QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES

Transcription

1 Your Company Name QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES Origination Date: XXXX Document Identifier: Date: Document Revision: QMS-00 QMS Policies and Procedures Latest Revision Date Abstract: This handbook documents (your Company's) quality management system policies and procedures. Orig

2 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures REVISION LOG Issue Date Comment Author Orig DOCUMENT CHANGE RECORD Issue Item Reason for Change NOTE: Company policies herein are expressed from the perspective of "As-a-Matter-of-Fact". To apply this perspective, mentally add the phrase to the beginning of each paragraph herein. Delete this note prior to release of quality handbook. Page 2 of 20

3 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Section 1: TABLE OF CONTENTS Scope...5 Section 2: Normative references...5 Section 3: Terms and Definitions...5 Section 4: Context of the Organization Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system... 5 Non-Applicable Provisions of the QMS Quality management system and its processes... 5 Section 5: Leadership Leadership and commitment General Customer focus Policy Developing the quality policy Communicating the quality policy Organizational roles, responsibilities and authorities... 7 Section 6: Planning Actions to address risks and opportunities Planning for the QMS Planning requirements Quality objectives and planning to achieve them Establishing quality objectives Achieving quality objectives Planning of changes... 8 Section 7: Support Resources General People Infrastructure Environment for the operation of processes Monitoring and measuring resources General Measurement traceability Organizational knowledge Competence Awareness Communication Documented information General Creating and updating Control of documented information Documents required by QMS and International Standard Activities for control of documented information Section 8: Operation...10 Page 3 of 20

4 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures 8.1 Organizational planning and control Requirements for products and services Customer communication Determining the requirements related to products and services Review of requirements related to products and services Ability to meet requirements Retain documented information of review Changes to requirements for products and services Design and development of products and services General through Design and development changes Control of externally provided processes, products and services General Type and extent of control Information for external providers Production and service provision Control of production and service provision Identification and traceability Property belonging to Customers or external providers Preservation Post-delivery activities Control of changes Release of products and services Control of nonconforming outputs Section 9: Identify and control nonconforming outputs Retain documented information for nonconformities Performance evaluation Monitoring, measurement, analysis and evaluation General Customer satisfaction Analysis and evaluation Internal audit Conduct internal audits at planned intervals Audit requirements Management review General Management review inputs Management review outputs Section 10: Improvement General Nonconformity and corrective action Required actions for nonconformities Required records for nonconformities Continual improvement Appendix A: Company Processes and Applicable ISO 9001 Clauses...16 Appendix B: Company Processes and Applicable Documents...17 Appendix C: Outsourced Processes...18 Appendix D: Quality Objectives...18 Appendix E: Identification of Key Realization Processes...19 Page 4 of 20

5 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Section 1: Scope (Your Company's) quality management system (QMS) policies and procedures summarize top management's stategic view to improve the QMS, enhance Customer satisfaction and assure consistent delivery of products and services that achieve conformance with Customer and applicable statutory and regulatory requirements. Section 2: Normative references Documents that are referenced herein are indispensable and their title's are displayed in Bold Italics. Section 3: Terms and Definitions Unless otherwise noted, the Company applies the definitions of key terms according to ISO 9001 and the QMS-16 Definitions and Abbreviations Procedure. Section 4: Context of the Organization 4.1 Understanding the organization and its context The Company considers, monitors and reviews internal and external issues that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure. 4.2 Understanding the needs and expectations of interested parties The Company considers the needs and expectations of interested parties that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure. 4.3 Determining the scope of the quality management system The Company's quality management system applies to all employees within all functional areas of the business operation. The Company provides the following products and/or services: Producer/Provider of [Your text] NAICS code: [Your code(s)] SIC code: [Your code(s)] QMS policies and/or procedures outline responsibilities, methods, measurements and related performance indicators to ensure effective operation and control of the quality management system. Non-Applicable Provisions of the QMS The Company cites no exclusions to the ISO 9001 standard. (list your exclusions to ISO 9001) 4.4 Quality management system and its processes The Company's quality management system is fully documented and implemented and is maintained as needed to meet the requirements of the Company's vision and governing policies. The Company uses a process-oriented method of management, which emphasizes the importance of: Page 5 of 20

