GMP Quality Manual质量手册
GMP Quality Manual
This quality manual for Good Manufacturing Practices is based on the ISO 9001 standard, and addresses the requirements of FDA's medical device regulations.
此GMP质量手册是基于ISO 9001标准，叙述FAD医用仪器的法规要求。
Table of Contents 目录
POLICY方针
QUALITY SYSTEM DESCRIPTION质量系统描述
QUALITY DEFINITIONS质量定义
QUALITY ACHIEVEMENT质量目标
QUALITY VERIFICATION质量确认
QUALITY IMPROVEMENT质量改进
ADMINISTRATIVE CONTROLS行政控制
Comparison Matrix比对矩阵
Organizational Matrix for Quality System Functional Responsibilities质量系统功能图Quality Systems Organizational Chart质量系统组织机构图
Parent Category 上级分类
Quality Manuals质量手册
POLICY 方针
Quality Policy质量方针
We are dedicated to achieving customer satisfaction through an uncompromising commitment to quality. 我们致力于让客户满意，承诺对质量永不妥协。
（保证产品质量，让用户满意）
These high standards are realized through the following practices:通过下列实践达到高标准1.An open door policy that enables all personnel to bring to management's attention any concerns regarding quality achievement and customer satisfaction.
保证产品质量，让用户满意应成为每一员工的工作关注点。
2.Personnel performing their work in a manner that ensures products and services meet all quality requirements.
员工的操作方式、行为规范要以满足所有质量要求为基本准则。
3.Enabling personnel to carry out their responsibilities by providing the necessary training, resources, and work environment.
为员工提供必要的培训、资源及工作环境以保证员工履行其职责。
4.The development of a multi-disciplinary collaborative team structure throughout all activities of the company.
构建多种学科协作的专业团队和组织架构。
5.The application of high standards to business conduct, including contacts with customers, co-workers, and collaborators.
建立和实施较高的企业营运（包括与与客户、合作商及合作人的联系与合作）操作标准。References:
?ISO 9001, 4.1.1, Quality Policy
Manual Objectives 质量目标
We have established a quality system that is designed to meet domestic and worldwide regulatory standards for its products in the market place. The key applicable regulatory standards include:
?21 CFR Part 820, Quality System Regulations for Medical Devices
?93/42/EEC, European Medical Device Directive
?ISO 9001, ISO Quality Management Systems Requirements
?EN ISO 13485:2001, ISO Quality Systems for Medical Devices
The quality system addresses the elements necessary for implementing quality management including the organizational structure, responsibilities, procedures, processes and resources.
The Quality Manual describes our quality system. The central objective of the Quality Manual is to help employees meet all applicable regulatory requirements and to understand the quality commitments. In Appendix A, the requirements of 21 CFR 820, ISO 9001 and the Medical Device Directive 93/42/EEC have been cross-referenced to the sections of this Quality Manual.
The manual describes an overall process approach of planning for quality, application to activities, verification, and improvement (Deming's PDCA cycle). Where applicable, Standard Operating Procedures (SOPs) applicable to each section are cited. The Quality Manual is updated, reviewed and approved every 2 years. The current version of the Quality Manual is distributed to all personnel.
References:
?12-0048-SOP, Controlled External Document File
?ISO 9001, 4.2.1, Develop Quality System Documents
QUALITY SYSTEM DESCRIPTION
Scope
The quality system applies to all our products and services. We have a single, global quality system applicable to all worldwide locations.
Commitment
Our commitment to quality is demonstrated with a comprehensive system that satisfies all applicable regulatory requirements. Assurance of quality and its continuous improvement requires the support of the entire organization. Quality is assured by working in a
systematic manner to eliminate defects, errors, and nonconformance through proper product and process design and implementation, and following formalized procedures and work instructions.
Employees are encouraged to bring to management's attention any concerns regarding quality achievement and customer satisfaction.
We enables all employees by providing the following support:
?Specific job skill training,
?Quality System training,
?The necessary tools and equipment,
?An environment and the resources that promote continuous improvement. Quality Planning
The quality planning process defines product specifications, meets the specific requirements for projects and contracts, and ensures customer needs and expectations are met or exceeded. Quality planning is achieved through a combination of business and product planning, project teams, quality improvement plans, review of Device Master Record documents, internal and supplier audits, and employee training. The quality system is fully documented to ensure that quality planning is consistent with all other requirements. References:
?12-0050-SOP, Design Control Guideline
?12-0072-SOP, Inspection and Test Requirements
?12-0073-SOP, Process Control General Requirements
?ISO 9001, 4.2.3, Control Quality System Documents
Organization
Responsibility and Authority
Executive management is responsible for ensuring that an effective Quality System is established and implemented. The success of the Quality System is impacted through commitment, and the demonstration and communication of that commitment, by senior staff.
The responsibility of ensuring that the quality system is established, implemented, practiced, and maintained lies with the Director, QA/QC, who is the designated Management Representative. The duties of the Management Representative include the final disposition/determination of products and processes, as well as, developing a set of measurements which are used by senior management to ensure the quality system is meeting or exceeding established requirements. Functionally, the Director of QA/QC reports directly to the Vice President of Operations. In addition, the Director of QA/QC has an unambiguous reporting relationship to the CEO/President for all matters related to the company's quality system and to resolve any quality issues that may arise due to a conflict of interest created by the direct reporting relationship to his/her Vice President.
The European QA/RA Manager assures compliance with the Quality Manual and appropriate regulatory requirements for local activities. The European QA/RA Manager functions as the local management representative and has an indirect reporting relationship with the QA/QC Director in all matters pertaining to quality policy and compliance. Functionally, the European QA/RA Manager reports to the VP, General Manager, Europe, however, he/she has direct access to the CEO/President through the QA/QC Director in matters pertaining to quality.
An integral part of the duties of department managers and personnel is the implementation of the quality system requirements and procedures into their daily activities. A matrix identifying functional responsibility for each of the areas listed in this quality manual is shown in the Organizational Matrix for Quality System Functional Responsibilities. An organizational chart showing the functional relationships between departments in shown in the Quality Systems Organizational Chart.
References:
?ISO 9001, 4.1.2.1, Responsibility and Authority
?Organizational Matrix for Quality System Functional Responsibilities
?Quality Systems Organizational Chart
Resources
Senior management ensures that resources are identified and assigned to appropriate tasks as needed to execute the requirements of the quality system. Each functional task is assigned to employees whose responsibilities are summarized and documented in job descriptions. Job descriptions establish the requirements of the task to be performed as well as the education and skill requirements. Functional tasks assigned to consultants are defined in contracts and the consultant's qualifications to perform the assigned task(s) are defined by their credentials.
References:
?ISO 9001, 4.1.2.2, Resources
Quality System Verification
Quality Assurance monitors the implementation and maintenance of the quality system by performing verification procedures to ensure compliance, suitability, and effectiveness of established requirements that pertain to the quality system.
The internal audit process is a verification procedure used by Quality Assurance to determine if elements of the quality system are effectively achieving the stated quality objectives and if there are adequate resources assigned to meet the requirements of the quality system. Appropriate corrective action is taken by senior management if the audit reveals inadequacies in any area of the quality system.
References:
?09-0009-SOP, Internal Quality Systems Auditing
Management Review
The quality system is reviewed at least once each calendar quarter by senior management to determine the effectiveness and suitability of the quality system to meet or exceed customer and product specifications. Specific measurement tools are used at senior management review meetings to ensure consistent commitment to continuously improve the product and process quality. These measurement tools include but are not limited to: results of internal and supplier audits, established quality objectives, customer complaints, corrective action results, and specific product performance reviews. Meeting records, including action item assignments, are created from the Senior Management Review meetings. Timelines are established as a way to follow action items and ensure action items are resolved and satisfactorily closed.
References:
?ISO 9001, 4.1.3, Management Review
Quality System Procedures
References:
?ISO 9001, 4.2.2, Prepare Quality System Manual
Documentation
The quality system is documented through a combination of procedures and instructions. The diagram below provides an overview of the relationship of the documentation within the company's quality system. A matrix of top level SOPs in the Quality Manual cross referenced to the applicable regulatory requirements is shown in Comparison Matrix.
Level 1 - At the apex of the pyramid, the Quality Manual is a summary of the company's quality system and provides an overview of how the applicable regulatory requirements are addressed.
Level 2 - Top-level Standard Operating Procedures (SOPs) that describe key aspects of the company's quality system are referenced throughout the Quality Manual. Additional Standard Operating Procedures (SOPs) are accessed through the Master Document File index. These additional SOPs are usually more specific in nature and may contain procedures that are department, method, or equipment specific.
Level 3 - Work instructions are documented as Manufacturing Batch Records (MBRs), Part Number Specifications (PNSs), Drawings (DWGs), Qualification and Validation Documents (QVDs), and Standard Operating Procedures (SOPs). Access to these documents is also through the Master Document File index. In addition, a number of Departmental Desk Guides are in use. The content of these desk guides is revision controlled by the department head as evidenced by a signature and revision date.
