How do printing companies face the upgrade of ISO quality system certification?
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The ISO9000 quality system is the most authoritative quality management system in the world. On June 1, 2001, the 2000 version of the ISO9000 family standard was officially implemented. The 1994 version of the ISO9000 family standard will expire at the end of 2003. How do printing companies seize the favorable opportunity of the ISO9000 family standard exchange and upgrade, and innovate quality management, and use this as a basis to drive and continuously improve the performance and efficiency of the company, and enhance the satisfaction of customers and other related parties, in the domestic and international markets. Show your skills? The author combines the status quo of quality management in the printing industry of Feizhou City, and talks about some of the points of understanding. If anything is wrong, please let us know.
First, Why does the printing enterprise establish an ISO9000 quality management system?
1. The system protection policy of the printing business will no longer exist with government bidding and social competition. In the face of the new situation, state-owned printing enterprises must re-position their roles, adjust their business management ideas, and establish a new mechanism to adapt to market competition. With China's accession to the WTO, foreign printing companies will also be able to compete in the domestic printing market, and domestic printing companies will have more opportunities to participate in international market competition. Whether the domestic market participates in competition or the international market develops new business areas, the ISO9000 quality management system is an important condition and a required pass.
2. In recent years, most printing companies have introduced a large number of advanced new equipment and adopted many new technologies and processes. However, the current operating procedures management and the technical quality of the employees cannot keep up with the requirements of new equipment and new technology. This limits the advantages of these new equipment and new technology. The process of establishing and implementing ISO9000 quality management will encourage enterprise production managers and workers to learn new technologies and new processes, thereby greatly improving the technical and technical quality of employees.
3, ISO9000 focuses on the use of human resources, technical processes, equipment manufacturing, inspection and testing methods and instruments to strengthen the quality control of the entire production process, establish a view of all services for the user, all prevention-oriented views, all with data to speak View. This is to change the traditional habits of many processes in China's printing industry, mainly relying on visual inspection and experience operation, to achieve standardization and dataization of quality management, so that the factors affecting product quality are under control in the whole process of production, thereby improving The ability of enterprises to guarantee their commitment to customers and enhance the trust and satisfaction of customers and related parties to the quality management of enterprises are of decisive significance. With this external advanced quality management system, it can promote and promote the improvement and leap of various management levels of enterprises, so that it meets the requirements of the "management science" of the modern enterprise system.
Second, where is the 2000 version of the ISO9000 family standard?
The new version of the 2000 version is a comprehensive integration of the ISO/TC176 Quality Management and Quality Assurance Technical Committee on the basis of the 1994 edition of the 1987 version of the technical adjustment and limited revision, the management principles, structure and technical content of the entire ISO9000 family of standards. From the quality assurance model to the quality management system, eight management principles (customer focus; leadership; full participation; process approach; systematic approach to management; continuous improvement; fact-based decision-making; Mutual benefit relationship) and use it as the basis of the entire standard, expand the terminology standard and increase the quality management system foundation, and integrate the original three types of organization different quality assurance models into a universal standard. The standard structure changes from a factor model to a process method. At the same time, it focuses on the coordination between internal standards and considers compatibility with other management systems. It can be said,The 2000 version of the ISO 9000 family of standards is a completely new version.
1. The system of the new standard has a clearer structure, more prominent points, more concise, perfect, scientific, reasonable and practical, and easier for enterprises to accept and operate: (1) The new standard ISO9000 adds “quality management system foundation” The chapter explains the theory and concepts of the quality management system. The old standard, after learning the terminology standard, has to refer to a series of relevant guidelines to understand, master and apply the required standards. The new standard only needs to pass the ISO9000 standard, and can have an overall understanding and understanding of the ISO9000 family standard, and understand the other standards by mastering the basic theories and terminology in the standard. (2) The ISO9001 standard is a versatile standard applicable to organizations of all types, sizes and offering different products, and is degradable. Any requirement that is not applicable due to the characteristics of the organization and its products may be required in Chapter 7, "Product realization", which does not affect the ability or responsibility of the organization to provide product satisfaction and applicable legal and regulatory requirements. Make a cut. The current standard system has four core standards, one auxiliary standard, six technical reports, two booklets, and one technical specification. There is no longer a standard for each standard.
2. The new standard upgrades the quality assurance model to a quality management system: this is not to say that quality assurance is not required, but that quality assurance is only a threshold that must be crossed in social trade. It emphasizes “quality management”, except for requirements. In addition to quality assurance, it also aims to enhance customer satisfaction. The original customer-based, quality system focuses on serving customers, and the organization is the benchmark, and the quality system focuses on serving the organization. This is also reflected in the standard representation of changes in supply chain terminology. The supply chain of ISO9001, ISO9002 and ISO9003 in 1994 is expressed as “sub-contractor-supplier-customer”; the 2000 version of the ISO9001 supply chain is changed to “supplier-organization-one customer”, and the “organization” replaces the original standard. “Suppliers” and “suppliers” are used to replace subcontractors. In this way, the initiative is handed over to the organization, and the organization is implemented to better serve the customer and enhance customer satisfaction, thus gaining an advantage in the market competition.