6 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures. During Management Review (see 9.3), process resources are discussed and allocated as applicable. Corrective action is taken to ensure processes achieve the desired results. Every process has at least one QMS Procedure that defines it in greater detail that may include a process map. Process maps define the details of each process, which includes The relationship between QMS procedures and their applicable ISO 9001 clauses is shown in Appendix A. See Appendix B for applicable Company processes and documents. Outsourced processes and their controls are defined in Appendix C. See Appendix E for identification of key realization processes. Left blank intentionally COMPANY VISION To continually improve our processes, products and services to QUALITY POLICY The Company is committed to providing high quality and high value products to its Customers, Customer Focus: Workplace Excellence: Empowerment: Intelligent Management: PRACTICAL STEPS TO SUPPORT POLICIES t. ENVIRONMENTAL POLICY To prevent production and distribution of products or waste materials that SEE SECTION 5 FOR DETAILS ON THESE PRACTICAL STEPS Page 6 of 20

7 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Section 5: Leadership 5.1 Leadership and commitment General The Company uses the quality management system to guide and validate its decisions and to Management participation in the QMS is described in the QMS-04 Management Process Procedure Customer focus The Company demonstrates leadership and commitment with respect to Customer focus by ensuring the maintenance and enhancement of Customer satisfaction through 5.2 Policy Developing the quality policy The Company's quality policy defines the purpose and context of the organization and its strategic direction, which includes a framework for Communicating the quality policy The Company's quality policy is available to interested parties and is maintained as documented information that is. 5.3 Organizational roles, responsibilities and authorities Assignment of responsibilities and authorities for relevant roles are communicated and understood throughout the organization according to the QMS-05 Responsibilities and Authorities Procedure to ensure the quality management system conforms to the requirements of ISO Responsible authorities confirm processes are IMPORTANT: The quality management system is maintained at its authorized revision level until planned changes are implemented. Section 6: Planning 6.1 Actions to address risks and opportunities Planning for the QMS Planning for the quality management system includes consideration of the context of the organization and the needs and expectations of interested parties. QMS-04 Management Process Procedure is used to address associated risks and Page 7 of 20

8 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures opportunities to achieve Planning requirements Proportionate actions are taken to address risks and opportunities that could impact requirements that are applicable to products and services according to the QMS-13 Corrective Action Procedure. The Company integrates and implements these actions into quality management system processes (see 4.4) and evaluates their effectiveness. 6.2 Quality objectives and planning to achieve them Establishing quality objectives The Company establishes and maintains documented information for quality objectives at relevant functions, levels and processes according to the QMS-04 Management Process Procedure. Quality objectives are consistent with the quality policy and are monitored, communicated and updated as required to enhance Customer satisfaction (see Appendix D) Achieving quality objectives The Company determines how to achieve its quality objectives according to 6.3 Planning of changes Changes to the quality management system are performed according to the QMS-02 Configuration Management Procedure, which considers the purpose of changes and potential consequences and Section 7: 7.1 Resources General Support The Company determines and provides the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system according to the QMS-04 Management Process Procedure, which considers People The Company determines and provides the people necessary for the effective implementation of its quality management system and operation and control of its processes according to the QMS-04 Management Process Procedure and QMS- 06 Training Procedure. Page 8 of 20

9 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Infrastructure The Company determines, provides and maintains the infrastructure necessary for the operation of its processes to achieve according to the QMS-04 Management Process Procedure Environment for the operation of processes The Company determines, provides and maintains the environment necessary for the operation of its processes to achieve Monitoring and measuring resources General The Company determines and provides resources needed to Measurement traceability Measuring equipment is identified for traceability then calibrated and/or verified prior to use and safeguarded from according to the QMS-15 Procedure Organizational knowledge The Company determines, maintains, uses and internally shares knowledge that is required to operate its processes. The Company considers the need for 7.2 Competence The Company determines the necessary competence for Employees whose work affects the performance and effectiveness of the quality management system. The Company ensures Employee competence according to the QMS-04 Management Process Procedure, QMS-06 Training Procedure and QMS-01 Control of Documented Information Procedure. 7.3 Awareness The Company ensures Employees and Contractors are made aware of the Company's quality policy and applicable quality objectives. In addition, Employees and Contractors are made aware of their according to the QMS-06 Training Procedure. Page 9 of 20

10 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures 7.4 Communication Internal and external communications relevant to the QMS are determined that includes QMS-04 Management Process Procedure. 7.5 Documented information General The Company's quality management system includes Creating and updating according to the During creation and update of documented information, the Company reviews and approves documents prior to release for according to the QMS- 02 Configuration Management Procedure. In addition, the Company determines an appropriate document format, which may include Control of documented information Documents required by QMS and International Standard The Company controls documented information Documented Information Procedure Activities for control of documented information according to the QMS-01 Control of The Company controls the distribution, access, retrieval, use, storage, preservation, legibility, revision level, retention and disposition of documented information that is maintained as evidence of conformity to Section 8: Operation 8.1 Organizational planning and control Processes that are used to achieve compliance with requirements for deliverable products and services are suitable for their purpose and are planned according to Section 6 herein. The Company applies QMS-07 Proposal Development and Contract Review Procedure to implement the processes and QMS-02 Configuration Management Procedure to approve processes and control changes. Consequences of unintended changes are Page 10 of 20

