Essentially, 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. Many businesses come across infinite technical glitches and procedural hindrances in course of implementation of ISO standards.  ISO 9001 has today become the paramount quality benchmark. Although, the due implementation and maintenance of the desired QMS can be fully assured only as per the accepted standards of the industry. But for that, it is essential to conduct an audit of the QMS. This article is based on an ISO audit 9001QMS of an organization.

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This article contains the following content to clear the concept of ISO audit

        1. What are the different ways of conducting quality management Audit
        2. What is the purpose behind internal Audit
        3. What does the internal Audit do for an organization
        4. Why do we need an internal Audit of our QMS
        5. What are the requirements of an Internal Audit
        6. How to conduct the Internal Audit
        7. How to decide the time and subjects of the Audit
        8. Why create an Audit schedule
        9. What is the objective of Pre-Planning the Audit schedule
        10. How to conduct the Internal Audit
        11. How are the observations of the Audit recorded
        12. Why and How to report the findings

What are the different ways of conducting quality management Audit

An audit of the Quality Management system based on its scope and objectives can be conducted in two ways—

Internal audit: This kind of audit is conducted within the organization by their top-level managers themselves.

External audit: This kind of audit is conducted in an organization with the assistance of a few experienced External auditors.

Out of the above two points, the most internal audit is the viable and economical method of audit and is preferred by many organizations.

What is the purpose behind Internal audit?

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

What does the internal Audit do for an organization

Following are the functions of Internal audit:

  • It demonstrates all the compliances with the structure of QMS whether it is desired or planned.
  • It enhances the functioning as per the desired model of QMS.
  • It tells how to process the QMS, properly implement and maintain.

Why do we need an ISO audit of our QMS

We need an Internal Audit for our QMS because:

  • It ensures the compliances with the need of the following:

(a) Internal organizational standards

(b) Industrial standards

(c) Global standards

  • Helps in determining the smoothness in the attainment of financial, environmental and qualitative objectives.
  • Enhance the QMS.
  • The internal QMS audit is a legal and statutory requirement in many spheres like the renewal of ISO standards.
  • Provide feedback to the top level management.

What are the requirements of an ISO audit 9001QMS

Following are the essential key that we need to have for an Internal audit:

  • Internal auditor: Internal auditor must be unbiased and should not be—

(a) In the same department

(b) The same person who is leading a process such as a head of a department.

(c) It is more feasible to hire an independent external auditor for this purpose.

  • Audit plan: It is needed to determine how, when and where to conduct the audit.
  • Audit checklist: It should be prepared strictly as per the requirements of the ISO 9001:2015 Certification.
  • Audit schedule: It is important to conduct the audit in an ordered manner.

How to conduct the ISO audit QMS

The internal audit of ISO 9001QMS is done basically in six following steps:

  • Decide the time and subjects of the audit
  • Create a schedule for an audit
  • Pre-plan the audit schedule
  • Conduct Internal audit
  • Record the observation
  • Report the observation

These steps are explained below in detail.

How to decide the time and subjects of an ISO audit 9001QMS

The first thing that should be kept in mind before initiating the internal audit, the management has to determine the following things—

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

Why create an Audit schedule

The purpose of creating an audit schedule is to intimate the staff about the upcoming audit. This further helps them to be prepared along with the requisite documentation and records close at hand while reviewing an audit. A plan for allocating resources is also involved which should be needed for the audit.

What is the objective of Pre-Planning the Audit schedule

The main objectives of Pre-planning the Audit schedule are as follows:

  • This makes the entire procedure of audit more hassle-free and effective.
  • Besides, the auditor requires to send the audit report to the respective department providing the information for the audit, like scope and objectives, criteria and documentation for the audit.

How to conduct the Internal Audit

There are two different methods through which internal audit can be done:

  1. Documentation review
  2. Interview & observation

The auditor will choose any of the above-mentioned methods based on the scope and objectives of the Internal audit or they can choose the combination of both. But they should ensure the two main aspects—

  • The internal audit must be fair and unbiased
  • The internal audit must cite and examine sufficient hard copy evidence of the compliances done.

How are the observations of the Audit recorded

Following are the manner at which an auditor must record and enlist all the findings:

  • The basic motive is to trace the gaps and seek the opportunity to fix these defects for improvement.
  • Observations and notes from the interviews are inclusive.
  • As per the recommendation of ISO 9001: 2015 Certification that the auditor shall provide snapshots of the observations that shall be served as evidence of the audit.

Why and How to report the findings

All the findings must be reported to the head of the department in a very legible format in the final report. The answer to the question “Why” is given below:

  • Through this, an evidence is created of the auditing and it is to be reviewed by the department head.
  • Moreover, it can include the corrective action plans which are to be implemented.

A judicious implementation of the Internal auditing steps leads to the successful conduct of the whole process as well as in the maintenance of ISO 9001 Certification.


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