Understand the Basics of Audits for an ISO 9001 Quality Management System

 

Audits are an indispensable part of the ISO 9001 certification. They are necessary to ensure that the Quality Management System (QMS) implemented in your organization meets every requirement of ISO 9001 and is uniformly effective at maintaining the quality of products or services. Audits should be performed by experienced officials or quality managers with intrinsic knowledge of the quality management standards. They should meticulously check every area of the QMS as well as your processes and policies to discover any gaps, discrepancies or deviations from the ISO 9001 quality management requirements. As a result, any issue in the QMS can be identified and you can take corrective actions to eliminate them. Hence, an audit prepares your organization for the final certification stage.

You should understand the real importance of audits to lay a competent and ISO-compliant QMS organization-wide. They drive continuous improvements of your processes and foster employee participation in maintaining the quality culture.  When employees are shown the key flaws in processes and QMS, they are motivated to do better and remove those flaws. 

Here is a clear explanation of the fundamentals of audits which can help you in performing the same for your own business. 


 

Basics of Performing Audits to Guide You Achieve ISO 9001

Objectives of Audits

No doubt, audits are important and an integral part of the ISO certification. But why is that so? There are many organizations that still skip the step to perform an internal audit before certification, only to face noncompliance issues and delay certification later. Clearly, they are not aware of the prime objectives of performing an audit. You should not make the same mistake.

A proficiently conducted audit enables you to:

• Measure the effectiveness of your organization’s process controls and quality management practices

• Achieve full compliance with ISO 9001 requirements

• Identify operational inefficiencies and address them to reduce downtime, wastes of resources, time and money

• Identify areas where improvements can be made to achieve operational excellence

• Assist the top management team to identity and resolve cross-departmental issues

• Get valuable insights on different processes which help in sound decision-making


Different Types of Audits

There are three different types of audits. You should choose one depending on your business or on the present stage of your certification process. 

1. Process audits where auditors thoroughly check your business processes, various work instructions, procedural controls, and quality management practices. They check every controlled document related to them and then physically evaluate processes to see if they are at par with the documents.


2. Product audits where auditors examine whether your products are conforming to the specifications of the standard, customers’ requirements, or an industry performance standard.

 
3. System audits where auditors examine and evaluate effectiveness of the management system (like QMS) implemented in the organization and ensure that it adheres to the regulations of a standard. 


Clearly, the third type of audit is a must for your businesswhen you are aiming to achieve the ISO 9001 certification. But, many organizations also conduct product or process audits or both alongside to be double sure of their competency and compliance efforts. 

Guidelines to Perform Audits Effectively

While audits are success pillars for implementing an ISO 9001 validated QMS, here are some guidelines to perform audits proficiently.

 

• Provide necessary training to employees so that they are well versed with the auditing process and cooperate with officials at every stage when they do the audit

• Gain management support and supervision to ensure there is smooth scheduling and completion of the audit, without creating any disruptions in other important areas of the business

• Consistency is necessary and hence make sure to use the same approach and same rules for every audit in your organization

• Being critical is the key to make your audits helpful. Seek details of the audit findings from the auditors, ask numerous questions, cross-check every fact, and then conclude by deciding what improvements are needed.
 

Bottom Line

Organizations need to understand the significance of audits for successfully establishing an ISO 9001 quality management system. With the systematic evaluation of your QMS, policies, and processes, auditors highlight the problems so that you can solve them and improve the efficiency of your QMS.  The external certification body, which is responsible for giving the ISO 9001 certification would not then find any faults or noncompliance in your QMS. They would hand over the ISO certification without doubting the competency of your QMS when they see that all nonconformities or inefficiencies in the QMS were already identified and resolved by you. 

Also Read: 7 Inevitable Elements of a Quality Assurance System

Contact Details:
Business Name: Compliancehelp Consulting, LLC
Email Id: info@quality-assurance.com
Phone No: 877 238 5855  

 

 

 

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