This is a complete Quality Policy Manual template meeting certification requirements of ISO-9001:2008. Once downloaded, you must read through it in detail and make sure it meets your company's needs. However, most of the repetitive customizations can be done by highlighting each term within a , highlighting it (including the brackets) and using Word's Find / Replace dialogue. This can save you 40-80 hours of engineering time or thousands of dollars of consulting fees!
Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX Company Information: Organization: <Company Name> Address: <Company Address> Management Representative: <Name of Management Representative> SIC Codes: <SIC Codes> ISO Registration: <ISO Registration #> Business Description (Scope): <Scope of activities performed at the facility / organization being certified> Organization: <Name of 2nd division if applicable> Address: Management Representative: SIC Codes: ISO Registration: Business Description (Scope): CONTROLLED Page 1 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX Organization: <3rd Division / Facility if Applicable> Address: Management Representative: SIC Codes: Business Description (Scope): CONTROLLED Page 2 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX Company Overview: <Basic information about your company, it’s history and the products and services provided> CONTROLLED Page 3 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX System Manual Table of Contents 1.0 Purpose 2.0 Scope 3.0 Responsibilities 4.0 Business Management System (BMS) 4.1 General Requirements 4.2 Documentation Requirements 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management Reviews 6.0 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7.0 Product Realization 7.1 Planning of product realization 7.2 Customer-related Processes 7.3 Design & Development 7.4 Purchasing 7.5 Production & Service Provision 7.6 Control of Measuring & Monitoring Devices 8.0 Measurement, Analysis, & Improvement 8.1 General 8.2 Measurement & Monitoring 8.3 Control of Nonconformity 8.4 Analysis of Data 8.5 Improvement Exhibit “A”: Organizational Chart Exhibit “B”: Definitions Exhibit “C”: System Procedure Listing 9.0 System Manual Change Control CONTROLLED Page 4 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX 1.0 PURPOSE This manual is intended to generally describe the processes and systems that make up the Business Management System at <company name>. This Manual and the systems and processes it describes serve to ensure: Conformance to customer requirements Conformance to ISO 9001-2008 Continued improvement of the Business Management System If this document is distributed outside of the company it is considered uncontrolled and therefore not maintained. 2.0 SCOPE 2.1 Requirements and descriptions contained in this Business Management System Manual are pertinent to <Company>’s processes and procedures as the leader in the design, develop, manufacture and coating of steel, polyethylene and natural gas, LPG, and methane recovery piping distribution systems. The effective implementation of the Business Management System is verified by regular inspections, reviews and audits that compare management practices against the requirements of the written procedures on Business Management System standards. Corrective actions are taken where necessary and are subsequently reviewed for effectiveness. A complete examination of the Business Management System requires the supporting documentation referenced within this manual. The following matrix promulgates the primary, secondary and clause exclusions for each <business name> location. CONTROLLED Page 5 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX Site Scope Standard/Location Corporate <Division 1> <Division 2> <Division 3> 4.0- BMS System Manual Control of Documentation Control of Records 5.0- Management Commitment Customer focus Policy Objectives Responsibility & Authority Management Representative Internal Communication Management Review 6.0- Infrastructure H/R - Training Infrastructure Work Environment 7.0- Product Realization Planning Customer Processes Design & Development Purchasing Product Realization Planning Sustaining Engineering Validation ID & Traceability Customer Property Preservation of Product Calibration 8.0- Continual Improvement Customer Satisfaction Internal Audits Measurement of Processes Measurement of Product Nonconforming Product Analysis of Data Continual Improvement Corrective Action Preventive Action Responsibility: P = Primary S = Secondary CONTROLLED Page 6 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX 3.0 RESPONSIBILITIES Detailed Job Descriptions, documenting position authority, responsibility requirements and duties for each position in the organization, are on file in Human Resources (Ref: Organizational Chart, Addendum A) President Assumes overall responsibility for the direction of the business and business practices as well as the proper implementation and execution of this and all other System procedures and documents. ISO Management Representative – Assigned by Top Management and given the organizational freedom to assume responsibility for the proper implementation, execution, and control of this document and the processes and procedures contained within. He/she is responsible for reporting on the performance of this system to Top Management as well as any need to improve the system and to promote throughout the organization an awareness of customer requirements. Quality Manager - Responsible for the operation of the Quality Department and, as such, has the final authority to release for sale of any product stocked by <Company>. The Quality Manager may delegate his authority to competent inspectors in the Quality Department. However, such delegation does not relieve the Quality Assurance Manager from the overall responsibility. Quality Inspectors - Are thoroughly familiar with all inspection methods, techniques and equipment used in their area of responsibility to determine the quality of airworthiness of an article purchased or sold. All inspection personnel must also maintain proficiency in the use of the various types of visual inspection aids to be used