11 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures 8.2 Requirements for products and services Customer communication The Company communicates with its Customers by providing information relative to its products and services according to the QMS-07 Proposal Development and Contract Review Procedure and by obtaining Additional Customer communication channels include according to the QMS-10 Production Procedure Determining the requirements related to products and services The Company ensures that it can meet the claims for products and services it offers and ensures requirements for products and services are defined, which includes according to the QMS-07 Proposal Development and Contract Review Procedure Review of requirements related to products and services Ability to meet requirements The Company reviews Customer requirements according to the QMS-07 Proposal Development and Contract Review Procedure before accepting a contract, which includes Retain documented information of review The Company maintains a record for each review that includes new requirements for products and services Changes to requirements for products and services When the requirements for products and services are changed, the Company 8.3 Design and development of products and services General through Design and development changes The Company's design and development process ensures design activities are conducted in a controlled manner that is defined in the QMS-17 Design and Development Procedure, which includes policies for: Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes Page 11 of 20

12 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures 8.4 Control of externally provided processes, products and services General The Company ensures that externally provided processes, products and services conform to requirements according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure. The Company determines the controls to be applied to externally provided processes, products and services when The Company determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers that is based upon according to requirements and QMS-08 Purchasing Procedure. The Company retains documented information of these activities and any necessary actions arising from the evaluations Type and extent of control The Company ensures that externally provided processes, products and services do not adversely affect the Company's ability according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure Information for external providers The Company ensures that mandatory requirements are according to the QMS-08 Purchasing Procedure. 8.5 Production and service provision Control of production and service provision The Company implements production and services under controlled conditions according to the QMS-04 Management Process Procedure and QMS-10 Production Procedure Identification and traceability The Company uses suitable means to identify outputs when identification of outputs when the QMS-10 Production Procedure. The Company controls the unique Property belonging to Customers or external providers Property used by the Company or under its control that is received from outside sources is controlled according to the QMS-10 Production Procedure Preservation The Company preserves production and service outputs to the extent necessary according to the QMS-10 Production Procedure and QMS-11 Shipping Procedure. Page 12 of 20

13 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Post-delivery activities The Company meets requirements for post-delivery activities associated with the products and services according to the QMS-05 Responsibilities and Authorities Procedure Control of changes To ensure continuing conformity with requirements, the Company according to the QMS-02 Configuration Management Procedure, QMS-10 Production Procedure and QMS-17 Design and Development Procedure. 8.6 Release of products and services In-process inspections are conducted during production and service activities to the QMS-10 Production Procedure. Products and services are released for delivery to Customers only after 8.7 Control of nonconforming outputs Identify and control nonconforming outputs according The Company ensures outputs that do not conform to requirements are according to the QMS-14 Control of Nonconformances Procedure. The Company takes appropriate actions based on Retain documented information for nonconformities Company records describe each nonconformance and include. Section 9: Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation General The Company's determines methods for monitoring, measurement, analysis and evaluation to according to the QMS- 04 Management Process Procedure, QMS-12 Internal Auditing Procedure and QMS-01 Control of Documented Information Procedure. Page 13 of 20

14 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Customer satisfaction To monitor and measure Customer satisfaction and fulfillment of expectations, the Company may collect information about: The Company continuously monitors Customer satisfaction according to the QMS-04 Management Process Procedure Analysis and evaluation The Company evaluates Procedure. 9.2 Internal audit Conduct internal audits at planned intervals The Company conducts internal audits at planned intervals to provide information Auditing Procedure Audit requirements The Company assigns Responsible Authorities to 9.3 Management review General according to the QMS-04 Management Process according to the QMS-12 Internal Top management reviews the Company's quality management system at planned intervals to ensure according to the QMS-04 Management Process Procedure Management review inputs Management review is planned and carried out according to the QMS-04 Management Process Procedure, which takes into consideration Page 14 of 20

15 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Management review outputs Results from management reviews include Procedure. Section 10: 10.1 General Improvement The Company determines and selects Procedure Nonconformity and corrective action Required actions for nonconformities according to the QMS-04 Management Process according to the QMS-04 Management Process When a nonconformance occurs, including according to the QMS-13 Corrective Action Procedure and QMS-14 Nonconformance Control Procedure. The Company evaluates the need for action to eliminate the cause of each nonconformance to prevent recurrence or occurrence somewhere else by corrective actions are appropriate to the effects of each nonconformance Required records for nonconformities The Company retains and maintains records regarding actions according to the QMS-01 Control of Documented Information Procedure Continual improvement The Company continually improves according to the QMS-04 Management Process Procedure using. Left blank intentionally The Company ensures Page 15 of 20

