Would you rather study randomly for a big certification exam or follow a structured plan to help you study all key topics, review them, and perhaps even take practice tests to gauge your understanding.
Your answer would be the latter, that’s similar to what ISO audits do for organizations.
ISO audits and certification are important steps towards improving any business, so it is vital to learn more about ISO and the benefits your company can reap from a standardized quality and management review. Let’s explore how to prepare and pass an ISO certification audit and fulfill ISO requirements.
What is an ISO audit?
Depending on which industry you work in, you likely have seen at least one ISO standard before. If you are wondering what an ISO standard is and what ISO audits entail, we have you covered.
ISO audits are like those practice tests for businesses. They are systematic evaluations of how well an organization complies with International Organization for Standardization (ISO) standards. These standards are international guidelines that help organizations improve their processes, ensure quality, and enhance safety across various industries.
There is no single ISO audit or standard. Being ISO-certified means that your organization has been found to align with industry standards. ISO standards and certifications carry a lot of authority, as the ISO (International Organization of Standardization) organization is an independent, non-governmental body. ISO was founded in 1947 and unites regulatory bodies from 167 different countries.
Some of the most common ISO standards that businesses seek to meet are ISO 50001, which audits a company’s energy usage, ISO 27001, which addresses information security, and ISO 9001, which ensures strict quality management.
The international standards that ISO publishes are carefully developed and evolve with different industries. ISO certifications ensure the quality and safety of products and services within a wide range of sectors. Covering industries from food safety to environmental or risk management, ISO is first and foremost a network that aspires to “make lives easier, safer and better”.
Successfully completing an ISO audit is your first step towards ISO certification. You can use an ISO internal audit to check whether your strategies meet the required standards and either get certified from there or continue working on your objectives.
Why are ISO audits important?
ISO certifications are invaluable assets to any organization as they help promote a positive brand image. Proving that your product or service adheres to industry standards builds consumer trust and help you obtain market recognition. Here are some benefits of using an ISO audit:
- Quality assurance: Just as studying ensures you know the material for your exam, ISO audits help organizations maintain high-quality products and services. For example, ISO 9001 focuses on quality management systems, ensuring that companies meet customer expectations consistently.
- Continuous improvement: Think of an audit as a feedback session after your practice test. It highlights areas where you excel and points out where you need more work. Similarly, ISO audits identify strengths and weaknesses in an organization’s processes, promoting ongoing improvement.
- Regulatory compliance: Many industries have specific legal requirements. An ISO audit helps organizations ensure they meet these regulations, much like knowing the rules of the exam you’re preparing for.
- Enhanced reputation: Just as good exam results can boost your confidence and reputation among peers, achieving ISO certification can improve an organization’s credibility and competitive edge in the market.
In order to get ISO certified, you need to perform ISO internal audits to ensure:
- The quality of your products or operations, for example by implementing a quality management system (QMS)
- That your workplace practices are compliant with ISO standards
- There are management strategies regarding global challenges, such as environmental or data security challenges, in place
ISO audits have a clear purpose: they help assess your progress and evaluate your internal procedures. An internal audit process is valuable not only to ensure ISO compliance but also to keep track of your operations. This way, you can continuously figure out what does and doesn’t work, undertake corrective actions, and optimize your workflow. Implement standardized systems and maintain them to save time and money in the long run, creating an efficient business.
Depending what your business is trying to achieve, you will seek out different ISO standards. For example, if you want to reassure business partners of your data security measures, you’ll want to pass an ISO 27001 audit. And if, like many businesses, you are beginning to pay more attention to sustainability, ISO 50001 would be the standard to meet.
Types of ISO audits
There are several types of ISO audits, and most play a role in every ISO certification process. There are three common types of audits that you need to know about: internal, supplier, and certification. They all serve different purposes and are relevant in their own right.
Before you start conducting your ISO internal audit, it is important to focus on the implementation of ISO standards first. Getting ISO certified is rewarding and beneficial, but it’s also a lengthy process that should be conducted carefully. You can work towards ISO certification internally or get in touch with a consultant for expert advice. Ask questions, set a system in motion to fulfill the requirements, and make a plan.
Once you have completed this step, it is time to get familiar with the audit types that await you.
The first-party audit
The first-party audit is widely known as the internal audit. During a first-party ISO audit, it is common to evaluate practices relating to risk management, varying operation processes, quality control, objectives, and documentation or resources.
You schedule and perform ISO internal audits with an internal auditor, who is typically part of a designated department within your company, although an external auditing team can also fill this position. First-party audits are especially important for the standards ISO 9001:2015, ISO 45001 or ISO 14001, but are also present in other certifications as well. These audits help you establish and maintain healthy internal processes.
