ATL QUALITY MANUAL Rev K.docx

ConfidentialDocument: QM-ATL UtahRevision:KQuality ManualPage: 38 of 38ATL TECHNOLOGYQUALITY MANUALPlease address all inquires to the Director of Quality, ATL Technology, USA9/9/2010Approvals:NameTitleSignatureDateArvin BurnsSR. Quality Engineer / AuthorDavid McDonaldDirector of QualityJohn HollowayVP EngineeringChuck BonacciPresidentBrad BrownCEORevision HistoryRevision:Effective Date:Author:Updates:H26 May 2006Initial Creation (ISO9001:2000)I15 May 2009Revisions to update to ISO9001:2008 / ISO13485:2003 standardsJ15 July 2009Revisions to update to ISO9001:2008 / ISO13485:2003 standardsJ.129 June 2010D. McDonaldRevision to update for English clarity & format.J.223 August 2010E. MancoRevision to produce ATL Utah quality manual for edits and updates J.330 August 2010A. BurnsRevisions to bring the QM compliant to ISO 9001 and ISO 13485 standardsJ.49 September, 2010D. McDonaldCorrections to grammar, terminology and content based on the review processes and input.K9 SeptemberA. BurnsReleased final copy with all revisions.TABLE OF CONTENTS0Introduction50.1General50.2Process Approach50.3Relationship with other Standards51Scope61.1General61.2Application and Exclusions62Normative references73Definitions and Conventions83.1ISO 13458:2003 Terms and Definitions84Quality management system104.1General requirements10Figure 1134.2Documentation requirements145Management Responsibility175.1Management Commitment175.2Customer focus175.3Quality policy175.4Planning185.5Responsibility, Authority and Communication195.6Management review206Resource management216.1Provision of resources216.2Human resources216.3Infrastructure216.4Work environment227Product realization237.1Product realization Planning237.2Customer-related process237.3Design and development257.4Purchasing277.5Production and service provision288Measurement, analysis and improvement338.1General338.2Monitoring and measuring338.3Control of nonconforming product358.4Analysis of Data358.5Continuous Improvement369Contacts389.1Primary Contacts:389.2Alternate Contacts:380 Introduction0.1 GeneralThis quality manual and standard specify the requirements for the ATL Technology Quality Management System and is used by our organization for design, development and the provisioning of related services0.2 Process ApproachATL Technology QMS is based on the SIPOC process approach. Any activity that receives inputs and converts them to outputs is considered a process. Often the output from one process directly forms the input to the next. 0.3 Relationship with other StandardsWhile this Quality Manual is a standalone document it follows the basic format of ISO 9001:2008 and adds the additional requirements of ISO 13485 in the appropriate sections. This manual, for convenience of use is formatted for the medical device community.1 Scope1.1 GeneralThis Quality Manual contains policies and documents that have been implemented into ATL Technologys Quality Management System (QMS) to demonstrate the companys ability to consistently provide product and services that meet customer and regulatory requirements. This Quality Manual establishes compliance with the standards and regulations listed in section 1.3 “Applicable standards and regulations” of this manual. This Quality Manual applies to research and development, design, production, sales, marketing, installation and servicing activities conducted by ATL Technology. This Quality Manual follows the basic format of ISO 9001:2008 and adds the additional requirements of ISO 13485 in the appropriate sections.1.2 Application and ExclusionsWhere any requirements of ISO 9001:2008 or ISO 13485:2003 cannot be applied due to the nature of ATL Technology activities and its products, they will be considered for exclusion. ATL Technologys QMS satisfies the full range of requirements of ISO 9001:2008 as well as ISO 13485:2003 standards with the following exclusions.1.2.1 Exclusions Ref: Para: 7.5.1.2.2 Installation ActivitiesJustification:ATL Technology does not provide or perform any installation activities and therefore is excluded from this requirement Ref: Para: 7.5.1.2.3 Servicing ActivitiesJustification:ATL Technology does not provide or perform any servicing activities and therefore is excluded from this requirement Ref: Para: 7.5.1.3 Sterile Medical Device RequirementsJustification:ATL Technology manufactures and/or assembles medical devices that may require further sterilization following shipment to our customers and may conduct additional actions as required by the customer to facilitate this requirement. However ATL does not currently provide or perform any sterilization activities internal to ATL facilities. Ref: Para: 7.5.3.2.2 Implantable Medical Device RequirementsJustification:ATL Technology does not currently manufacture or assemble any implantable medical device and therefore is excluded from this requirement2 Normative references2.1.1 ISO 9001:2008, Quality management systems Requirements2.1.2 ISO 13485:2003, Quality management standard for Medical Devices2.1.3 ISO 14001:2004, Environmental management system Requirements2.1.4 Cross reference matrix of ATL Technology procedures, forms, &c with ISO 9001 and ISO 13485 requirements. See appendix A2.1.5 Documentation Master List. See appendix B2.1.6 ATL Technology Quality Manual 9001 2008 rev. 2.1.7 NOTE: This document is maintained on the Companys network. It is the responsibility of the user to verify that this copy is of the latest revision.2.1.8 BPI Matrix Business Performance Indicator Matrix. 