AS9120B & ISO 9001:2015 Quality Systems Manual

Transcription

AS9120B & ISO 9001:2015Quality Systems ManualThis manual is the property of SERVTRONICS INC. It must not be reproduced in whole or in part orotherwise disclosed without written consent from SERVTRONICS INC.The Quality Manual shall be made available to all employees via the ServTronics, Inc intranet under thepublic drive of the network server. This is a “read only” file as to prohibit any unauthorized changes. All, ifany, hard copies of this manual shall be considered and marked UNCONTROLLED unless annotatedotherwise. An electronic Copy of the Quality Manual will be made available to Customer, Vendors, andRegulatory Agencies via the company website: http://www.servtronics.com/Dale Spears, PresidentServTronics, Inc.

TABLE OF CONTENTSAS9120B Quality ManualRevision: -QUALITY SYSTEMS MANUAL - TABLE OF CONTENTSTable of Contents . .1Introduction . 61.0 Scope . .71.1 Purpose of this Manual .72.0 Normative References .82.1 Conformance and Compliance Standards .83.0 Terms and Definitions 84.0 Context of the Organization 114.1 SERVTRONICS INC. and Its Context 114.2 The Needs and Expectations of Interested Parties . . .114.3 Determining the Scope of the Quality Management System . .114.4 Quality Management System and Its Processes . .124.4.1 General .124.4.2 Requirements .125.0 Leadership . .135.1 Leadership and Commitment . 135.1.1 General . 135.1.2 Customer Focus . .145.2 Quality Policy . 145.2.1 Developing the quality policy 14AS9120B Quality ManualPage 1 of 52

AS9120B Quality ManualRevision: -5.2.2 Communicating the quality policy . .155.3 Organizational roles, responsibilities and authorities . 155.3.1 Management Representative .156.0 Planning .166.1 Planning . .166.2 Quality Objectives and Planning to Achieve Them . 176.3 Planning of Changes . .177.0 Support . .177.1 Resources . . .177.1.1 General . .177.1.2 People . 187.1.3 Infrastructure . . 227.1.4 Environment for the Operation of Processes 237.1.5 Monitoring and Measuring Resources . .237.1.5.1 General . 237.1.5.2 Measurement traceability . . 237.1.6 Organizational Knowledge . 247.2 Competence .247.3 Awareness 257.4 Communication . 257.5 Documented Information . .267.5.1 General .267.5.2 Creating and Updating . .267.5.3 Control of Documented Information . 26AS9120B Quality ManualPage 2 of 52

AS9120B Quality ManualRevision: -7.5.3.1 Purpose . . .267.5.3.2 Requirements . 268.0 Operation 288.1 Operational Planning and Control . 288.1.1 Not Used . . .298.1.2 Configuration Management . . 298.1.3 Not Used . . .308.1.4 Prevention of Counterfeit Product . 308.1.5 Prevention of Suspected Unapproved Parts . .308.2 Requirements for Products and Services . .308.2.1 Customer Communication . .308.2.2 Determining the Requirements Related to Products and Services . 318.2.3 Review of Requirements for Products and Services . .318.2.3.1 General . .318.2.3.2 Documented Information 318.2.4 Changes to Requirements for Products and Services . 328.3 Design and Development of Products and Services Not Applicable . . 328.4 Control of Externally Provided Processes, Products, and Services . . 328.4.1 General . .328.4.1.1 Evaluating External Providers . .338.4.1.2 Type and extent of control of external provision . 338.4.2 Verification of External Providers . .348.4.2.1 Verification of externally provided processes, products and services .348.4.3 Information for External Providers . .35AS9120B Quality ManualPage 3 of 52

