How to conduct the Internal audit of ISO 9001 QMS of an organisation?

Evidently, the ISO 9001:2015 has laid down explicit guidelines for devising and implementing homogenized strategies for sagacious strategic management and for seamlessly making headway towards developing an ideal Quality Management System in any organization. 

No doubt, every business comes across infinite technical glitches and procedural hindrances in course of implementation of ISO standards.

As the most sought after Quality Management standard across the globe, ISO 9001 has today become the paramount quality benchmark.

However, the due implementation and maintenance of the desired QMS can be fully assured only as per the accepted standards of the industry. And for that, it is essential to conduct an audit of the QMS.

#1. What are the different ways of conducting Quality Management Audit?

Based on its, scope & objective, an audit of the Quality Management System can be conducted in 2 ways-

• Internal audit: This type of audit is conducted within the organization by their top-level managers themselves.
• External audit: This type of audit is conducted in an organisation with the assistance of a few experienced External auditors.

Among these 2, the most internal audit is the more viable and economical method of audit and is prefered by many organisations.

We will be discussing the Internal audit in full length.

#2. What is the purpose behind Internal audit?

The main objective of conducting the Internal audit is to assess the effectiveness of the Quality Management System and the overall performance of an organization.

#3. What does the Internal audit do for an organization?

Given below are the functions of Internal audit:

• It demonstrates the compliances with the desired or planned structure of QMS.
• It helps to function according to the desired model of QMS.
• It tells how the QMS processes are implemented and maintained.

#4. Why do we need an Internal audit of our QMS?

The  purpose of an Internal audit of QMS is to:

1. Ensure the compliance with the need of-

1. Internal standards (organizational)
2. Industrial standards (within the sphere of an business activity) and
3. Global standards

2. Determine the smoothness in the attainment of financial, environmental, and qualitative objectives.
3. Enhancement of the QMS.
4. Internal QMS audit is a legal and statutory requirement in many spheres such as renewal of ISO standards.
5. Feedback to the top level management.

#5. What are the requirements of an Internal Audit?

Given below are the key essentials we need to have for an Internal audit:

1. Internal auditor: An Internal auditor should be totally unbiased and should not be-

• From the same department.
• The same individual leading a process, such as a head of a department.
• It can be much more feasible to hire an independent external auditor for this purpose.

2. Audit plan: The Audit plan is prepared to determine how, when and where to conduct the audit.
3. Audit checklist: The Audit checklist should be prepared strictly as per the requirements of the ISO 9001:2015 certification.
4. Audit schedule: This is very important so as to conduct the audit in an ordered manner.

#6. How to conduct the internal audit?

The internal audit of a QMS is done in 6 steps that are explained below in depth:

1. Deciding the time and subjects of the audit.
2. Creating an audit schedule
3. Pre Planning the audit schedule
4. Conducting the internal audit
5. Recording the observation
6. Reporting the observation

These will be explained in depth.

#7. How to Decide the time and subjects of the audit?

Before initiating the internal audit, the management has to determine-

• What processes have to be audited?  
• The scope and objective of the audit so as to assist in creating an audit schedule.

#8. Why Create an audit schedule?

The main purpose of creating an audit schedule is to intimate the staff about the upcoming audit.

• This helps them to be prepared with the necessary documentation and records close at hand while reviewing and audit.
• It also involves a plan for allocating resources needed for the audit.

#9. What is the objective of pre-planning the audit schedule?

The purpose of pre-planning the audit schedule is to-

• Be fully prepared before the audit is conducted. This makes the process of audit more hassle-free and effective.
• Moreover, the auditor needs to send the audit report to the respective department providing the information for the audit, such as scope and objective, criteria, and documentation for the audit.

#10. How to Conduct the internal audit?

The internal audit can be done using 2 different methods-

• Documentation review  
• Interview & observation

On the Basis of the scope and objective of the audit, the auditor will choose any of the abovementioned methods or a combination of these 2. The auditor must ensure 2 main aspects-

• The audit must be fair & unbiased.
• The audit shall cite and examine sufficient hard copy evidence of the compliances done. The guidelines for this step are clearly explained in ISO 9001:2015 version.

#11. How are observations of the audit recorded?

At this step, the auditor shall enlist all the findings and record them numerically in serial wise manner.

• The main aim is to trace the gaps and seek the opportunity to fix these defects for improvement.
• It also includes observations and notes from the interviews.
• It is also recommended as per ISO 9001:2015 certification that the auditor shall provide snapshots of the observations, which will serve as evidence of the audit.

#12. Why & how to report the findings?

The findings are to be reported to the head of the department in a very legible format in the Final Audit Report.

• This serves as evidence of the audit and is to be reviewed by the departmental head.
• Preferably, it can include the corrective action plans to be implemented.

A judicious implementation of the aforesaid steps can help in the successful conduct of the internal audit and adequate maintenance of ISO 9001 certification.

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