Every organization undertaking internal or external audits of their quality management systems should use ISO 19011. It is appropriate for a wide variety of prospective users, including auditors. You must carry out management system audits for regulatory and compliance reasons if you plan to develop a quality management system.
To facilitate the implementation of quality management systems, ISO 19011 also contains recommendations for conducting external audits, certification, and supplier quality inspections. Are you interested in learning what are the requirements for auditing Processes and reports in line with ISO 19011 guidelines? YES!!
Then, read on!
ISO 19011: A Few Important Definitions
In order to fully understand ISO 19011, it is crucial first to know specific basic definitions.
Audit: The term "audit" refers to a systematic, independent, and documented process for gathering factual material and fairly assessing it to ascertain the amount to which the audit criteria are met.
Audit programme: Arrangements for a group of one or more audits scheduled for execution over a predetermined time and with a predetermined goal.
Audit Scope: Refers to the extent and bounds of an audit.
Audit Plan: Description of the procedures and activities involved in an audit.
Audit Criteria: A group of specifications used as a benchmark to which objective evidence is contrasted.
Non-conformity: Failure to meet a requirement.
So what is ISO 19011?
The ISO 19011 document serves as a guide for businesses creating audit plans and conducting audits of current management systems. From the conceptual design to the final review, it covers the entire lifespan of the auditing system. The auditing standards include continual improvement techniques for long-term audit implementation and are based on seven guiding concepts.
ISO 19011, currently in its 2018 edition, establishes the benchmark for creating a top-notch auditing system for organizations. Keep in mind that there are no certification requirements associated with this standard. Instead, cross-checking procedures and extensive documentation, among other things, help organizations implement ISO's management system standards properly.
What is the Goal of ISO 19011?
Standards for a standardized and effective auditing system are set forth in ISO 19011. It gives them a strong foundation upon which to construct their procedures for examining management systems and developing audit programmes. Because of this, organizations can plan, carry out, and manage audits in an organized and impartial way.
What Are the ISO 19011 Auditing Process Requirements and Report Requirements?
Now, let's go over the essential procedures for managing an audit programme while keeping in mind the PDCA, which should always be the cornerstone of any quality process.
1. Setting up the Audit Process
The audit programme setting up is the first step in administering an audit programme according to ISO 19011. This entails various actions that can be summed up as follows:
duties and obligations of the person in charge of the audit programme
the ability of the person in charge of the audit programme
determining the audit program's scope
identifying and assessing the risks of the audit programme
establishing the audit program's processes
Identifying resources for the audit programme
This preparatory phase is vital because it enables us to begin the audit efficiently and professionally by allowing us to prepare in advance for audit operations.
2. Executing the Audit
The PDCA cycle's DO phase makes up the implementation stage for an audit activity. The audit aim, scope, and criteria are defined as the first phase in the implementation process. Additionally, a mechanism for the audit must be chosen. One might imagine several auditing techniques, such as:
The auditor's physical presence at the organization's location during an on-site audit.
Remote audit, also known as a communication-based evaluation.
3. Observation of an Audit
The Check Phase of the PDCA cycle may be compared to the audit's monitoring. The following tasks must be completed:
Analyze whether the goals are being met.
Analyze the performance of the audit team.
Examine the capacity of audit teams to carry out audit plans.
Analyze management suggestions
Pay attention to modifications that affect the audit programme.
4. Review Follow-Up
The results of an audit may point to areas that need improvement, corrective action, or correction. The auditee makes these decisions and takes action within the predetermined time limit. Verification of these steps' completeness and efficacy is required; the verification may form part of a later audit.
We have summarized the essential requirements for auditing processes and reports in line with ISO 19011 guidelines. ARISCU’s auditing processes and software to monitor compliance is framed around this standard, as well as other ISO standards. Contact us today for a quick chat about how we can assist you!