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:

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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:

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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:

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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:

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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:

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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:

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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:

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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:

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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:

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ISO 9001, 4.1.3, Management Review

Quality System Procedures References:

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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.

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