16 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Appendix A: Company Processes and Applicable ISO 9001 Clauses Process Applicable ISO 9001 Clauses Configuration Management See for 8.3.6, Design and Development Changes, Control of Changes (was ) Control of Documents 7.5.2, Creating and Updating, Control of Documented Information (was ) Control of Records 7.5.2, Creating and Updating, Control of Documented Information (was ) Control of Nonconformances 8.7 Control of Nonconforming Outputs (was ) Corrective Action 10.2 Nonconformity and Corrective Action (was ) Internal Auditing 9.2 Internal Audit (was ) 4.4 Quality Management System and its Processes (was ) 7.5 Documented Information (was ) 5.1, Leadership and Commitment, General (was ) Customer Focus (was ) 5.2, 5.2.1, Policy, Developing the Quality Policy, Communicating the Quality Policy (was ) 6.0 Planning (was 5.3 Organizational Roles, Responsibilities and Authorities (was ) 5.3 Organizational Roles, Responsibilities and Authorities (was ) 7.4 Communication (was ) 9.3 Management Review (was ) 7.1.1, General, People (was ) Management 7.2 Competence (was ) Infrastructure (was ) Environment for the Operation of Processes (was ) See for 8.3.6, Design and Development Changes, Control of Changes (was ) Customer Communication (was ) 8.5.1, Control of Production & Service Provision, Post Delivery Support (was 1) Monitoring and Measuring Resources (was ) Measurement, Analysis & Improvement: General (was ) (was General (was ) Analysis and Evaluation (was ) 10.1 General, Continual Improvement (was ) 8.1 Operational Planning and Control (was ) Production 8.5.1, Control of Production and Service Provision, Post Delivery Support (was Identification & Traceability (was Property Belonging to Customers or External Providers (was ) Preservation (was ) 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was ) Proposal Development & Contract Review Determining the Requirements Related to Products and Services (was ) Review of Requirements Related to Products and Services (was ) Purchasing 8.4.1, General, Type and Extent of Control (was ) Information for External Providers (was ) 8.6 Release of Products and Services (was oduct) Identification & Traceability (was ) Receiving Property Belonging to Customers or External Providers (was ) Preservation (was ) 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was ) Determining Requirements Related to Products and Services (was ) 8.5.1, Control of Production and Service Provision, Post Delivery Support (was ) Shipping Identification & Traceability (was Preservation (was 8.7 Control of Nonconforming Outputs (was ) Left blank intentionally Page 16 of 20

17 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Appendix B: Company Processes and Applicable Documents Process Applicable Company Procedures Applicable Company Records Corrective Action QMS-13 Corrective Action Corrective action records 10.2 (was ) Realization processes and resulting product meet requirements 8.1 (was ) Design and development planning (was ) Design inputs records (was ) Design & Development QMS-17 Design & Development Design review records (was ) Design verification records (was ) Design validation records (was ) Design and development outputs (was ) Design change records see for (was ) Internal Auditing QMS-12 Internal Auditing Internal audits 9.2 (was 8.2.2) QMS-00 Quality Handbook Management review minutes (was ) QMS-01 Control of Documented Info Training records 7.2, 7.3 (was ) QMS-02 Configuration Management QMS-04 Management Process records (was ) Management Procedure QMS-05 Responsibilities & Authorities QMS-06 Training QMS-15 QMS-16 Definitions and Abbreviation Traceability records (if required) (was ) Records of loss, damage or nonconformances (was Production ) QMS-10 Production Records of release authority of inspected product 8.6 (was QMS-14 Control of Nonconformances ) Records of first article inspection 8.6 (was ) Control of nonconformances 8.7 (was ) Proposal Development & Contract Review QMS-07 Proposal Development & Contract Review Contract review records (was ) Purchasing QMS-08 Purchasing Supplier evaluation records 8.4.1, (was ) Receiving Records of loss, damage or nonconformances (was QMS-09 Receiving ) QMS-14 Control of Nonconformances Control of nonconformances 8.7 (was ) Shipping Records of loss, damage or nonconformances (was QMS-11 Shipping ) QMS-14 Control of Nonconformances Control of nonconformances 8.7 (was ) Left blank intentionally Page 17 of 20

18 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Appendix C: Outsourced Processes The following processes are outsourced and controlled as indicated: Appendix D: Quality Objectives Process Quality Objective Metric Corrective Action Design & Development Internal Auditing Management Production Proposal Development & Contract Review Purchasing Receiving. Shipping Page 18 of 20

19 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures Appendix E: Identification of Key Realization Processes C U S T O M E R Resource Needs RFQ Quote Market Research Sales Key Realization Processes Business Plan and Objective Management Review Management Responsibility A n a l y s i s a n d C U S T O M E R Page 19 of 20

20 CAGE: xxxxx Your Company Name QMS-00 Policies and Procedures 8 Mandatory Procedures (delete this table prior to release of quality handbook) 22 Mandatory Forms (delete this table prior to release of quality handbook) Page 20 of 20

21 Your Company Name CONTROL OF DOCUMENTED INFORMATION Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Control of Documented Information Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete Location on Server (if used) Abstract: This procedure describes methods for controlling documented information.