Often, internal audits can also function as gap analysis, which identify operational weaknesses within your company. Internal audits are incredibly useful and can highlight structural problems that you otherwise may not have uncovered on time.
The second-party audit
The second-party, or supplier audit, is important for manufacturers or retailers when assessing new potential suppliers. In a supplier audit, auditors evaluate health and safety strategies and appropriate processes. Generally speaking, as long as your operations involve a purchasing phase, supplier audits are necessary.
The standards and regulations vary per industry and supplier audits should be conducted every two years on average. This way, you can be sure your suppliers remain compliant. A third-party inspector usually carries out supplier audits, but a company’s internal team can also perform them.
There are three different types of supplier audits:
- Announced audits; in an announced audit, the company is aware that an inspection is happening ahead of time. This means that they were given time to prepare, which can influence the authenticity of the audit.
- Unannounced audits; as the name suggests, unannounced audits occur spontaneously and without warning. Since there have been no preparations made, results provide a more accurate picture of day-to-day operations.
- Desktop audits; unlike announced and unannounced site inspections, desktop audits are conducted remotely. They check documentation or certifications in order to make sure suppliers are meeting the required standards.
The third-party audit
An officially recognized certification body carries out a third-party audit, also known as a certification audit. These audits occur every three years to oversee standard compliance. Your organization must prove it is using a management system for 2-6 months before the certification body conducts the audits in two steps.
In the initial step, documents collected during a desk audit are checked for completeness. In the second step, ISO auditors conduct a compliance audit to examine procedures, instructions, and records.
These two steps are crucial, and if your company passes them without complaints, the inspectors of the certification body will recommend your company for an ISO certification. However, this isn’t the end – ISO certificates are usually valid for three years before they need to be renewed. In the time leading up to renewal, your company will be regularly evaluated and audited. In the fourth year, inspectors will perform a re-certification audit.
Overview of key ISO standards
Since it was founded, ISO has published over 24,000 standards which seek to achieve 17 sustainability goals, including eliminating poverty, improving education, climate action, and more. Since ISO standards are all quite different, it is impossible to create a general list of requirements. However, ISO themselves encourage you to view the standards regardless, for better clarity.
The most popular standards fall into one of six categories.
- Quality management standards
- Environmental management standards
- Health and safety standards
- Energy management standards
- Food safety standards
- IT security standards
ISO standards provide a framework for ensuring quality, safety, and efficiency across various industries. Here are some key standards that might be relevant to your organization:
- ISO 9001 (Quality Management Systems): This standard focuses on delivering consistent quality products and services by establishing a robust quality management system. It helps you improve customer satisfaction and streamline processes, ensuring that your organization meets customer and regulatory requirements efficiently.
Pro tip: You can look at our ISO 9001 templates to simplify your quality management documentation and enhance operational effectiveness.
- ISO 14001 (Environmental Management Systems): Designed to help you manage your environmental responsibilities, this standard provides a framework for reducing waste and minimizing environmental impact. Implementing ISO 14001 can lead to cost savings and enhance your reputation as an environmentally responsible organization, fostering sustainable practices.
Extra note: Check out our free templates to assist in your environmental management planning and achieve your sustainability goals.
- ISO 45001 (Occupational Health and Safety Management Systems): This standard aims to improve workplace safety and reduce risks by creating a safer working environment. By implementing ISO 45001, you can reduce the likelihood of accidents, enhance employee well-being, and comply with legal safety requirements, thus promoting a culture of safety.
Take note: Our free ISO 45001 templates can guide you in setting up effective safety management protocols and ensure a proactive safety strategy.
- ISO 27001 (Information Security Management Systems): In an era where data breaches are common, ISO 27001 helps you protect your information assets. It provides a framework for managing sensitive company information, ensuring data security and compliance with legal requirements, thereby safeguarding your organization’s reputation. Utilize our templates to bolster your information security measures and maintain robust data protection.
- ISO 55001 (Asset Management Systems): This standard focuses on managing the lifecycle of assets to optimize value and performance. It helps organizations ensure that their asset management processes are aligned with business objectives, enhancing efficiency and reducing costs while maximizing asset utilization.
Pro tip: We have free dedicated templates to streamline your asset management strategies and achieve operational excellence.
- ISO 17025 (Testing and Calibration Laboratories): This standard specifies the general requirements for the competence of testing and calibration laboratories. It ensures that laboratories operate competently and generate valid results, fostering confidence in their work and ensuring accuracy. Our templates can assist in maintaining the quality and consistency of your laboratory operations, ensuring reliable outcomes.
