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ISO 19011 - Section 1
Explanations in Plain English

ISO 19011 - Section 1 - Scope, reference and definitions

SCOPE:

ISO 19011 provides guidance on the principles of auditing, managing audit programs, conducting quality management system (QMS) audits and Environmental Management System (EMS) audits, as well as guidance on the competence of quality and environmental management system auditors.

It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit program.

References:

The following documents contain provisions which, through references in this text, constitute provisions of this Standard.

ISO 9001:2008, Quality Management Systems Fundamentals and Vocabulary

ISO 14050:2002, Environmental Management Vocabulary

Terms and definitions:

For the purpose of ISO 19011 the terms and definitions given in ISO 9000 and ISO 14050 apply, unless superseded by the terms and definitions given below.

Audit: systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled

NOTE 1: Internal audits, sometimes called first party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and may form the basis for an organization’s self-declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by freedom from responsibility for the activity being audited.

NOTE 2: External audits include those generally termed second and third party audits. Second party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third party audits are conducted by external, independent auditing organizations, such as those providing registration or certification of conformity to the requirements of ISO 9001 or ISO 14001.

NOTE 3: When a quality management system and an environmental management system are audited together, this is termed a combined audit.

NOTE 4: When two or more auditing organizations cooperate to audit a single auditee this is termed a joint audit.

Audit Criteria: set of policies, procedures or requirements

NOTE: Audit criteria are used as a reference against which audit evidence is compared.

Audit evidence: records, statements of fact or other information, which are relevant to the audit criteria and verifiable

NOTE: Audit evidence may be qualitative or quantitative.

Audit findings: results of the evaluation of the collected audit evidence against audit criteria.

NOTE: Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.

Audit conclusion: outcome of an audit, provided by audit team after consideration of the audit objectives and all audit findings.

Audit client: organization or person requesting an audit

NOTE: An audit client may be the auditee or any other organization which has the regulatory or contractual right to request an audit.

Auditee: organization being audited

Auditor: person with the competence to conduct an audit

Audit team: one or more auditors conducting an audit, supported if needed by technical experts

NOTE 1: One auditor of the audit team is appointed the audit team leader.

NOTE 2: The audit team may include auditors-in-training.

Technical expert: person who provides specific knowledge or expertise to the auditor

NOTE 1: Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited, or language or culture.

NOTE 2: A technical expert does not act as an auditor in the audit team.

Audit program: set of one or more audits planned for a specific time frame and directed towards a specific purpose

NOTE: An audit program includes all activities necessary for planning, organizing and conducting the audits.

Audit plan: description of the activities and arrangements for an audit

Audit scope: extent and boundaries of an audit

NOTE: The audit scope generally includes a description of the physical locations, organizational units, activities and processes, as well as the time period covered.

The links below are excerpts from the our e-book

"Explanations and Definitions for ISO 19011:2002"

Section 1. ISO 19011 Scope reference and definitions

Section 2. ISO 19011 Principles of auditing

Section 3. ISO 19011 Managing an audit program

Section 4. ISO 19011 Audit program implementation

Section 5. ISO 19011 Audit activities

Section 6. ISO 19011 Preparing for onsite activities

Section 7. ISO 19011 Conducting onsite activities

Section 8. ISO 19011 What the auditor is looking for

Section 9 ISO 19011 Audit reporting

Section 10. ISO 19011 Audit techniques

Section 11. ISO 19011 Audit path

Section 12. ISO 19011 Effective communications

Section 13. ISO 19011 Sampling

Section 14. ISO 19011 Audit completion and follow-up

Section 15. ISO 19011 Competence and evaluation of auditors

This represents a summary of the section in ISO 19011:2002. It's suggested that you obtain a copy of our ebook to refer to when auditing.

EBook "Explanations and Definitions for ISO 19011:2002

What are Quality Management Systems?

ISO 9001-2008 Changes

Online ISO 9000/9001 Overview Course

Auditor Training: Online

Auditor Training Courseware

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ISO 19011