AS9120B Quality ManualRevision: -8.5 Production and Service Provision . .368.5.1 Control of Production and Service Provision .368.5.1.1 Control of Equipment, Tools, and Software Programs . .378.5.2 Identification and Traceability .378.5.3 Property Belonging to Customers Or External Providers 388.5.4 Preservation . .398.5.5 Post-Delivery Activities .398.5.6 Control of Changes 398.6 Release of Products and Services . 408.7 Control of Nonconforming Outputs . . .408.7.1 General . .408.7.2 Documented Information Nonconforming Output . . .419.0 Performance Evaluation . 429.1 Monitoring, Measurement, Analysis, and Evaluation . .429.1.1 General . . .429.1.2 Customer Satisfaction . . 429.1.3 Analysis and Evaluation . . .439.2 Internal Audit . 439.2.1 General . .439.2.2 Requirements of the Internal Audit . .449.3 Management Review . . .449.3.1 Inputs of the Management Review . .449.3.2 Outputs of the Management Review . 4510.0 Improvement . 45AS9120B Quality ManualPage 4 of 52

AS9120B Quality ManualRevision: -10.1 General . 4510.2 Nonconformity and Corrective Action . . 4610.2.1 Action Taken . 4610.2.2 Documented Information of Nonconformities . . 4610.3 Continual Improvement . 46Revision History . . 48Appendix A – Sequence and Interaction Diagram . 49Appendix B – Organization Chart . . 50Appendix C – Quality Policy . . . .51Appendix D – Objectives, Metrics & Targets . .52AS9120B Quality ManualPage 5 of 52

AS9120B Quality ManualRevision: -INTRODUCTIONSERVTRONICS INC. developed and implemented a Quality Management System in order todocument the company’s best business practices, better satisfy the requirements andexpectations of its customers and improve the overall management of the company.To fully understand SERVTRONICS INC. and its context, SERVTRONICS INC. determinedthe external and internal issues that are relevant and that affect its ability to achieve theintended results of the quality management system.The Quality Management System of SERVTRONICS INC. meets the requirements of theinternational standard ISO 9001. The system addresses the design, development, production,installation, and servicing of the company’s products. It incorporates the process approachwhere consistent and predictable results are achieved more effectively and efficiently whenactivities are understood and managed as interrelated processes.This process approach provides for the management of the quality system and its processesthrough the application of a “Plan-Do-Check-Act” methodology and a focus on “Risk-BasedThinking” leading to the prevention of undesirable outcomes.The manual is divided into sections that correlate to the Quality Management System sectionsof ISO 9001:2015. The manual describes the Quality Management System, delineatesauthorities, inter relationships and responsibilities of the personnel responsible for performingwithin the system. The manual also provides the documented information with procedures orreferences for all activities comprising the Quality Management System that ensures thecompliance to the necessary requirements of the standard.This manual is used internally to guide the company’s employees through the variousrequirements of the ISO standard that must be met and maintained in order to ensurecustomer satisfaction, continuous improvement and provide the necessary instructions thatcreate an empowered work force.This manual is used externally to introduce our Quality Management System to our customersand other external organizations or interested parties. The manual is used to familiarize themwith the controls that have been implemented and to assure them that the integrity of theQuality Management System is maintained and focused on customer satisfaction andcontinuous improvement.The manual is approved by top management.Dale Spears, President: DaleAS9120B Quality ManualSpears Date: 3/1/18Page 6 of 52