22 Your Company Name Control of Documented Information CAGE: xxxxx REVISION LOG Issue Date Comment Author Orig DOCUMENT CHANGE RECORD Issue Item Reason for Change

23 CAGE: xxxxx Your Company Name Control of Documented Information TABLE OF CONTENTS 1.0 PURPOSE OF DOCUMENT AND RECORD CONTROL THEORY DOCUMENT TYPES QUALITY HANDBOOK QUALITY MANAGEMENT SYSTEM PROCEDURES GENERAL WORK INSTRUCTIONS INSPECTION INSTRUCTIONS FORMS EXTERNAL DOCUMENTS PERIODIC RE-EVALUATION OF DOCUMENTS CONTROL OF RECORDS... 8 APPENDIX A: RECORD RETENTION MATRIX... 10

24 CAGE: xxxxx Your Company Name Control of Documented Information 1.0 PURPOSE OF DOCUMENT AND RECORD CONTROL This procedure defines the requirements for the control of documents and records within the quality management system (QMS). The scope of this procedure is to control documents specifically defined in section 3.0. The Document Control Center ensures that documents are controlled so that information on them is accessible, legible and suitably maintained and obsolete documents are stamped "Superseded". The following documents are not subject to this procedure: 2.0 THEORY ms Documents must be controlled so that only reviewed and approved information is released and used by employees. This ensures that no mistakes are made due to the usage of obsolete information. A record is so that the information on them is 3.0 DOCUMENT TYPES 3.1. Quality Handbook: 3.2. QMS Procedures: 3.3. General Work Instructions: 3.4. Inspection Instructions: Records must be controlled 3.5. Forms:

25 CAGE: xxxxx Your Company Name Control of Documented Information 3.6. Records that are created for temporary retention of miscellaneous information are 4.0 QUALITY HANDBOOK 4.1. Establishing the Quality Handbook The Quality Handbook has been established by top management of the Company, which includes 4.2. Review and Approval The Quality Handbook is reviewed and approved by top management before release. Approval is indicated by 4.3. Distribution The Quality Handbook is distributed electronically through the Company's internet server. The Document Control Center Each employee must 4.4. Change Control Any employee may request a change to the Quality Handbook. Requests for changes may be made by 5.0 QUALITY MANAGEMENT SYSTEM PROCEDURES 5.1. Creating New QMS Procedures QMS procedures should be created as soft files (MS Word, etc.). It is recommended 5.2. Review and Approval QMS Procedures are

26 CAGE: xxxxx Your Company Name Control of Documented Information 5.3. Distribution QMS procedures are distributed electronically through the Company's internet server and/or via the intranet. The Document Control Center may 5.4. Change Control Changes to QMS procedures are 6.0 GENERAL WORK INSTRUCTIONS Each employee must 6.1. Creating New Work Instructions Where necessary, work affecting quality is described by clear and complete documented work instructions that define Work instructions should include, as applicable: NOTE REGARDING JOB SPECIFIC WORK INSTRUCTIONS: Engineering may develop work instructions that are specific to a given job, which are 6.2. Review and Approval Work instructions must be reviewed and approved by 6.3. Distribution General work instructions are distributed electronically through the Company's internet server and/or via the intranet. The Document Control Center may Each employee must 6.4. Change Control Changes to general work instructions are

27 CAGE: xxxxx Your Company Name Control of Documented Information 7.0 INSPECTION INSTRUCTIONS 7.1. Creating New Inspection Instructions New inspection instructions are developed by or under the supervision of the Responsible Authority using NOTE REGARDING JOB SPECIFIC INSPECTION INSTRUCTIONS: Engineering may 7.2. Review and Approval Approval is indicated by 7.3. Distribution Inspection instructions are distributed electronically through the Company's internet server and/or intranet. The Document Control Center may Each employee must 7.4. Change Control Any employee may request a change to inspection instructions by completing a Request for Change form and submitting it to 8.0 FORMS 8.1. Creating New Forms Forms undergo a streamlined creation and control process. Any department manager or area supervisor 8.2. Review and Approval Forms may be reviewed and approved by the manager of the department or area primarily affected by the form. Forms do not

