Analysis of the Full Process of ISO9001 Internal Audit in the Group's Business Division
In today's highly competitive business environment, the standardized operation of group companies is of crucial importance. The group company we belong to has several business divisions. Recently, two of these divisions need to conduct routine internal audits, management reviews, and external audits. Next week, the internal audit of one of the business divisions will be launched. The core purpose of this audit is to conduct an in - depth examination of the operation of the company's quality management system and to lay a solid foundation for the second supervision audit in September. Although I'm not responsible for the detailed ISO work, the task of macro - level planning has fallen on my shoulders. Next, I will elaborate on the complete process of the ISO9001 internal audit based on my own work.
I. Preparation for Internal Audit: Make Adequate Preparations and Lay a Solid Foundation
Two months before the external audit, preparations for the internal audit should be put on the agenda. The work at this stage is like the foundation of a building, directly influencing the smooth progress of the subsequent internal audit work.
First of all, it is necessary to identify the management representative and the audit team leader. The management representative plays a crucial role in the quality management system and needs to have rich management experience and a profound understanding of the quality management system. The audit team leader should possess strong organizational and coordination abilities as well as professional auditing knowledge, and be able to lead the audit team to efficiently complete the audit tasks.
Secondly, understand the number of internal auditors and the situation of the members. Internal auditors are the specific executors of the auditing work, and their professional qualities and business capabilities are directly related to the quality of the audit. It is necessary to have a detailed understanding of the professional background and work experience of each internal auditor so as to reasonably assign audit tasks.
Meanwhile, communicate with the on - site department supervisors to roughly confirm the audit time. This requires taking into account the work arrangements and production plans of each department to avoid causing excessive impact on normal business due to the audit work.
In addition, improving the checklists of each department is also an important step. The checklist is an important tool for audits. It should be refined and optimized based on the company's quality management system documents and actual business conditions to ensure that the work of each department can be comprehensively and accurately inspected.
II. Internal Audit Plan: Careful Planning and Rational Arrangement
One and a half months before the external audit, formulating an internal audit plan is of utmost importance. A scientific and reasonable internal audit plan can provide a clear guiding direction for the audit work.
The audit plan should cover key elements such as the audit purpose, scope, criteria, team leader, members, and schedule. The audit purpose should be clear and specific, for example, to check the effectiveness and compliance of the quality management system. The audit scope needs to be clearly defined, specifying which departments and business processes are involved. The audit criteria should be based on the company's quality management system documents and the ISO 9001 standard.
The internal audit schedule is the core part of the plan. It should include the time, location, host, participants of the opening and closing meetings, as well as the audit time for each department, relevant clauses, and the corresponding internal auditors. When making the arrangement, the principles of fairness, impartiality, and rationality should be followed. The work characteristics and audit difficulties of each department should be fully considered to ensure the smooth progress of the audit work.
III. Internal Audit Announcements: Clarify Requirements and Promote Collaborative Cooperation
Based on the internal audit plan, a separate explanation of relevant matters should be provided. The internal audit notice is like an action guide, offering clear work instructions for all relevant personnel.
In the internal audit notice, internal auditors should be reminded to get ready for mobilization to ensure that they can fully engage in the audit work. Meanwhile, all departments are required to make preparations for the upcoming audit and appoint a juror. The role of the juror is to assist the auditors in understanding the actual situation of the department and promote the smooth progress of the audit work.
IV. Distribution of Documents: Standardize Processes and Ensure Implementation
The internal audit plan and internal audit announcements need to be submitted for approval through hierarchical review, which is an important step to ensure the compliance and authority of the documents. After the approval process is completed, they should be distributed to all relevant departments and internal auditors one week before the audit, and a receipt record should be kept. The receipt record can not only prove the delivery of the documents but also provide a basis for traceability in subsequent work.
V. Preparations before the audit: Be meticulous and ensure foolproofness
Before the audit, all kinds of preparatory work should be done well. The sign - in sheets, agendas, and nameplates for the opening and closing meetings should be prepared in advance. The checklist and the non - conformity report form should be distributed to each internal auditor in a timely manner so that they have enough time to familiarize themselves with the audit content.
A few days before the audit, relevant personnel can be notified again via internal email to ensure that everyone has a clear understanding of the audit work. If necessary, a small communication meeting with the auditors can also be organized to answer their questions and unify the audit standards.
