Certification Popular Science | Understand the Entire Internal Audit Process for Enterprise System Certification Application at Once!

1. Develop Annual Audit Plan

At the beginning of each year, the quality manager organizes the preparation of the annual audit plan. The audit methods are divided into Full-process management system audit and Management system element audit The full-process management system audit should be arranged at least once a year, and the annual plan should cover all elements and all departments involved in the management system.

The audit frequency should be increased under the following special circumstances:

a. When there are significant changes in the management system or major changes in organization and functions;

b. When internal supervisors find serious nonconformities in certain quality elements;

c. When quality incidents occur, or customers continuously complain about a certain link;

d. Before on-site assessments or surveillance audits arranged by certification and accreditation bodies;

After approval of the annual audit plan, the organization implements it.

2. Preparation before the audit

Establish the internal audit team:

The quality manager forms the internal audit team based on the audit content and audit objects in the management system audit annual plan. Team members should have passed training and assessment, obtained internal auditor qualification certificates, and have no direct responsibility relationship with the audited departments. The quality manager convenes a meeting of the internal audit team members, appoints the team leader, reads the internal auditor code of conduct, and proposes the purpose, scope, content, and requirements of this audit based on the annual audit plan.

Formulation of the internal audit implementation plan:

The internal audit team leader formulates the internal audit implementation plan based on the organization's function allocation table, preparing the review content for each audited department. After approval by the quality manager, it is implemented. The implementation plan should be sent by the team leader to all relevant departments and personnel one week before the formal audit.

Audit team preparatory meeting:

After the internal audit implementation plan is approved by the quality manager, the audit team leader convenes a preparatory meeting to study relevant system documents and decide whether supplementary documents are needed, clarify division of labor and requirements, ensuring every internal auditor clearly understands the audit tasks and completes all preparations before the audit.

Preparation of checklists:

Before the audit, internal auditors should prepare checklists according to their division of labor. The quality of the internal audit checklist directly affects the quality of the audit implementation, so it is crucial throughout the internal audit. At Jiunaohui Academy, we remind everyone that the audit content in the checklist should be based on the functions of the audited department, highlighting the main functions of the audit area; the audit methods and approaches (checking, questioning, listening, observing) should be appropriate; the sample size for the audit should be reasonable.

Typical key quality issues should be selected as the focus for preparation (such as information from the last audit, weak points in management, customer feedback, past quality problems, etc.).

All internal auditors' checklists combined should cover all functions of the management system, including some special requirements of the laboratory and customers. After using the checklist for a period, it should form relatively stable content as a standard checklist to provide reference for future internal audits.

1. Audit Notification

The internal audit should notify the audited department of the specific audit date, arrangements, and requirements at least one week in advance, which can be in written or oral form. If necessary, the audited party should prepare a basic situation introduction, and the audit implementation plan should be confirmed by the audited party.

2. Opening Meeting

Before the on-site audit, the internal audit team leader convenes and hosts the opening meeting, attended by the quality manager, the head of the audited department, all internal audit team members, and related personnel. Attendees must sign in.

The opening meeting includes:

Introducing the internal audit team members and their division of labor to the audited party's leader;

Explaining the audit purpose, scope, basis, and the methods and procedures adopted;

Reading the audit implementation plan and explaining unclear parts of the plan;

Establishing formal contact between the internal audit team and the audited department.

3. On-site Audit

1) Principles to follow during on-site audit

Principle based on objective facts. Objective facts are evidence-based, can be stated and verified, and do not include personal reasoning;

Principle of checking standards against actual conditions. Items not checked against standards and actual conditions cannot be judged as conforming or nonconforming;

(continued from previous)

Principle of stepwise audit. The audit includes: whether the required procedures exist, whether they are executed, and whether records exist after execution;

Principle of independence and impartiality.

2) Collecting objective evidence

Internal auditors collect objective evidence item by item according to the audit implementation plan and the internal audit checklist through methods such as interviews, document review, on-site inspection, and investigation verification, recording facts truthfully. Records should be clear, understandable, comprehensive, easy to review and trace; accurate and specific, such as document names, contract numbers, record numbers, equipment numbers, report numbers, and job positions. During the audit, auditors should communicate and provide feedback on findings to the audited party in a timely manner and confirm factual evidence.

4. Nonconformity and Correction Report

In the later stage of the on-site audit, the audit team leader hosts an internal audit team meeting to organize, analyze, and screen the objective evidence collected during the on-site audit to obtain audit evidence.

Compare the audit evidence with quality system documents and other bases, make objective judgments and comprehensive evaluations, form audit findings, identify nonconformities, and determine the type of nonconformity based on the cause of occurrence as systemic nonconformity, implementation nonconformity, or effectiveness nonconformity;

According to the nature of the nonconformity, determine whether it is a minor nonconformity or a major nonconformity, and at the same time propose corrective actions based on the type and nature of the nonconformity.

When internal auditors prepare internal audit nonconformity reports regarding facts, types, conclusions, etc., the description of nonconformity facts should be specific and accurately report the observed facts, and the clauses and procedures serving as the basis for the nonconformity judgment must be clearly stated.

5. Closing Meeting

The internal audit team leader organizes the internal audit team and relevant personnel (same as the opening meeting) to hold the closing meeting, and attendees sign in. The closing meeting is the last activity of the audit team during the on-site audit phase, reporting the audit situation to the audited department and unit leaders.

Main contents of the meeting: Reiterate the purpose, scope, and basis of the audit; introduce the audit situation; read out the nonconformity report, make audit evaluations and conclusions; propose follow-up work requirements, including corrective actions, follow-up verification, and requests.

6. Preparation of the Audit Report

The internal audit report is a formal document issued after the internal audit activity ends, which should truthfully reflect the methods, audit process, observations, and conclusions of this management system audit.

Contents of the audit report:

Purpose, scope, methods, and basis of the audit;

Audit team members, audited departments;

Audit implementation details (including audit dates, brief overview of the audit process, etc.);

Description of audit findings and statistical analysis of nonconformities;

Analysis of major existing problems and improvement suggestions;

Correction status of major nonconformities from the last audit; disputed issues during the audit and handling suggestions;

Audit conclusions (comprehensive evaluation of the operation status of the quality management system, evaluation of the effectiveness and compliance of the implemented management system, affirming strengths, pointing out deficiencies, and making audit conclusions);

Approval and distribution scope of the audit report.

7. Implementation of Corrective Actions and Follow-up Verification

After the audit, each department analyzes and studies the causes of nonconformities found in the audit and weak points in the laboratory system, formulates plans for corrective, preventive, and improvement measures, clarifies completion dates, and organizes implementation. Internal auditors review and verify the corrective actions taken by the audited departments according to the plan, and judge, evaluate, and record the corrective results.