2.1.9 Company Information DetailATL Technology Corporate Offices Utah (ATLUSA) 1335 West 1650 NorthSpringville, UT 84663Telephone: 801-489-9100Representative: Chuck Bonnaci, PresidentAcura Technology Limited Dongguan (ATL-DG)Xi Zing Road, XiTou VillageKang Le Nan Main Road, HouJie Town, Dong Guan City, Guang Dong province, PRCTelephone: 0086-769-8863 3868Fax: 0086-769-8863 0468Representative: Ken Wang, General Manager3 Definitions and ConventionsThe terms and definitions given in ISO 9001:2008, Quality management systems Requirements and ISO 13485:2003, Quality management standard for Medical Devices apply. Other terms are added as new or different processes are reviewed and edited. Where the term applicable standards and regulations are used in the Quality Manual, all documents listed in section 1.3. Applicable standards and regulations of this document apply.Throughout this Quality Manual, where the term “organization” is used it refers to ATL Technology. BPI Matrix Business Performance Indicator Matrix, containing quality objectives from the Management Review Meeting. CAPA Corrective and Preventive Action. NC Non conformity Executive Management ATL Technologys President, CFO, CEO, VP of Engineering, Director of Quality, Taiwan Office General Manager and China Facility General Manager forms the Executive Management Team. The Executive Management Team has responsibility for performance of the business and the quality management system. QMS - Quality Management System. QP- Quality procedure - procedures and standards in the body of the Quality Manual identify reference documents supporting a particular element of the manual. Documented procedure. Means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. 3.1 ISO 13458:2003 Terms and Definitions 3.1.1 Active implantable medical device Active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure 3.1.2 Active medical deviceMedical 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 gravity3.1.3 Advisory noticeNotice 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 the use of a medical device, the modification of a medical device, the return of the medical device to the organization that supplied it, or the destruction of a medical device NOTE: Issue of an advisory notice might be required to comply with national or regional regulations. 3.1.4 Customer complaintWritten, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market 3.1.5 Implantable medical deviceA medical device intended to be totally or partially introduced into the human body or a natural orifice, or to replace an epithelial surface or the surface of the eye, by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which can only be removed by medical or surgical intervention NOTE: This definition applies to implantable medical devices other than active implantable medical devices. 3.1.6 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 NOTE: Some regional and national regulations refer to “labeling” as “information supplied by the manufacturer.” 3.1.7 Medical deviceAny instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. NOTE: This definition has been developed by the Global Harmonization Task Force (GHTF).3.1.8 Sterile medical devicesCategory of medical device intended to meet the requirements for sterility NOTE: The requirements for sterility of a medical device might be subject to national or regional regulations or standards 4 Quality management system4.1 General requirementsExecutive Management has established and maintains a documented Quality Management System in order to meet the requirements of the ISO 13485:2003, Quality management standard for Medical Devices as well as the ISO 9001:2008, Quality management systems Requirements standard. As the business scope of ATL Technology expands to encompass new markets and regions; the QMS is updated to incorporate any regulatory requirements mandated by the governments of these markets and regions. The QMS is also periodically reviewed for its effectiveness in accordance with the standards with the goal of increased product quality, process efficiency and customer satisfaction. Executive Management has: a) Identified and determines the processes needed for the QMS and their application throughout the organization per the Documentation Master List. In addition, ATL Technology has ensured that any regulatory or international standards that are applicable to the organization are in place and the processes meet the requirements. (Example: The Canadian CMDR requirements, the Medical Device Directive 93/42/EEC of the European Union, and the Quality System requirements of the FDS 21 CFR 820)b) Determines