3. The terminology standard has been expanded and expanded: (1) The term is expanded from 4 to 10, and the total number is increased from 67 to 80, but 28 of the old standard terms are not included in the new terminology standard. Or included in the new terminology, an increase of 41, accounting for half of the total number of terms; (2) The new term added is the most in terms of quality assurance of the measurement process, all of which are new; , 9 and 8 respectively. It can be seen that the new terminology standard pays special attention to these aspects. In addition, the standard also adds a reminder appendix that specifies the method used to define the terms in the standard and outlines the relationship between the terms in the specific concept areas related to the quality management system. The defined method is more scientific and rigorous, and the terminology system is more comprehensive and complete.
4. Adopting the process method to replace the element structure: The old standard is based on the element structure, while emphasizing that the quality system is implemented through the process. The old standard puts forward the requirements of mandatory procedural documents for the elements and the realization of the elements. The program files of the whole system appear numerous and criss-cross, and it takes a lot of effort to construct and improve the system documents. Long-term implementation and continuous improvement of these procedures are even more of a great project for the organization. In many cases, the organization's energy is mainly used to improve the file system itself, but it does not care whether the documents can be operated effectively.
The new standard replaces the element structure model with a process approach. The so-called "process approach" is the application of systems in processes within an organization, along with the identification and interaction of these processes and their management. This has the advantage of continuous control over the connections between individual processes in the processes of the processes, as well as the organization and interaction of the processes. At the same time, objective and applicable requirements for the obligation of the program documents are made. In ISO9001:2000, only six requirements for “procedures for document formation” are proposed: document control procedures, quality record control procedures, internal quality audit procedures, Non-conforming product control procedures, corrective action procedures, preventive measures procedures. Thereby avoiding the weakness of the file system and the disadvantages of unfavorable operation, and strengthening the effective control of the operation of the quality management system.
The new standard also introduces the "PDCA" approach and briefly describes the use of the PDCA model in the standard: "p - Planning: Establishing the necessary goals and processes for providing results based on customer requirements and organizational guidelines; D - Implementation: Implementation process; C - Inspection: Monitor and measure processes and products according to policies, objectives and product requirements, and report results; A - Disposal: Take measures to continuously improve process performance."
5. In the new version, ISO9001 and IS09004 are a set of consistent quality system standards: their application range is different, but they have similar structures, can complement each other, or can be used alone. ISO 9001 specifies the requirements of a quality management system to verify that an organization has products and capabilities that provide “meeting customer requirements” and “appropriate legal and regulatory requirements”. Designed to give product quality assurance and customer satisfaction, it can be used internally by the organization, as well as for certification, regulatory or contractual purposes. In terms of satisfying customers, it is concerned with the effectiveness of the quality management system. ISO9004 is more concerned with the continuous improvement of the overall performance and efficiency of the organization. For the organization that top management wants to surpass ISO9001 through continuous pursuit of performance and continuous improvement, the standard recommends guidelines, but the standard is not used for certification, regulation or contract purposes. Not an implementation guide for ISO9001.
6. The new standard places special emphasis on compatibility with other management systems: it is committed to matching the results related to quality objectives, appropriately meeting the needs, expectations and requirements of relevant parties, complementing other objectives. Can be combined or integrated with the relevant management system, which is conducive to planning, resource allocation, identifying complementary goals, and evaluating the overall effectiveness of the organization, facilitating the organization to compare its requirements, each or a merger review, for the organization to build and Through a corresponding management system audit, a platform for greater potential development is preset. The ISO9011 Quality and Environmental Management System Audit Guide is an example. This guide can be used separately for quality system audits. Or the audit of the environmental management system can also be applied to the audit of the quality and environmental management system. This standard replaces the original 1993 version.
ISO10011-1, ISO10011-2, ISO10011-3 and 1996 versions of ISO14010, ISO14011, ISO14012.
Third, the 2000 version of the standard certification work is more organized, concise, orderly, applicable
In implementing the requirements of the new standard, the main procedures for consultation and certification are:
1. Select and determine the consulting and certification body: Before selecting, the enterprise should check whether the institution is accredited by the State Quality and Technical Supervision Bureau and the National Accreditation Committee of the China Quality System Certification Body. Only the accredited certification body has issued the certification certificate. Have legal effect. In general, the consulting and certification bodies should be identified separately, as the institution receiving the consultations may not perform the certification work at the same time. After confirming the consulting and certification body, you need to fill in the application for consultation or certification, submit relevant information, sign a formal consultation or certification contract, clarify the relevant fees and delivery time, methods, and negotiate the consultation and certification work process schedule.
2. Overall planning: The main work is to publicize the relevant standards of ISI9000; to train internal auditors; to formulate overall planning arrangements; to clarify the responsibilities and authority of the organization.
3. Identify and determine the process, build the process network: Take a process as an example, determine the process mode model with the quality management department and relevant departments of the enterprise, plan, identify, and clarify the process of the department, and determine its input, resources, activity methods and guidelines. Control requirements and outputs such as process operation, monitoring and measurement, process flow chart of the process, and form the product realization process network and management process network of the enterprise.