28 CAGE: xxxxx Your Company Name Control of Documented Information 8.3. Distribution Forms are made available through the Company's internet server, intranet or Document Control Center. These may be 8.4. Change Control Any employee may submit a Request for Change to the appropriate area manager responsible for the form and the manager 9.0 EXTERNAL DOCUMENTS 9.1. Some external (third party) standards or specifications may be maintained on file without Unless otherwise specified, if the revision level is 9.2. Third party specifications and engineering drawings, including those of the Customer, are controlled according to the QMS-02 Configuration Management Procedure. Where control of an external document is deemed necessary, In some cases, a hardcopy of the external document may Each employee must 10.0 PERIODIC RE-EVALUATION OF DOCUMENTS The entire set of quality documentation is subject to 11.0 CONTROL OF RECORDS 11.1 The controls for each type of record are defined in Appendix A of this procedure The listed "controller" must ensure 11.3 Records for active contracts are maintained in the department handling the operations. Records are

29 CAGE: xxxxx Your Company Name Control of Documented Information 11.4 The Document Control Center maintains archive files for records. Records shall be 11.5 Records that are discarded after retention shall 11.6 Hardcopy records are 11.7 Records are 11.8 Records are 11.9 The Company does not require vendors to maintain records for the Company; instead, Electronic records are Local computer data that is stored on company computers must When making corrections to written record entries, the error is Correction fluid or correction tape is not to be used on any quality records. Left blank intentionally

30 CAGE: xxxxx Your Company Name Control of Documented Information APPENDIX A: RECORD RETENTION MATRIX Required Record or Document Type Company Record Controller Type Location records Form Contract review records Contract review Form Control of nonconformances RFS Form Corrective actions RFS Form Design change records Engineering order Form Design input records Engineering order Form Design review records Engineering order Form Design validation Production records inspection Form Design verification Production records inspection Form First Article Inspection First article Form Internal audit records Internal audit Form Lost, damaged or unsuitable Customer property Customer property Form Management review Management meeting reports review report Form Record of realization process Engineering order Form Record of release of Production product inspection Form Supplier evaluation Supplier evaluation Form Production Traceability records inspection Form Training records Training record Form Minimum Retention

31 Your Company Name CONFIGURATION MANAGEMENT Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Configuration Management Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete Location on Server (if used) Abstract: This document describes configuration management procedures.

32 Your Company Name Configuration Management CAGE: xxxxx REVISION LOG Issue Date Comment Author 0-0 DOCUMENT CHANGE RECORD Issue Item Reason for Change

33 CAGE: xxxxx Your Company Name Configuration Management TABLE OF CONTENTS 1.0 PURPOSE THEORY CONFIGURATION DOCUMENTATION CONFIGURATION CONTROL BOARD (CCB) CONFIGURATION CHANGE CONTROL SUBCONTRACTOR AND VENDOR CHANGES PRODUCT AND TEST SOFTWARE CONTROL... 7

34 CAGE: xxxxx Your Company Name Configuration Management 1.0 PURPOSE This procedure defines the requirements for the management of the configuration of products produced by the Company's configuration management activities include the following: The following are not governed by this control procedure: 2.0 THEORY Part configuration includes a variety of aspects of a given part, including This procedure has been developed based on 3.0 CONFIGURATION DOCUMENTATION 3.1. The current configuration of a given part is identified through applicable technical documents. These may include, but are not limited to: 3.2. All such technical documents are developed and approved by the Responsible Authority, which are 3.3. Configuration documents and Customer intellectual property received by is the Company are 4.0 CONFIGURATION CONTROL BOARD (CCB) 4.1. Responsible Authorities (RA) serve as the Configuration Control Board, which has full authority and responsibility for

35 CAGE: xxxxx Your Company Name Configuration Management 4.2. CCB responsibilities include: 5.0 CONFIGURATION CHANGE CONTROL 5.1. Evaluation of a change in configuration for a deliverable item takes into consideration 5.2. All associated changes and affected hardware items or computer programs are included on 5.3. Types of Configuration Change Changes to the configuration are implemented after approval of The definition for each is as follows: Engineering Change: Deviation: Waiver:

36 CAGE: xxxxx Your Company Name Configuration Management 5.4. Change Classification Changes in configuration are classified by the CCB as either Class I or Class II. The change classification assigned by the CCB is entered on Class I Changes The engineering change is classified as Class I when it affects one or more of the following: t Non-technical contractual provisions are affected, such as, but not limited to: o o o o o Class II Changes Any change that does not fall within the Class I definition is a Class II change. Class II changes are 5.5. Change Implementation The Responsible Authority verifies Superseded revision levels of electronic documents are Proposed Class I engineering changes are approved by the CCB and are submitted to the Customer in the form of