the sequence and interaction of these processes. This sequence and interaction are documented per the Process Interaction Matrix c) Determines criteria and methods needed to ensure that both the operation and control of these processes are effective per the Management Review Procedure, QP-060d) Ensures the availability of resources and information necessary per the Resource Management Procedure, QP-600 and information necessary to support the operation and monitoring of these processes per the Infrastructure Procedure, QP-630 including the development of appropriate departments to handle defined responsibilities as part of the QMSe) Develops systems to monitor, measures where applicable, and analyses these processes per the Management Review Procedure, QP-060 and implemented processes necessary to achieve planned results and developed systems to monitor and provide for continual improvement of these processes.f) Implements actions necessary to achieve planned results and continual improvement of these processes per the Management These processes are managed by ATL Technology in accordance with ISO 9001:2008, Quality management system Requirements and ISO 13485:2003, Quality management standard for Medical Devices standards and regulations. Where ATL Technology outsources any process that affects product conformity to requirements, ATL Technology ensures control over such processes per the Supplier Partnership Program. The type and extent of control applied to these outsourced processes are defined within the within the QMS.This document is maintained on the Companys network. It is the responsibility of the user to verify that this copy is of the latest revision. These processes include management activities, provision of resources, product realization, measurement, analysis and improvement.Ensuring control over outsourced processes does not absolve ATL Technology of the responsibility of conformity to all customer statutory and regulatory requirements. The type and extent of control that ATL Technology applies to the outsourced process are influenced by:i) The potential impact of the outsourced process on ATL Technology capability to provide product that conforms to requirements,ii) The degree to which the control for the process is shared,iii) The capability of achieving the necessary control through the Supplier Partnership Program. This document is maintained on the Companys network. It is the responsibility of the user to verify that this copy is of the latest revision.The extent of the ATL Technologys QMS is based on:i) The size of the organization and type of activities,ii) The complexity of processes and their interactions, andiii) The competence of personnel per the Training Procedure. Quality System Process FlowgFigure 1 - Model of a ATL Technologys process-based QMS Value adding activities Process flow Information flow ImprovementATL Technology Key ProcessesKey ProcessProcess OwnerMetricReporting FrequencyOutgoing QualityPlant General ManagerDPPMEach lotIn Process QualityQuality ManagerDPPMHourlyCustomer On Time DeliveryProduction Manager% OTDPer Shipment4.2 Documentation requirements4.2.1 GeneralATL Technology QMS documentation includes the followinga)Documented statements of the quality policy per the Quality Policy and quality objectives per the BPI Matrix,b)This Quality Manual,c)Documented procedures and records required by ISO 9001:2008, Quality management system Requirements and ISO 13485:2003, Quality management standard for Medical Devices standards and regulations. d)Documents per the Documentation e)Documentation needed by the organization to ensure the effective planning, operation and control of processesf)Any other documentation specified by national or regional regulationsWhere international standard specifies that a requirement, procedure, activity or special arrangement be documented it shall also be implemented, maintained and periodic reviewed for effectively.For each type of medical device, ATL Technology has established and maintains a unique file identifying documents defining product specifications and quality management system requirements. These documents define the complete manufacturing process, and if applicable, installation and servicing. These include following:a)Design History Files (DHF) when ATL has design authority, otherwise this is customers responsibility.b)Device Master Records (DMR)c)Production History Reportsd)Technical Filese)Device History Records (DHR)ATL Technology maintains its documents on various media such as paper, electronic, magnetic, optical, etc.The ATL Technology documentation system consists of four levels of documentation:a) This Quality Manual - is the top level document which briefly describes the quality policy, quality targets, and the quality systemb) Quality Procedures (QPs) are the second level of documents which describes the necessary methods and procedures of quality activities for achieving the quality policy.c) The Quality Plan and working instructions (SOP) which specially describe the methods and steps required to accomplish certain