Level 4 - Quality records generated by the company's quality system are collected and archived primarily by Document Control. These records include, but are not restricted to, completed Device History Records, QC test and inspection records, Qualification and Validation Reports, quality system audit reports, Instrument History Records, equipment calibration and maintenance records, and customer complaints.
The Master Document File index is maintained by Document Control. Copies of current revisions of all documents are issued to Authorized Document Manuals located throughout the company to provide access for employees who use the documents in the performance of their work.
Technical Documentation
The technical documentation that supports CE approvals and demonstrates conformance to the Medical Device Directive are also part of our quality system documentation. The technical documentation is located at the company's worldwide headquarters location and a summary file is located at the Europe headquarters. The documentation is available upon request by competent authorities and/or the Notified Body.
References:
?09-0001-SOP, Document Control and Change Procedure
?09-0180-SOP, EC Notification of Change Procedure
?09-0199-SOP, Technical Documentation for CE Marked Product
?09-0218-SOP, Classification and Conformity Assessment Route Determination for Medical Devices Intended for European Market
?09-0220-SOP, CE Marking of Medical Devices
?12-0059-SOP, Quality Records Collection and Retention
?Comparison Matrix
QUALITY DEFINITIONS
Sales (Contract Review)
All proposed business offerings to customers are appropriately reviewed to ensure that ourproducts are accurately represented, properly promoted, and fairly priced. When it is useful in the conduct of our business, either to us or our customers, supply contracts may be entered into. These contracts are reviewed with particular regard to ability to supply and the appropriateness of economic terms and conditions to specific classes of trade. Customer purchase orders are reviewed to verify that we can meet all obligations as defined in the
contract. All discrepancies between the customer and us are resolved prior to commencement of any work.
References:
?13-0001-SOP, Promotional Material and Advertising Procedure
?13-0004-SOP, Contract Review
?13-0007-SOP, Order Processing Europe
?ISO 9001, 4.3, Contract Review
Design Control
Our strategy for design and development of quality products and services is to clearly define products and services in terms of customer expectations, medical treatments, product performance, marketing and distribution requirements, manufacturing/quality assurance, safety, legal, and regulatory requirements. The design of all new products or any significant changes to current products are controlled through a project management system with multi-disciplinary participation. Specifications, procedures and systems are established during product development to insure that product and services consistently and reliably meet requirements. Design reviews are held during the development cycle. Senior management is responsible for administration and maintenance of design control. References:
?09-0175-SOP, Software Validation
?09-0224-SOP, Risk Analysis
?12-0027-SOP, General Qualification & Validation Guideline
?12-0049-SOP, Engineering Documentation, Change & Control
?12-0050-SOP, Design Control Guideline
?12-0058-SOP, Software Development Procedure
?12-0065-SOP, Design Stage Deliverables
?12-0066-SOP, Design Review
?12-0072-SOP, Inspection and Testing General Requirements
?12-0073-SOP, Process Control General Requirements
?18-0001-SOP, Clinical Documentation
?ISO 9001, 4.4, Product Development and Design
Purchasing
Key suppliers and subcontractors are identified and chosen for their ability to provide product and service to defined requirements. Qualified suppliers are added to the Qualified Supplier List maintained by the Materials Control department. Through the use of established assessment procedures, we continuously monitors suppliers to ensure that they are conforming to specified purchaser requirements. The extent of assessment for a supplier is dependent upon the significance of the product and/or service purchased and, where applicable, upon previously demonstrated performance.
All purchased materials and services intended for use in production processes are specified in the purchasing documents. All component/material specification documents are reviewed and approved by management personnel prior to use. Additional requirements not specified on component/material specifications are conveyed via purchase orders or contracts. Purchase orders and/or contracts convey the degree of control we establish with our suppliers to ensure quality product and/or service.
References:
?09-0003-SOP, Raw Material Quality Assurance Procedure
?09-0010-SOP, Supplier Qualification and Auditing Procedure
?10-0021-SOP, General Purchasing Guidelines for Inventory Control/Production
?10-0023-SOP, Supplier Performance Evaluation Procedure
?10-0026-SOP, General Purchasing Procedure - Europe
?ISO 9001, 4.6, Purchasing Requirements
Customer Supplied Product
Product owned by a customer and held by us for further manufacturing is received, stored, handled, and maintained as defined in approved contracts. Prior to the manufacturing of customer supplied product, procedures and specifications are established and approved in concert with customer requirements. All activities involving customer supplied product are performed in a manner consistent with the Quality System.
References:
?12-0076-SOP, Contract Manufacturing
?ISO 9001, 4.7, Customer-Supplied Products
QUALITY ACHIEVEMENT
Manufacturing
Process Control
The manufacturing processes are defined in production documents, planned with work orders, and performed by appropriately trained employees. These processes are performed under controlled conditions, with documented instructions, established workmanship criteria, and appropriate processes and equipment. Manufacturing documents also include requirements for health, cleanliness, and clothing of personnel, and the appropriate environmental requirements.
During production, processes that can not be verified by end product testing are monitored and controlled. Inspections and tests are used at critical steps to prevent the production of substandard product.
Procedures that control facilities, utilities and the manufacturing environment are also established and documented to ensure that acceptable conditions exist for performing environmentally sensitive processes. Defined aler t limits for environmental control exist and there are clear procedures for responding when the limits are exceeded. Critical processing
equipment and associated methods for using the equipment are validated for inclusion in manufacturing process.
Records of all process activities identify the documentation used, the operator, and the date the process was conducted. Records are also retained as part of the Device History Record. References:
?09-0003-SOP, Raw Material Quality Assurance Procedure
?09-0004-SOP, Discrepancy Report Procedure
?09-0006-SOP, Device History Record
?09-0007-SOP, Device Master Record
?09-0041-SOP, Manufactured Material Quality Assurance Procedure
?09-0175-SOP, Software Validation
?11-0050-SOP, Facilities Change Control Procedure
?11-0061-SOP, Preventive Maintenance Program
?12-0027-SOP, General Qualification and Validation Guidelines
?12-0072-SOP, Inspection and Test General Requirements
?12-0073-SOP, Process Control General Requirements
?ISO 9001, 4.9, Process Control Requirements
Product Identification and Traceability
Raw materials, components, and finished product are identified during all stages of processing to ensure that only acceptable materials are used in manufacturing. The product and intermediates are labeled and marked by part number and lot number from receipt of material to distribution and use. Expiration dates are monitored so that expired material is not used in the product.
All raw materials, components, and finished product are traceable through all stages of manufacturing. Traceability is assured through the process of marking and recording material throughout manufacturing and service using archived records and a computer based materials control system.
References:
?10-0002-SOP, Materials Control - Raw Material
?10-0003-SOP, Materials Control - Finished Goods
?10-0004-SOP, Expiration Date Assignment
?10-0008-SOP, Materials Control - Work in Process
?10-0015-SOP, Product Traceability - Europe
?10-0025-SOP, Part Numbering
?12-0012-SOP, Lot Number Assignment
?ISO 9001, 4.8, Product Identification and Tracing
Post Production Operations
(Handling, Storage, Packaging, Preservation and Delivery)
Raw materials, components, and finished products are handled and stored in a manner to prevent damage, deterioration, or contamination. The handling, storage, and delivery requirements are defined and specified for all material requiring special handling to ensure conformance to the customer needs and product stability. Product labels are maintained under strict controls to prevent inadvertent use of obsolete or incorrect labels. Packaging is designed to protect product/material from damage or deterioration during storage and transportation. The labeling on the package clearly describes the contents of the package to prevent mix-ups, and assist with materials management and control. Where appropriate, product packaging is designed to maintain the sterility of the product and to allow it to be used in an aseptic manner. The package design prevents use of non-sterile product because it is obvious when the product has been opened.
We arrange for the transportation of the product to the customer's site and ensures it is protected from damage or deterioration. Freight carriers are selected on the basis of their ability to provide service commensurate to the needs of the customer. Records of product packaging and shipment are maintained to allow traceability of the product to the destination. The personnel responsible for packaging and authorizing the shipment are recorded.
References:
?06-0001-SOP, Packaging & Inspection of Final Assemblies
?07-0001-SOP, Product Labeling: Printing, Operations, and Inspections
?09-0014-SOP, Product Recall Procedure (Domestic Market)
?09-0141-SOP, Product Recall Procedure (Europe)
?10-0002-SOP, Materials Control - Raw Material
?10-0003-SOP, Materials Control - Finished Goods
?10-0004-SOP, Expiration Date Assignment
?10-0007-SOP, Packaging and Shipping of Approved Products
?10-0008-SOP, Materials Control Work In Process (WIP)
?10-0019-SOP, Intra-Company Transportation of Materials
?10-0021-SOP, General Purchasing Guidelines for Inventory Control/Production
?ISO 9001, 4.15, Handling, Storage, and Delivery
Servicing
Procedures for after sales warranty (contractual) service are developed and maintained. Service performance is verified to specified requirements. Product returned for servicing is clearly marked and segregated to prevent mix-ups with new product and to ensure that it is not shipped as new product. The quality system established for servicing operations conducted or controlled by us include procedures for maintenance, review, and evaluation of service records for the detection of systematic quality problems.
