Each company can decide according to its own situation, and there are 3-4 layers. They are Quality Manual (QM), Program Files (QP), Level 3 Files (WI), Record Forms (QR), and of course there may be other program codes, but the meaning is more or less the same.
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What are the files used in the quality management system?①: quality manual
②: program files
③: departmental operating instructions, operating procedures and some technical files
④: quality records (record forms)
Quality management system ISO9000 and other letters mean,1, you know "ISO " is what it means?
A: ISO refers to the International Organization for Standardization, a worldwide federation of international standardization groups (ISO member groups). The development of international standards is usually accomplished by ISO's technical committees, and member groups are entitled to participate in the work of their technical committees if they are interested in the projects established by them.
2. Do you know the difference between "ISO9001" and "GB/T19001" and where it comes from?
A: ISO9001 refers to the international quality management system, the introduction of the process, the international standard will be converted to a national standard, the conversion method has the equivalent of the adoption and the equivalent of the adoption of two kinds of, in our country is the use of the adoption of the same way to adopt the standard, that is to say, without making any changes to the reference to this standard. In order to facilitate the identification of the reference to the international standard we added "10000", so the reference to the quality management system after the standard is correctly written: ISO9001: 2008 idt GB/T19001-2008. idt means equivalent to the adoption of the meaning of GB/T on behalf of the meaning of the national recommended standards.
3, you know GB/T19000 family of standards including those standards?
It includes:
a) GB/T19000 Quality Management System Fundamentals and Terminology
b) GB/T19001 Quality Management System Requirements
c) GB/T19004 Quality Management System Performance Improvement Guidelines
d) GB/T19011 Quality and/or Environmental Management System Audit Guidelines.
4, you have heard of "PDCA"?
A: PDCA was founded by the famous American quality management master Mr. Deming, so it is also known as "Deming ring", which proposes to do every activity from planning (Plan) → implementation (Do) → check (Check) → improvement (Action) of a link.
To achieve continuous improvement of management performance, the purpose of continuous improvement.
5, you understand the quality management system in the "eight management principles"?
Answer:
Principle 1: customer focus;
Principle 2: leadership;
Principle 3: full participation;
Principle 4: process approach;
Principle 5: systematic approach to management;
Principle 6: continuous improvement;
Principle 7: decision-making based on factual Principle V: A systematic approach to management;
Principle VI: Continuous improvement;
Principle VII: Fact-based decision-making;
Principle VIII: Mutually beneficial relationships with suppliers.
Difference between ISO 14000 and ISO 9000 standards
ISO 14000 and ISO 9000 series of standards are both management standards, *** with the same adherence to general management system principles.
ISO 14000 part of the content of the ISO 9000 standard is directly adopted, some of the management mode and certification program is more or less the same. But environmental standards and quality standards are different, it has the following characteristics:
1, ISO 14000 focuses on activities, products, services, environmental impact; and ISO 9000 focuses on product design, development, production, inspection, use and service process quality requirements.
2, because ISO 14000 involves the impact of the entire environment, so it is not only to consider the needs of customers, but also to consider a broader range of interests; and ISO 9000 is involved in all employees within the enterprise, which focuses on the "quality, site, cost, efficiency," the sense of reality.
3, ISO 14000 applies to all sizes of enterprises, small and medium-sized enterprises to regulate the behavior is more important; ISO 9000 is also applicable to all sizes of enterprises.
4, ISO 14000 adopts the product life cycle approach, with the guidance of enterprises in the whole process of production and implementation of environmental standards, which is conducive to protecting the environment, resource conservation, cost reduction; ISO 9000 emphasizes the action of statistical techniques, which requires enterprises to select the appropriate statistical methods, and seriously use, and verify the effectiveness of the use.
5, ISO 14000 focuses on creating a good environment; ISO 9000 focuses on quality records.
6, ISO 14000 is not a mandatory standard, but can be used internally and externally for certification, registration and so on.
From the above, we can see that ISO 14000 and ISO 9000 in the form and content of a lot of differences, are two sets of mutually independent implementation of the standard system, can not replace each other.
Quality management system, input, process, output, respectively, how to define
Remember to be concise: input: how to ask you to do; output: how much you do the requirements. In fact, just like a computer, I hit a "C" on the keyboard this is the input, the output is to see if the display shows the "C" or show the degree of how much.
What are the 40 records, 26 files, and 27 regulations in the QMS requirements?Quality management system requirements, only six must form a file program: 1, file control program, 2, record control program 3, internal audit control program 4, nonconformity control program 5, corrective action control program 6, preventive action control program. For how many forms of records and does not specify, according to the size of the enterprise company to determine their own, as long as they can provide evidence of the process on the line,
The role and significance of the quality management system for medical devices are?
1. External to be able to prove that the quality of the products it produces is stable and continuously safe and effective.
2. Internally to improve the level of quality management.
3. Continuous improvement of its quality management and product quality.
iso13485 quality management system in the sixth chapter, chapter 7, chapter 8 are what
6 resource management
7 product realization
8 measurement, analysis, improvement
ISO quality management system has that a few principles and a few elements, what are they?Eight principles:
Customer focus
Leadership
Full participation
Process approach
System approach to management
Continuous improvement
Decision-making approach to the basic facts
Mutually beneficial relationship with the supply side
Suzhou Modern Junming Enterprise Management Center. Professional system certification boasts, internal auditor training, enterprise management company
*** Eight principles: customer focus, leadership role, full participation, process approach, continuous improvement, a systematic approach to management, a fact-based approach to analysis, and a mutually beneficial relationship with the supply side. However, now there are few elements of the statement, elements of the 94 version of the inside of the term, that is, 9001 has 20 elements.
What is the role of the technical section in the quality management system, the distinction between the technical file and the quality system file?
If only the design and development, you need:
1, "design and development control program": clearly define the design and development process how to go, and what needs to be done at each step of the work of the formation of which files, the process of when to confirm and review, how to do it, and who is involved. Including design development, design changes in the regulations.
2, technical information and file management specifications
3, various types of technical standards: such as guidelines for the receipt of raw materials or technical confirmation of the table, the product inspection standards, the technical requirements of general materials, quality characteristics of the classification, the special process control methods and control points, the product requirements for production and storage and transportation.
4. Various forms at work.
If there is also the function of the process, you also need:
Process identification of the operating instructions, process flow charts, process codes or operating instructions, safety regulations, and various forms used in the work, etc.
The work of the process identification of the process, the process flow charts, process codes or operating instructions, safety regulations, and various forms used in the work.