Ultimate ISO Audit Guide

What is an ISO Audit?

Depending on which industry or sector you work in, you likely have seen one or several of the ISO standards and certifications. If you are wondering what exactly an ISO audit is and what they entail, we have you covered.

There is no single ISO audit/standard. Being ISO-certified endorses an organization by validating that its processes align with the industry standards. ISO standards and certifications carry a lot of authority, as the organization is an international body that acts independently and is non-governmental. Founded in 1947, ISO stands for International Organization of Standardization and unites national standards bodies from 167 different countries globally.

The international standards that ISO publishes are carefully developed and a reaction to the ever-changing industry and public landscape. In response to the COVID-19 pandemic, for example, the organization released a guideline for the development of safer COVID testing methods in 2022.

ISO aims to ensure the quality and safety of products and services within a wide range of sectors. Covering multiple 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”.

An ISO audit is how you can achieve an ISO certification. Use an ISO audit to check whether your strategies meet the required standards and either get certified from there or continue working on your objectives.

You want 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.

In this guide, we will discuss:

1. Why ISO audits are important

2. Types of ISO audits

3. Common ISO requirements

4. How to get ISO certified successfully

4.1 What it means to be ISO certified

4.2 ISO certification cost

4.3 How long it takes to be ISO certified

5. How to best prepare and conduct ISO audits

Why Are ISO Audits Important?

ISO certifications are invaluable assets to any organization as they can influence a brand’s image positively. Proving that a product or service adheres to the industry standards, builds consumer trust, and ensures an organization’s recognition on the market.

In order to get ISO certified, you need to perform ISO audits to control:

• The quality of your products or operations (e.g. work on implementing a quality management system (QMS)
• The regulation of current practices in accordance with ISO standards
• Management strategies regarding global challenges (e.g. environmental, data security, etc.)

ISO audits have a clear purpose: help you 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, implement corrective actions, and optimize your mechanisms. By implementing a standardized system and regularly ensuring its upkeep, you can save time and money in the long run and lead an efficient business.

The Different Types of ISO Audits

There are several types of ISO audits and most of them are included in every ISO certification process. There are generally three 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 can begin thinking of the official audits, however, 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 approached appropriately. You can begin your ISO journey 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:

1. The First-Party Audit
   
   The first-party audit is widely known as the internal audit. During these audits, it is common to check up on structures surrounding risk management, varying operation processes, quality control, objectives, as well as documentation or resources.
   
   Internal audits need to be scheduled and performed by an internal auditor. This auditor is usually part of a designated department, however, the position can also be filled by an external auditing team.
   
   First-party audits are especially important for the standards ISO 9001:2015, ISO 45001 or ISO 14001, but just as well for a plethora of other standards. They serve your organization well and are important for healthy internal processes.
   
   Often, internal audits can also function as gap analyses to 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.


2. The Second-Party Audit
   
   The second-party or supplier audit is important for manufacturers or retailers when assessing new potential suppliers. Auditors look out for health and safety strategies and appropriate processes. The general rule is that as long as there is a purchasing process involved in your operations, a supplier audit is necessary.
   
   The standards and regulations vary per industry and supplier audits should be conducted every two years on average. This way, the supplier's practices can be properly observed for compliance. Usually, third-party auditors will carry out the inspections, however, they can also be performed by a company’s internal team.
   
   There are three different types of supplier audits:
   
   
   1. For an announced audit, the company is aware that an inspection is happening ahead of time. This means that the organization has time to prepare which can influence the authenticity of the audit.
   2. Unannounced audits, as the name suggests, occur spontaneously and without warning. As there is no preparation time, the inspection results may be more realistic and provide greater insight into the day-to-day operations.
   3. Desktop audits, unlike announced and unannounced site inspections, are conducted remotely. They check documentation or certifications in order to make sure suppliers are meeting the required standards.
   
   
3. The Third-Party Audit
   
   Also known as certification audit, the third-party audit is carried out by a certification body that must be accredited and officially recognized. Certification audits are performed every three years to oversee standard compliance. Broken down into two stages, the third-party audit will generally only be carried out if an organization can prove that it has implemented a management system for 2-6 months.
   
   In the initial stage, the desk audit, documents are checked for completeness. In stage two, ISO auditors conduct a compliance audit where they 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, the journey isn’t complete yet - ISO certificates are generally valid for three years before they need to be renewed. In the meantime, your company will be regularly evaluated and audited. In the fourth year, a re-certification audit will be carried out.

ISO Standards, Requirements and Examples

Since its founding days, ISO has published over 24,000 standards within 17 sustainability goals ranging from no poverty, quality education, climate action, and more. Since they vary heavily from each other, it is impossible to simply create a general list of requirements. However, ISO themselves encourage you to view the standards regardless as they are self-described as a “formula that describes the best way of doing something ”.

