ISO 9001 certification is known as "passport to the international market", ISO 9000 family standards is a concept proposed by the International Organization for Standardization (ISO) in 1994, which refers to "the ISO/Tc176 (International Organization for Standardization Quality Management and Quality Assurance) The international standard formulated by the International Organization for Standardization (ISO) is one of the most influential standards issued by the International Organization for Standardization (ISO).
ISO 9001:2015 introduces the concept of risk thinking, pays more attention to the operational risk and performance of the organization, and puts more emphasis on the role of leadership in the management system, while fully taking into account today's ever-changing business environment to help organizations respond to the ever-changing needs of customers , enhance the competitiveness of enterprises, maintain survival and development. Therefore, the quality management system is no longer limited to the traditional manufacturing industry, and more and more industry enterprises such as services, medical care, public utilities, etc. have also introduced the new version of the ISO 9001 standard to integrate quality management into enterprise operations.
ISO9001 is the full name of ISO9001 quality assurance system, which is used to verify that the organization has the ability to provide products that meet customer requirements and applicable regulatory requirements, with the purpose of enhancing customer satisfaction.
The ISO9001 certification process is as follows: 1. First, establish a documented quality management system, and implement a trial operation for more than three months. Organize at least one internal audit and management review of the internal quality management system, and the internal audit needs to cover all sites. and standard terms, and prepare relevant quality manuals and procedure documents.
2. Submit the application form, application materials, etc. to the certification body, confirm the scope of certification, and sign the certification contract.
3. After signing the contract, enter the first stage of audit, mainly document audit. The audit team leader conducts an on-site audit on the quality management system manual and procedure documents submitted by the auditee according to the certification requirements, and informs the audit results in writing. Correction required.
4. Enter the second stage of audit, evaluate the compliance of the auditee to the standard requirements by means of sampling audit, and determine whether it can pass the certification.
5. After obtaining the ISO9001 certification, it will undergo regular supervision and auditing. The certification company will make decisions to maintain, expand, shrink, suspend and cancel the certification according to the audit results.
6. When the ISO9001 certificate expires, a re-evaluation application should be submitted to the certification company. After passing the qualification, a new certificate should be issued. The re-evaluation procedure is consistent with the certification procedure.
ISO 9001 is based on seven quality management principles:
1. Customer orientation
2. Leadership
3. Full commitment
4. Process method
5. Improvements
6. Evidence-Based Decision Making
7. Relationship Management