37 Your Company Name Configuration Management CAGE: xxxxx 5.6. Document approval is indicated by any of the following methods: 6.0 SUBCONTRACTOR AND VENDOR CHANGES 6.1. Supplier and vendor requests for change are controlled according to 7.0 PRODUCT AND TEST SOFTWARE CONTROL Revision control is applicable to software programs that are used for

38 Your Company Name MANAGEMENT PROCESS Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Abstract: This document describes the management review process. Management Process Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete Location on Server (if used)

39 Your Company Name Management Process CAGE: xxxxx REVISION LOG Issue Date Comment Author 0-0 DOCUMENT CHANGE RECORD Issue Item Reason for Change

40 CAGE: xxxxx Your Company Name Management Process TABLE OF CONTENTS 1.0 PURPOSE THEORY MANAGING AS A PROCESS PROCEDURE: MANAGEMENT REVIEW PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION PROCEDURE: RESOURCE MANAGEMENT... 9 Appendix A: Process Map... 10

41 CAGE: xxxxx Your Company Name Management Process 1.0 PURPOSE This document defines the Management process, including or making reference to procedures for the various activities within the Management process. 2.0 THEORY The Company believes in intelligent management, which enables the Company to make decisions based on 3.0 MANAGING AS A PROCESS The Company recognizes that it has to manage processes identified in the Quality Management Policies and Procedures handbook; however, management itself must also be treated as a process. This means Management is responsible for implementation and application of the following QMS requirements: 4.0 PROCEDURE: MANAGEMENT REVIEW 4.1 The management of the Company performs formal management review of the Quality Management System a minimum of

42 CAGE: xxxxx Your Company Name Management Process 4.2 This review shall include 4.3 Minutes of the meetings are taken and maintained. The Management Review Report Template may be used as a guide for the records or may be completed and retained as the record. 4.4 The Management Review meeting should include analysis of the following inputs: m 4.5 Management shall use action items or the corrective action system to take recorded actions as a result of review topics in an effort to See the QMS-13 Corrective Action Procedure.

43 CAGE: xxxxx Your Company Name Management Process 4.6 Management shall determine internal issues that affect its ability to achieve intended results, which may include, but are not limited to: 4.7 Management shall determine external issues that affect its ability to achieve intended results, which may include, but are not limited to: s ations 5.0 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES 5.1 Each process identified in the Quality Management System has at least one objective. The objective is

44 CAGE: xxxxx Your Company Name Management Process 5.2 Each process objective 5.3 Top management will 5.4 Throughout the year, assigned managers and staff will 5.5 During Management Review 5.6 When a process does not meet a goal, 5.7 The current metrics, standings, previous goal and revised goals shall be (See section 4.0 above.) 5.8 Over time, management shall assess performance of each process against the goals according to the QMS-13 Corrective Action Procedure. 6.0 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION 6.1 Internal communication is an important facet of the way the Company does business. By this we mean that information must be able to flow in all directions, from The following methods are used for internal communications: 6.2 External communications that are relevant to the quality management system must Confidential Company Information Company Employees must not reveal Confidential Company Information to External Parties except to the extent such disclosures are necessary

45 CAGE: xxxxx Your Company Name Management Process Basic Company Information Company Employees must not communicate Basic Company Information to External Parties except to the extent that such communication is part of their normal responsibilities. For example, Only Authorized Responsible Authorities may communicate about the Company or its business, or communicate as a representative of the Company, with any of the following External Parties: Only Authorized Responsible Authorities may communicate about the Company or its business or communicate as a representative of the Company on Written Company Information All Written Company Information must conform to guidelines established from time to time. All Written Company Information must be approved by the appropriate Responsible Authority before it is communicated to any External Party. With respect to any Written Company Information regarding new business, clients, or other contract counterparties, or other Third Parties with a business relationship with the Company, care must be exercised to Written Company Information regarding approved by the appropriate Responsible Authority. must also be

46 CAGE: xxxxx Your Company Name Management Process 7.0 PROCEDURE: RESOURCE MANAGEMENT 7.1 The management of resources is a critical component to the management activities of the Company. Resources requiring such management includes: vities ation 7.2 Like other management activities, resource management must. 7.3 To manage resources, top management must 7.4 During Management Review, managers shall 7.5 From that data, top management can

47 CAGE: xxxxx Your Company Name Management Process Appendix A: Process Map Objective: INPUT from other processes Conduct Management Review Meeting according to section 4.0. Review all agenda items and current data against most current internal and external issues.. MANAGEMENT Owner: Objective met? NO Revise goal? YES continued next page INPUT from other processes NO

48 CAGE: xxxxx Your Company Name Management Process from previous page NO Planning, resources or controls needed? YES ALL other processes OUT

49 Your Company Name RESPONSIBILITIES AND AUTHORITIES Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Responsibilities and Authorities Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete Location on Server (if used) Abstract: This document describes responsibilities and authorities of Company personnel.

