ISO 19011 is a set of guidelines for auditing management systems. It is an international standard to help organizations perform these audits.
ISO 19011 is designed to advise organizations on preparing audit programs for auditing their management systems, such as environmental, risk, and quality management systems.
However, ISO 19011 is not a set of requirements that a company has to follow step by step, as an organization can’t become ISO 19011 certified. Instead, an organization should adopt ISO 19011 guidance as appropriate to suit the specific needs and requirements of the particular audit program.
ISO 19011 differs from the ISO 9001 international standard that specifies requirements for quality management systems in that ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify.
What is the purpose of ISO 19011?
ISO 19011 serves as a fundamental guidepost, establishing standardized practices for efficient and systematic audit processes within management systems. It doesn’t just outline a set of rules but provides a structured framework enabling organizations to build robust auditing methodologies.
This international standard empowers organizations to plan, execute, and manage audits precisely and objectively. It becomes a cornerstone for organizations aiming to assess and enhance their management systems, aligning with different ISO standards such as ISO 9001 (Quality Management System), ISO 14001 (Environmental Management System), and ISO 31000 (Risk Management System), among others.
The multifaceted nature of ISO 19011 stretches across diverse facets, including audit planning, setting audit objectives, compiling audit reports, and evaluating auditors’ competence. It emphasizes the criticality of a risk-based approach, aligning audit activities to organizational goals while fostering continual improvement.
Notably, ISO 19011 caters to internal and external audits, ensuring that audit programs adhere to international standards and promote ongoing enhancement of management systems. This standard serves as a guidepost, promoting compliance and a culture of excellence and adaptation within organizations.
What is the latest version of ISO 19011?
In its ISO 19011:2018 – Guidelines for Auditing Management Systems, the International Organization for Standardization (ISO) defines an audit as “[the] systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.”
That means that an auditor or audit team looks at what a company is doing, collects evidence, and compares that evidence to the controls the organization is supposed to be doing.
In terms of ISO standards, there are two main types of ISO audits:
- Internal audits (first-party audits )
- External audits (second-party and third-party audits)
ISO 19011, which specializes in first-party and second-party audits, targets individual and larger audit teams conducting comprehensive enterprise audits.
The company itself conducts internal audits. These internal audits generally focus on evaluating effectiveness, determining conformity, and identifying areas that you can improve. Although a company may do a first-party audit to prepare for a third-party audit, a first-party audit never results in an ISO certification.
External audits include second-party and third-party audits. A second-party audit is performed at a customer’s request (or a company contracted to act on the customer’s behalf) on a supplier of products or services.
An independent organization with no vested or conflict of interest in the company audited, such as those organizations that provide certification, can conduct the third-party audit.
ISO 19011 contains three important sections about auditing management systems:
- How to manage an audit program
- The seven principles of auditing
- Approaches for evaluating the competence of auditors
ISO 19011 also focuses on applying the principles of continuous improvement to an audit program. These include ensuring that the audit program’s objectives align with the main goals of the business and that the needs and best interests of customers and other stakeholders are prioritized.
What is the difference between ISO 9001 and 19011?
ISO 9001 and ISO 19011 significantly contribute to organizational management in distinct ways. Understanding their varying scopes and applications is crucial:
| ISO 19011:2018 | ISO 9001:2015 | |
| Name | Quality Management Systems – Guidelines for Auditing Management Systems | Quality Management Systems – Requirements |
| Latest Version | 2018 | 2015 |
| Content | Guides evaluating existing management systems and establishing effective audit programs. | Outlines requirements and best practices for building a Quality Management System (QMS). |
| Purpose | Guides organizations in assessing management system performance and facilitating improvement. | Sets standards for quality metrics and processes in organizational outputs. |
| Best Used for | Implementing best practices in creating robust auditing systems. | Establishing and maintaining ISO-certified quality systems. |
| Certifiable? | No | Yes |
While ISO 19011 focuses on guiding organizations in evaluating their management systems and enhancing audit methodologies without providing certification criteria, ISO 9001 specifically delineates requirements and best practices necessary for certification in Quality Management Systems.
These standards are complementary in that ISO 9001 provides the foundation for building a QMS, while ISO 19011 aids in ensuring the efficacy and continual improvement of these management systems through effective auditing practices.
7 Principles of ISO 19011 Auditing
ISO 19011 introduces seven foundational principles that underpin effective auditing within management systems:
- Integrity: Auditors must exemplify honesty and fairness throughout the audit process, ensuring transparent and ethical practices.
- Fair Presentation: Emphasizing objectivity and impartiality in presenting audit findings and conclusions, maintaining neutrality in assessments.
- Due Professional Care: Conducting audits with precision, diligence, and thoroughness, adhering to high ISO 9001 standards of professionalism.
- Confidentiality: Upholding acquired audit information’s confidentiality ensures sensitive data remains secure and protected.
- Independence: Maintaining an unbiased stance during audits, avoiding conflicts of interest to ensure impartial ISO 9001 evaluations.
- Evidence-Based Approach: Relying on factual evidence to substantiate audit conclusions, ensuring assessment credibility and reliability.
- Risk-Based Approach: Identifying and evaluating ISO 9001 risks to effectively allocate audit resources and efforts.
Following these principles ensures auditors undergo proper ISO 9001 training and evaluation to perform different audits competently throughout the management system life cycle.
This enables the identification of nonconformities, implementation of corrective actions, and overall ISO 9001 management systems improvement. Adhering to ISO 19011:2018, whether conducting first-party, second-party, or third-party audits, is critical for auditors to effectively assess management system standards like ISO 9001 or ISO 45001.
Best practices for ISO incident management
ISO 19011:2018 encourages effective incident management within the auditing process approach for quality management systems like ISO 9001. Following ISO auditing principles and Annex A guidelines, best practices include:
- Robust Incident Recording: Establishing clear protocols aligned with ISO 9001 standards for recording and documenting incidents during on-site internal audits and external audits. This ensures proper information security.
- Thorough Analysis: Conducting in-depth investigations following ISO 9001 guidelines to understand the root causes of incidents. Lead auditors should oversee this process.
- Corrective Actions: Implementing timely and appropriate ISO 9001-aligned corrective measures to address identified issues. These actions should align with continual improvement objectives.
- Continuous Improvement: Emphasizing a culture of continual improvement by learning from incidents and integrating lessons into future ISO 9001 audit programs and procedures. This should involve proper auditor training and evaluation.
Following these best practices for auditing management systems enables organizations to enhance incident management through rigorous ISO 9001 protocols. Robust incident handling is critical for successful internal and external audits and quality management system improvement.
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