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. These criteria usually refer to the development of a product or the provision of a service. By obtaining ISO 9001 certification, your company proves its reliability, attention to quality, and general competitiveness. ISO 9001 addresses a company’s quality management system and helps identify areas for optimization. The standards contained in this certification also inform those set out in an IATF 16949 supplier audit.
Using a digital ISO 9001 audit checklist prepares your quality management system (QMS) to meet ISO 9001 certification requirements. The current ISO 9001 regulations were published in 2015 (ISO 9001:2015), but are regularly updated. Using a checklist is a great way to track any changes to the standard.
Table of contents:
2.4. Process approach
4.4. First stage audit
4.5. On-site audit
What should an ISO 9001 audit checklist include?
When designing an ISO 9001 audit checklist, make sure that you address every aspect of your QMS. There are seven main areas to evaluate with an ISO checklist. They are:
- Context of your organization
- Planning the QMS
- Support for the QMS
- Operational planning
- Performance evaluation
Within these areas, you’ll need to design questions that assess how well your organization is complying with specific ISO 9001 requirements. To do this, look at the general principles that ISO have defined.
What are The 7 principles of ISO 9001 audit checklists?
The International Standardization Organisation has developed 7 quality management principles that guide you through meeting requirements and obtaining an ISO 9001 certification. Adhering to these principles will not only help you obtain certification, but strengthen your overall process and product quality.
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. A positive experience means your customer may recommend your business to family and friends. Therefore, thinking about how your processes serve customers should always be center stage, and you should constantly review those processes to optimize them.
As the head of the organization,it’s leadership’s job to thoroughly establish the organization’s products in order to achieve success. This means your company’s leadership needs to be in charge of developing a quality management system and choosing people responsible for applying the properties of that QMS to the business.
3. Involvement of employees
Since your employees are the people most involved with producing your products and providing services, they should be aware of their role in your QMS. They should also be appropriately trained. It’s leadership’s responsibility to provide the training and decide whether or not an employee needs additional or supplementary training.
4. Process approach
To complete work efficiently, your business needs established processes. An inspection test plan checklist can help you develop processes, get an overview of your organization, and apply quality procedures across the whole company. You should also appoint at least one person responsible for organizing these processes.
The world is constantly changing, and so should you. Constant improvement is essential for businesses. The goal of these improvements should be to prevent rather than scramble to solve problems. Adopting a proactive approach keeps management from having to troubleshoot all day.
6. Evidence-based decision making
Making decisions carries a lot of risk. Wrong choices can have heavy consequences. But the right choice can increase your company’s reputation, improve your products and their quality, and make you more successful. When making decisions, you should analyze your product, the way your customers feel about your product, and what they would like you to improve.It’s also helpful to analyze your sales metrics and your customer’s buying behavior..
7. Relationship management
Your organization isn’t only influenced by its customers and leadership, but also by interested parties such as investors or suppliers. You should work together with interested parties toward a common goal, and communicate clearly so everyone knows their responsibilities. For example, your supplier needs to understand the company’s quality standards so that their products can meet those standards.
Follow these principles above and keep them in mind when performing a quality management audit with one of Lumiform’s templates.
How important are ISO 9001 audits?
ISO is part of the World Standards Cooperation (WSC). They develop and publish international quality standards. To meet these standards and their requirements, you should perform regular ISO 9001 audits, so you can guarantee compliance with international quality regulations.
ISO 9001 is one of the most impactful 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 are able to continually monitor and improve company management. The standard also helps clarify and structure every stakeholder’s responsibilities.
Is ISO 9001 certification mandatory?
ISO 9001 certification is not mandatory for your business. However, documenting your QMS, as well as using DIN ISO 9001 certification requirements as a guide, is a proven and renowned solution for management teams. Each company should individually weigh the advantages and disadvantages of certification according to ISO 9001.
How can you obtain ISO 9001 certification?
Getting your organization ready for an ISO 9001 audit is a multi-step process. There are five stages that will help you develop a QMS and obtain certification in accordance with the rules of ISO 9001.
Choose a person responsible for the QMS (the so-called quality representative), ideally someone who is part of leadership or management. They can even be a regular employee, but they must be appropriately qualified. Your quality representative should be assertive and knowledgeable about 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 is especially useful for ensuring projects are implemented on time. The most important factors for this plan 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. When looking for a certification officer, consider how much their services cost and their proximity to your company. This inspector will help you perform an internal ISO 9001 audit.
First stage audit
After the internal compliance check, the first documentation check should be carried out by your certification officer as soon as possible.
Finally, the actual ISO 9001 certification audit is conducted on site. This involves coordinating your prepared documentation with the actual on-site procedure. If all is in order, you will obtain your ISO 9001 certification after the on-site audit.
What are the advantages of a digital ISO 9001 audit checklist?
A digital checklist lets you easily perform your ISO audits anywhere and anytime, as long as you have a mobile device. Digital checklists also provide an overview of your reports and the questions you’ve failed. If you find any issues, you can report them to your supervisor in just one click. Simply download a quality management system template and you can start an inspection right away.
Why use Lumiform for ISO 9001 audits?
With Lumiform, you can implement a digital ISO audit checklist. You can either use one of our 12,000 templates or create your own using our checklist builder . In addition, you can analyze the reports or share them with interested parties, colleagues, or your supervisor.
Our mobile app saves you time. No more paperwork and no more searching through a mass of files, since the Lumiform app saves all your data to the cloud.
When you use Lumiform, you get:
- Comprehensive analyses that help pinpoint inefficient areas in your company more quickly and facilitate continuous improvement.
- Real-time data concerning internal processes, so you can easily measure quality and security
- Increased efficiency: Thanks to streamlined communication between team members, third parties, and management, you can solve incidents up to 4x faster than before.
- Continuous quality and safety improvements: With the flexible checklist builder, you can easily adjust audits to the specifics of your business. Since Lumiform guides the examiner through the exam, no training is required.