References:
?05-0004-SOP, Instrument Service and Repair Procedure
?05-0005-SOP, Instrument Installation Procedure
?05-0006-SOP, Instrument Periodic Maintenance Procedure
?05-0008-SOP, Instrument Refurbishment Procedure
?09-0011-SOP, Customer Complaint Procedure
?09-0014-SOP, Product Recall Procedure (Domestic Market)
?09-0141-SOP, Product Recall Procedure (Europe)
?10-0017-SOP, Returned Goods Procedure
?ISO 9001, 4.19, Servicing Requirements
Control of Nonconforming Product
Nonconforming product is controlled by clear identification and segregation to prevent inadvertent use or shipment. All nonconformity incidents are reviewed by the Material Review Board and formal disposition of nonconforming product/materials is identified. Corrective action to prevent further nonconforming product is identified and implemented (see section 6.1). All reworked nonconforming product/material is verified to be conforming before release for use. Any request for a concession to the nonconformity is reviewed for compliance with customer's requirements and regulatory requirements.
References:
?09-0004-SOP, Discrepancy Report Procedure
?09-0015-SOP, Material Review Board
?10-0017-SOP, Returned Goods Procedure
?10-0024-SOP, Return of Non-conforming Product to Supplier
?10-0032-SOP, Returned Goods Procedure Europe
?12-0021-SOP, Rework/Reprocessing Procedure
?ISO 9001, 4.13, Control of Nonconforming Products
Statistical Techniques
Statistical techniques are used for the following activities:
?monitor the performance of key manufacturing facilities, utilities, and processes, ?to monitor product characteristics on a lot to lot basis,
?in qualifications and validations of facilities, manufacturing processes, and test methods, and
?in development of product/process specifications.
Electronic databases are maintained to facilitate the review of environmental monitoring and of quality characteristics for water used in production. Electronic databases are also maintained for key raw materials, subassemblies, and final product to facilitate review of processes and product performance over time.
Statistically based sampling plans, process controls, and process capability studies will be incorporated into appropriate aspects of inspection and testing, as well as manufacturing processes and related validations. The methods and tools that will be used for this process are based on techniques described in ISO TR 8550 and ISO 2859-1.
References:
?09-0074-SOP, QC Sampling Techniques
?09-0189-SOP, Master Sampling Plan
?ISO 9001, 4.20, Statistical Techniques
?ISO TR 8550, Guide for the Selection of an Acceptance Sampling System, Scheme or Plan for Inspection of Discrete Items in Lots
?ISO 2859-1, Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
QUALITY VERIFICATION
Inspection and Testing
All incoming parts and materials used in manufacturing steps are inspected or verified to established requirements prior to use. Purchasing efforts are directed at establishing successful partnerships with suppliers to assure that all incoming parts and materials meet specifications. Final product is not released for use until it is verified to be in conformance with the specifications.
In-process inspection is carried out as stated in Manufacturing Batch Records and Part Number Specification documents. If a part is needed for further manufacturing prior to the completion of inspection and testing, approval by appropriate management personnel is obtained via a Discrepancy Report.
Final inspection and testing is performed before release of the product for shipment. The final product release review procedure includes a verification that all acceptance data is present and that all specifications were met.
Each step of inspection and testing activities is controlled and results are recorded to provide evidence that each stage is completed. Records are maintained to show the pass or fail status of the test/inspection compared to specified acceptance criteria. The records also identify the QA/QC Department Head responsible for the release of the product. References:
?06-0001-SOP, Packaging and Inspection of Final Assemblies
?09-0003-SOP, Raw Material Quality Assurance Procedure
?09-0004-SOP, Discrepancy Report Procedure
?09-0006-SOP, Device History Record
?09-0041-SOP, Manufactured Material Quality Assurance Procedure
?09-0074-SOP, QC Sampling Techniques
?09-0084-SOP, QC Test Failure, Repetition and Investigation Rules
?09-0088-SOP, Retention Sample Requirements
?12-0072-SOP, Inspection and Test General Requirements
?ISO 9001, 4.10, Product Inspection and Testing
Inspection, Measuring, and Test Equipment
Equipment used for inspection and testing is selected based on applicability and sensitivity of measurement for the particular product attribute being evaluated. Test equipment is controlled through periodic calibration and maintenance activities to ensure the integrity of the equipment. The calibration status for each piece of test equipment is indicated on the equipment. When equipment found to be out of calibration is used to test product and parts, a product impact assessment is performed and, where appropriate, those products and parts are retested before release. Calibration and maintenance activities are recorded and accessible to personnel using the equipment and/or involved with the calibration and maintenance activities.
Test equipment is stored and maintained in the appropriate environment to achieve the limits for accuracy and precision. Test hardware and software is verified according to documented procedures and schedules.
References:
?11-0033-SOP, Instrument Calibration Program
?11-0061-SOP, Preventive Maintenance Program
?11-0079-SOP, General Calibration Protocol
?11-0080-SOP, Vendor Calibration
?12-0026-SOP, Master Equipment Files
?ISO 9001, 4.11, Control of Inspection Equipment
Inspection and Test Status
The inspection/test status of all raw materials, components, and finished products is identified by labeling, segregating, and recording at all phases of production, testing, installation, servicing, and warehousing. Inspection and test results are documented as the material/product progresses through the production process. The inspection/test status identifies the material status and those items which do not conform to specifications. References:
?09-0003-SOP, Raw Material Quality Assurance Program
?09-0041-SOP, Manufactured Material Quality Assurance Procedure
?10-0002-SOP, Materials Control - Raw Materials
?10-0003-SOP, Materials Control - Finished Product
?10-0008-SOP, Materials Control - Work in Process (WIP)
?ISO 9001, 4.12, Inspection and Test Status of Products
QUALITY IMPROVEMENT
Corrective and Preventative Action
Corrective action is a documented activity used to stimulate continuous improvement to quality problems. Corrective action includes: 1) identification of the nonconforming material, process, facility, and/or equipment, 2) identification of deviations from established procedures/processes or specifications, 3) identification of the cause for nonconformities or deviations, 4) implementing activities designed to stimulate improvement, and 5) assessing and verifying the effectiveness of the corrective action. The corrective action systems responds to feedback from internal and external sources, and insures that post production experience with the products are systematically reviewed for improvement opportunities. The preventive action program includes the review and analysis of quality data to identify systematic problems that cause nonconformance and other quality problems, and to identify opportunities for improvement with product, design and the quality system. References:
?09-0004-SOP, Discrepancy Report Procedure
?09-0011-SOP, Customer Complaint Procedure
?09-0015-SOP, Material Review Board
?09-0075-SOP, Product Performance Review
?09-0178-SOP, Medical Device Reporting - Europe
?09-0179-SOP, Medical Device Reporting - USA
?09-0217-SOP, Quality Improvement Program Monitoring System
?ISO 9001, 4.14, Corrective and Preventive Action
Quality Audits
The audit program includes internal audits, product audits, and supplier audits. Internal quality system audits are planned and performed periodically and are scheduled on the importance and status of the activity being audited. These audits verify that quality activities and related results comply with the specified requirements of the quality system, as well as determine its effectiveness. The audit results identify deficiencies and plan for appropriate corrective action to eliminate the root cause. Follow-up audit activities evaluate the impact of corrective action and are documented. Product audits are conducted to review the continued performance of the product against its specifications and to identify quality improvement opportunities. Supplier audits are performed as part of the supplier management program to assess the supplier's potential for providing product or material that conforms to specifications.
References:
?09-0009-SOP, Internal Quality Systems Auditing
?09-0010-SOP, Supplier Qualification and Auditing
?09-0075-SOP, Product Performance Review
?10-0023-SOP, Supplier Performance Evaluation Procedure
?ISO 9001, 4.17, Internal Quality Audit Requirements
ADMINISTRATIVE CONTROLS
Document Control
All documents, document changes and their distribution are controlled in a defined and formal manner. Control includes an annual audit by the originator of the last revision, approval by a technical authority, and inclusion of supporting data when necessary to ensure the document is adequate in fulfilling its intended purpose or requirement. Approved documents are assembled in Authorized Document Manuals, available to users at designated work locations, and are periodically audited.
Document revisions are reviewed and approved by the departments who initiated the original review and approval process (unless otherwise specified). The review and approval of documents includes technical authorities, responsible department heads, and Quality Assurance. Changes that may affect patient safety or have a significant impact on product quality are validated before implementation. Revised documents are distributed to the Authorized Document Manuals in a timely manner by the Document Control group to ensure that only documents of the current revision are distributed. Invalid or obsolete documents are removed from use, are clearly identified as such, and properly archived. References:
?09-0001-SOP, Document Control and Change Procedure
?09-0007-SOP, Device Master Record
?ISO 9001, 4.5, Document and Data Control
Records Control and Retention
Records are maintained to demonstrate conformance to requirements and the effective operation of the quality system. Key records relating to the quality system, conformance to standards and regulatory requirements, and historical records of product quality are stored in Document Control. Other records are maintained in departmental files. The records are properly labeled, legible, and organized for easy retrieval. The records are stored and maintained to prevent damage and deterioration.
