Iso 9001 2015 Quality Management System-Books Pdf

ISO 9001 2015 Quality Management System
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Number M 001, Revision A, Page 2 of 22, Sean Duclos. Revision History, Date Change Notice Change Description. 11 02 2015 1001 Original Release to ISO9001 2015, Page 2 of 22. Number M 001, Revision A, Page 3 of 22, Introduction 5. 0 1 General 5, 1 1 General Error Bookmark not defined.
2 Normative References 5, 3 Terms and Definitions 5. 4 Context of the Organization 6, 4 1 Understanding the Organization and its Context 6. 4 2 Understanding the Needs and Expectations of Interested Parties 6. 4 3 Determining the Scope of the Quality Management System 6. Scope of Registration 6, 4 4 Quality Management System and its Processes 7. 5 Leadership 7, 5 1 Leadership and Commitment 7, 5 2 Policy 8. Quality Policy 8, 5 3 Organizational Roles Responsibilities and Authorities 9.
6 Planning 9, 6 1 Actions to Address Risks and Opportunities 9. 6 2 Quality Objectives and Planning to Achieve Them 9. 6 3 Planning of Changes 10, 7 Support 10, 7 1 Resources 10. 7 2 Competence 11, 7 3 Awareness 12, 7 4 Communication 12. 7 5 Documented Information 12, 8 Operation 13, 8 1 Operational Planning and Control 13. 8 2 Requirements for Products and Services 13, 8 3 Design and Development of Products and Services 14.
8 4 Control of Externally Provided Processes Products and Services 16. Page 3 of 22, Number M 001, Revision A, Page 4 of 22. 8 5 Production and Service Provision 17, 8 6 Release of Products and Service 18. 8 7 Control of Nonconforming Outputs 19, 9 Performance Evaluation 19. 9 1 Monitoring Measurement Analysis and Evaluation 19. 9 2 Internal Audit 20, 9 3 Management Review 20, 10 Improvement 21. 10 1 General 21, 10 2 Nonconformity and Corrective Action 21.
10 3 Continual Improvement 22, Page 4 of 22, Number M 001. Revision A, Page 5 of 22, Introduction, 01 General. At Millennium Precision LLC we know that an inferior component can cost you money time and. credibility In high tech manufacturing the only tolerance is zero defects We understand the. importance of prompt quote response quality manufacturing and on time delivery Millennium. Precision has achieved customer loyalty by practicing a policy of strong communication and. working closely with customers to deliver to their exact specifications. Our investment in the best technology allows our engineering department to communicate with. customers efficiently throughout the design manufacturing and assembly processes. Millennium Precision LLC, 234 Abby Road, Manchester NH 03103. Phone 603 644 1555 Fax 603 644 21555, www millenniumprecisionllc com. This Quality Manual specifies requirements that Millennium uses to address customer. satisfaction to meet customer and applicable regulatory and statutory requirements and to meet. ISO 9001 2015 requirements and is supported by additional procedures where necessary The. quality management principles stated in ISO 9000 and ISO 9004 have been taken into. consideration during the development of this Quality Policy Manual. This Quality Manual specifies the general requirements for Millennium competence towards a. management system for quality administrative and technical operations. This Quality Manual specifies requirements for a quality management system where Millennium. a Needs to demonstrate its ability to consistently provide product and services that meet. customer and applicable statutory and regulatory requirements and. b Aims to enhance customer satisfaction through the effective application of the system. including processes for improvement of the system and the assurance of conformity to. customer and applicable statutory and regulatory requirements. All the requirements of this ISO 9001 2015 are generic and are intended to be applicable to any. organization regardless of its type or size or the products and services it provides. 2 Normative References, The following documents in whole or in part are normatively referenced in this document and.
are indispensable for its application For dated references only the edition cited applies For. undated references the latest edition of the referenced document including any amendments. ISO 9001 2015 Quality management systems Fundamentals and vocabulary. 3 Terms and Definitions, For the purposes of this document the terms and definitions given in ISO 9000 2015 apply. Page 5 of 22, Number M 001, Revision A, Page 6 of 22. 4 Context of the Organization P 002, 4 1 Understanding the Organization and its Context. Millennium has determined external and internal issues that are relevant to its purpose and its. strategic direction and that affect its ability to achieve the intended result s of its quality. management system, Millennium monitors and reviews information about these external and internal issues. 4 2 Understanding the Needs and Expectations of Interested Parties. Due to their effect or potential effect on Millennium s ability to consistently provide products and. services that meet customer and applicable statutory and regulatory requirements Millennium. determined, a The interested parties that relevant to the quality management system.
b The requirements of these interested parties that are relevant to the quality management. Millennium monitors and reviews the information about these interested parties and their relevant. requirements, 4 3 Determining the Scope of the Quality Management System. Millennium has determined the boundaries and applicability of the quality management system to. establish 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 within. the determined scope of its quality management system. The scope of Millennium s quality management system is available and maintained as. documented information The scope states the types of products and services covered and. provides justification for any requirements that Millennium has determined is not applicable to the. scope of its quality management system, Conformity to ISO 9001 are only claimed if the requirements determined as not being applicable. do not affect Millennium s ability to ensure the conformity of its product and services and the. enhancement of customer satisfaction, Scope of Registration.
