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ISO 9001 Audit Checklist: How It Simplifies Your Audit Process?

01 Aug 2023

Obtaining your ISO certification requires you to meet all the documentation requirements of the standard and to ensure that your team follows best practices. It might not sound like a demanding task while it is. It requires your team’s commitment to culture of quality wherein everyone contributes to making process and product quality better. 

In this post, we will have deeper insights into ISO 90001 Audit Checklist and how this checklist streamlines your audit process. 

Precisely what is an ISO 9001 Audit Checklist? 

As a requirement of the ISO 9001 standard, a process audit must be planned and carried out with the help of an ISO 9001 audit checklist. Checklists for internal quality audits consist of questions based on the company’s quality management system and process documentation. 

Internal audits: Why do they matter? 

Organizations conduct internal audits for a variety of reasons, such as: 

  • Meeting compliance with internal standards, industry regulations, and international standards. 
  • Using the system to determine if it meets specific objectives (quality, environmental, financial). 
  • Examining areas for improvement. 
  • Conforming to regulation and legislation. 
  • Offering suggestions to management. 

ISO Audit Checklist: Why it is Important? 

ISO 9000 and other quality standards require regular internal and external audits. As part of an ISO audit, companies are checked to ensure that their internal processes adhere to the ISO standard. The test’s purpose is to confirm that the system is functioning correctly, identify areas for improvement, and fix or prevent any issues identified. Companies can increase their chances of success with an ISO compliance checklist, even when challenging audits and inspections. To create an audit checklist and plan, review the ISO standard, and understand what an auditor is looking for. 

ISO 9001:2015 Audit checklist: What It Comprises? 

The ISO 9001:2015 Audit checklist comprises the following components: 

1. Organization’s Context 

Firstly, it is important to clearly define the context of the organization to understand what issues they intent to resolve with the QMS. It can be completed it in four steps: 

  1. Determining the internal and external issues that organization is trying to solve and how they will evaluate the effectiveness of the action plans implemented. 
  2. Determining the needs and expectations of the people who are interested. 
  3. Defining the scope of the quality management system – whether it is covering the processes, products, services, or all of them. Also, the everything should be well documented and readily available to the involved parties. 
  4. Implementing the right quality management system that can cater to the needs and expectations of the organization. 

2. Leadership and Commitment Values 

The next thing in the row is the leadership and commitment values of the management. Are they really willing to take the accountability of the QMS? The leadership and commitment values reflect through the following factors: 

  1. The risk-based thinking and problem-solving approach, and how well is the QMS integrated with the business processes. 
  2. The focus on the customer satisfaction by improving their experience with the quality products, services, and support. 
  3. The commitment to establishing Quality Policy, communicating it, defining the roles and responsibilities. 

3. Planning Processes 

An organization’s take on planning tells a lot about its culture. Hence, it is very important to consider the planning processes for: 

  1. Addressing risks and opportunities identified and evaluating the effectiveness of the action plan implemented. 
  2. Defining and achieving the quality objectives. 
  3. Managing and executing change processes.  

4. Resource Management 

Managing resource efficiency is one of the common yet critical business challenges. Resource management includes: 

  1. Having all the resources required for implementing and maintaining the efficiency of the quality management system. 
  2. Having the skilled and competent workforce to manage QMS processes effectively. 
  3. Having the right equipment and infrastructure to deliver conforming products and services. 
  4. Having the right working culture and environment. 
  5. Defining the metrics to measure effectiveness of the processes and products. 
  6. Keeping the staff well informed of their roles, responsibilities, and expectations. 
  7. Streamlining the communication and collaboration throughout the organization. 
  8. Keeping all the information and processes well documented. Also, ensure it is safe from unauthorized access. 

5. Operational Efficiency 

In addition to resources, operational efficiency also plays a significant role in an organization’s success. Therefore, organizations must ensure that: 

  1. They have all the required resources to plan, control, and implement the quality processes. 
  2. They are meeting customer expectations in terms of quality products and services. 
  3. They have streamlined and standardized design and development process for their products and services. 
  4. They have good control of production processes. 
  5. They have proper plans and controls in place to monitor, evaluate, and communicate with the external providers. 

6. Performance Evaluation 

How an organization evaluate the performance and effectiveness of the QMS can make a huge difference. It is important for an organization to: 

  1. Plan how they will monitor, measure, analyze, and evaluate the QMS effectiveness. 
  2. Choose the right metrics, tools, and methodologies to cover all the aspects of performance. 
  3. Have right controls in place to validate the outcomes that your QMS is producing. 
  4. Maintain all the records including the results and their effectiveness for meeting compliance. 
  5. Analyze all the inputs and outputs to make informed business decisions on the improvements required (Having clarity of risks severity can also help). 
  6. Have appropriate measures in place to ensure customer satisfaction. 
  7. Plan timely management reviews for quality inputs. 

Related Article: Do Internal Audits Help Analyze Your QMS’s Performance?

7. Continous Improvements  

Continous improvement is a very important principle of quality management that determines the long-term success of an organization. It is important to understand: 

  1. Whether the organization has identified the improvements opportunities. 
  2. Whether the organization is taking all the required actions to address long-term business needs and expectations. 
  3. Whether the organization has adopted the proactive approach to manage quality issues and prevent their recurrence. 
  4. Whether the organization has all the plans and procedures in place to deal with the nonconformances. 
  5. Whether the organization is taking continual steps to improve the overall adequacy, effectiveness, and performance. 

The above-mentioned checklist is just a summarized version. The ISO 9001:2015 Audit checklist contains a lot more factors. You cannot manage them all manually. It’s high time that you upgrade to an advanced audit management software. The software allows you to set all the requirements, evaluation criteria, and performance metrics at one place. Also, you need not worry about the documentation since the next-generation, cloud-based solutions automatically stores all the details. 

The cloud-based audit solutions give you a greater flexibility, security, and reliability to manage your business-critical data and processes.  

One such solution is Qualityze Audit Management Software Solution. It enables organizations to manage end-to-end audit processes effectively and efficiently. It allows organizations to perform timely audits, guaranteeing product quality and safety following regulatory requirements. 

If you are still unsure about investing in Qualityze Audit Management Solution, we can assist you by conducting a comprehensive product demo, and you can check out all the best-practices auditing capabilities it has for you.  

For more information on smarter quality solutions of Qualityze EQMS Suite, please contact our customer success team by calling +1-877-207-8616 or emailing us at info@qualityze.com, and we will be happy to assist. 

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