Retention times of quality records are in accordance with the legal and contractual requirements applicable to us. Records are maintained for five years after the last product lot is manufactured or from the date the instrument is removed from service. References:
?09-0001-SOP, Documentation Control & Change Procedure
?09-0006-SOP, Device History Record
?09-0007-SOP, Device Master Record
?09-0213-SOP, Instrument Device History Record
?12-0026-SOP, Master Equipment Files
?12-0059-SOP, Quality Records Collection and Retention
?ISO 9001, 4.16, Control of Quality Records
Training
Personnel at all levels of the organization, including temporary employees, receive training in the areas of quality system regulations, specific job-related tasks, and safety. Training requirements are identified to ensure that training is continuously provided and is appropriate for each operation (process) affecting quality. Personnel required to work under special environmental conditions or requiring specialized skills are trained to insure their competency. Records of training and certification are maintained to verify that individuals have appropriate training.
References:
?09-0076-SOP, QA\QC Department Job Skill Training
?09-0094-SOP, QA\QC Microbiology Job Skill Training
?10-0010-SOP, Materials Control Department Job Skill Training
?11-0062-SOP, Facilities Department Job Skill Training
?12-0004-SOP, Quality Systems / Regulatory Requirements Training
?12-0017-SOP, Manufacturing Job Skill Training
?12-0043-SOP, Antibody Development - Departmental Job Skill Training
?12-0044-SOP, Engineering Department Job Skill Training
?12-0055-SOP, Process Biochemistry Department Job Skill Training
?13-0005-SOP, Marketing Department Job Skill Training
?15-0012-SOP, R&D Flow Cytometry Job Skill Training
?ISO 9001, 4.18, Training Requirements
? 2006 Doxpub, Inc. | Terms of Use|
公司质量手册
公司质量手册 集团文件版本号：（M928-T898-M248-WU2669-I2896-DQ586-M1988）
锦州电力电容有限责任公司质量管理体系手册 200309 质量手册 QUALITYMANUAL 锦州电力电容器有限责任公司JINZHOUPOWERCAPACITORLIABILITYCO.,LTD 质量手册 （第3版第1次修订） 手册编号： 副本控制： 持有者： 2001年5月28日发布2001年06月01日实施 目录 发布令
质量管理体系组织机构图 前言 (1) 0质量方针和质量目标 (3) 1范围 (5) 2引用标准 (6) 3术语和简称 (7) 4质量管理体系 (10) 4.1总要求 (10) 4.2文件要求 (11) 5管理职责 (13) 5.1管理承诺 (13) 5.2以顾客为关注焦点 (15) 5.3质量方针 (16) 5.4策划 (17) 5.5职责、权限和沟通 (18) 5.6管理评审 (19)
6资源管理 (21) 6.1资源的提供 (21) 6.2人力资源 (22) 6.3基础设施 (23) 6.4工作环境 (24) 7产品实现 (25) 7.1产品实现的策划 (25) 7.2与顾客有关的过程 (27) 7.3设计和开发 (29) 7.4采购 (32) 7.5生产和服务提供 (34) 7.6监视和测量装置的控制 (36) 8测量、分析和改进 (37) 8.1总则 (38) 8.2监视和测量 (39)
8.3不合格品控制 (41) 8.4数据分析 (42) 8.5改进 (44) 9质量手册的管理 (46) 附录A质量管理体系程序文件清单 (48) 附录B质量手册编写人员名单 (49) 附录C质量手册更改控制表 (50) 发布令 锦州电力电容器有限责任公司（JR）在多年推行全面质量管理的基础上，不断深化完善质量体系。依据GB/T19001-1994idtISO9001：1994《质量体系设计、开发、生产、安装和服务的质量保证模式》对原JR《质量手册》进行换版。编写了JR《质量手册》（第二版）。适用于JR产品的全过程的质量保证，并于1998年4月完成了对GB/T19001-1994idtISO9001：1994《质量体系设计、开发、生产、安装和服务的质量保证模式》在锦州电力电容器有限责任公司的实际应用，同时通过了质量认证。
部门管理手册模板
职能部门管理体系手册
职能部门管理体系手册 一、部门职能 根据公司《XXX》[XXX号]文件规定：本部门管理职能共16条： 1.负责督促建立各级安全生产保证体系。 2.负责组织制订公司年度安全质量环境保护管理目标并督促设施，对有关安全质量信息进行综合分析，提出意见，供公司领导决策； 3. 组织对公司安全质量管理制度与流程执行情况进行监督检查。 4.负责组织开展公司安全质量教育培训工作；配合有关部门做好项目经理、安全生产总监、安全质量管理人员和特种作业人员的安全培训、考核、办证工作；负责公司安全生产许可证的申办、复审和管理工作。 5.负责组织开展“安全月”和“质量月”等活动，并配合有关部门做好安全质量、文明施工的宣传教育工作。 6.负责组织或参与公司应急救援管理工作。 7.负责组织或参与安全质量事故调查处理，制定防范措施，并督促实施。 8.负责组织公司优质工程、安全标准工地建设及省部级以上优质工程的推荐申报工作。 9. 负责公司各类伤亡事故、工程质量事故的登记、统计和上报。 10. 监督在建项目安全生产费用的使用情况。
11.参与公司施工组织设计和施工方案评审工作，督促安全防护设施落实到位。参与变更设计、施工组织、新技术、新工艺、新设备、新材料等有关安全、质量技术措施的评审工作。 12.参与公司项目中标后的施工调查、安全管理交底和责任矩阵、项目管理策划书等前期策划工作。 13.参与施工生产相关的合同范本制定、合同履约评审工作。 14.参与对项目部绩效考核工作。 15.参与劳务队伍管理工作，参与分包考核评价、责任成本考核、经济活动分析工作。 16.参与审计与监察、后评价工作。 二、工作目标 （一）2017年年度工作目标实现情况： （二）2018年年度工作目标： 三、职责权限 本部门现有工作人员4人，其中：部长1人，部员3人。 其中：部长的职责权限是： 1.负责组织年度管理目标，建立健全安全质量环境管理体系。 2.负责组织开展公司安全质量教育培训工作。 3.负责组织开展公司安全生产宣传教育活动、日常及专项安全质量环保监督检查活动。 4.负责组织开展隐患排查治理工作。 5.负责组织开展公司优质工程、安标工地申报工作。 6.负责组织部门开展安全质量管理工作和安全质量稽查工作
公司质量管理手册
0.1 目录 0.1 目录………………………………………………………………… 1-2 0.2 公司概况…………………………………………………………… 1-1 0.3 质量手册公布令…………………………………………………… 1-1 0.4 治理者代表任命书………………………………………………… 1-1 0.5 质量方针、目标…………………………………………………… 1-1 0.6 质量目标展开……………………………………………………… 1-1 0.7 质量手册治理方法………………………………………………… 1-1 第1章范围………………………………………………………………… 1-1第2章引用标准…………………………………………………………… 1-1