The Scope associated with Millennium activities and registration is. Contract Manufacturer of Swiss style machined components for. Page 6 of 22, Number M 001, Revision A, Page 7 of 22. 4 4 Quality Management System and its Processes, 4 4 1 Millennium has established implemented maintains and continually improves a quality. management system including the processes needed and their interactions in accordance with. the requirements of this International Standard, Millennium has determined the processes needed for the quality management system and their. application throughout Millennium and, a 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 measurements. and related performance indicators needed to ensure the effective operation and control. of 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 the. requirements of 6 1, g Evaluates these processes and implement any changes needed to ensure that these. processes achieve their intended results, h Improves the processes and the quality management system. 4 4 2 To the extent necessary Millennium, a Maintains documented information to support the operation of its processes See. procedure list, b Retain documented information to have confidence that the processes are being carried. out as planned See Records Table, 5 Leadership, 5 1 Leadership and Commitment.
5 1 1 General, Top management demonstrates leadership and commitment with respect to the quality. management 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 quality. management system and are compatible with the context and strategic direction of. Millennium, c Ensuring the integration of the quality management system requirements into. Millennium 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 the. quality management system requirements, g Ensuring that the quality management system achieves its intended results.
Page 7 of 22, Number M 001, Revision A, Page 8 of 22. h Engaging directing and supporting persons to contribute to the effectiveness of the. quality management system, i Promoting improvement and. j Supporting other relevant management roles to demonstrate their leadership as it applies. to their areas of responsibility, 5 1 2 Customer Focus. Top management demonstrates leadership and commitment with respect to customer focus by. ensuring 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 the.
ability to enhance customer satisfaction are determined and addressed and. c The focus on enhancing customer satisfaction is maintained. 5 2 Policy, 5 2 1 Developing the Quality Policy, Top management has established implemented and maintains a quality policy that. a Is appropriate to the purpose and context of Millennium and supports its strategic. b Provides a framework for setting quality objectives. c Includes a commitment to satisfy applicable requirements and. d Includes a commitment to continual improvement of the quality management system. 5 2 2 Communicating the Quality Policy, The Quality Policy. a is available and maintained as documented information. b is communicated understood and applied within the organization and. c is available to relevant interested parties as appropriate. Quality Policy, TO ENSURE QUALITY IS PRESENT FROM INCEPTION TO COMPLETION IN ALL. THAT WE DO, As a Service Driven Contract Manufacturer Millennium Precision Provides and. Continually Improves Quality of Product On Time Delivery and the Overall Service. Experience While Meeting or Exceeding the Requirements and Expectations of. Our Customers Millennium Precision Commits to Review the Continued Suitability. of This Policy Promotes this Throughout the Organization Assures Compliance. with All Requirements and Continually Maintains the Effectiveness of the QMS. while complying with ITAR EAR requirements, Sean C Duclos.
Page 8 of 22, Number M 001, Revision A, Page 9 of 22. 5 3 Organizational Roles Responsibilities and Authorities. Top management ensures that the responsibilities and authorities for relevant roles are assigned. communicated and understood within Millennium, Top management assigns the responsibility and authority for. a Ensuring that the quality management system conforms to the requirements of this. International Standard, b Ensuring that the processes are delivering their intended outputs. c Reporting on the performance of the quality management system and on opportunities for. improvement see 10 1 in particular to top management. d Ensuring the promotion of customer focus throughout Millennium and. e Ensuring that the integrity of the quality management system is maintained when. changes to the quality management system are planned and implemented. 6 Planning, 6 1 Actions to Address Risks and Opportunities. 6 1 1 When planning for the quality management system Millennium considered the issues referred to. in 4 1 and the requirements referred to in 4 2 and determined the risks and opportunities that. need to be addressed to, a Give assurance that the quality management system can achieve its intended results.
b Enhance desirable effects, c Prevent or reduce undesired effects and. d Achieve improvement, 6 1 2 Millennium plans, a Actions to address these risks and opportunities. 1 Integrate and implement the actions into its quality management system. processes See 4 4, 2 Evaluate the effectiveness of these actions. Actions taken to address risks and opportunities are proportionate to the potential impact on the. conformity of products and services, 6 2 Quality Objectives and Planning to Achieve Them. 6 2 1 Millennium has established quality objectives at relevant functions levels and processes needed. for the quality management system, The quality objectives are.
a Consistent with the quality policy, b Measurable. c Taken into account applicable requirements, d Relevant to conformity of products and services and to enhancement of customer. satisfaction, e Monitored, Page 9 of 22, Number M 001. Revision A, Page 10 of 22, f Communicated and, g Updated as appropriate. Millennium maintains documented information on the quality objectives dashboard. This Quality Manual specifies requirements for a quality management system where Millennium a Needs to demonstrate its ability to consistently provide product and services that meet customer and applicable statutory and regulatory requirements and b Aims to enhance customer satisfaction through the effective application of the system including processes for improvement of the system and

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