AS9120B Quality ManualRevision: -1.0 – SCOPEThe scope of the Quality Management System is defined as everything within directcontrol and authority of SERVTRONICS INC. The scope includes the organization’s mainprocesses for its product realization and service categories that include primary functionsDistribution Management of Electronic Components.Non-Applicability SERVTRONICS INC. has determined that Section 8.3 Design is notapplicable. The Organization maintains the design criteria/product requirements and theorganization has not begun any design of service/logistics support to date. Justification:SERVTRONICS INC. is a distributor of electronic components and does not design ordevelop products, Customer specify all principal product characteristics.The Quality Management System will demonstrate its ability to consistently provide productsand services that meet customer and applicable statutory and regulatory requirements, andaims to enhance customer satisfaction through the effective application of the system.1.1 PURPOSE OF THIS MANUALSERVTRONICS INC.’s overall commitment to quality in work and customer service is definedthrough its Standardized Business Processes. Each of these processes align with the QualityManagement System herein to create organized goals and a strategic organization. TheQuality Management System as described herein this Quality Manual defines thecorporation’s commitment: By demonstrating its ability to consistently provide quality products and services thatmeet all customer satisfactory requirements. By addressing customer satisfaction through application of the system includingprocesses and procedures for continual improvement of quality and prevention of nonconformities. Through employee empowerment, allowing the freedom for innovation and actions toimprove performance. Through orderly change management that will maintain a high level of service andorganization in the events of technological, technical skill or capability changes withinSERVTRONICS INC.’sThis Quality Systems Manual provides an overview of the quality processes, polices, and keyrequirements for the corporation. This Quality Systems Manual is the source of reference forall matters conferring and revolving around quality. It is available for inspection by ourcustomers, potential customers, third party quality auditors and regulatory agencies.AS9120B Quality ManualPage 7 of 52

AS9120B Quality ManualRevision: -2.0 – NORMATIVE REFERENCESThe following documents, in whole or in part, are normatively referenced in this document andare indispensable for its application. For dated references, only the edition cited applies. Forundated references, the latest edition of the referenced document (including anyamendments) applies.2.1 CONFORMANCE AND COMPLIANCE STANDARDSThe Quality Systems Manual is intended to demonstrate conformance to3.0 SAE AS9120B Quality Management Systems – Requirements for Aviation, Space andDefense Organizations. This standard has been revised to incorporate therequirements of ISO 9001 as such, ISO 9001 has also been listed below as a standardto which this quality management system conforms. ANSI/ISO/ASQ Q9001 American National Standard: Quality Management Systems –Requirements. This standard is the United States’ legal equivalent of the ISO 9001international standard. These two standards may be referenced interchangeably in thismanual and the quality management system. In all other references to thisconformance standard in this manual or quality management system documents, thereference to the year of the current revision may or may not be used. Reference to thisconformance standard also implies reference to all guidance standards containedtherein.– TERMS AND DEFINITIONS3.1 Article: Material, part, component, assembly, or appliance which is listed by the designorganization as eligible for installation in/on the product or included in the design dataapproved by the authority.3.2 Authorized Release Certificate: Document attesting that a product is released for use(e.g., release or return to service) and certifying that the activities performed, and theresults achieved, conform to established organization, regulatory, and customerrequirements.3.3 C&PA: Corrective & Preventive Action3.4 Certificate of Conformity (commonly referred to as a ‘Certificate ofConformance’): Documented information that attests to product conformity; conformanceto defined process, design, and specification requirements.3.5 Counterfeit Part: An unauthorized copy, imitation, substitute, or modified part (e.g.,material, part, component), which is knowingly misrepresented as a specified genuine partAS9120B Quality ManualPage 8 of 52