第3章术语和定义………………………………………………………… 1-1 第4章质量治理体系总要求…………………………………………… 1-4 第5章治理职责…………………………………………………………… 1-3 第6章资源治理…………………………………………………………… 1-1 第7章产品实现…………………………………………………………… 1-6 第8章测量、分析和改进………………………………………………… 1-3 附录A：质量治理体系组织机构图 附录B：质量治理体系职能分配表 附录C：程序文件清单 附录D：工艺流程图
0.2 公司概况
公司地址:********* 邮政编码;000000 电话: 11111111 传真：11111111 0.3手册发布令
包装印刷有限公司《质量手册》由治理者代表组织编写，手册符合GB/T19001-2008 idt ISO9001-2008《质量治理体系——要求》标准规定，符合国家有关法律法规的要求，符合本公司的实际，现予以公布。 本“质量手册”规定了本公司的质量方针和质量目标，是全体职员在各项质量活动中必须遵循的准则，也是本公司质量法规性文件。 本“质量手册”自公布之日起生效，希望全体职员认真学习，深入领会，切实贯彻执行。 总经理： 日期：
品质手册范本
ISO9000-2000版质量体系文件范本
0.1 目录 标题 ISO 9001：2000标准条款对照 0.1目录 0.2质量手册说明 5.5.5 0.3质量手册修改控制 0.4企业概况 1.0公司组织机构图 2.0公司质量管理体系结构图 3.0质量管理体系过程职责分配表 4.0质量管理体系 4.1、4.2.1、4.2.2 4.2.3文件控制程序 4.2.3 4.2.4质量记录控制程序 4.2.4 5.0管理职责 5.0 5.1~5.3管理承诺/以顾客为关注焦点/质量方针 5.1 、5.2、5.3 5.4管理策划控制程序 5.4.1、5.4.2 5.5职责和权限 5.5.1 、5.5.2 、5.5.3 、5.5.4 5.6管理评审控制程序 5.6
6.0~6.1资源管理 6.0、6.1 6.2人力资源控制程序 6.2 6.3~6.4设施和工作环境控制程序 6.3 、 6.4 7.0产品实现 7.0 7.1实现过程的策划程序 7.1 7.2实现过程的策划程序 7.2 7.3设计和（或）开发控制程序 7.3 7.4采购控制程序 7.4 7.5生产和服务运作控制程序 7.5 7.6测量和监控装置的控制程序 7.6 8.0测量、分析和改进 8.1 8.2.1顾客满意程序测量程序 8.2.1 8.2.2内部审核程序 8.2.2 8.2.3~8.2.4过程和产品的测量和监控程序 8.2.3、8.2.4 8.3不合格控制程序 8.3 8.4数据分析控制程序 8.4 8.5改进控制程序 8.5 附录1 第二级文件清单 附录2 质量记录清单
0.2 质量手册说明 1 手册内容 本手册系依据ISO 9001：2000《质量管理体系——要求》和本公司的实际相结合编制而成，包括： （1）公司质量管理体系的范围，它包括了ISO 9001：2000标准的全部要求； （2）质量管理标准和公司质量管理体系要求的所有程序文件； （3）对质量管理体系所包括的过程顺序和相互作用表述。 2 术语和定义 本手册采用ISO 9000：2000《质量管理体系——基本原理和术语》的术语和定义。 3 本手册为公司的受控文件，由总经理批准颁布执行。手册管理的所有相关事宜均由质管部统一负责，未经管理者代表批准，任何人不得将手册提供给公司以外人员。手册持有者调离工作岗位时，应将手册还质管部，办理核收登记。 4 手册持有者应使其妥善保管，不得损坏、丢失、随意涂抹。 5 在手册使用期间，如有修改建议，各部门负责人应汇总意见，
品质部管理制度
品质部管理制度 一、目的 明确品质部人员职责、权限，规范产品品质控制流程，特制定本制度。 1.1适用范围 适用于品质部的管理、公司产品的品质控制。 1.2主要职责 1.2.1品质部负责人负责编制本部门各岗位工作人员的岗位职责、权限。 1.2.2各岗位人员依据本人的岗位职责、权限在工作中建立联系，履行相应职责。 1.3品质部架构
二、品质部职责 1)建立品质控制体系，制定品质管理制度； 2)制定工作流程、工作标准和考核办法； 3)编制公司各类产品和物料的质量标准； 4)来料、制造、成品品质检验规范的制订与执行； 5)来料、制造过程品质的巡回检验和出货检验； 6)不合格品处置及预防措施的订立与执行； 7)品质成本的分析与品质控制事项的制定； 8)评定产品质量水平，报告存在的质量缺陷； 9)计量具、量表、检测仪器、设备、工装治具的校验与控制； 10)对供应商的评定，品质能力的辅导、控制，保证物料的质量； 11)受理客户产品质量抱怨和投诉，原因分析及制定改善措施； 12)品质培训计划的制定及执行； 13)对质量管理类文件进行维护和控制。 2.1品质部经理岗位职责 2.1.1岗位名称：品质部经理 2.1.2直接上级：总经理 2.1.3直接下级：品质保证工程师、品质控制工程师、文员 2.1.4工作职责： 1)建立、健全公司品质管理控制体系；制定本部的各项管理制度、工作流程、工作标 准和考核办法；管理品质部的正常运作；对品质系统的正常运作负责；对公司内部的品质事故负责。 2)品质管理体系的设计，程序的拟定。 3)成品、物料检验计划的制订，品质成本的控制并监督完成。 4)按照生产出货要求制订检验计划，生产急件优先检验安排。 5)物料、制造过程、出货品质的质量控制，检查现场检验状态标识和追溯。 6)让步接收批准与否决；不合格处置及评价；成品品质鉴定与判定意见的签署；处理 存在或是潜在的质量问题，及时纠正并采取预防措施。 7)控制检验中发现的不合格现象不再重复发生，进行质量问题的分析、改进、跟踪。
企业品质手册
XXXXX 光电有限公司 XXXXXXXX OPTO-ELECTRONIC CO.,LTD. 编 号：QM-01 版 本：1.2 修订日期：2013.08.01 拟案单位：QA 发 行 章：
0.1 目录 0 封面(批准页) (1) 0.1 目录 (2) 0.2修订履历 (3) 0.3颁布令 (4) 0.4 管理者承诺 (5) 0.5 公司简介....................................................................................6-7 0.6 范围 (8) 0.7 公司组织架构与职责和权限 (9) 1.0 质量方针、目标及绩效指标 (10) 2.0公司的过程模式...........................................................................11-31 附件一：组织架构图 (32) 附件二：管理者代表任命书 (33) 附件三：过程与程序文件清单...............................................................34-35 附件四：ISO9001:2008 要求与公司过程矩阵图.................................... 36-37 附件五：过程绩效指标 (38)
修订记录
0.3颁布令 本公司依据ISO 900l:2008《质量管理体系—要求》编制完成了《品质手册》（QM-01 1.2版本），现予以批准颁布并于 2013 年 08 月 01 日正式生效实施。 本手册是本公司品质管理体系的法规性文件，是指导本公司建立并实施品质管理体系的纲领和行动准则。本公司全体员工必须遵照执行。 总经理： 日期：
品质部管理制度(1).
文件修订履历 版次 修订内 容 修订页 次 修订日 期 A/0 初版 发行 无 制定：潘亚磊审核：批准： 品质部内部管理制度 1.0 目的: 加强部门管理，规范职员的行为，确定工作标准，提高员工的工作积极性和敬业精神， 使质检员工的个人素质得以提高，有利于团队建设，树立部门的良好形象。以公司员工 绩效评价制度指导，以品质岗位职责基础，通过对个人的业绩、能力、态度等的评价， 鼓励先进，改进落后，实现绩效的持续改进，并以此作为晋升、提薪、教育等的依据。 2.0 范围： 品质部所有员工均适用之。
3.0 定义： 无 4.0 权责： 4.1 品质部负责制定及维护本制度执行状况。 4.2 相关部门及上级负责监督品质部执行效果。 5.0 内容： 5.1 新进人员入职需知： 5.1.1 新进人员经过行政、部门面试合格后简历入档，至品质文员处登记部门人事资料。 5.1.2 新入职人员上岗前培训期为七个工作日，由直接上司负责主导培训工作；培训期结束 进行上岗考核，考核合格发放上岗证。考核不合格者由直接上司决定是否继续培训或淘 汰。 5.1.3 在上岗前培训期间内，无论是新入职人员感觉不适应还是部门管理感觉其不能胜任岗 位要求而提出辞职或解聘都无工资发放，也不需缴纳培训费用。 5.1.4 在岗前培训期间内新入职人员可随时提出离职或调动；培训期结束正式上岗试用期间 提出离职将扣除公司培训费用（培训天数*负责培训人员日工资），特殊情况经直接上 司同意者可免扣培训费用。 5.1.5 品质部新入职人员试用期为1~3个月；品质部员工离职需提前一个月提出书面申请， 品质部管理离职需提前两个月提出书面申请，经批准后到期办理离职手续。
