How to Prepare an ISO 9001 Quality Audit

What Is ISO 9001?

ISO 9001 2015 is a quality management system (QMS) standard regulating any company or business that wishes to provide a product or service of consistent quality subject to its clients’ expectations. ISO (International Organization for Standardization) is an independent group that provides standards and measures to assist organisations, businesses, and companies internationally. 

ISO international standards, like ISO 9001, aren’t a set of rules or obligations that a business needs to follow. It’s a flexible set of guidelines to assist organisations in creating opportunities for improved quality control processes. A company can define its regulations by international standards. The ISO 9001 outlines policies for organisations to meet their customers’ needs and maintain consistent quality in their products or services. 

Why Do You Need ISO 9001?

Implementing the ISO 9001 system as a quality management system has many benefits. The system will improve your business’s ability to focus on the customer and meet their needs. This is a corrective action process and can improve efficiency, improve competitiveness leading to higher profit potential, motivate staff with clear objectives, and enhance the brand name to one with a mark of quality.

This system isn’t a once-off fix-all solution but is continually assessed and reviewed to determine its effectiveness in the business’s quality process. This continual improvement is one of the most impressive reasons to integrate ISO 9001 into your company. By continuously improving the business processes, the organisation is allowed to grow and change for the good of the employers, staff, and customers. These audits are performed periodically and look at the quality control processes of each company. 

Why Do You Need to Get ISO 9001 Audits?

To get ISO 9001 Certification and keep it valid, you need to have an official assessment sanctioned by the ISO. During the ISO certification process, the audit will determine if you fulfil the criteria for selling a product or rendering a service. Consumers are assured of the quality, reliability, and safety of the products or services provided by ISO 9001 certified organisations.

Steps to Prepare an ISO 9001 Audit

First of all, take the negative connotation away from the auditing process. The certification audit is an assessment of quality, and quality control procedures aim to highlight processes or habits that can help or harm an organisation’s reputation and profit potential. It’s a management review that is beneficial for the company. Businesses work differently on an audit schedule and usually do an internal audit before the external ISO audit.

You can do a few things to prepare for an ISO 9001 audit to proactively reassure yourself and become aware of shortfalls before they’re audited. You can also ensure that the QMS works well with other systems like the Environmental Management System (ISO 14001) or the Occupational Health and Safety Management System (ISO 45001). 

Ways to prepare:

  1. Allow auditors as much access as possible.

Auditors follow specific plans and outline to conduct an ISO 9001 audit. The management team might prioritise some information above others, but the truth is the more the auditor has access to, the more accurate and detailed the audit results will be. You’ll have more to work off of to make improvements on the organizations quality procedures.  

  1. Keep to the eight management principles of the ISO 9001 system.

The eight management principles of the ISO 9001 system help you create quality objectives and focus on why you’re implementing ISO 9001 as a QMS. These principles are leadership, customer focus, systematic approach to management, factual approach to decision-making, a mutually beneficial supplier relationship, people’s involvement, process approach, and continual improvement.

  1. Do an internal audit or gap analysis.

Use someone from inside the company to compare the current QMS with the ISO 9001 guidelines outlined by the ISO. This will often draw your attention to any shortcomings or flaws in the existing QMS. This analysis of the system’s gaps will prepare you for feedback during the external audit or assist a company to meet requirements before the external audit is done. A gap analysis will immediately highlight opportunities for improvement.

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