ISO 9001:2015 Quality Management System

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QUALITY MANUAL

ISO 9001:2015 Quality Management System

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Sean Duclos Owner

Number: M-001 Revision: A Page 2 of 22

Revision History

Date 11/02/2015

Change Notice 1001

Change Description Original Release to ISO9001:2015

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Contents

Introduction.................................................................................................................................................... 5 0.1 General ........................................................................................................................................ 5

1 Scope ................................................................................................................................................... 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

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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

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Number: M-001

Revision: A

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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



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.

1

Scope

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) applies.

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.

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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 system.

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 industry.

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4.4 4.4.1

4.4.2 5 5.1 5.1.1

Quality Management System and its Processes

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.

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).

Leadership

Leadership and Commitment

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;

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h) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

i) Promoting improvement; and

5.1.2

j) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

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;

5.2 5.2.1

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. Policy 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 direction;

b) Provides a framework for setting quality objectives;

5.2.2

c) Includes a commitment to satisfy applicable requirements; and d) Includes a commitment to continual improvement of the quality management system. 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

President

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