4. Standardize and construct a quality management system: According to the ISO9001 standard, determine the quality management system numbering principle, determine the organization quality policy, quality objectives and quality objectives of each department or relevant level, formulate measures to achieve quality objectives, and prepare 6 procedures. Documents, clear requirements for deletion, preparation of quality manuals and work instructions, design and improvement of relevant records, single format, etc.
5. Trial operation and internal audit: All departments of the enterprise operate for 3 months according to the requirements of the documents, establish and maintain records, and pass the internal audit and management review, improve the quality management system, ensure its suitability and effectiveness, and plan how to meet the formal Review.
6. Audit and certification:
(1) Initial review (or pre-visit): The certification body shall determine the scope of the audit according to the enterprise's certification application and conduct preliminary examination of the documents, and raise the existing problems. The enterprise shall propose and implement the improvement measures accordingly, when there are on-site audit conditions. The certification body audit team will notify the company. Enterprises should make the above preparations before the audit team enters: 1 Widely advertised, so that all employees understand the meaning of the audit and the way of working; 2 Designate the accompanying personnel familiar with the quality system for the audit team; 3 Prepare relevant documents; 4 Prepare office resources such as office and telephone for the audit team.
(2) On-site audit: 1 First meeting: After the audit team is stationed, it usually holds a meeting attended by the top management of the audited party. The two parties introduce each other and clarify the audit method and plan. The meeting is presided over by the auditing organization. Need to cooperate actively; 2 Audit: The basic method is to be sampled by the audit team, and should not be avoided. After the on-site audit, the audit team will notify the auditee of the non-conformities found during the inspection and request confirmation. 3 Last meeting: In the final stage of the on-site audit, the audit team will hold the final meeting, the final meeting, read the unqualified report, evaluate the quality system, draw the conclusion of the audit, and propose the corrective measures and verification methods.
(3) Tracking verification: At this stage, the enterprise shall analyze the reasons and formulate corrective measures according to the unqualified report issued by the audit team. The “general unqualified” certification body is required to be resolved within one month; the “seriously unqualified” item is required to be resolved within three months. The verification method is verified on site and verified by objective evidence such as text, video, photo, etc., or verified by supervision.
At this point, the review is over. The audit team will submit the report to the auditing organization, and after the auditing organization approves the registration, the certificate can be issued to the auditee.
7. Post-certification supervision: The purpose of post-certification supervision is to verify whether the quality system of the auditee continues to meet the requirements of the certification standard. Generally, once a year, the procedures are the same as auditing, but generally only some items are selected. The focus of the spot check is product quality information. Feedback records, how to use the certificate, etc. The certificate is valid for three years. Upon expiration of three years, the certification body will re-issue the certificate according to the review results.
The author believes that to spread the ISO9000 standard, printing companies should seize three key points:
(1) It is necessary to publicize the importance of the standard certification among all employees, organize standard training and study, and be familiar with the process technology and quality management, have certain writing organization ability, and obtain internal audit personnel after training. The personnel who took the film were the main ones, and the system documents were carefully prepared. The preparation of the document itself is a process of re-learning, understanding, summarizing, digesting and absorbing the ISO9000 family standard. The more in-depth and meticulous the process is, the closer it is to the actual combination of the enterprise, the stronger the role of the document will be, and the application effect will be The better. It is imperative to save or apply other people's system documents.
(2) Effectively guarantee the trial operation of the system documents. If the preparation of the ISO9001 quality system document is a cumbersome and complicated task, then running according to this document will be a more difficult task, and it will be difficult to change the concept. Under the long-term planned economic system, many comrades are accustomed to obeying the administrative orders of the leaders, not accustomed to doing things according to the system; getting used to doing things, not accustomed to keeping records, used to operating according to experience, "one set of one person ", not accustomed to operating according to standards. In this regard, there should be sufficient ideological preparations, timely change and conceptual education, and focus on solving the problem of scientific decision-making at the leadership level, solving the problem of blindness in the management, and solving the problem of random operation at the executive level. Everyone strictly follows the documents, "write what I did, do what I wrote."
At the same time, in the simulation operation and internal audit, through the PDCA method, that is, planning-implementation-inspection-disposal, further modify and improve the documents; in the operation, everyone understands that in their own positions, they should "produce on what basis." , what to produce, what to operate, what to test, what to correct, what to record, to ensure that every item of the quality document can be fully and in place, laying a solid foundation for formal certification.
(3) To overcome the short-term behavioral thinking, we must take certification as a new starting point, conduct regular internal audits in future quality work, ensure the normal operation of the quality system, and constantly revise and upgrade the system so that it can be continuously improved. In order to ensure that every review and renewal process in the future can be successfully passed. At the same time, we should actively create conditions to promote the ISO09004 standard when the time is right, further enhance the quality management level of the company, enhance the satisfaction of customers and other related parties, and continuously improve the performance and efficiency of the company. With ISO9000, the company is in the domestic and foreign markets. Create a “highway” with high quality and high efficiency of survival and development.