医药公司质量手册
山东鲁华能医药有限公司 本质量手册由管理者代表组织编写，经审查符合GB/T 19001—2008 idt ISO9001:2009标 准《质量管理体系要求》和YY/T 0287—2003 idt ISO13485:2003《医疗器械质量管理体系用于法规的要求》标准，现予以批准、发布。 质量手册作为全公司质量工作的法规和纲领性文件，用以统一协调全公司的质量管理活 动，各级人员都要在本职工作中认真贯彻执行。 总经理： 日期：年月日 山东鲁华能医药有限公司 山东鲁华能医药有限公司于二00八年八月，在山东松海药业有限公司的基础上进行改制变更。公司先经营医疗器械范围为： ⅡⅢ类：6864 医用卫生材料及辅料 6865 医用缝合材料及粘合剂 Ⅱ类： 6823 医用超声仪器及有关设备 6826 物理治疗及康复设备 6840 临床检验分析仪器（体外诊断试剂除外） 6854手术室、急救室、诊疗室设备及器具 6855口腔科设备及器具 6866医用高分子材料及制品（一次性无菌医疗器械除外） 由于业务需要，拟增加Ⅲ类:6846植入材料和人工器官、6810矫形外科（骨科）手术器械。公司器械部10人，其中质量管理人员3人。医疗器械经营面积62平方米，医疗器械仓库面积50平方米。 公司严格按照IS09001标准质量管理体系的要求，建立质量管理网络，从医疗器械的进
货、验收、储存、出库、销售和售后服务各个环节建立了控制程序，确保销出使顾客满意的医疗器械产品。公司按照《医疗器械经营企业许可证管理办法》、《山东省医疗器械经营企业许可证管理办法实施细则》及其补充规定要求，完善质量管理。 电话：3 地址：济南市历城区二环东路3362号润昌商务大厦南楼7层 邮编：250100 法人代表：李传杰 山东鲁华能医药有限公司 为确保本公司质量管理体系的建立、实施和保持有效运行，兹任命李秋燕同志担任本公司管理者代表，代表本公司管理层负责本公司质量管理体系的建立、实施和保持，向本公司管 理层报告质量管理体系的运行情况，及时处理影响质量管理体系运行的有关问题。 总经理： 日期：年月日 山东鲁华能医药有限公司 山东鲁华能医药有限公司
品质管理部工作手册
质量管理体系 品质部工作手册 （修改版） 文件编号： 生效日期： 编 制： 编制日期： 审 核： 审核日期： 批 准： 批准日期： （盖受控章处） 目录 北京阳光泰来商务服务有限公司 质量管理体系 品质部工作手册
品质部岗位职责 品质部经理岗位职责 1.负责制定本部门工作计划，并组织实施和按期上报，按时提交总结； 2.负责执行、监督本公司管理制度以及各项规章制度在本公司的执行、监 督与反馈； 3.负责制定本部门各项相关管理制度、岗位职责及工作流程； 4.负责本部门管理费用预算的制定及审核； 5.了解、掌握物业管理法律、法规方面的信息，并负责传达公司各部门； 6.审查公司项目日常服务工作标准，并上报巡查结果； 7.负责编制本公司《质量，环境管理手册》、质量计划、作业规程文件；并 负责质量体系运作监督、检查工作； 8.负责修改与审定作业规程文件，作业指导书及各种报表和运行路线； 9.负责公司质量体系内部审核、统计、分析与评定以及外部审核的组织、安排； 10.投标文件及标书的编写工作； 11.本部门月度考核任务和年度的各项经营和管理目标的落实和完 成工作； 13.总经理交办的其它工作事务。 品质主管岗位职责 1.在品质管理部经理的领导下，负责质量体系标准化执行管理工作， 2.协助经理完成公司各部门品质监督检查工作；
3.负责各类管理体系文件、材料的采集、整理、建档保存，并做好公司年度品质管理的计划和总结； 4.依据《质量，环境管理手册》，制定质量管理管理月度工作计划； 5.负责公司环境、安全检查工作，确保公司管理体系正常运作和及时改进； 6.负责重大服务投诉的调查取证工作，对需整改的工作进行检查督促； 7.负责公司各部门工作进展的检查督促，确保《质量，环境管理手册》的切实贯彻实施； 8.负责本部门的文件、档案、资料、电子文档及实物保存与管理； 9.完成领导交办的其他工作。 品质专员岗位职责 1.了解、掌握物业管理法律、法规方面的信息，并负责传达各部门； 2.负责定期对项目服务日常工作进行监督检查； 3.按照品质检查制度制作《质量月报》，监督整改； 4.建立完善的培训体系与培训制度； 5.负责公司员工的质量体系相关培训工作及培训效果的跟踪； 6.协助编制本公司《质量手册》、质量计划、作业规程文件和质量体系运作监督、检查工作； 7.负责修改与审定作业规程文件，作业指导书及各种报表和运行路线； 8.完成领导交办的其它工作。 文员岗位职责 1.负责部门文档打印复印、登记发放、归档整理等工作； 2.负责部门内会议的记录，整理；
XX公司质量手册(DOC 10页)
1.0前言 1.1概述: 本手册规定了本公司总体的质量方针、程序、职责和实践。本手册也是全公司质量体系的最高准则。 1.2范围： 本手册适用于公司质量方面的各项运作。 1.3质量手册的修改: 按《文件控制程序》修改及发出。 2.0建立质量体系： 2.1目的 建立一个以客户为中心的质量体系,为客户提供优质的模具及满意的服务。 2.2策划 2.2.1标准的采用及剪裁说明 由于公司生产的产品是由客户完成设计的，所以采用的标准为ISO9０02(１994版)，同时满足ＩSO9001(2 ００0版)的要求,并删减7．3 设计的要求。 2.2.2所需的过程及其顺序 a.组织架构的建立及职责的设定 b.资源的提供 c.产品的实现 d.测量、分析和改进 2.2.3过程的相互作用 ?由质量手册识别质量体系所需要的过程 ?确定这些过程的顺序和相互作用 ?由程序文件有效运作和控制所需要的准则和方法 ?由各个程序确保获得必要的信息以支持这些过程的有效运作和监控
?测量、监控和分析这些过程，实现必要的措施，并实现所策划的结果和持续的改进 3.0设立管理架构与职责: 3.1职责和权限 3.1.1由《公司架构与部门职责》设立公司架构,确定公司 管理层和各部门的职责。 3.1.2《公司架构与部门职责》由工程部编制,总经理批准。 3.1.3由《部门架构与岗位职责》设立部门架构，确定部门 中各岗位的职责及标准。 3.1.4《部门架构与岗位职责》由工程部编制,管理者代表 批准。 3.1.5职责和权限设置时需注意下列几点: ?确定管理者代表的职责及权限 ?负责质量判定及验证的人员须具有独立职责的能力与权限 ?具有一个上司的原则 3.2内部沟通 3.2.1《内部沟通管理程序》规定了不同层次和职能之间的 有效的沟通程序。 3.2.2内部沟通应包括体系的各个过程,外部信息的传递， 内部信息的沟通的策划及要求。 3.3文件控制 3.3.1《文件控制程序》需规定文件及批准、修改、识别的 有效方法,应包括对外部文件的控制的方法。 3.3.2所有作业的方法都应以文件的形式下发。 3.4质量记录的控制 3.4.1由《质量记录控制程序》规定质量记录的控制方法。 3.4.2过程中质量记录应按照过程中的文件要求进行。 3.5管理评审
《结构部品质量管理一》讲师手册周仲建
TCL家庭网络事业部 《结构部品质量管理（一）》培训课程大纲 【课程目标】：保证产品质量，生产顺利进行；为结构工程师提供学习晋升机会；【适合对象】：结构工程师 【课程时间】：2H 【课程大纲】：结构部品质量管理 第一部分：公司质量体系简介 ●家网质量体系介绍 ?家网质量体系统 ?PCP质量子流程 ●研发质量管理概要 ?设计质量保证 ?设计质量角色 ?VOC到CTQ,到设计规范 第二部分：结构部品质量管理 ●研发质量管理 ?设计规格产生，CTQ的确定 ?部品测试方案 ?部品应用测试 ●部品质量管理 ?部品CTQ测试 ?部品规格测试验证 ●部品认可和来料检查 ?供应商品质检查 ?IQC来料检查
★课程学习目标和意义：1缩短产品开发周期 2减少设计变更和更改 3降低研发质量成本 4提高工作效率 5优化产品设计 6提高产品档次 7提高标准化程度 8提高公司效益；
第一部分：公司质量体系简介 1.家网质量体系统 BPR Business process reengineering业务流程再造 SIPOC Supplier Input Process Output Customer六西格玛工具之一 DPMO Defeats Per Million Opportunities每百万机会的缺陷数 QFD Quality Function Deployment质量功能展开六西格玛工具之一 FMEA Failure Model Effect Analysis失效模式及后果分析 MSE Measurement System Evaluation测量系统分析 SPC Statistics Process Control统计的流程控制 VOP Voice of Process流程之声六西格玛工具之一 DOE Design of Experiment试验设计六西格玛工具之一 C&E Matrix Cause and Effect Matrix原因结果矩阵六西格玛工具之一 VOC Voice of Customer顾客之声 COPQ Cost of Poor Quality低质量成本 CTQ Critical To Quality 关键质量特性 ERP Enterprise Resource Planning企业资源规划 KPIV Key Process Input Variable流程关键输入变量 KPOU Key Process Output Variable流程关键输出变量 SOP Standard Operation Procedure 标准作业程序 6M Man, Machine, Material, Method, Mother Nature, Measurement人，设备，材料，方法，自然环境，测量Sub Sub-Process子流程 Micro微观的 KANO满意度分析模型
