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Use a ISO 9001 Audit Checklist To Develop a QMS

Evaluate the effectiveness of your company's Quality Management System (QMS) with a digital checklist and meet ISO 9001 requirements. Learn what you’ll need to know and do to get ISO 9001 certified with Lumiform’s free online templates.

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What Is an ISO 9001 Audit Checklist?


An ISO audit is an official assessment approved by the International Organization for Standardization (ISO) to determine if a company meets certain criteria. This usually involves, the development of a product or the provision of a service. With the ISO 9001 certification, your company proves its quality awareness, its reliability in production and services and its general competitiveness. The global industry standard specializes in the quality management system and helps companies efficiently improve quality for optimal customer satisfaction. The standards contained in this certification also inform those set out in an IATF 16949 supplier audit.


Using a digital checklist for an ISO 9001 audit helps assess the effectiveness of a company's quality management system (QMS) and whether it meets ISO 9001 requirements for certification. The standard is regularly updated with the current version being from 2015 (ISO 9001:2015). The templates are great tools to help implement a QMS and prepare for an ISO 9001:2015 certification audit.


Start with the ISO 9001:2015 failure analysis and internal audit checklist created with Lumiform. Use the digital tool to assess your organization's QMS, identify gaps and areas for improvement, and assign actions to the appropriate departments.



This article covers the following topics:


1. The Importance of ISO audits


2. The 7 Principles of ISO


3. Advantages of a Digital ISO Audit Checklist


4. How to get ISO 9001?


5. Why Use Lumiform for ISO 9001 Audit?


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How Important Are ISO Audits


The International Standardization Organisation (ISO) is a part of the Worlds Standards Cooperation (WSC). They develop and publish international quality standards. To meet these standards and their requirements, you should perform regular ISO audits to guarantee quality and safety within your products and services on international grounds.


The ISO 9001 is one of the most successful and most certified ISO standards in the world. More than one million companies use the standard for their QMS. With ISO 9001, managers and responsible persons can continuously monitor the company management with regard to quality standards and sustainability as well as improve themselves internally through self-control. In this way, the responsibilities of all stakeholders are structured, developed, and optimized for the long term.



What Are The 7 Principles of ISO? And Is It Mandatory?


The International Standardization Organisation has developed 7 principles for Quality Management to assist you to meet their requirements and get their certification. However, your main goal should not only be that certification but also (mainly) your own product quality. So what should you focus on in order to get that?


1. Focus on Your Customers


The customers are your most important focus. They are the people buying, using, and recommending your product. Therefore, they are the ones who you ultimately have to satisfy. Only then they will buy it again, and only then they will recommend it to their friends and families. The service orientation should always be the central focus and should be constantly reviewed to achieve sustainable success.


2. The Leadership


As the head of the organization, it is the leadership’s job to thoroughly establish the organization’s products in order to lead the departments and teams to success. Due to that, they have to be the ones to develop a quality management system and to choose a qualified person responsible to apply the properties of the QMS to their business.


3. Involvement of Employees


Since the employees are mainly the people to actually produce the product or provide the service, they should be accurately informed of their task. In addition to that, they should have training whenever necessary. It is the leadership’s duty to provide the training and to decide whether or not an employee needs additional or supplementary training.


4. Process Approach


The most efficient outcomes can be accomplished with the help of established processes. An inspection test plan checklist can help guide you through the process, achieve a better overview of what's going on, and plan procedures within the whole company. The leadership should announce a responsible person or a response team to organize the processes.


5. Improvement


The world is constantly changing, so should you! Improvements are very important for companies. Prevention instead of follow-up of existing problems should be considered as intention. A certain proactive approach puts the focus of management on promotion instead of stagnant troubleshooting.


6. Evidence-based Decision Making


Making decisions can be really risky. Wrong choices can lead to immense consequences and could destroy your company. On the contrary, the right choice can increase your company’s reputation, improve your products and their quality, and make you more successful. Therefore, you should analyze your product, whether your customers/clients like it, and what they would like you to improve. In accordance with that, you could analyze your numbers, your customer’s buying behavior, or implement customer questionnaires.


7. Relationship Management


An organization and its management are not only influenced by its customers and leadership, but also by their interested parties such as investors or suppliers. The organization should work together with interested parties toward a common goal and communicate in a way that everyone is aware of their responsibilities. In the case of the supplier, for example, the supplier should understand the company’s quality standards and their products should strive to meet those standards.


Follow these principles above and keep them in mind when performing a quality management audit with one of Lumiform’s templates.


Is a ISO 9001 Certification Mandatory?


ISO 9001 is not a mandatory obligation for companies. However, the documentation of the QMS, as well as the adjustment to the DIN ISO 9001 certification, is a proven and renowned solution for management teams. Nevertheless, each company should individually weigh the advantages and disadvantages of certification according to ISO 9001.



Advantages of a Digital ISO Audit Checklist


A digital checklist gives you the opportunity to easily perform your ISO audits anywhere and anytime—you only need your mobile device! You also have a great overview of your reports and the questions you’ve failed. Download a quality management system template and start right away with your inspection. Did you find a deficiency? Send it straight to your supervisor or a co-worker to take care of it, just by one click.


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How to Get ISO 9001 Certified?


The following six steps will make it easier for you to get started with the development of a QMS and the certification according to ISO 9001:


QB


Choose a person responsible for the QMS (the so-called quality representative) who can be part of leadership or management. He can even be a regular employee, but his suitability is important, i.e. he should be assertive and have a good knowledge of the company and the requirements of the QMS. The QB can also be the internal auditor of the QMS.


Create a Project Plan


Having a project plan in place helps especially with the timely implementation of the project. For this purpose, the most relevant factors are how the documentation is processed, how much time it will take, and when the actual certification will be issued.


Find a Certification Officer


Next, you should find an external inspector. Relevant factors you should take into account are the price for the services and proximity to your company.


First Stage Audit


After the internal conformity check, the first documentation check should be carried out by the external certifier as soon as possible.


On-site Audit


Finally, the actual certification according to ISO 9001 is carried out on site. This consists of coordinating the documentation with the actual on-site procedure. In the best case, you will obtain your ISO 9001 standard certificate in this way.


Why Use Lumiform for ISO 9001 Audit?


With Lumiform, you can implement a digital ISO audit checklist. You can either use one of our 9000 templates or create your own. In addition, you can analyze the reports or share them with interested parties, colleagues, or your supervisor.


Save time with our mobile app. No more paperwork and no more searching through your countless files since the Lumiform App saves all data to the cloud.


Advantages:


  • Comprehensive analyses help you to identify inefficient areas in your company more quickly and, thus, you can continuously improve your audit processes.
  • Generate real-time data via internal processes. This makes quality and security measurable, and you can use the data to continuously optimize processes.
  • Increase the efficiency of your internal processes: Through more efficient communication within the team, third parties, and management, you can solve incidents up to 4x faster than before.
  • Save time by analyzing all data more easily and quickly identifying areas that need your attention.
  • Continuous improvement of quality and safety: With the flexible checklist construction kit you can constantly optimize internal tests and processes. Since Lumiform guides the examiner through the exam, no training is required.
  • The very simple operation offers no margin for error for inspectors on site. The app offers less complexity in documenting or filling out checklists than tedious paper or Excel lists.
  • Depending on the application, tests are carried out about 30%-50% faster.

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