ISO50430 Certification - Quality System Internal Audit Control Procedure:

1.0 Purpose

Conduct regular and irregular audits of the company's quality management system, extensively verify the implementation of various quality management systems by various departments, to timely identify problems and take appropriate improvement measures, so as to continuously improve the quality management system and ensure its continuous and effective operation.

2.0 range

Applicable to the audit of the relevant departments of the company's quality management system.

3.0 Definitions

  without.

4.0 Powers and Responsibilities

4.1 Management representative: responsible for formulating the annual internal quality audit plan, appointing the leader of the internal audit team and members of the internal audit team, and coordinating various internal audit operations.

4.2 Internal Audit Team: Responsible for the implementation of internal audit, the proposal of non-conformance items and the follow-up verification of corrective and preventive measures.

5.0 Program

5.1 Types and timing of internal quality audits:

5.1.1 Regular audit: organize a comprehensive audit of the quality management system at least once a year, and the audit scope must cover all relevant departments, all products and all provisions of ISO9001:2008 and GB/T50430-2007.

5.1.2 Temporary audit: In any of the following situations, the general manager or management representative may arrange a temporary audit as needed. The audit scope can be the entire system, or individual departments, products or ISO9001:2008, GB/ T50430-2007 Separate Clause.

5.1.2.1 Significant changes to the quality management system;

5.1.2.2 Serious abnormality occurs in product quality;

5.1.2.3 Before conducting the audit required by the second party, third party or laws and regulations;

5.1.2.4 Circumstances that the general manager or management representative deems necessary to review.

5.2 Annual internal audit plan

5.2.1 In December every year, the management representative will draw up the "Annual Internal Audit Schedule" according to the specific situation of each department and the previous audit results, submit it to the general manager for approval and send it to each department.

5.2.2 Internal auditors should be qualified through internal quality audit training. Internal auditors should have a certain understanding of the business of the audited department, and have no direct responsibility relationship with the audited department.

5.2.3 For temporary internal audit, the management representative temporarily assigns the internal audit team.

5.3 Audit Notice

5.3.1 Before reaching the Internal Audit Implementation Plan, the management representative shall designate the members of the internal audit team;

5.3.2 The internal audit team leader is responsible for dividing the audit work according to the specialties of each internal auditor, and scheduling the audit schedule. Fill in the Internal Audit Implementation Plan at least three days before the audit, and send it after the management representative has reviewed it. to the audited department.

5.3.3 If the audited department has any objection to the audit schedule, internal auditor and audit content, it can coordinate with the internal audit team to resolve it within two days.

5.4 Audit preparation

5.4.1 Internal auditors prepare the "Internal Audit Checklist" based on the business scope of the audited department and relevant management documents, as well as the non-conformities in previous audits.

5.4.2 The audited department shall prepare relevant quality records, required documents, and designate accompanying persons.

5.5 Audit Implementation

5.5.1 The first meeting: chaired by the leader of the internal audit team, or by the management representative if necessary. The members participating in the meeting are mainly composed of the person in charge of the audited department, members of the internal audit team and other relevant personnel. The chairperson of the meeting introduces the members of both parties. , The internal audit team leader introduces the audit content and schedule. If there are special circumstances, the "Internal Audit Implementation Plan" should be sent to the person in charge of the audited department.

5.5.2 On-site audit

5.5.2.1 Internal auditors conduct on-site audits on the audited departments objectively and fairly according to the Internal Audit Checklist.

5.5.2.2 When internal auditors find serious non-conformities or clues, they have the right to expand the scope of audit and increase audit content.

5.5.2.3 The methods for internal auditors to collect information and evidence are as follows:

a) Review relevant document requirements and quality records.

b) Ask the operator how to operate and how to record.

c) In-depth field observation and verification.

d) Verification of necessary processes and product quality, etc.

5.5.3 The final meeting: generally chaired by the head of the internal audit team. If necessary, the management representative will preside over the meeting. The head of the internal audit team will report the audit situation, including advantages and disadvantages and necessary improvement plans. In case of special circumstances, the internal audit team leader should fully communicate and coordinate with the person in charge of the audited department on the non-conformities and observations found in the audit during the audit process. If no consensus is reached, a final meeting should be held. Adjudicated by management representatives.

5.6 Audit report

5.6.1 The internal audit team sorts out the non-conformance reports in a timely manner, and fills in the "Internal Audit Non-Conformance Report" for the non-conformities and sends them to the audited department.

5.6.2 The head of the internal audit team shall fill in the Internal Audit Report within seven days after the audit to briefly describe the entire internal audit result, and send it to the management representative for review, so as to achieve the senior management's understanding of the operation status of the quality management system.

5.7 Missing improvement and tracking

5.7.1 After receiving the "Internal Audit Non-conformity Report", the audited department draws up "Corrective and Preventive Actions Handling List", analyzes the reasons, proposes improvement measures and deadlines, and submits it to the internal auditor after being approved by the management representative. For tracking purposes.

5.7.2 Internal auditors are listed in accordance with the "Control Procedure for Corrective and Preventive Actions", and follow up and verify in a timely manner according to the improvement period.

5.7.3 The internal auditor records the verification results in the Corrective and Preventive Actions Handling Sheet, and submits it to the management representative for approval whether the case is closed or not.

5.8 Record keeping

After the audit is completed, the internal audit team shall submit the audit records to the management representative for archival management.

5.9 Statistics of non-conforming items

5.9.1 After the annual audit is completed, the management representative will count the distribution of non-conformance items in each department, and compile a statistical analysis table for non-conforming items in the internal audit and submit it to the management representative.

5.9.2 The statistical results of the distribution of non-conformance items in the internal audit shall be used as one of the management review inputs, and the management representative shall present a report in the management review meeting.

6.0 Quality Records

6.1 "Annual Internal Audit Schedule"

6.2 "Internal Audit Implementation Plan"

6.3 "Internal Audit Checklist"

6.4 Internal Audit Report

6.5 "Internal Audit Nonconformity Report"

7.0 related documents

7.1 Corrective and Preventive Action Control Procedures

7.2 "Management Review Control Procedures"