The world is constantly changing and evolving, and with this ever-shifting landscape comes a need for standards and guidelines.
The International Organization for Standardization, also known as ISO, is a globally recognized leader in developing standards to ensure the safety, effectiveness, and sustainability of our products and processes. These guidelines, auditors, and other initiatives are helping to create a better future for us all.
In this blog post, we will explore how the ISO works to keep the world safe, effective, and sustainable.
What is the ISO?
The International Organization for Standardization (ISO) is an independent, non-governmental international organization responsible for establishing standards in many industries to ensure products and processes are safe, effective, and sustainable.
ISO 19011 is a standard that sets forth guidelines for auditing management systems. It outlines what constitutes an audit program and the principles of conducting an audit. An audit program is a planned and systematic process for obtaining information about the adequacy and effectiveness of activities relating to a given purpose.
ISO 19011:2018 provides information on how to improve an audit program by understanding the needs of customers and other interested parties when pushing for improvements. Additionally, it has integrated risk throughout the audit program management section of the ISO 19011:2018 standard.
On the other hand, ISO 9001 is a standard that lays out what is required for quality management systems and is based on 8 principles of quality management. This encourages organizations to focus on the areas where auditing improvements can bring the greatest value.
What Does the ISO Do?
The ISO’s goal is to provide a common language for businesses and organizations so they can work together efficiently and with mutual understanding. The ISO creates industry-specific standards that cover everything from the design of products and processes to the management of quality control, environmental protection, and health and safety procedures.
To ensure companies comply with their particular industry’s rules and regulations, the standards are designed to be as comprehensive as possible. Companies must meet the ISO’s standards to be certified. Additionally, they need to be aware of any updates or changes in the standards to stay compliant.
Moreover, the ISO provides a range of tools, such as audit programs and certifications, that enable companies to prove their compliance with the standards. The ISO has auditors who regularly inspect businesses to check that they are following the rules and guidelines of the ISO standards. Then, they issue certificates of compliance to prove that a company is meeting all of the requirements.
Why Are ISO Standards Important?
ISO standards are important in today’s globalized world as they help to ensure product safety, quality, and sustainability. Here are just some of the reasons why ISO standards are so important:
- They help to establish an internationally recognized set of rules and guidelines for businesses and organizations.
- They create consistency and uniformity among products and services, allowing for safe and reliable operation.
- They provide a framework for organizational compliance with laws, regulations, and industry standards.
- They can increase customer satisfaction and trust by ensuring that products and services meet high standards of quality and safety.
- They can help organizations reduce costs associated with quality control, training, and certification.
- They enable better communication between organizations, stakeholders, and customers.
- They ensure the protection of the environment by encouraging the use of sustainable materials and processes.
- They help to improve the overall quality of products and services, leading to increased efficiency and profitability.
What is an ISO Audit?
An ISO audit is an independent, methodical examination of the activities a business is implementing to confirm that the management system is conforming with the relevant ISO standard. This confirms the quality objectives set out by the company are being met by the actions and processes being taken.
Additionally, it keeps the system effective, efficient, and suitable to achieve objectives. During an ISO audit, the auditing group will review and evaluate all aspects of the organization’s quality management system to ensure it meets the standards set by ISO.
Various Types of Audits
The International Organization for Standardization (ISO) has four main types of audits. Each type of audit is designed to assess an organization’s compliance with ISO standards and guidelines. Here, we will discuss each type of audit in detail.
- Internal Audits: These are conducted by members of an organization’s management or staff, using a set of specific tools to measure up to ISO standards. The results of these audits provide insight into the organization’s level of compliance with applicable ISO requirements.
- External Audits: These are conducted by independent third parties to assess an organization’s ability to meet its commitments. These audits are often used to evaluate a supplier’s quality management system to meet the needs of their customers.
- Certification and Recertification Audits: These are conducted to verify whether a company meets the requirements of an ISO standard and issues a certificate of compliance. Recertification audits are periodic reviews that occur after some time to ensure continued compliance with ISO standards.
- Surveillance Audits: Surveillance audits are conducted to review how an organization responds to the recommendations from internal audits. These are needed to evaluate management’s performance and the effectiveness of the quality management system.
How ISO 9001 is Conducted with Various Audit Types?
When it comes to ISO 9001 audits, three main types of audits can be conducted. All three have their advantages and disadvantages, depending on the size, complexity, risk, and nature of the organization. Without further ado, let’s explore them.
- On-site Audits: On-site audits are the most common form of audit for organizations that hold ISO 9001 certification. An on-site audit typically takes a few days to complete, depending on the size and complexity of the organization. The International Accreditation Forum (IAF) has provided guidelines for registrars to calculate the necessary audit time needed to complete an on-site audit.
- Remote Audits: Remote audits are less common than on-site audits and are typically less effective than on-site audits. A remote audit is conducted entirely online, through video conferencing or other means. The registrar may still ask for evidence to prove that the organization complies with ISO 9001 requirements, such as process documentation and records.