AS9120B Quality ManualRevision: -of an original or authorized manufacturer. NOTE: Examples of a counterfeit part caninclude, but are not limited to, the false identification of marking or labeling, grade, serialnumber, date code, documentation, or performance characteristics.3.6 Distributor: An organization carrying out the purchase, storage, splitting, or sale ofproducts without affecting product conformity. The term ‘organization’ in the context of thisstandard means a distributor.3.7 DMR: Defective Material Report3.8 GFP/E: Government Furnished Property or Equipment3.9 GFM: Government Furnished Material3.10 HSPP&D: Handling, Storage, Packaging, Preservation & Delivery3.11 Infrastructure: Buildings, workspace, utilities, process equipment and supportingservices provided by SERVTRONICS INC. determined as necessary to achieve conformityof product requirements.3.12 IQA: Internal Quality Audits3.13 ISHA: Inventory Storage Handling Area3.14 ISO: International Organization for Standardization3.15 M&MD: Monitoring & Measuring Devices3.16 MC: Master Copy3.17 Metrology: The science and practice of precision measurement, specifically thevarious disciplines of calibration required by SERVTRONICS INC.’s3.18 MR: Management Representative3.19 NCR: Non-Conformance Report – A system and specific document used to reportand disposition non-conformances identified within our quality system.3.20 OA: Office Administrator3.21 OPSA: Order Process Staging Area3.22 PDF: Portable Document Format, a file system extension used to designate adocument that conforms to the requirements of the international standard ISO 32000-13.23 Product Safety: Maintaining the state of product so that it is able to perform to itsdesigned or intended purpose without causing unacceptable risk of harm to persons ordamage to property.3.24 Product: The end result of meeting all contractual terms and conditions. Throughoutthis document and all documents related to the Quality Management System the word“service” is identical in meaning to “product.”3.25 Procedure: Maintained DocumentationAS9120B Quality ManualPage 9 of 52

AS9120B Quality ManualRevision: -3.26 PO: Purchase Order3.27 QM: Quality Manual3.28 QMS: Quality Management System3.29 QPs: Quality Procedures3.30 R&A: Responsibility & Authority3.31 Record: Retained Documentation3.32 RFQ: Request for Quote3.33 Risk: An undesirable situation or circumstance that has both a likelihood of occurringand a potentially negative consequence.3.34 RMA: Return Material Authorization3.35 Splitting: The division of product either physically or by batch quantity, withoutaffecting the product characteristics or conformity.3.36 Special Requirements: Those requirements identified by the customer, ordetermined by the organization, which have high risks of not being met, thus requiring theirinclusion in the operational risk management process. Factors used in the determination ofspecial requirements include product or process complexity, past experience, and productor process maturity. Examples of special requirements include performance requirementsimposed by the customer that are at the limit of the industry’s capability, or requirementsdetermined by the organization to be at the limit of its technical or process capabilities.3.37 Suspected Unapproved Part: A part for which there is objective and credibleevidence indicating that the part is likely an unapproved or counterfeit part. NOTE: Thisincludes: articles shipped to an end user by a supplier who does not have direct deliveryauthorization from the approved production organization; new articles that do not conformto the approved design/data; articles that have not been manufactured or maintained by anapproved source; articles that have been intentionally misrepresented, including counterfeitparts and articles with incomplete or inappropriate documentation.3.38 Test Report: Documented information that shows objective evidence provided byeither the manufacturer or a certified testing facility that the product conforms with specificdesign requirements, product or performance characteristics.3.39 Unapproved Part: A part that was not produced or maintained in accordance withapproved or acceptable data and applicable statutory, regulatory, and customerrequirements.3.40 USG: United States GovernmentAS9120B Quality ManualPage 10 of 52

AS9120B Quality ManualRevision: -4.0 – CONTEXT OF THE ORGANIZATION4.1 SERVTRONICS INC.AND ITS CONTEXTSERVTRONICS INC. has determined external and internal issues that are relevant to itspurpose and its strategic direction and that affect its ability to achieve the intended result(s) ofits quality management system.SERVTRONICS INC. will monitor and review the information about these external andinternal issues.4.2 THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIESDue to their effect or potential impact on the organization’s ability to consistently provideproducts and services that meet customer and applicable statutory and regulatoryrequirements, SERVTRONICS INC. has determined:a) The interested parties that are relevant to the quality management system.b) The requirements of these interested parties that are relevant to the quality managementsystem.Top Management has identified internal interested parties as employees and owner(s) ofthe company. External interested parties include customers, vendors, regulatory agencies,and certification bodies.SERVTRONICS INC. monitors and reviews the needs and expectations of all interestedparties and their relevant requirements during Management Review Meetings.4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEMSERVTRONICS INC. has determined the boundaries and applicability of the qualitymanagement system to establish its scope.When determining this scope, SERVTRONICS INC. will consider:a) The external and internal issues referred to in 4.1b) The requirements of relevant interested parties referred to in 4.2c) The products and services of the organization SERVTRONICS INC. will apply all therequirements of this International Standard if they are applicable within the determinedscope of its quality management system.The quality manual outlines the policies, procedures and requirements of the QualityManagement System. The system is structured to comply with the conditions set forth in theInternational Standard ISO 9001:2015 and SAE AS9120B. The purpose of registration is thewarehousing and distribution of fasteners and electro-mechanical hardware, primarily tocommercial aerospace and medical equipment industries. Interaction of process defines andAS9120B Quality ManualPage 11 of 52

