ISO 9001 Gap Analysis Guide

22/07/2022by admin0Read: 3 minutes

ISO 9001 gap analysis is the fundamental step towards achieving ISO 9001: 2015 certification. It can be performed internally at an organisation equipped with the essential resources and expert knowledge, or with the assistance of a professional ISO 9001 consultant.

In this blog, we will define ISO 9001 gap analysis, its purpose, and the steps to be taken. But, before that, it is essential to define and understand the ISO 9001 standard.

ISO 9001 Standard

ISO 9001 is the international standard for implementing robust quality management systems (QMS) for your business in Australia and the world. It is the most popular global standard that can be easily integrated with other ISO standards.

Achieving ISO 9001 compliance has a lot of benefits like enhanced customer loyalty, quality assurance, and enhanced efficiency, to name a few.

Conformance with ISO 9001 is essential to achieve ISO 9001: 2015 certification. A gap analysis audit is performed to check the same.

ISO 9001 Gap Analysis – Definition

An ISO 9001 gap analysis is the fundamental step to achieving ISO 9001 certification and compliance. It involves conducting an in-depth, objective assessment of your organisation’s existing quality management system (QMS) against the standard requirements given in the ISO 9001 standard guide and spotting non-compliant areas.

Purpose of ISO 9001 Gap Analysis

The key purpose of a gap analysis audit is to analyse and test your company’s quality management system’s current state against ISO 9001 requirements and identify areas of noncompliance. This process will help in defining potential risks that need to be addressed and overcome to apply for the ISO 9001 certification. A registered certification body will further do an assessment and provide you with the standard certification.

Conducting ISO 9001 Gap Analysis

We have provided below a step-by-step procedure to perform ISO 9001 gap analysis for your company’s QMS.

1. Setting Organisation’s Goal

Prior to the commencement of the gap analysis for your company’s QMS, it is essential to have clarity on your organisation’s goal behind achieving ISO 9001 certification and the benefits it would bring. For this, it is essential to do proper planning.

2. Define Scope and Focus area

You must define your quality management system’s scope and focus area that highlights the various departments and business locations it will cater to. You can do gap analysis internally or hire an experienced ISO 9001 consultant to conduct the same.

3. Role of ISO 9001 Consultant

An ISO 9001 consultant will compare your current QMS and business practices against the requirements mentioned in ISO 9001 standards clauses 4 -10. They will use a checklist to tick all compliant areas and highlight the non-compliant ones that need improvement.

4. Report and Documentation

Based on their findings, the professionals will prepare a report on the gap analysis audit. Standard documentation in the PDF format will help in future reference to any specific area and provide you with information and expert guidance to overcome setbacks in your company’s existing QMS. Documentation of internal policies will also help to have a set of rules to be followed like done as per external policies and regulations.

5. ISO 9001: 2015 Certification

Once your company’s quality management fulfils all the requirements outlined in the ISO 9001: 2015 certification guide, your organisation can apply for an ISO 9001: 2015 certification on your own or with the help of an ISO consultant.

Gap analysis must be done in an accurate way to avoid any extra cost incurred or inaccuracies. Hence, we would recommend taking professional help in performing the same.

Anitech’s expert QMS consultants can help your business in overcoming the non-compliant issues and setbacks in your current quality management system and perform a gap analysis to enhance your business process. You and your staff will learn some valuable insights during the audit. We will also provide training and relevant information that will be useful to make you understand each step of the service provided and the methodology used.

If you have a question, feel free to call us on 1300 802 163. You can email us at – info@anitechgroup.com or enquire here. Our consultants will be happy to help!

ISO 9001: 2015 certification lasts for three years and needs renewal. Therefore, ISO 9001 gap analysis audit should be performed once every three years and as per the certification requirement.


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