ISO9001：2022质量手册-英文版.docx

ISO9001：2022质量手册-英文版 Quality Management System Policy Manual ISO 9001:2022 11-8-17 Date Printed: _ 1. Quality Management System Scope COMPANY NAME establishes this quality policy manual to implement and maintain a quality management system meeting the requirements of ISO 9001:2022, to ensure customer satisfaction in the manufacturing of stamped, formed, machined and fabricated metal parts, weldments, subassemblies and painting of metal parts to customer and COMPANY NAME specifications 1.1. Non-applicable Clauses of ISO 9001: 1.1.1. 8.3 Product Design & Development of Products & Services COMPANY NAME is a custom manufacturer and designs are provided by our customers. 2. Quality Policy Statement COMPANY NAME is committed to continually improving all products and services to achieve our customers expectations. We do this by: 1) Living our values, 2) Providing opportunities for employee involvement, motivation and training, 3) Developing, documenting and following processes. 3. Quality Objectives COMPANY NAMEs quality management system objectives are to enable COMPANY NAME to be our customers first choice by: 1) Achieving satisfactory ratings on quality, delivery and other key metrics tracked and reported by our customers through their formal supplier evaluation and performance systems, 2) Achieving a level of 700 ppm as tracked through COMPANY NAMEs RA system for customers without a formal supplier evaluation system for quality, 3) Achieving a 95% on-time delivery to the COMPANY NAME warehouse for customers without a formal supplier evaluation system for delivery. Policy Manual Revisions Log Date 3/22/17 8/7/17 Summary of Revisions Rewrite of Quality Policy Manual to meet ISO 9001:2022. 1. Revised 4.2 to include “employees”, “owners” and “regulators”. Made By JGV JGV 2. Added Figure 2 to support to support the COMPANY NAME QMS Process Flow 11-8-17 Updated to clarify risk, inputs, out puts and KPIs for Support and Management Process in QMS Process Reference page (page 6) JGV Management Approval Name: Title: Signature: Date: Paul Gintner President 4. Context of the Organization 4.1. Understanding the Organization & Its Context Top Management determines the external and internal issues that are relevant to our quality management system and its strategic direction, and that affect our ability to achieve the intended results. COMPANY NAME is a contract manufacturer in a competitive market, therefore we must maintain on-time delivery, product quality, and good customer service. Our key internal issues are to maintain production capacities, including competent people, capable processes, and maintained equipment. COMPANY NAME monitors and reviews information relevant to internal and external issues through our management review meetings. 4.2. Understanding the Needs and Expectations of Interested Parties Due to their potential effect on the organizations ability to consistently provide products that meet customer requirements, Top Management determines: 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 management system. COMPANY NAMEs Top Management has determined that our customers, suppliers, employees, owners (Ottertail) and regulators (OSHA) are the interested parties that we need to be concerned with and will strive to meet their needs and expectations. Top Management monitors and reviews relevant measurements and information about these interested parties and their relevant requirements through management review meetings. 4.3. Determining the Scope of the Quality Management System Top Management determines the boundaries and applicability of the quality management system to establish its scope. (Ref. Section 1.) When determining this scope, Top Management has considered: a) The external and internal issues referred to in 4.1. b) The requirements of relevant interested parties. c) The products and services of the organization. We apply all the requirements of the standard that are applicable within the scope of the quality management system. With only one exclusion section 8.3 Product Design & Development of Products & Services - (Ref. Section 1.1.1) Top Management ensures the scope of the quality management system is available and maintained, as documented in Section 1, including the types of products and services covered by the quality management system, and justification for any requirements determined not applicable to the scope of the quality management system. Top Management ensures conformity to the standard(s) referred to in Section 1, and that any requirements determined as not applicable do not affect our ability or responsibility to ensure the conformity of our products and services and the enhancement of customer satisfaction. 4.4. Quality Management System and Its Processes 4.4.1. Top Management establishes, implements, maintains, and continually improves a quality management system, including the processes needed and their interaction, in accordance with the requirements of the standard. Top Management determines the processes needed for the quality management system and their application throughout the organization, and: a) Determines the inputs required and the outputs expected from these processes; b) Determines the sequence and interaction of these processes (Ref. Figure 1); c) Determines and applies the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes; d) Determines the resources needed for these processes and ensures their availability; e) Assigns the responsibilities and authorities for these processes; f) Addresses the risks and opportunities as determined in accordance with Section 6.1; g) Evaluates these processes and implements any changes needed to ensure that these processes achieve their intended results; h) Improves the processes and the quality management system. Figure 1 Quality Management System Processes COMPANY NAME QMS Process Flow Customer Feedback Captured