for inspection of the items undergoing acceptance inspection. A complete and current list of Authorized Inspection Personnel is kept in the office of the Quality Manager. CONTROLLED Page 7 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX 4.0 BUSINESS MANAGEMENT SYSTEM 4.1 General Requirements This manual defines our process based Business Management System , and how it is established, documented, implemented, maintained, improved, and managed throughout our organization in accordance with the standards listed in Section 1. Our process based system model, shown below, illustrates the process linkages presented in clauses 4 thru 8 of the standard. Our model shows that our customers, as well as other interested parties play a significant role in defining our input requirements. Monitoring the satisfaction of our customers requires the evaluation of information relating to the perception of the customers as to whether the organization has met their requirements. Management Responsibility 5 ISO Measurement, Resource System 8 Management 6 Analysis, Model Improvement Product 7 7 Realization Customer Customer Requirements Satisfaction <Company> has identified the processes, pictured on the next page, needed for our Business Management System (BMS) and their sequence and interaction, as well as, the criteria required to ensure effective operation and control of our system. Methods employed to ensure effective operation and control of our system processes are provided in lower level procedures. CONTROLLED Page 8 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX BMS Process Sequence & Interaction [Insert Flowchart Here] CONTROLLED Page 9 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX MBS Processes Key MBS Processes Program/Process KPI 1 Doc, Data & Record Control Controlled & Accurate Data 2 Management & Analysis Business Focus & Continual Improvement 3 Planning & Customer Customer Satisfaction 5 Design Control Meet Customer Requirements & Needs 6 Purchasing Control On Time – Quality Materials & Services 7 Production & Service On Time – Quality Products 8 Internal Audits Continual Improvement 9 Inspection/Test/NCM RMA - Escapes 10 Corrective & Preventive Action Continual Improvement <Company> ensures the availability of resources and information necessary to support the operation, measurement, monitoring and analysis of these processes and any action necessary to achieve planned results and continual improvement of our processes. Any outsourced process that affects <Company>’s product conformity will be controlled through the purchasing process to ensure conformity with requirements. The following processes are currently outsourced: Outside Process Outside Process Outside Process Outside Process Outside Process Outside Process Outside Process CONTROLLED Page 10 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX 4.2 Documentation Requirements 4.2.1 General Documentation Requirements The Business Management System documentation is based upon the requirements of ISO 9001. To ensure effective operation and control of our processes, <Company> utilizes a variety of documentation types and medium applicable to the size and complexity of our operations. In addition to the procedures relating to this standard, specific consideration has also been given to the establishment and maintenance of files containing <Company> documents, defining the product specifications, including complete manufacturing and quality assurance specifications for each type/model of product produced by <Company>. The documentation structure of our quality system is as follows: * <Company> will employ job specific Work Instructions on an as needed basis. CONTROLLED Page 11 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX The Business Management System documentation includes: documented statements of a quality policy; documented statements of system goals / objectives; our System Manual; documented System procedures within the scope and requirements of the ISO 9001 standard and this Business Management System (see addendum C); Records required by the ISO 9001 standard and this Business Management System. 4.2.2 System Manual (MA-400-1) The <Company> System Manual was established as part of the overall Business Management System and is maintained to: demonstrate the scope of <Company>’s Business System ; document System procedures within the scope of this Business Management System ; Describe the sequence and interaction of the system processes within the Business Management System. The <Company> System Manual is controlled in accordance with lower level procedures. 4.2.3 Control of Documents (OP-400-1 ) <Company> has established and maintained documented procedures to control all documents supporting the business system including external documents Document owners, review, maintain, and approve procedures, work instructions, and other quality documentation. It is the owner’s responsibility to create and submit a document in its final form for control and publishing by documentation control. Documents are reviewed and approved for adequacy by authorized personnel before issue. The <Company> internal website, containing the document control CONTROLLED Page 12 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX matrix that identifies the current revision status and is readily available to ensure correct documents are used. Documents are available where needed, as determined by management or area supervisors, to ensure quality system operations. Invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use. Any obsolete documents that are preserved are identified and archived. Changes to documents are reviewed and approved by the same authority group as the originals, unless otherwise designated by management. Background information is available to those who review and approve changes. Documents are periodically reviewed during internal audits. A configuration management process appropriate to the type of products manufactured by <Company> has been established and is maintained. 