(1) The quality system audit is based on a formalized, documented quality system.
The quality system audit should judge and evaluate the conformity, effectiveness and suitability of the quality system. First, the quality system must be based on formalization and standardization, while formalization and standardization require documentation. Only by establishing a documented quality system can the operation be implemented, and the possibility of comparison and evaluation can be achieved, thus having the necessary conditions for quality system audit.
(2) Systematicity of quality system audit.
The systematic nature of the quality system audit is first manifested in the fact that the audit is a formal activity that requires an organized, planned, step-by-step and prescribed procedure. The selection of the sample, the collection of objective evidence, and the conclusion of the audit There must be a set of effective procedures and methods for tracking corrective actions. The systemic nature of the quality system audit is also reflected in the fact that the focus of the audit is to find that the problems found in the objective evidence review of the system failure cannot be on the surface, but systematically to find the cause of the failure.
(3) The independence of the quality system audit.
The independence of the quality system audit means that the institutions and personnel performing the audit are independent. In general, the auditing agency must be a department that is not directly responsible for the quality activities of the audited content, either a full-time agency or a part-time organization. The audit task undertaken by the auditor and the object to be audited must have no direct responsibility relationship with his own job position. The independence of the audit also requires auditors to respect objective facts, be free from any pressure or inducement, be free from prejudice and emotional influence, adhere to objective and fair, and maintain independent judgment.
(4) The risk of quality system audit.
Quality system audit is a process of sampling inspection. The quality system is a “big system”. Due to time and personnel restrictions, the audit work must be completed in a short period of time. Only sampling inspection methods can be adopted, including extracting a certain number of system documents, quality records, and asking a certain number of personnel. , check a number of equipment, observe several processes, and so on. This method of reviewing a complete quality system with a small sample of audit results is inevitably risky.
Therefore, in the process of auditing, random sampling should be used in a scientific and rigorous manner to conduct a comprehensive analysis to minimize the risk of auditing.
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