The most popular standards can be found in the following six categories:

• Quality Management Standards
• Environmental Management Standards
• Health and Safety Standards
• Energy Management Standards
• Food Safety Standards
• IT Security Standards

ISO 9001: “The World’s Favorite Standard”

One of the most-used standards is ISO 9001, a general quality management standard and part of the “ISO 9000 family”. This standard acts as a base and prerequisite for many others. The IATF 16949 audit, for example, defines guidelines for a QMS in the automotive industry and can be largely understood as an addition to ISO 9001:2015. Other standards, such as ISO 13485, addressing the quality management for medical devices, also use ISO 9001 as their baseline.

ISO 9001 is a powerful and versatile standard that can be used by any kind of organization, no matter its size. According to ISO, one million organizations across the globe adhere to ISO 9001 guidelines.

As with most standards, ISO 9001 is divided into multiple requirement chapters that support a company’s top management structure, customer relationship, and process approach. As the world’s leading quality management standard, being certified with ISO 9001 helps you to build trust, offer great quality services and products, and forge strong business relationships.

ISO/IEC 27001: Information Security

ISO 27001 details requirements for information security management systems (ISMS) and is part of the 27000 Family. Providing security for any kind of digital information, ISO 27001 can be employed in companies of any size and supports them in their goals.

Organizations can effectively minimize security risks, and prevent data loss and misuse by implementing ISO 27001. Even if you don’t get certified for the standard (something that is not obligatory), simply adhering to the requirements can greatly benefit your organization with its strict and approved guidelines of best practices to follow.

ISO Certification: All You Need To Know

What Is 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 upon which certifications are based, but the actual issuing is performed by an external certification body that needs to be accredited.

An ISO certification is an endorsement for you and your organization. It proves to third parties that you comply with the standards and have implemented structures to ensure your business works well, is stable, and can be trusted. Depending on your line of business and the certifications obtained, this means that your services are outstanding, your products are high quality, your customers are well taken care of, and your results are trustworthy. Such an endorsement is desired in any field and valuable for every organization.

In order to find the perfect certification body for you, ISO recommends following the subsequent steps:

1. Evaluate several certification bodies in order to be able to make an informed decision.
2. Ensure that the body is accredited.
3. 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 it Cost to Get ISO Certified?

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, but, on occasion, can also lead to discounts. These are some of the factors that influence your expenses:

• 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 if you request quotes from several certification bodies and choose the one that best suits your needs and budget.

How Long Does it Take to Get Certified?

As with costs, it is difficult to predict how long it will take for your organization to be fully ISO certified, however, you can expect a timeframe of anywhere from 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 all depends on the systems and documentation you already have in place, as well as your planning and strategizing.

In general, ISO certification audits are a fairly long process that follows this timeline or one similar:

1. Everything starts with the 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.
2. You remain in contact with your consultant whilst you/they prepare all the necessary documents and procedures.
3. What follows is the so-called stage one assessment where documents will be reviewed.
4. In the last step, the stage two assessment, an external auditor will observe the workings within your company in order to make sure that everything is in accordance with the standard.

How To Prepare For, Plan, and Conduct ISO Audits

As previously mentioned, getting ISO certified can be a lengthy process that requires attention and careful planning in order to be successful. With diligent preparation and planning, however, 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 from happening. This leads to smooth operations and successful management.

• Review the ISO Standard
  
  It should go without saying that you need to review your chosen ISO standard extensively as the first part of your preparatory work. Do so with a selected ISO management team and get to know 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 adopt the correct mindset and ingrain it 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 are open to addressing issues with an open mind, you are well on your way to certification.
• Perform Internal Audits Regularly
  
  Perform internal audits to figure out any issues, streamline your processes and prepare adequately. Be as diligent as possible, so that your certification can run 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 let them know about the steps you are taking and why so that the whole organization can work as one to implement ISO standards for better business, more safety and higher quality.

2. Conduct

1. Schedule
   In order to successfully conduct an ISO audit, you need to first schedule a date and prepare your team for the audit. Inform them of your intention and give them all the necessary details regarding the standard and the audit so that they are aware of what to expect.
2. 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.
3. Audit
   While performing the audit, make sure that the auditors pay attention to everything diligently. Have them review records, assess functions, run issue detection, and interview employees. Let them formulate suggestions for corrective actions and point out areas and sites that could be improved upon.
4. Report
   After the audit, the auditors will summarize their findings in a detailed report and discuss the inspection findings with you and your management team. Figure out how improvements can be made together, and develop strategies.
5. Reflect
   Once the audit is complete, it is important to circle back and review it once in a while. Remember: ISO audits are an ongoing process and optimization is always possible. These documents are great to reflect on how far you’ve come, if you’re happy with the path you chose, and if there is anything that still needs improvement.

Frequently Asked Questions

What is the meaning of ISO?

ISO stands for International Organization of Standardization and unites national standards bodies from 167 different countries across the globe. ISO standards and certifications carry a lot of authority, as the organization is an international body that acts independently and is non-governmental.

How do I get ISO certified?

In order to get ISO certified, you need to perform ISO audits to control the quality of your products or operations (e.g. work on implementing a quality management system (QMS), regulating current practices in accordance with ISO standards, and work on management strategies regarding global challenges (e.g. environmental, data security, etc.).

What are the different types of ISO audits?

• The First Party Audit
• The Second Party Audit
• The Third Party Audit