What information is required for 2010 ISO9001 quality system audit?

1) A copy of the business license of the enterprise and a copy of the ** certificate of the organization.

2) Copies of production licenses, qualification certificates, compulsory certification certificates, etc. (according to the laws, regulations and standards of the state, industry and department).

3) A brief description of the activities related to the product or service for which the certification is sought.

4) Product production process and service process diagram.

5) Management system manuals and procedure documents.

6) List of laws, regulations and standards that must be complied with and compliance records (such as accident records, records of violations of laws, regulations or rules) involved in the scope of certification.

7) Spot check report of the state or industry competent authority in the past two years (if any).

8) If there are special danger zones or restricted areas, provide explanatory materials.

It's basically no big deal to get the quality manual and program documentation right!

In fact, there are not a lot of things needed, there are many things that enterprises will have, so it is nothing, the most troublesome thing is that enterprises need to establish a system first, and run, because after submitting the certification, the certification body is directly sent to check the operation of the system, according to this standard to measure whether the enterprise can pass the certification and obtain the certificate.

Therefore, it is recommended that you find a certification consulting agency to make preliminary preparations for you, and then pass in one fell swoop.

If you apply for certification in the early stage, provide the company's business license Enterprise organization** If you sign a certification contract to go to the enterprise for review, you need to submit a quality manual and other materials, which requires too many materials.

is09000Quality management systemThe content is:

(1) To meet the needs of customers as their own responsibility. ISO9000 aims to fully meet the needs of customers, and stipulates the rights and obligations of buyers and sellers. Enterprises can only truly win the market by having a firm grasp of this purpose, focusing on customer needs, and producing marketable products.

(2) Pay attention to process control. ISO9000 standard.

It is very important that enterprises must establish and improve the quality system.

It takes the idea of whole-process control as its basic idea, which can be seen from the 18 process elements that make up the quality system specified in ISO9001.

(3) Emphasis on prevention. Modern quality management ideas are emphasized"From post-inspection to pre-prevention, prevention is the mainstay"It is also well represented in ISO9000. Many of the provisions of the ISO9000 international standard are imitation provisions from the perspective of prevention.

For example, quality planning is required.

This includes the development of quality plans, the provision of necessary equipment and testing methods, the identification and preparation of quality records, etc. ISO9004"The focus of the quality system is on preventing problems from occurring, rather than relying on post-event inspections. "It was also pointed out that it was important not only to ensure that the elements were under control in good condition, but also to have emergency measures in place that could quickly restore control in an emergency.

(4) Continuous quality improvement. One of the core ideas of ISO9000 is continuous quality improvement, and quality improvement is used as the driving force to improve the quality system.

The contents of ISO9000 quality management system include: 1. It is our responsibility to meet customer needs. ISO9000 focuses on meeting the needs of customers and stipulates the rights and obligations of both buyers and sellers.

(2) Pay attention to process control. 3. Continuous quality improvement. Quality improvement is the driving force for improving the quality system.

Quality Management System - ISO 9000

1. Introduction to the standard.

In order to better meet the requirements of customers and laws and regulations, and enhance customer satisfaction, the International Organization for Standardization (ISO) issued five ISO9000 series quality management standards in 1987. Later, in response to the problems in the application of ISO9000 family standards, four revisions were made, and the 1994, 2000, 2008 and 2015 versions of ISO9000 family standards were released. The standard is formulated on the basis of summarizing the practical experience and theory of international quality management, and the organization establishes, implements, maintains and continuously improves the quality management system according to the requirements of the quality management system standards, which will improve the quality of products and services, enhance customer satisfaction and improve market competitiveness.

Standard features: 1.Based on the seven principles of quality management, it is widely used in various fields of quality management.

2.It is widely versatile and suitable for all kinds of organizations. 3.Moderately simplified, after three revisions, the standard has been simplified in content and quantity, the requirements for directive documents have been greatly reduced, and the flexibility and operational guidance of the standard are better.

4.Establish, implement and continuously improve the quality management system using the process method and PDCA cycle model.

5.Improved compatibility with environmental, occupational health and safety management systems can bring greater benefits to the organization.

Second, the benefits of adopting standards.

The application of family standards provides requirements and guidelines for organizations to enhance customer satisfaction and improve organizational performance.

2.Prevent non-tariff technical barriers, in terms of quality and international bridge Qihe, become a "passport" to enter the international market.

3.The establishment of a quality management system can effectively improve the management level and overall performance of the organization.

4.It helps to mobilize the enthusiasm of all employees and improve the quality awareness and law-abiding awareness of all employees.

Reference - Quality Management System.

The specific process of ISO 9000 implementation is as follows:

Stage 1: Submit the application. Applicants (e.g., enterprises) submit a written application to the system certification body in accordance with the prescribed content and format, and submit a quality manual and other necessary information.

The content of the quality manual should be able to demonstrate that the quality system meets the requirements of the applied quality assurance standard (GB T19001 or 19002 or 19003).

Phase 2: System Review. The system certification body assigns an audit team to conduct document review and on-site audit of the applied quality system. The purpose of the document review is mainly to examine whether the provisions of the quality manual submitted by the applicant meet the requirements of the applied quality assurance standards.

The main purpose of the on-site audit is to check whether the operation of the quality evaluation system is consistent with the provisions of the quality manual by collecting objective evidence, to confirm that it meets the requirements of quality assurance standards, to give audit conclusions, and to submit an audit report to the system certification Biye organization.

Stage 3: Approval and issuance of certificates. The system certification body reviews the audit report submitted by the audit team, and issues a system certification certificate to the applicant for the approval certification that meets the specified requirements, and the certificate is valid for i years; If the requirements are not met, the applicant will also be notified in writing.

Phase 4: Supervision and management. ISO 9000 certification system also attaches great importance to the supervision and management after certification, if the certificate holder changes its quality system when the audit is recognized, the change must be reported to the certification body in a timely manner, and the system certification body decides whether to re-evaluate according to the specific situation, and at the same time, the system certification body conducts supervision and audit of the quality system of the certificate holder at least once a year to ensure that its quality system can continue to be maintained.