and Utilized for Continuous Improvement and Future Quotes Quote Provided to Customer Output Risk Monitoring Customer Places Order Customer Requirements EDI/Forecast Inaccuracy and order cancelation Daily forecast and order confirmation Inputs Risk Monitoring Outputs Inputs Order Qty, Due date and Container Job Created Changing customer orders and WC capacity limitations Daily exception reporting and weekly WC load meetings. Risk Outputs Inputs Monitoring Material Purchased Material needs, Due Date, Work Center Assignment Communication with Sales Team, Supplier Performance/ Report Cards Material availability, Supplier OTD Outputs Inputs Risk Monitoring Daily Exception Reporting, Communication with Production and Daily Planners, Weekly Load Report Meeting Job Planned Process Job WC Capacity, BOM Item Availability, Man Power Material Delivery Date Outputs Inputs Risk Monitoring Productivity, MDI data, LPA program, Safety Audit, Delivery to the Warehouse, EQCPs , Supplier Report Cards Job scheduled, Material Delivery, WC Load, Containers Machine, Manpower, Tooling, Safety, Process Adherence, OSS OTD, Part Quality Inputs Outputs Inputs Risk Monitoring Product Placed in Inventory Delivery to the Warehouse, Preservation of product, Inventory Accuracy Labeled Product and Inspection Data MDI Data, Random Inventory Audits, FIFO processes, Outputs Inputs Risk Monitoring Product Shipped to Customer Short/Over shipments, late shipments, Understanding Customer Ship Requirements Picking Verification Processes and Software, Customer Ship Notes, OTD to Customer, Shipping Errors Reported by Customer Labeled Product and Inspection Data *See Figure 2 to reference specific processes that facilitate the COMPANY NAME QMS Process Flow Customer Uses Product Figure 2 Quality Management System Reference Processes Rev:11-08-17 Core Flow Processes Support Processes Management Processes Quote Provided to Customer * LAU2-001 Product Realization PRO2-002 Non-Conforming Product SLS2-001 Quoting * LAU2-002 Part Manufacturing Qualification PRO2-004 Production Part Deviation CHN2-005 Obsolete Part * LAU2-003 Proto Process * LAU2-010 New Customer Launch Process PRO2-005 Corrective Action *Launch (New Product) if applicable * LAU2-006 Customer Supplier Guide Review STD2-008 STD2-003 STD2-007 STD2-004 STD2-005 COMPANY NAME Management Review Internal Audit Customer Places Order SLS2-002 Process Customer Orders SCH2-005 SCH2-001 SCH2-006 Supplier Assessment and Selection Establish New Vendor Layered Process Audit Job Created Monitoring and Measuring of Processes Risk Assessment Matrix Outsourcing In-House Painted Parts Material Purchased PRO2-008 Master Planning of Direct Materials HRE2-004 Onboarding Employees SHP2-002 Receive Material or Service CHN2-001 ECN Engineering Change Notification SCH2-004 Purchase Indirect Materials or Services CHN2-003 Request for Operation or Rate Change See STD2-004 and STD2-005 for Inputs/Outsputs/KPI's for all Support and Management processes Job Planned PRO2-007 Daily Production Planning STD2-002 STD2-001 BMS Document Control BMS Document Revision PRO2-009 Expedite Customer Orders STD2-006 Records Control SCH2-003 Temporary Outsourcing Process Job Product Placed in Inventory PRO2-003 Part Production Color Key: Key ISO Processes CHN2-002 NSM Non-Standard Manufacturing QMS Processes Flow Steps CHN2-004 QAD Addition FAE2-007 LAU2-004 Work Center Transfer Container Designation Process PRO2-001 Monitoring and Measuring of Product PRO2-006 Transfer of Temporary Work Product Shipped to the Customer SHP2-001 Ship Customer Orders 4.4.2. Top Management ensures the organization: a) Maintains documented information to support the operation of its processes; b) Retains documented information to have confidence that the processes are being carried out as planned. This documentation includes the “Quality Manual”, which consists of this Quality System Policy Manual, as well as the quality system procedures, which are located and controlled as defined under documentation requirements per Section 7.5. 5. Leadership 5.1. Leadership & 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 the quality policy statement and objectives are established for the quality management system and are compatible with the context and strategic direction of the organization; c) Ensuring the integration of the quality management system requirements into the organizations business p rocesses; 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; h) Engaging, directing, and supporting personnel to contribute to the effectiveness of the quality management system; i) j) Promoting improvement; 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; c) The focus on enhancing customer satisfaction is maintained. 5.2. Policy 5.2.1. Establishing the Quality Policy Top Management establishes, implements, and maintains a quality policy statement that: a) Is appropriate to the purpose and context of the organization and supports its strategic direction; b) Provides a framework for setting quality objectives; c) Includes a commitment to satisfy applicable requirements; d) Includes a commitment to continual improvement of the quality management system. 5.2.2. Communicating the Quality Policy Top Management ensures the quality policy statement is: a) Available and maintained as documented information, ref. Section 2; b) Communicated, understood, and applied within the organization; c) Available to relevant interested parties, as appropriate. 5.3. Organizational Roles, Responsibilities, & Authorities Top Management ensures that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization. Top Management assigns responsibility and authority for: a) Ensuring that the quality management system conforms to the requirements of the standard, per Section 1; 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 , in particular to top management; d) Ensuring the promotion of customer focus thr