AS9120B Quality ManualRevision: -explains the contracting, subcontracting, warehousing and managing of the fasteners andelectro-mechanical hardware distribution process.SERVTRONICS INC. has determined that Section 8.3 Design is not applicable. TheOrganization maintains the design criteria/product requirements and the organization has notbegun any design of service/logistics support to date. Justification: SERVTRONICS INC. is adistributor of fasteners and electro-magnetic hardware and does not design or developproducts, Customer specify all principal product characteristicsConformity to this International Standard may only be claimed if the requirements determinedas not being applicable do not affect the organization’s ability or responsibility to ensure theconformity of its products and services and the enhancement of customer satisfaction.4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES4.4.1 GENERALSERVTRONICS INC. will establish, implement, maintain and continually improve aquality management system, including the processes needed and their interactions, inaccordance with the requirements of this International Standard.The organization’s quality management system will also address customer and applicablestatutory and regulatory quality management system requirements.SERVTRONICS INC. has determined the processes needed for the quality managementsystem and their application throughout SERVTRONICS INC. and shall:a) Determine the inputs required and the outputs expected from these processesb) Determine the sequence and interaction of these processesc) Determine and apply the criteria and methods (including monitoring, measurements andrelated performance indicators) needed to ensure the effective operation and control ofthese processesd) Determine the resources needed for these processes and ensure their availabilitye) Assign the responsibilities and authorities for these processesf) Address the risks and opportunities as determined in accordance with the requirementsof 6.1g) Evaluate these processes and implement any changes needed to ensure that theseprocesses achieve their intended resultsh) Improve the processes and the quality management systemNOTE: Sub clauses a) through h) are considered essential to the adoption of a process approach.4.4.2 REQUIREMENTSTo the extent necessary, SERVTRONICS INC. shall:a) Maintain documented information to support the operation of its processesAS9120B Quality ManualPage 12 of 52

AS9120B Quality ManualRevision: -b) Retain documented information to have confidence that the processes are being carriedout as plannedSERVTRONICS INC. will establish and maintain documented information that includes:a. A Quality Manual that contains information including documents, records and otherrelated documented information established for the quality management system, orreference to it.b. a general description of relevant interested parties (see 4.2 )c. the scope of the quality management system, including boundaries and applicability(see 4.3)d. a description of the processes needed for the quality management system and theirapplication throughout the organizatione. the sequence and interaction of these processesf. assignment of the responsibilities and authorities for these processesSee PM4.4 Quality Management System and its Processes5.0 – LEADERSHIP5.1 LEADERSHIP AND COMMITMENT5.1.1 GENERALTop management will demonstrate leadership and commitment with respect to thequality management system by:a) Taking accountability of the effectiveness of the quality management systemb) Ensuring that the quality policy and quality objectives are established for the qualitymanagement system and are compatible with the strategic direction and the context ofthe organizationc) Ensuring the integration of the quality management system requirements into theorganization’s business processesd) Promoting the use of the process approach and risk-based thinkinge) Ensuring that the resources needed for the quality management system are availablef) Communicating the importance of effective quality management and of conforming to thequality management system requirementsg) Ensuring that the quality management system achieves its intended resultsh) Engaging, directing and supporting persons to contribute to the effectiveness of theAS9120B Quality ManualPage 13 of 52