- Self-Audits: Self-audits do not necessarily mean an internal audit and can be requested by the customer to eliminate the need for them. They can use their resources while still having some assurance that the requirements are met. A self-audit is conducted by the organization itself and involves a review of documents and interviews with personnel.
The Comparison Between ISO 19011:2011 and ISO 19011:2018
Practically, ISO 19011:2018 is just an upgraded version of ISO 19011:2011. Therefore, we can expect to see some differences or changes. Let’s see the following table to review them –
ISO 19011:2011 | ISO 19011:2018 |
It is an international standard that provides guidance on auditing management systems, including the principles of auditing, managing an audit program, and conducting audits. | It contains several important changes that have been designed to make the standard more user-friendly and applicable to a wider range of organizations. |
It was first published in 2002 and revised in 2011. | The latest revision of this standard was published in 2018. |
Auditors focused solely on conformity to standards. | In addition to standards, auditors must now consider potential risks and opportunities. |
Wasn’t much about the audit program risk. | This section expands on the guidance from the 2011 version. |
There wasn’t any section on audit planning | The new version adds new requirements for audit objectives, scopes, planning documents, and resources. |
There weren’t any generic competence requirements for Certified Quality Auditors (CQAs). | This has now been included. |
Nothing about adjustments to terminology. | The 2018 revision of ISO 19011 also includes some adjustments to terminology. For example, the term “auditee” has been replaced with “audit object” and “auditee representative” with “audit contact.” |
There were disciplines for auditing specific management systems in the Annex. | This has been removed. |
Guidelines for ISO Audit Preparation
The process of ISO audit preparation is an important step in achieving compliance with ISO standards. By following these guidelines, you can ensure that your organization is ready for an ISO audit.
- Create an audit schedule that includes a timeline for certification, if applicable. Your audit schedule should include when to conduct audits and any required follow-up activities.
- Compile audit checklists that cover each component of the applicable ISO standard. Ensure that the checklists are up-to-date and address the specific requirements of the ISO standard.
- Determine your goals and keep them in mind when creating the audit schedule. This will help you set realistic expectations and ensure that the audit is tailored to your organization’s specific needs.
- Get organized and have documents ready for review before the audit. Ensure that all the necessary documents, such as policies, procedures, records, and logs, are easily accessible during the audit.
- Conduct internal audits first to demonstrate your organization’s commitment to ISO compliance. Internal audits are a great way to identify potential problems before an official audit.
What Will Happen If an Organization Fails an ISO Audit?
If an organization fails an ISO audit, it must take corrective action to fix the problems that led to the failed audit. The enterprise must show that these corrective actions were successful before another audit can be conducted. There are two types of non-conformance:
- Minor non-conformance – This involves something that isn’t considered essential to meet the standard and won’t necessarily prevent certification.
- Major non-conformance – This is something that significantly prevents an organization from meeting the required standard and must be fixed before the enterprise can be certified.
To achieve certification, the enterprise will have to schedule another audit after the corrections have been made. This is to make sure that all the requirements are met and that the problems have been resolved.
Overall, failing an ISO audit is not the end of the world, but it does require some work on the part of the enterprise to make sure that they can meet the necessary standards. With proper corrective action and a commitment to quality, any enterprise can get ISO certification.
FAQ
Which ISO guidelines apply to information security?
Ans: The primary ISO guidelines for information security are ISO/IEC 27001 and ISO/IEC 27002. These standards outline requirements for the implementation of an Information Security Management System (ISMS) to protect the confidentiality, integrity, and availability of information.
How does an ISO audit work?
Ans: An ISO audit is conducted to verify whether an organization meets the requirements outlined in an applicable ISO standard. The audit assesses the organization’s processes, procedures, documents, and management systems to evaluate their compliance with the standards.
How do I get ready for an ISO audit?
Ans: To get ready for an ISO audit, organizations should have an established ISMS. Then, implement a series of internal audits to verify that their processes and documentation meet the requirements of the ISO standard. Additionally, organizations should be prepared to provide evidence of their compliance with the ISO requirements.
How much time does it take to obtain ISO certification?
Ans: The time required to obtain ISO certification will vary depending on the size and complexity of the organization, as well as the type of ISO standard being implemented. Generally, the process will take between 6 and 12 months if all required documentation and processes are in place.
Bottom Line
The International Organization for Standardization (ISO) is an essential part of modern life, setting industry standards to keep products and processes safe, effective, and sustainable. It offers various audit types to ensure that organizations comply with its guidelines.
An ISO audit is conducted to ensure that an organization meets the ISO requirements. Failure to do so can result in negative consequences. Organizations should be aware of the various ISO requirements, audit types, and guidelines to ensure they are prepared and compliant with the standards set forth by the ISO.