The implementation of the "five stages and fifteen steps" working method of ISO9000 standard can be adjusted according to the specific situation of the enterprise.
First, the training began, the division of functions:
Second, prepare documents, pilot operation:
Three. Internal audit and formal operation:
Four, simulation audit, to prepare for certification:
Verb (abbreviation of verb) formal audit and system maintenance:
First, the training begins, and the division of functions: (back to the top)
1. Training begins:
A. train all employees in basic knowledge of ISO9000.
A. Training purpose
1. Understand the contents of ISO9000 family standards;
2. Understand the basic requirements of ISO9000 family standard;
3. Understand the implementation method of ISO9000 family standard;
4. Understand the significance and plan of implementing ISO9000 in enterprises.
B learning content:
1. What is the ISO9000 family standard?
2. Understanding of standards;
3. The significance of implementing ISO9000 in our company;
4. Our company's plans and requirements for implementing ISO9000.
C. participants and research time:
1. Participants: all personnel.
2. Study time: 3 person days.
B. backbone training
A. Training purpose
1. Understand the basic content of ISO9000 family standard;
2. The role of leadership in the quality system;
3. Understand why ISO9000 should be implemented;
4. Understand how to implement ISO9000.
B. Learning content
The structure, principle and content of 1 Overview of ISO9000 family standards;
2. Important quality concepts;
3. The guiding ideology of implementing standards;
4. The role of leadership in the system;
5. The process of system certification, maintenance and improvement.
C. Participants and research time
1. Participants: general manager, deputy general managers, managers and heads of relevant departments.
2. Study time: 2-4 person days.
C, document writing skills training
Training purpose
1. Master the method of official document writing;
2. How to compile relevant documents according to the actual situation of our company?
Learning content
1. Overview of quality system documents;
2. Compilation of quality manual;
3. Program documentation;
4. Preparation of working papers;
5. Quality planning;
6. Quality records.
C. Participants and research time
Participants: leaders of relevant departments of enterprises, members of ISO9000 working group and full-time quality management personnel.
Study time: 3-5 person days.
Establish an organization
A. Leading Group-ISO9000 Committee
Leadership is the key to the implementation of ISO9000. Business leaders should make correct decisions and actively take the lead in this work.
Take the lead in learning the basic knowledge of ISO9000;
Actively promote the company's work;
Give human and material support;
Set up a leading group, all the main leaders should participate;
Appoint a management representative to be responsible for the responsibilities specified in the standard;
Handle relevant major issues in a timely manner;
Organize management review.
B. Working organization-Quality Control Department
In order to carry out ISO9000, the company should set up a special working organization to be responsible for organizing and coordinating ISO9000 throughout the company. It should be ensured that:
All relevant departments can participate in the working group;
Having full-time staff;
Have backbone. Key personnel should have a comprehensive and systematic study of ISO9000, and it is best to have some relevant work experience.
C. management representative
The company shall appoint management representatives according to the standard requirements.
The management representative is appointed by the top management;
The management representative shall be a member of the company's management;
The management representative shall have the following responsibilities:
Ensure the establishment, implementation and maintenance of quality system requirements according to standards;
Report the implementation of the quality system to the manager in order to review and improve the quality system;
The responsibilities of the management representative also include liaising with external institutions on the quality system.
3. Systematic investigation-diagnosis
First, the purpose of diagnosis
Through diagnosis, the following purposes are achieved:
A. Compliance of existing quality system with standards:
Find out the gap with the standard;
Find out the reasons for these differences.
B. identify and determine the contents of quality system modification:
(1). System standards and component selection;
(two) the content of institutional adjustment;
(3) List of system documents;
(4) Newly compiled documents (list).
B, the basis of diagnosis
In general, the diagnosis work should be based on appropriate quality system standards, main contracts and some basic laws and regulations of the unit. According to the specific situation of each unit, the basis of diagnosis can be summarized as follows:
A. quality system standards:
For example, the standard of ISO900 1:2000: 2000 should be the same as the standard for applying for certification.
B. contract:
The quality system should basically meet the requirements of customers, therefore, the contract should be used as an important basis for judgment.
C. Basic regulations and procedures of this unit:
Such as standardization, metrology and safety. , these regulations and procedures are reasonable and reasonable content is effective operation, what to check when diagnosis.
D. Relevant social or industrial regulations
The quality system should not only meet the company's quality system standards, contracts and relevant regulations, but also meet the requirements of relevant laws, regulations and rules of the country, region and industry, which should be considered in diagnosis.
(1). Relevant safety regulations;
(2) Relevant measurement laws and regulations;
(3) Relevant environmental protection laws and regulations;
(4) Relevant labor laws and regulations.
C, the implementation of diagnosis personnel
The person who carries out the diagnosis can be an internal person of the company or an external organization entrusted by the company, such as a consulting organization, so the person who carries out the diagnosis can be:
A. consultants:
If the company hires consultants, it can mainly carry out diagnostic work. For this reason, the consulting organization can designate a special diagnostic inspection working group to make a plan, and make a diagnosis according to the plan on the basis of enterprise confirmation.