Insider tip: You can even build your own template in our digital form builder, import a PDF or use our AI prompt. We’ve got you covered.
- ISO 13485 (Medical Devices Quality Management Systems): This standard is specific to the medical device industry, focusing on quality management systems that meet regulatory requirements. Implementing ISO 13485 helps ensure the safety and effectiveness of medical devices, supporting compliance and quality assurance.
Top tip: Access our templates to support your medical device quality management processes and enhance product reliability.
- ISO 22000 (Food Safety Management Systems): This standard addresses food safety by providing a framework for managing food safety risks throughout the supply chain. It helps organizations ensure that food products are safe for consumption, enhancing consumer trust and regulatory compliance. To take it to the next level we have our templates that can improve your food safety management practices and ensure high standards of food safety.
- ISO 50001 (Energy Management Systems): This standard provides a framework for establishing energy management best practices to improve energy efficiency and reduce costs. It helps organizations develop a systematic approach to energy management, promoting sustainability and cost-effectiveness.
Recommendation: Explore our ISO 50001 templates to optimize your energy management initiatives and achieve energy savings.
- ISO 19600 (Compliance Management Systems): This standard provides guidance on establishing, developing, implementing, evaluating, maintaining, and improving an effective compliance management system within an organization. It enhances your ability to meet compliance obligations and manage risks, fostering a culture of integrity. Our templates can guide you in setting up a comprehensive compliance management framework and ensure regulatory adherence. Check them out here.
- ISO 31000 (Risk Management): This standard provides guidelines on managing risk faced by organizations, helping them increase the likelihood of achieving objectives and improve the identification of opportunities and threats. It is applicable to any organization regardless of size, industry, or sector, promoting resilience and strategic planning.
Useful tip: Leverage our templates to enhance your risk management capabilities and ensure proactive risk mitigation.
Best practices for conducting a thorough and effective ISO audit.
Conducting a thorough and effective ISO audit requires a structured approach and attention to detail. Begin by ensuring that your audit team is well-trained and familiar with the specific ISO standard being audited.
This preparation helps in accurately assessing compliance and identifying areas for improvement. Prior to the audit, review all relevant documentation and processes to understand the current state of compliance within the organization.
During the audit, maintain clear communication with all stakeholders involved. This includes explaining the audit process, objectives, and any findings in a transparent manner. Engage employees at different levels to gain insights into process implementation and verify alignment with necessary standards.
Use checklists and digital tools, like Lumiform, to streamline data collection and ensure consistency. After the audit, provide a detailed report that highlights both compliance successes and areas needing improvement.
Offer actionable recommendations to address non-conformities and establish a follow-up plan to ensure implementation of corrective actions. By fostering a culture of continuous improvement and open communication, you enhance the effectiveness of your ISO audit and contribute to the overall quality and efficiency of the organization.
How can you obtain an ISO certification?
Before we get into the details about ISO certifications, their processes and benefits, it is important to note that the ISO network itself does not perform certifications. The institution develops and publishes the standards for certifications, but an external certification body issues the certifications. Because there are many different types of standards, no single set of ISO certification requirements exists.
An ISO certification is an endorsement for you and your organization. It proves to third parties that you have passed your ISO audit, comply with industry standards, and have implemented structures that ensure your business is stable and trustworthy. Depending on your industry and exact certification, this means that your services are outstanding, your products are high quality, and you have customer satisfaction. Such an endorsement is valuable for every organization.
In order to find the perfect certification body for you, ISO recommends that you:
- Evaluate several certification bodies and decide which you would like to work with.
- Ensure that the body is accredited.
- Asses whether the chosen body adheres to the appropriate CASCO standard.
It also helps to remember that not every ISO standard needs to be certified to be implemented successfully. Some ISO standards require a certification, while others are voluntary.
How much does ISO certification cost?
As there are so many different ISO standards, ISO certification costs vary greatly. They generally depend on the size of your organization and on how much or how little work you have already invested. Additionally, it may be that you want to get certified for more than one standard at a time, which can also drive up costs. Depending on your certification body, it can also lead to discounts. Some things which influence your expenses are:
- Organization size
- Sector/industry in which you operate
- Annual revenue
- Number of employees
- Surveillance audits
- Cost of internal audits
- Maintenance costs
Overall, it is best to request quotes from several certification bodies and choose the one that best suits your needs and budget.
How long does it take to get ISO certified?
As with costs, it is difficult to predict how long it will take for your organization to be fully ISO certified. The general timeframe is 3 to 6 months. If your business is particularly large, the certification process may take up to a year.
Some standards also take more time to be certified than others; it depends how well your existing systems meet ISO certification requirements and how extensive your documentation is.