质量管理考核标准手册
质量管理考核标准手册 Company number：【WTUT-WT88Y-W8BBGB-BWYTT-19998】
新永茂不锈钢有限公司 质量生产考核内容及执行标准 编制: 持有人：受控状态：发放号 1 范围 本标准规定了原材料、设备状态、生产工序及辅助工序的操作指导书、操作规范、规程、工艺设定和计划安排、检验方法、检验结果、客户需求而判定规则的处置方法，全面提升公司产品质量的必要措施。纠正及预防生产违规造成的不良品出现，有效遏制不合格品的产生及减少设备、辅助备件和产品的损失、实行全员参与品质工作而制订的考核标准。 2 考核流程图（引用PDCA物流循环控制） 3 原料 根据客户需求及生产储备进行原料采购，进料渠道和原料供应必须出具质量证明书及有关报告。 对原料的状态实施全面监控和质量进行评估审核，建立有效的原料资质及适应生产状况、质量状态和使用情况进行存档、评定。 原料符合生产需求及客户使用需求引用：GB/T4237-2009 不锈钢热轧钢带、 GB/T3280-2009不锈钢冷轧钢板和钢带、 GB/T4238-2009耐热钢板和钢带、 BG /T24588-2009 弹簧用不锈钢冷轧钢带 GB/T9684-2011《食品安全国家标准不锈钢制品》原料必须符合生产、检验、使用质量标准。 根据原料状况制订生产工艺、不同材质按不同的轧制工艺进行匹配，当原料出现不稳定因素造成的损失和损耗及重量，由品质部负责收集有关数据进行文件性反馈采购部或者直接反馈原料供应商。
品质部定时、定批次进行抽样检测/检查，制订和建立原料检查数据备案存档。 4 机电/维修 建立和制订设备台帐、机电维修记录台帐，负责公司设备的全面检查和异常处理的工作。 制订机电维修操作规程及申报设备配件的采购和协调工作。 整理及清除维修场地和报废品配件的回收统一置放。 定时、定期进行设备的正常维护保养和检修、大修工作的落实及执行，彻底解决设备异常导致生产进程受到影响。考核按照设备正常运行情况及维修时间和次数，根据实际产量相结合进行月底计算。 机电维修值班人员在值班工作期间不能故意拖延抢修时间，在维修和抢修过程必须上报主管和确认签字加班单，并且填写维修记录方可生效。 5 原料纵剪 原料钢卷（热轧钢卷、冷轧钢卷）进厂后，由原料仓库仓管员对进厂原料进行重量、规格核对；并对钢卷外观实施检验，将钢卷明细提供质检部，在钢卷分条时由质检员按规定进行取样。 各种原料必须按品种分别堆放，并设置标牌。 厚度检验每个钢卷至少需测量二次厚度，此二次测量位置为：头、中间、尾各一次，每次测量三个点（两边、中间各一点），并记录同位厚度最大及最小厚度值。厚度误差标准按《GB/T3280-2009》执行。 表面品质检验 原料钢带不得有分层，表面不得存在对使用有害的裂纹、气泡、夹杂、结疤等缺陷，经酸洗供应的钢带表面不得有氧化皮和过酸洗。合同另有规定的按合同要求检验。 原料钢卷存在的常见缺陷包括：介在物、剥片、孔洞、线缝、楔形等。 原料缺陷的处置 5.6.1由现场品检人员/原料纵剪主操在日常的品检工作中记录原料缺陷类别、宽度位置、程度及长度等，品 管部质量管理员、主管加以整理统计，提出索赔。 5.6.2拍照时应尽可能将缺陷照得很明显，尽量显现出缺陷所在的宽度位置、局部的设备，还应在照片上 显示钢卷编号。
品质部管理规章制度
品质部规章制度（试运行） 一、目的： 为了规范管理质量部员工及管理人员的工作行为，维持良好的生产秩序，建立团结、高效的员工队伍，树立良好的团队精神和企业形象，特制定本制度。 二、适用范围 品质部各级管理人员及全体员工。自批准之日起生效。 三、职责 总经理——负责对本制度的批准及争争议问题的最终裁决 品管部经理——负责对本制度的制定、修改及实施监督。 品管部主管——负责对本车间范围所有人员的培训及监督执行。 品管部各员工——负责执行本制度。 四、制度内容 1、早上上班必须提前10分钟到车间（不定期开早会），由主管以上主持（特殊情况除外），会议内容为：总结昨日生产情况及遇到的问题，布置当日工作计划及注意事项，品质部所有员工必须准时参加，否则按迟到处理。 2、旷工按天数双倍扣罚全额工资，连续旷工3天，按自动离职处理。 3、员工进入厂区需要佩戴工牌、穿着工作服，一次不穿者罚款5元，二次不穿者罚款10元，以此累加，情节严重不听从管教者自行离职。 4、上班时间内未经领导批准不得擅自离岗，违者处以10-20元罚款。 5、请假需要提前一天提出（特殊情况除外），必须填写《请假单》，
且需经主管或部内经理签字批准后方可离厂，否则按旷工处理。6、上班期间员工需外出时，需开出《外出批准单》经主管或经理批准后方可离开厂区，否则按早退或旷工处理。 7、按时上岗，不得早退、不得请假，如有事应及时告之领导，对人员组织安排顶岗、替岗; 8、下班前做好本班工作，及时清理、清扫工作区域的脏污，切断电源。 9、上班时间应维持良好的工作秩序，不得擅自串岗、换岗、聊天、玩手机、打瞌睡，不得做与工作无关的事情，初次违规者200元的罚款；二次违规者自动离职。 10、辞职者须提前一个月打辞职报告，同意后方可辞职，自行离职者扣发当月工资。 11、未经允许，不得擅自操作他人岗位，擅自操作他人岗位造成后果者，责任自负。 12、做好6S管理，保持桌面清洁,地面不能有任何产品和配合件;桌面不能有私人物品, 检验标识区域划分明确，办公区域干净整洁。
品质手册质量目标、方针
0.1 颁布令 质量手册是公司质量体系的纲领性文件，是公司各项质量工作的基本准则和指南，希望公司全体员工在推动各项质量工作中，严格按照质量手册所描述的质量体系的要素和内容执行，不断满足顾客需求。 质量手册自生效之日起，正式在本公司颁布执行，今后随着市场的变化和顾客的需求变化，以及产质量水平的不断提高，将对本手册不断修改，以满足顾客和公司发展的要求。 总经理： 年月日
0.2目录
0.3 质量手册的管理控制 0.3.1质量手册适用X围 本质量手册阐述了适用于公司产品质量体系的要求。 0.3.2质量手册的编制、审核、批准 本质量手册由ISO推广管理部编制、总经理批准后颁布实施。 0.3.3 质量手册的管理 1）本质量手册分为受控原件、受控副本和非受控副本。受控原件由文件控制中心存档，作为复印用的标准文件。受控副本为受控原件的复印件，发放时每页加盖红色“受控”印章，作为有效文件使用，向顾客或公司以外的其他人员（即本手册0.4节“质量手册发放控制”所列发放对象之外）提供手册时，须经管理者代表批准，且文件每页须加盖“非受控”印章，该文件作为非受控副本不受文件修改的控制。非受控副本可不在公司X围内使用。 2）质量手册受控副本根据本手册0.5节“质量手册发放控制”的规定，由文件控制中心发放，并按照《文件控制程序》的要求予以登记。根据认证机构或其他方面的要求，所规定的受控类别可能会发生改变。当发生该情况时，由管理者代表与其共同确定该份手册的受控方式并通知文件管理人员（因这种受控方式可能与公司相关程序中的规定不同）。 0.3.4质量手册的修改 各种原因均可导致质量手册的修改。修改应按照《文件控制程序》进行，报管理者代表审核、总经理批准后，更改质量手册的版次，并由文件控制中心更换受控原件和所有已发放的旧版受控副本。 0.3.5支持程序 《文件控制程序》 COP-0501
品质管理部工作手册(修改版)
阳光泰来商务服务XX 质量管理体系 品质部工作手册
质量管理体系 品质部工作手册 （修改版） 文件编号： 生效日期： 编制：编制日期： 审核：审核日期： 批准：批准日期： （盖受控章处） 目录 品质部岗位职责 文件档案管理制度
培训工作作业指导 品质部员工培训实施标准作业规程 管理评审作业指导 管理评审控制标准作业规程 内部质量审核实施标准作业规程 服务品质抽检作业流程 项目服务质量检查流程 计划工作管理制度 信息发布管理制度 品质部岗位职责 品质部经理岗位职责 1.负责制定本部门工作计划，并组织实施和按期上报，按时提交总结； 2.负责执行、监督本公司管理制度以及各项规章制度在本公司的执行、监 督与反馈； 3.负责制定本部门各项相关管理制度、岗位职责及工作流程； 4.负责本部门管理费用预算的制定及审核； 5.了解、掌握物业管理法律、法规方面的信息，并负责传达公司各部门； 6.审查公司项目日常服务工作标准，并上报巡查结果； 7.负责编制本公司《质量，环境管理手册》、质量计划、作业规程文件；并 负责质量体系运作监督、检查工作； 8.负责修改与审定作业规程文件，作业指导书及各种报表和运行路线； 9.负责公司质量体系内部审核、统计、分析与评定以及外部审核的组织、安排；