50 Your Company Name Responsibilities and Authorities CAGE: xxxxx REVISION LOG Issue Date Comment Author 0-0 DOCUMENT CHANGE RECORD Issue Item Reason for Change

51 CAGE: xxxxx Your Company Name Responsibilities and Authorities TABLE OF CONTENTS 1.0 PURPOSE THEORY RESPONSIBILITIES & AUTHORITIES... 4

52 CAGE: xxxxx Your Company Name Responsibilities and Authorities 1.0 PURPOSE This document provides an overview of the responsibilities and authorities for key positions within the Company. 2.0 THEORY It is important to define the responsibilities and authorities of key positions so that employees understand their work and the relationships they have with other positions within the Company. 3.0 RESPONSIBILITIES & AUTHORITIES 3.1 Operations Manager The Operations Manager is responsible for 3.2 Quality Manager The Quality Manager is responsible for The Quality Manager The Quality Manager also 3.3 Facilities Manager The Facilities Manager is responsible for 3.4 Production Manager The Production Manager is responsible for 3.5 Business Manager The Business Manager is responsible for 3.6 Product Managers The Company utilizes Product Managers for

53 CAGE: xxxxx Your Company Name Responsibilities and Authorities Product Managers are responsible for, which includes consideration for: 3.7 Administrative Assistant The Administrative Assistant is responsible for 3.8 Accounting Manager The Accounting Manager is responsible for 3.9 Environmental Health & Safety Manager The EHS Manager is responsible for 3.10 Quality Group Staff & Inspectors (including Receiving) The Quality Group includes 3.11 Production Operators Production operators include 3.12 Internal Auditors Internal Auditors are responsible for 3.13 Shipping Personnel Shipping personnel are responsible for

54 CAGE: xxxxx Your Company Name Responsibilities and Authorities 3.14 Human Resources Staff Human Resource staff is responsible for 3.15 Purchasing Staff Purchasing staff is responsible for

55 Your Company Name TRAINING PROGRAM Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Training Program Abstract: This document describes training program and requirements. Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete Location on Server (if used)

56 Your Company Name Training CAGE: xxxxx REVISION LOG Issue Date Comment Author 0-0 DOCUMENT CHANGE RECORD Issue Item Reason for Change

57 CAGE: xxxxx Your Company Name Training TABLE OF CONTENTS 1.0 PURPOSE THEORY TRAINING PROCEDURE... 4

58 CAGE: xxxxx Your Company Name Training 1.0 PURPOSE This document provides details on the Company s training program and requirements. 2.0 THEORY Employees can only perform their duties adequately when properly trained. The Company intends to ensure adequate employee performance through 3.0 TRAINING PROCEDURE 3.1 Hiring Employees are hired on their basis to To accomplish this, potential candidates are 3.2 Initial Indoctrination and Orientation Once hired, new employees are assigned to their position and undergo initial indoctrination and orientation. This introduces the employee to 3.3 On the Job Training Once an employee has completed initial indoctrination, they undergo on-the-job training relative to their position. This training is 3.4 Additional Training At the discretion of management, additional training may be conducted at any time. This may be necessitated by

59 Your Company Name PROPOSAL DEVELOPMENT AND CONTRACT REVIEW Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Proposal Development and Contract Review Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete Location on Server (if used) Abstract: This document describes the procedures used to review contracts and develop proposals.

60 Your Company Name Proposal Development and Contract Review CAGE: xxxxx REVISION LOG Issue Date Comment Author 0-0 DOCUMENT CHANGE RECORD Issue Item Reason for Change

61 CAGE: xxxxx Your Company Name Proposal Development and Contract Review TABLE OF CONTENTS 1.0 PURPOSE THEORY PROCEDURE PROCESS MAP... 6

62 CAGE: xxxxx Your Company Name Proposal Development and Contract Review 1.0 PURPOSE This document defines the Proposal Development and Contract Review process including or making reference to procedures for the various activities within the process. 2.0 THEORY The Company can only meet Customer requirements by ensuring that all such requirements are obtained from the Customer, then 3.0 PROCEDURE When addressing Customer needs and industry trends, the Company considers Documentation is not required for The Company determines its capability to meet Customer requirements by: a) b) c) d) 1) 2)

63 CAGE: xxxxx Your Company Name Proposal Development and Contract Review e) 1) 2) f. g. h. i. j. The organization negotiates a mutually acceptable requirement with the Customer when See Process Map.