VI. Venue Setup and Preparation: Create an Ambiance and Ensure the Success of the Meeting
It is best to notify all participants by phone half an hour before the meeting. In a company, there are always some people who forget about the meeting or are late. Phone notifications can effectively reduce the occurrence of such situations.
Meanwhile, it is necessary to arrange the meeting venue well, including the placement of nameplates, chairs, purified water, and flower pots. When the participants arrive, it is necessary to record their signatures for the purpose of statistical analysis and management of the meeting attendance.
VII. First Meeting: Unify Thoughts and Clarify Goals
The first meeting, which serves as the kick - off ceremony for the internal audit work, lasts approximately 30 minutes. The meeting officially begins after all the participants have arrived. Everyone stands up and salutes to create a solemn meeting atmosphere.
The host explains the theme of the meeting. The deputy general manager delivers a speech, emphasizing the importance of the review work. The management representative introduces the overall situation of the quality management system. The leader of the internal audit team details the purpose, scope, basis, methods, and requirements of this internal audit. The host presents the internal audit schedule and the members of the internal audit team, and confirms with the department heads whether there are any unclear points or objections. Finally, the management representative gives a mobilization speech, encouraging everyone to actively cooperate with the audit work. The host then announces the end of the first meeting.
VIII. On - site Audit: Rigorous, Meticulous, Objective and Impartial
The auditors conduct on - site audits according to the schedule of the audit plan. There are various audit methods, including checking, inquiring, observing, and actual testing. The auditors should comprehensively and meticulously examine the work of each department based on the checklist.
During the audit process, it is necessary to confirm whether the quality management system is implemented in accordance with the specified requirements based on records and evidence materials. For the non - conformities found, they should be promptly filled in the "Internal Quality Audit Non - Conformity Report" form and discussed and confirmed with the audit team leader for reporting at the closing meeting.
IX. Re-arrangement and Preparation of the Meeting Venue: Continue with the Standards to Ensure the Success of the Meeting
The venue preparation for the closing meeting is the same as that for the opening meeting. It is necessary to ensure that the venue environment is clean and comfortable to guarantee the smooth progress of the meeting.
10. Closing Meeting: Summarize the achievements and put forward requirements
The closing meeting lasts about an hour and is a comprehensive summary of the internal audit work. After all the participants have arrived, the meeting begins, and everyone stands up and salutes.
The host explains the theme of the meeting and reiterates the purpose, scope, and basis of the internal audit. The auditors of the internal audit team present a report, elaborating on the problems and non - conformities discovered during the audit process. The leader of the internal audit team solicits opinions from the supervisors of the audited departments, aiming to understand their views and suggestions on the audit work.
The leader of the internal audit team restated the methods and characteristics of this audit. The management representative summarized the audit and put forward improvement requirements and expectations. Finally, the host announced the end of the closing meeting.
XI. Internal Audit Report: Present Objectively and Define the Direction
Preparing and issuing the internal audit report form is an important manifestation of the results of internal audit work. The content of the report should briefly state the purpose, scope, basis, time of the audit, and the members of the audit team. The key part should elaborate in detail on information such as an overview of the audit situation, the audited unit, descriptions of non - conformities, the violated system documents and ISO9001 standards, oral deficiencies, suggestions, types of non - conformities, audit conclusions, and the opinions of the management representative.
The internal audit report needs to be submitted for approval through multiple levels and then distributed to all relevant units, providing clear directions for the improvement work of each department.
12. Internal Audit Tracking: Continuously Improve to Ensure Effectiveness
Send the "Non - Conformance Report for Internal Quality Audit" issued during the on - site audit to the responsible department. Require the responsible department to specify the reasons for the non - conformances, corrective and preventive measures, and the completion deadline. Subsequently, we will follow up based on the preventive measures and completion deadlines specified by the responsible department and confirm by signature.
Meanwhile, create the "Internal Audit Oral Deficiency Tracking Form", distribute it to each unit, and confirm the responsible unit and the completion deadline. Finally, conduct follow - up based on this information to ensure that all problems are effectively resolved. Evidence of the tracking results should be collected and stored, such as taking photos or making form records, for subsequent analysis and summary.
So far, the internal audit process is basically completed. Next, we will carry out the work of management review to further improve the company's quality management level.