4.2.4 Control of records (<Procedure#>) Procedures are documented and maintained for identification, collection, indexing, access filing, storage, maintenance, and disposition of records. Controlled records define the conformance to specified requirements and effectiveness of the quality system. Controlled records received from suppliers will be included in the element. System records are legible and stored in secure locations to prevent loss or damage. Records are maintained as stated in OP-400- 1 Control of Documents and Records. If contractually stipulated, customers have access to quality records. CONTROLLED Page 13 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX 5.0 MANAGEMENT REOPOSIBILITY 5.1 Management Commitment Top Management is committed to the development and improvement of our Business Management System and to all of our company values, and proves that commitment by: Maintaining awareness of customer requirements as well as customer satisfaction among employees; Establishment of our Quality Policy, goals and objectives; Reviewing the Business System as part of normal business operations; Providing the necessary resources to meet customer and regulatory requirements. 5.2 Customer Focus Top Management, through the use of the established systems, ensures that customer requirements are understood and met, in order to enhance customer satisfaction. We have implemented and maintained appropriate procedures to identify and meet any legal and regulatory requirements related to the quality of our products and services. 5.3 Quality Policy Top Management is committed to meeting customer requirements and continual improvement by adhering to a Quality Policy that is appropriate for our company. Top Management strives to ensure that employees understand our Quality Policy, and how they contribute to its success. We communicate our Quality Policy to new employees, and reinforce the Quality Policy with current employees by applying our System Objectives to <Company>’s Business Values. We accomplish this by disseminating the information throughout the organization through training, graphic displays posted throughout the facility, as well as special attention to the subject during regular employee meetings and rallies. The continued suitability of our Quality Policy is monitored through the Management Review procedure of our Business Management System. The <Company> Quality Policy is controlled by this System Manual. <Company> Quality Policy badges, postings, etc. are for reference only and therefore are uncontrolled. CONTROLLED Page 14 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX <Company>’s Quality Policy: <Describe your company’s Quality Policy>. We have established quality goals and objectives at each function and level within the organization. Descriptions of and instructions on meeting these objectives can be found in lower level documents. Review and subsequent changes to plans take place during <Company>’s Management Review of Quality. We will pursue these objectives based upon a philosophy of the eight management principles. Customer-Focused Organization Leadership Involvement of People Process Approach System Approach to Management Continual System Improvement in processes and systems Factual approach to decision making Mutually beneficial supplier relationships Accordingly, Our noble purpose is: To create personal, professional, and financial growth for all (including customers, suppliers, employees and the greater community). Based on Shared values of: Integrity, competence, collaboration and accomplishment. In order to ensure: CONTROLLED Page 15 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX Ongoing Viability of the Organization through balancing growth and responsible profit. Customer Enthusiasm through highest quality, on-time delivery, shortest lead-time at the lowest cost. Personal, Professional and Financial Growth supported through a safe, open work environment which embraces mutual respect, information sharing, healthy conflict and challenging opportunities that are meaningful to each individual. Optimization of the System through alignment of goals and resources to meet the changing context within which we live and work. Our goals are the: Continual Improvement of Customer Satisfaction Continual Improvement of Safety Continual Improvement of Quality Continual Improvement of Speed Continual Improvement of Flexibility Continual Improvement of Value Our business plan: Documents annual objectives and allocation of resources necessary to achieve corporate goals. Performance metrics: Monitor and measure progress toward stated aims, goals, and objectives and provide feedback to individuals, groups, and the company related to successful performance and opportunities for improvement. CONTROLLED Page 16 of 53 Control No: QM-1 Rev: Language: English SYSTEM MANUAL Author: <Author> Approved By: <President/CEO> Approval Date: XX/XX/XXXX 5.4 Planning 5.4.1 System Objectives We have established and documented our quality objectives in our Management Review Minutes, and promulgated the applicable requirements to relevant functions and levels within the organization. Instructions on meeting these objectives can be found in lower level documents, such as Procedures, and in individual order specifications and/or requirements as documented in various forms of work instructions. Measurement and analysis of the System Objectives are made and reviewed through review meetings to ensure consistency with the Quality Policy and continual improvement of our products and processes. Objectives are dynamic in nature and therefore not listed here, but are documented in our Management Review meeting minutes. 5.4.2 System Planning Top Management shall document planning conducted to identify the necessary processes and resources needed to achieve our System Goals and Objectives. The documented output of our planning shall focus on the continual improvement of our Business Management System. Changes to plans are done in a controlled manner to maintain the integrity of our Business Management System . 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority Our <President> assumes the ultimate responsibility for the proper implementation and execution of this, and all other, Quality System procedures
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