ISO 9001:2015 Quality Management System

Number:M-001Revision:APageQUALITY MANUALISO 9001:2015Quality Management SystemPage 1 of 221 of 22

Number:M-001Revision:APage2 of 22Sean DuclosOwnerRevision HistoryDateChange NoticeChange Description11/02/20151001Original Release to ISO9001:2015Page 2 of 22

Number:M-001Revision:APage3 of 22ContentsIntroduction. 50.11General . 5Scope . 51.1General . Error! Bookmark not defined.2Normative References . 53Terms and Definitions . 54Context of the Organization . 64.1Understanding the Organization and its Context . 64.2Understanding the Needs and Expectations of Interested Parties . 64.3Determining the Scope of the Quality Management System. 6Scope of Registration . 64.45Quality Management System and its Processes . 7Leadership . 75.1Leadership and Commitment . 75.2Policy . 8Quality Policy: . 85.3678Organizational Roles, Responsibilities, and Authorities . 9Planning . 96.1Actions to Address Risks and Opportunities . 96.2Quality Objectives and Planning to Achieve Them. 96.3Planning of Changes . 10Support . 107.1Resources . 107.2Competence . 117.3Awareness . 127.4Communication . 127.5Documented Information . 12Operation . 138.1Operational Planning and Control . 138.2Requirements for Products and Services . 138.3Design and Development of Products and Services . 148.4Control of Externally Provided Processes, Products, and Services . 16Page 3 of 22

Number:M-001Revision:APage94 of 228.5Production and Service Provision . 178.6Release of Products and Service . 188.7Control of Nonconforming Outputs . 19Performance Evaluation . 199.1Monitoring, Measurement, Analysis and Evaluation . 199.2Internal Audit . 209.3Management Review . 2010Improvement . 2110.1General . 2110.2Nonconformity and Corrective Action . 2110.3Continual Improvement. 22Page 4 of 22

Number:M-001Revision:APage5 of 22Introduction.01GeneralAt Millennium Precision LLC we know that an inferior component can cost you money, time andcredibility. In high tech manufacturing, the only tolerance is zero defects. We understand theimportance of prompt quote response, quality manufacturing and on time delivery. MillenniumPrecision has achieved customer loyalty by practicing a policy of strong communication andworking closely with customers to deliver to their exact specifications.Our investment in the best technology allows our engineering department to communicate withcustomers efficiently throughout the design, manufacturing and assembly processes.Millennium Precision LLC234 Abby RoadManchester, NH 03103Phone: 603.644.1555 Fax: 603.644.21555www.millenniumprecisionllc.comThis Quality Manual specifies requirements that Millennium uses to address customersatisfaction, to meet customer and applicable regulatory and statutory requirements and to meetISO 9001:2015 requirements, and is supported by additional procedures where necessary. Thequality management principles stated in ISO 9000, and ISO 9004, have been taken intoconsideration during the development of this Quality Policy Manual.This Quality Manual specifies the general requirements for Millennium competence towards amanagement system for quality, administrative and technical operations.1ScopeThis Quality Manual specifies requirements for a quality management system where Millennium:a) Needs to demonstrate its ability to consistently provide product and services that meetcustomer and applicable statutory and regulatory requirements, andb) Aims to enhance customer satisfaction through the effective application of the system,including processes for improvement of the system and the assurance of conformity tocustomer and applicable statutory and regulatory requirements.All the requirements of this ISO 9001:2015 are generic and are intended to be applicable to anyorganization, regardless of its type or size, or the products and services it provides;2Normative 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 any amendments)applies.ISO 9001:2015, Quality management systems — Fundamentals and vocabulary3Terms and DefinitionsFor the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.Page 5 of 22