10.投标文件及标书的编写工作； 11.本部门月度考核任务和年度的各项经营和管理目标的落实和完 成工作； 13.总经理交办的其它工作事务。 品质主管岗位职责 1.在品质管理部经理的领导下，负责质量体系标准化执行管理工作， 2.协助经理完成公司各部门品质监督检查工作； 3.负责各类管理体系文件、材料的采集、整理、建档保存，并做好公司年度品质管理的计划和总结； 4.依据《质量，环境管理手册》，制定质量管理管理月度工作计划； 5.负责公司环境、安全检查工作，确保公司管理体系正常运作和及时改进； 6.负责重大服务投诉的调查取证工作，对需整改的工作进行检查督促； 7.负责公司各部门工作进展的检查督促，确保《质量，环境管理手册》的切实贯彻实施； 8.负责本部门的文件、档案、资料、电子文档及实物保存与管理； 9.完成领导交办的其他工作。 品质专员岗位职责 1.了解、掌握物业管理法律、法规方面的信息，并负责传达各部门； 2.负责定期对项目服务日常工作进行监督检查； 3.按照品质检查制度制作《质量月报》，监督整改； 4.建立完善的培训体系与培训制度； 5.负责公司员工的质量体系相关培训工作及培训效果的跟踪； 6.协助编制本公司《质量手册》、质量计划、作业规程文件和质量体系运作监督、检查工作； 7.负责修改与审定作业规程文件，作业指导书及各种报表和运行路线； 8.完成领导交办的其它工作。 文员岗位职责 1.负责部门文档打印复印、登记发放、归档整理等工作； 2.负责部门内会议的记录，整理；
企业质量手册版完整版
企业质量手册版 HEN system office room 【HEN16H-HENS2AHENS8Q8-HENH1688】
质量手册更改控制页
质量手册目录 内容与标准条款页码
发布令 为提高公司质量管理水平，持续稳定地提高产品质量，根据要求在 GB/T19001-2008标准的基础上，转版为GB/T19001-2016《质量管理体系要求》标准，并结合本公司质量管理体系实际情况，编制了《质量手册》。本《质量手册》规定的公司质量方针和目标，质量管理体系及其实施的总体要求和基本准则，是公司质量管理的法规和纲领性文件，用来统一协调公司的质量管理和质量控制活动，现批准颁布实施。我公司所有部门和全体员工，必须严格按照《质量手册》的规定贯彻执行。 总经理：XXX 2017年3月1日 管理者代表任命书 为适应管理体系建立、运行和改进的需要，特任命XX为我公司管理者代表，其职责权限是： 1、确保建立、实施和保持公司的质量管理体系； 2、负责内部质量审核的组织领导； 3、定期向总经理报告质量管理体系运行情况及持续改进的有关需求； 4、确保在公司内提高满足顾客要求的意识； 5、就质量管理体系有关事宜与外部各方进行联系。 管理者代表是代表公司总经理行使权力，希望公司所有员工服从领导，共同履行质量管理职能，确保质量管理体系有效运行。 总经理：XXX 2017年3月1日 质量方针 公司质量方针经干科职工集思广益，总经理办公会讨论通过，由总经理批准发布： 质量方针
“优质价廉、顾客至上， 持续改进、质量第一”。 内涵： 1.持续改进质量第一： 在公司质量管理现有基础上，依据GB/T19001-2016标准建立了新的质量管理体系，逐步实现与国际标准接轨，学习国际上先进的管理理论和方法，从而使我公司的质量管理水平更上一层楼。 2.优质价廉顾客至上： 优质价廉是顾客的需求。质量管理体系的建立，使公司的质量管理更加规范化，顾客至上让全体员工都知道何时、何地做什么、怎么做、达到什么标准，确保产品质量稳定，优质价廉。通过提供满足要求的产品，达到顾客满意，从而提高公司的质量信誉度。优质价廉顾客至上是公司可持续发展的基础和动力。 质量目标 公司的质量目标，经质检科提请，总经理审核批准发布： 质量目标： 产品出厂合格率为100% 产品一次检验合格率95% 顾客满意度达90%以上。 质量目标分解（占比）
技术质量工艺标准化手册(上)
技术质量工艺准化手册（上）Standardization manual for technical quality technology
前言 随着我国社会的高速发展，建筑工程质量和服务质量总体水平不断地提高，“百年大计，质量第一”是我国强调的质量方针。随着国民经济的不断发展，人民生活不断地提高，居住环境在人们的生活中逐渐占有重要的位置。无论是建筑市场的大环境还是小业主的的要求都越来越强调质量品质，而从企业自身来说，企业发展规模的不断壮大，新员工快速的增加，企业的品质要提升，因此也越来越要求我们提升过程中的工艺质量管控。为加强对工程质量事前、事中的把控，降低质量风险，特编制此手册。 本手册收集了五局范围内较为成熟与先进的工艺做法，结合国家相关规范与企业相关管理要求，对施工过程中遇到的质量通病、过程工艺关键控制点出发，旨在通过标准工艺做法及小工具的使用提升过程工序质量。 本手册分为上下两册，手册内做法为推荐性做法不强制要求使用。上册为主体结构工程的技术质量工艺标准化做法，包含模板工程、钢筋工程、混凝土工程、砌体工程中的部分关键做法。下册为装饰装修工程、防水工程、机电安装工程的相关关键做法，目前正在编制中，2018年下半年发布实施。 建议各公司及项目在编制策划、方案及交底时根据项目实际情况选择运用手册内的做法，扩大推广使用的范围。 由于时间仓促，编者水平有限，不妥之处恳请各单位在使用的过程中进行批评指正，我们收集反馈意见后，将及时修订完善，切切实实达到技术质量工艺标准化编制的初衷。 手册在编写过程中得到了东北公司、北京公司的大力协作与帮助，在此表示感谢！ 中建五局科技质量部 二〇一八年一月
品质部工作手册
中山市**照明有限公司ZHONGSHAN ** LIGHTING CO.,LTD 品控部 工 作 手 册 文件编号： 编写： 审核：
目录 一、品质部介绍 1）部门及部门工作职责介绍 2）质量方针与目标 3）品质部组织结构图 4）工厂品质控制流程图 二、品质部内部流程 1）进料检验控制程序 2）过程的监视和控制程序 3）成品的检测和控制程序 4）不合格品的控制程序 5）纠正和预防控制程序 6）3C认证程序 三、部门岗位职责 1）品质主管岗位职责与权限 2）IQC检验员岗位职责与权限 3）IPQC、OQC检验员岗位职责与权限 四、内部使用表单汇总 1) IQC使用表单 2) IPQC\QA使用表单 3) 不合格品控制程序使用表单 4) 纠正预防控制程序使用表单 5）3C认证申请表单 6) 其它流程
部门及部门工作职责介绍 一、部门介绍： 齐天照明有限公司在成立初期便建立了自己完善的品质保证体系，先后通过ISO9000：2008版的质量认证体系，品质部定期组织工厂内部审核，通过管理者代表始终保持质量体系运行的稳定性和实效性。 品质部目前一共有3人，主管一人，IQC一人，QA一人。 品质部拥有一批专业的实验、检测用仪器：耐压测试仪、接地电阻测试仪、万用表、精密电源、烤箱等。对于一些无法测试的项目，我部借助雷士光电科技有限公司的实验室的检测设备进行测试，保证产品的质量。 二、部门工作职责： 1）质量管理体系的建立、实施及维护，定期召开质量会议 2）年度质量目标的制订及执行 3）检验规范、标准的建立及实施； 4）品质成本统计与分析； 5）负责公司原材料、零部件及产品的检验和试验并做记录； 6）质量控制点的监视和测量工作，负责对主要过程的巡回监视 7）产品信息（数据）的收集与分析 8）不合格品的处理和过程的监控 9）检测和试验设备的记录、报告和管理归档 10）售后产品的质量状况的分析及纠正改善预防措施 11）供应商质量评估系统的建立及实施 12）品检人员培训教育； 13）外协送检和自行测试试验； 14）检验、测量和试验设备的管理维护； 15）纠正与预防措施的落实监督； 16）品质部内部流程的编写及实施； 17）内、外部质量审核的计划和推行； 18）客户质量投诉的分析处理与改善效果的确认 19）重大质量事故的处理 20）质量宣传工作
《质量手册》部门的职责和权限
《质量手册》部门的职责和权限 3.1.1最高管理者——总经理 a)主持本公司生产经营管理工作，对本企业生产经营活动负全面责任； b)对本企业产品的安全质量（即“特种设备的安全性能”）负责； c)具体主管本企业产品的营销工作和物资的采购供应工作； d)负责组织以下活动来实现建立、实施和改进质量保证体系的承诺： ——向全体员工宣贯保证产品安全性能及满足顾客要求的重 要性； ——制定质量方针与质量目标，确保质量目标的实现； ——定期主持管理评审； ——确保可获得必要的资源。 e)决定公司组织架构及规定各职能部门和高层管理人员的职责、权限及其相互关系，建立在不同的层次和职能之间、以及就质量保证体系的过程有效性的沟通渠道与确保其畅通； f)组织建立和批准企业重要的规章制度和财务管理制度； g)负责直接领导生产副总经理、质量保证工程师或总工程师和各
部门部长的工作以及企业财务运作；决定主要管理及技术人员的聘用与辞退。 3.1.2质量保证工程师（管理者代表） a)负责组织建立、实施和完善质量保证体系，主持编制《质量保证手册》，审批质量保证体系程序文件和重要作业指导书，组织贯彻实施公司质量方针和质量目标，保持质量保证体系的有效运行； b)向总经理报告质保体系运行业绩、确定与实施体系必须改进的措施； c)按期组织与主持内部质量审核，包括负责策划内审工作所需资源，选择审核员，任命审核组长，向公司管理评审会议报告质保体系运行情况； d)代表公司接受许可资质审核机构或质量体系认证机构审核； e)对公司所属各部门实施质量保证体系情况有监督和奖罚审批权； f)负责就企业质量保证体系有关事宜与各部门的联络工作。 说明：后述各部门负责人均为“各质量控制系统责任人员”。具体见任命书。 3.1.3总工程师（企业技术负责人） a)在总经理领导下，完善公司技术管理，保证产品质量、特别是确保 其安全性能； b)负责贯彻执行国家相关法规与技术标准；组织编写、审查企业