, regulatory and statutory requirements and the importance of meeting these requirements. Informational meetings, plant meetings are conducted periodically. Training is conducted on a regular basis according to the requirements specified in the training procedures, this includes training to regulations, safety etc. New employees go through a series of training, so they have a thorough understanding of the company, product, customer and regulatory requirements. Management Reviews, internal and external audits are conducted periodically to ensure that the Quality System is effective. Management Review is the mechanism by which opportunities to improve are identified and resources are allocated to achieve those improvements. Quality objectives are defined at these reviews. Personnel and other necessary resources are provided to accomplish the goals of the quality system. Confluent Medical Technologies Quality Manual QM-0000, Rev. AH Page 10 of 32 5.2 Customer Focus In addition to communicating the importance of meeting customer requirements, top management ensures that customer requirements are determined, understood and met. Processes have been established to ensure device customer safety and efficacy. Within the scope of the quality management system, contracts and agreements are defined and reviewed between Confluent Medical Technologies and its customers for work to be performed or product to be delivered. Requests for Quotations (RFQ) and Purchase Orders (PO) are reviewed to assure that requirements are defined and understood, and that Confluent Medical Technologies can meet the requirements. The individual receiving the RFQ or PO (the Recipient) sponsors a Contract Review. Representatives of Sales/Customer Service, Operations (production), QA, and the Manufacturing Engineering participate in the Review, as necessary. Others may be included as needed. The review assures that the customer's requirements are defined, documented, and understood and that they can be met. Reviews include as a minimum: specification requirements, documentation, manufacturability, price and delivery. Differences and/or specification conflicts are resolved before approving the Contract Review and accepting an order. Initial reviews are approved by Managers, Directors, or higher levels in the organization. Repeat orders with previously reviewed requirements may be reviewed and approved by the Recipient. Results of the Contract Review are documented and maintained as records and are filed by Sales/Customer Service in the Customer Order File. 5.3 Confluent Medical Technologies Quality Policy The Confluent Medical Technologies Quality Policy is defined in Section 3.1 of this Quality Manual. The quality policy is communicated and understood within Confluent Medical Technologies and is reviewed periodically by top management. The quality objectives derived from the quality policy are reviewed annually and updated as needed by top management to maintain effectiveness of and compliance to the quality management system. (Section 3.2 of this Quality Manual) 5.4 Planning 5.4.1 Quality Objectives The company management team is responsible for setting quality objectives and goals for the company. Functional Managers establish goals and objectives that are aligned with company goals for their departments.