AS9120B Quality ManualRevision: -quality management systemi) Promoting improvementj) Supporting other relevant management roles to demonstrate their leadership as it appliesto their areas of responsibilityNOTE: Reference to “business” in this International Standard can be interpreted broadly to meanthose activities that are core to the purposes of the organization’s existence; whether SERVTRONICSINC. is public, private, for profit or not for profit.5.1.2 CUSTOMER FOCUSTop management will demonstrate leadership and commitment with respect to customerfocus by ensuring that:a) Customer requirements and applicable statutory and regulatory requirements aredetermined, understood and consistently metb) The risks and opportunities that can affect conformity of products and services and theability to enhance customer satisfaction are determined and addressedc) The focus on enhancing customer satisfaction is maintainedd) Product and service conformity and on-time delivery performance are measured andappropriate action is taken if intended results are not, or will not be, achieved5.2 QUALITY POLICY5.2.1 DEVELOPING THE QUALITYPOLICYTop management has established, implemented and maintained a quality policy that isidentified in Appendix C SERVTRONICS INC. that has ensured that this policy:a) Is appropriate to the purpose and context of SERVTRONICS INC. and supports itsstrategic directionb) Provides a framework for setting quality objectivesc) Includes a commitment to satisfy applicable requirementsd) Includes a commitment to continual improvement of the quality management systemThe quality policy and quality objectives are relevant to the company’s goals and theexpectations and needs of its customers. This policy has been communicated to all employeeswithin the scope of the Quality Management System. Quality is paramount to the culture ofSERVTRONICS INC.Top management ensures that its Quality Policy is understood through proper employeetraining and continuous communication.5.2.2 COMMUNICATING THE QUALITYAS9120B Quality ManualPOLICYPage 14 of 52

AS9120B Quality ManualRevision: -The quality policy shall:a) Be available and be maintained as documented information.b) Be communicated, understood and applied within the organization.c) Be available to relevant interested parties, as appropriate.5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES5.3.1 MANAGEMENT REPRESENTATIVETop management will ensure that the responsibilities and authorities for relevant rolesare assigned, communicated and understood within the organization. Top management willassign the responsibility and authority for:a) Ensuring that the quality management system conforms to the requirements of thisInternational Standardb) Ensuring that the processes are delivering their intended outputs;c) Reporting on the performance of the quality management system and on opportunitiesfor improvement to top managementd) Ensuring the promotion of customer focus throughout the organization;e) Ensuring that the integrity of the quality management system is maintained whenchanges to the quality management system are planned and implementedTop Management has appointed the Quality Manager/Administrator as ManagementRepresentative. As Management Representative the Quality Manager/Administrator, inaddition to the responsibilities associated with the Quality Manager/Administrator, has thefollowing authority: Ensure that processes and procedures needed for the Quality Management System areestablished, implemented and maintained Ensure that Quality Systems Manual requirements are established, implemented andmaintained in accordance with the Standard Report on the performance of the Quality Management System and document neededimprovements Act as a liaison with external parties, such as customers or auditors, on matters relatingto the Quality Management System Organizational freedom and unrestricted access to top management to resolve matterspertaining to quality. Promote awareness of customer requirements throughout the organizationNOTE: The responsibility of a management representative includes being a liaison with externalparties on matters relating to the quality management system.AS9120B Quality ManualPage 15 of 52

AS9120B Quality ManualRevision: -See PM5.0 Leadership6.0 – PLANNING6.1 PLANNING6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES6.1.1When planning for the quality management system, the organization will considerthe issues referred to in 4.1 and the requirements referred to in 4.2 anddetermine the risks and opportunities that need to be addressed

requirements of ISO 9001 as such, ISO 9001 has also been listed below as a standard to which this quality management system conforms. ANSI/ISO/ASQ Q9001 American National Standard: Quality Management Systems – Requirements. This standard is the United States’ legal equivalent of the I