B. internal auditors:
If the company has well-trained and qualified personnel who are competent for the job, they can be authorized to carry out diagnostic work.
C. Personnel of third-party audit institutions:
If the company needs it, it can hire auditors from external audit institutions to diagnose the company.
D, the implementation process of diagnosis work
A. determine the diagnosis team.
B. determine the diagnosis basis and diagnosis object.
C. Make a diagnosis plan and prepare a diagnosis working document.
D. On-site diagnostic inspection
(1). Talk with field personnel to find out the situation;
(2). Check the site documents and records;
(3) Truthfully record the current situation of system operation.
E. Submit the diagnosis report
(1). Nonconformity report;
(2). Diagnostic conclusion;
(3) List of system documents;
(4) Documents (list) that need to be newly compiled and revised.
4. Function Division-System Design
A. establish a quality policy;
B. Appointment of management representative Main responsibilities:
A assist the manager to ensure that the quality system is established according to the requirements of the standards.
B. be responsible for the implementation and maintenance of the quality system.
C organize internal quality system audit and report the implementation of the system to the top management for review and improvement.
D. contact with the outside world on quality system issues.
C. Design and adjust the organizational structure
A the responsibilities of each department should cover the standard requirements.
B. Each department has clear responsibilities.
C. there is a reasonable connection between the work of various departments.
D the division of functions is written and fully discussed.
Quality planning, control, coordination, inspection and improvement should be reflected.
D. Delete the quality system standard
A according to ISO900 1:2000: 2000, when any requirement of this standard is not applicable due to the characteristics of the organization and its products, you can
Consider deleting it. Unless the deletion is limited to the contents in Chapter 7 of this standard, it will not affect the organization's provision of services to meet customers and
Apply the ability or responsibility requirements of products required by laws and regulations, otherwise it cannot be claimed to meet this standard.
B. According to the contract requirements, specify the supplementary requirements of the quality system, such as statistical process control requirements and safety requirements.
E. determine that file structure in the new system
A. Typical file hierarchy
Second, write a document, pilot operation: (return to the top)
1. Write file
A. List documents:
Quality Manual: Composition of Manual
Functional distribution
Inter-organizational interface
Description of the elements in the manual
Relevant supporting documents
Program documentation: What program documentation do you need to compile?
Each program file corresponds to a standard element.
Whether there is duplication or omission between program files.
Records formed by each program file
Relevant supporting documents
Working paper: job description
Technical documents such as process documents.
management document
Reports and forms
B, clear which old documents are invalid and which are reserved:
C. assigning file writing tasks:
Participation of all departments
Concentration of quality control departments
D, drafting documents:
workflow
A simple explanation
language standard
File transfer
E. document discussion:
Internal discussion-applicability
External inspection-integrity
F, document approval takes effect
Review and approval
Copying and binding
Controlled, registered
Entry into force and signature
2. Train guided operation
A, system disclosure:
Manual: characteristics, use and storage requirements;
Procedures: characteristics, matters needing attention, record formation and interface between procedures;
Working document: You must know how to record key problems and report nonconforming products.
B. training and publicity:
Training: On-the-job training;
Special post training assessment;
Training of management procedure documents;
Quality policy and target training for all employees.
Publicity: quality policy;
Trial operation plan;
ISO9000 certification scheme;
Introduction of system documents.
C. other support work:
Measurement;
Allow qualified subcontractors;
The making of signs.
D, debugging:
Complement and improve the basic work: improve the three-level documents while running;
Modify system files: modify inappropriate files at runtime;
As a record, and keep the record as evidence.
Three. Internal Audit and Official Operation: (Return to the top)
1. Department Audit and Management Review:
A. Conduct at least one internal audit, and the organization shall formulate audit plans, audit lists, audit reports, and records and documents related to the tracking and supervision of nonconformities, which shall be kept intact for certification inspection.
B, arrange at least one management review to evaluate the effectiveness and applicability of the new system, and at the same time accumulate records of management review activities, and the review shall be carried out according to the requirements of the procedure documents.
2. Official operation:
Through internal audit and management review, the unrealistic or inappropriate clauses in the system documents are revised in time. After a series of revisions, the second edition of the quality manual and program files was released for official operation.
Fourth, simulate the audit and prepare for certification: (Return to the top)
1. In order to reduce some possible risks of one-time certification, before the formal audit by a third party, the internal auditor can form a similar external organization to conduct mock audit or invite the confirmed certification organization to conduct pre-audit.
2. Enterprises should choose certification bodies in line with their own favorable views, generally considering the following aspects:
A. customer requirements;
B. the area where the enterprise is located; When choosing a certification body, it should be convenient in principle;
C. the scope and effectiveness of certification by certification bodies;
D. costs; Normal certification fees and other expenses such as transportation and accommodation.
Verb (abbreviation for verb) formal review and system maintenance: (back to the top)
1. Accept the formal audit of the selected certification body.
2. System maintenance and improvement
A, check the problems existing in the site, and constantly improve and consolidate;
B, further improve the system documents, strengthen coordination and supervision;
C, regularly carry out internal quality audit and management review.