Number:M-001Revision:APage4Context of the Organization (P-002)4.1Understanding the Organization and its Context6 of 22Millennium has determined external and internal issues that are relevant to its purpose and itsstrategic direction and that affect its ability to achieve the intended result(s) of its qualitymanagement system.Millennium monitors and reviews information about these external and internal issues.4.2Understanding the Needs and Expectations of Interested PartiesDue to their effect or potential effect on Millennium’s ability to consistently provide products andservices that meet customer and applicable statutory and regulatory requirements, Millenniumdetermined:a) The interested parties that relevant to the quality management system;b) The requirements of these interested parties that are relevant to the quality managementsystem.Millennium monitors and reviews the information about these interested parties and their relevantrequirements.4.3Determining the Scope of the Quality Management SystemMillennium has determined the boundaries and applicability of the quality management system toestablish its scope.When determining this scope, Millennium considered:a) The external and internal issues referred to in 4.1;b) The requirements of relevant interested parties referred to in 4.2;c) The products and services of Millennium.Millennium applies all the requirements of this International Standard if they are applicable withinthe determined scope of its quality management system.The scope of Millennium’s quality management system is available and maintained asdocumented information. The scope states the types of products and services covered, andprovides justification for any requirements that Millennium has determined is not applicable to thescope of its quality management system.Conformity to ISO 9001 are only claimed if the requirements determined as not being applicabledo not affect Millennium’s ability to ensure the conformity of its product and services and theenhancement of customer satisfaction.Scope of RegistrationThe Scope associated with Millennium activities and registration is:Contract Manufacturer of Swiss style machined components forindustry.Page 6 of 22

Number:M-001Revision:APage7 of 224.4Quality Management System and its Processes4.4.1Millennium has established, implemented, maintains, and continually improves a qualitymanagement system, including the processes needed and their interactions, in accordance withthe requirements of this International Standard.Millennium has determined the processes needed for the quality management system and theirapplication throughout Millennium, anda) Determined the inputs required and the outputs expected from these processes;b) Determined the sequence and interaction of these processes;c) Determined and applied the criteria and methods (including monitoring, measurementsand related performance indicators) needed to ensure the effective operation and controlof these processes;d) Determined the resources needed for these processes and ensure their availability;e) Assigns the responsibilities and authorities for these processes;f)Addresses the risks and opportunities as determined in accordance with therequirements of 6.1;g) Evaluates these processes and implement any changes needed to ensure that theseprocesses achieve their intended results.h) Improves the processes and the quality management system.4.4.2To the extent necessary, Millennium:a) Maintains documented information to support the operation of its processes (Seeprocedure list);b) Retain documented information to have confidence that the processes are being carriedout as planned (See Records Table).5Leadership5.1Leadership and Commitment5.1.1GeneralTop management demonstrates leadership and commitment with respect to the qualitymanagement system by:a) Taking accountability for the effectiveness of the quality management system;b) Ensuring that the quality policy and quality objectiveness are established for the qualitymanagement system and are compatible with the context and strategic direction ofMillennium;c) Ensuring the integration of the quality management system requirements intoMillennium’s business process;d) Promoting the use of the process approach and risk-based thinking;e) Ensuring that the resources needed for the quality management system are available;f)Communicating the importance of effective quality management and of conforming to thequality management system requirements;g) Ensuring that the quality management system achieves its intended results;Page 7 of 22

Number:M-001Revision:APage8 of 22h) Engaging, directing and supporting persons to contribute to the effectiveness of thequality management system;5.1.2i)Promoting improvement; andj)Supporting other relevant management roles to demonstrate their leadership as it appliesto their areas of responsibility.Customer FocusTop management demonstrates leadership and commitment with respect to customer focus byensuring that:a) Customer and applicable statutory and regulatory requirements are determined,understood and consistently met;b) The risks and opportunities that can affect conformity of products and services and theability to enhance customer satisfaction are determined and addressed; andc) The focus on enhancing customer satisfaction is maintained.5.2Policy5.2.1Developing the Quality PolicyTop management has established, implemented and maintains a quality policy that:a) Is appropriate to the purpose and context of Millennium and supports its strategicdirection;b) Provides a framework for setting quality objectives;c) Includes a commitment to satisfy applicable requirements; andd) Includes a commitment to continual improvement of the quality management system.5.2.2Communicating the Quality PolicyThe Quality Policy:a) is available and maintained as documented information;b) is communicated, understood and applied within the organization; andc) is available to relevant interested parties, as appropriate.Quality Policy:TO ENSURE QUALITY IS PRESENT FROM INCEPTION TO COMPLETION IN ALLTHAT WE DO As a Service Driven Contract Manufacturer, Millennium Precision Provides andContinually Improves Quality-of-Product, On-Time Delivery and the Overall ServiceExperience While Meeting or Exceeding the Requirements and Expectations ofOur Customers. Millennium Precision Commits to Review the Continued Suitabilityof This Policy, Promotes this Throughout the Organization, Assures Compliancewith All Requirements and Continually Maintains the Effectiveness of the QMSwhile complying with ITAR/EAR requirements.Sean C. DuclosPresidentPage 8 of 22