In general, ISO certification audits are fairly long processes where:
- You begin with an ISO internal audit. After you have completed this in accordance with your consultant’s advice, they will set up a review meeting with you in order to go forward.
- You remain in contact with your consultant to prepare all the necessary documents and procedures.
- Documents are reviewed in the stage one assessment.
- An external auditor conducts the stage two assessment to observe the workings within your company in order to make sure that everything is in accordance with the standard.
How can you prepare for, plan, and conduct ISO audits?
As previously mentioned, becoming ISO certified can be a lengthy process that requires attention and careful planning in order to be successful. But with said planning, you can conduct ISO audits effortlessly and reap the benefits – whether you choose to actually get certified or not.
1. Plan and prepare
The first step to success is to prepare and plan appropriately. The more you anticipate, the more issues you can prevent. The best way to ensure you receive a certification is with an ISO audit checklist, and the most commonly used checklists are ISO 9001 audit checklists, ISO 50001 audit checklists, and ISO 27001 audit checklists.
These are the key steps of an ISO audit process.
- Review the ISO standard: It should go without saying that you need to review your chosen ISO standard extensively. Do so with a selected ISO management team and learn the standard inside and out in order to be able to fulfill requirements later.
- Implement management structures: In order to successfully pass an external examination, you need to ingrain an ISO mindset into the company culture. An ISO audit is never complete; you can always optimize or at the very least maintain the standards you have set out to achieve. If you implement a structured management schedule, review operations regularly, and address issues with an open mind, you are well on your way to certification.
- Perform internal audits regularly: Regular internal audits help identify issue, streamline your processes, and prepare you for your ISO audit. Be as diligent as possible so that your certification runs smoothly.
- Implement corrective actions: As soon as you identify problems, figure out their root cause and address them. Develop strategies to prevent them from occurring in the future. By regularly checking for problems, you are never left surprised.
It is equally important that you prepare your employees and inform them of the steps you are taking so that the whole organization can work as one to implement ISO standards and work towards a safer, higher quality business.
2. Conduct
- Schedule: In order to successfully conduct an ISO internal audit, you need to first schedule a date and prepare your team for the audit. Give them all the necessary details regarding the standard and the audit so that they are aware of what to expect.
- Assign: Strategize with your managers about the best timing for the audit and choose auditors to carry out the inspection. You can, of course, also assign more than one auditor, depending on the size of your organization.
- Audit: Make sure that auditors pay attention to everything when conducting their audit. Give them an ISO audit checklist so they know what to look for. Let them suggest corrective actions and point out areas for improvement.
During the audit, engage with employees across various levels of the organization to gain insights into how procedures are implemented on the ground. Conduct interviews and observe operations to verify that processes align with documented standards.
Use a structured checklist to ensure that all aspects of the standard are covered, and leverage digital tools like Lumiform for efficient data collection and analysis.
Maintain open communication with auditees throughout the process, explaining the purpose of the audit and any findings in a transparent manner. This approach fosters trust and encourages collaboration, making it easier to identify and address non-conformities.
Preparing your organization for an audit in the most time and energy-efficient way possible is easy with Lumiform. After deciding which ISO certification you want, use one of our templates from our template library to check what is required, and make sure your business meets those requirements.
3. Report and follow-up
After conducting an ISO audit, the next crucial step is to report the findings and follow up on any identified issues. Begin by compiling a comprehensive audit report that details the audit scope, objectives, methodologies, and outcomes.
This report should highlight areas of compliance as well as any non-conformities or opportunities for improvement. Ensure that the report is clear and concise, providing actionable insights that management can use to enhance their processes.
Once the report is ready, engage with the relevant stakeholders to discuss the findings and agree on corrective actions. This collaborative approach ensures that everyone is aligned on what needs to be done to address any gaps. Set realistic timelines for implementing these actions and assign responsibilities to ensure accountability.
Finally, schedule follow-up audits or reviews to verify that corrective actions are in progress. This step is crucial for maintaining ongoing compliance and fostering a culture of continuous improvement. By systematically addressing audit findings and monitoring progress, you can ensure that your organization not only meets ISO standards but also continuously enhances its operational efficiency and quality management.
Improve your compliance with ISO audits
ISO audits are essential for ensuring that your organization meets international standards and continuously improves its processes. By conducting thorough audits, you not only enhance operational efficiency but also build trust with stakeholders and customers. These audits provide valuable insights that drive quality and compliance across your business.
To streamline your audit process and ensure comprehensive evaluations, consider using Lumiform. Our digital platform simplifies data collection and analysis, making it easier for you to maintain compliance and implement improvements.
Sign up for a 14-day free trial today and take the step to amazing audit experiences.