What is ISO 19011?
In a nutshell, ISO
19011:2002 provides effective
guidance on the conduct of
internal or external quality
and/or environmental management
system audits, as well as on the
management of audit programs as
required by both ISO 9001:2000
and ISO 14001:1996. Intended
users of ISO 19011 include
auditors, organizations
implementing quality and/or
environmental management systems
and organizations involved in
auditor certification or
training,
certification/registration of
management systems,
accreditation or standardization
in the area of conformity
assessment.
The group of experts that
created ISO 19011 has worked
diligently to ensure that the
standard is flexible and can
apply to a range of potential
users. Its clauses and
requirements break down into
seven clauses:
- Clauses 1, 2 and 3 deal
with scope, normative
references and terms and
definitions respectively.
- Clause 4 describes the
principles of auditing.
- Clause 5 provides
guidance on establishing and
managing audit programs.
Issues such as assigning
responsibility for managing
audit programs, establishing
the objectives, coordinating
auditing activities and
providing sufficient audit
team resources are addressed
here.
- Clause 6 contains
guidance on conducting
quality and/or environmental
management system audits,
including the selection of
audit teams.
- Clause 7 provides
guidance on auditor
competence. It outlines the
knowledge and skills needed
to be competent to conduct
an audit and provides
guidance on the personal
attributes needed to be an
auditor, such as education,
work experience, auditor
training and audit
experience that are
indicators of whether a
person has acquired the
appropriate knowledge and
skills. It also outlines a
process for the evaluation
of auditors.
Of course, the concept behind
ISO 19011 is integrated
auditing, which can lead to
tremendous benefits for an
organization if done properly.
This type of auditing can be the
most cost-effective way to audit
an organization now and in the
future. Where quality and
environmental management systems
are implemented together, ISO
19011 can be used to conduct
joint audits with enhanced
results. However, it is at the
discretion of the user whether
audits are conducted separately
or together.
How does ISO 19011 address
internal audits for ISO
9001:2000 and ISO 14001?
ISO 19011 doesn’t have
specific guidance for internal
audits of ISO 9001:2000 or ISO
14001:1996. It is a generic
document that offers guidelines
for all types of auditing,
including other management
system audits such as OHSAS
18001. Its guidance also can be
used to monitor conformance to
other requirements as well, such
as product specifications or
laws and regulations.
ISO 19011:2002 content
includes generic guidance on the
following topics:
- Principles of auditing
- Managing an audit
program
- Audit program
implementation, monitoring
and reviewing
- Initiating the audit
- Appointing the audit
team leader and establishing
the audit team
- Defining audit
objectives, scope and
criteria
- Determining the
feasibility of the audit
- Establishing initial
contact with the auditee
- Conducting document
review
- Preparing the audit
- Conducting the opening
meeting
- Communication during the
audit
- Collecting and verifying
information
- Generating audit
findings
- Conducting closing
meeting
- Preparing, approving and
distributing the audit
report
- Conducting audit
follow-up
- Competence of auditors
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QUALITY MANAGEMENT SYSTEMS,
GENERAL REQUIREMENTS, DOCUMENTATION REQUIREMENTS, GENERAL, QUALITY MANUAL, CONTROL OF
DOCUMENTS, CONTROL OF RECORDS, MANAGEMENT
RESPONSIBILITY, MANAGEMENT COMMITMENT, CUSTOMER FOCUS, QUALITY POLICY, PLANNING, QUALITY OBJECTIVES, QUALITY MANAGEMENT SYSTEM PLANNING, RESPONSIBILITY, AUTHORITY AND COMMUNICATION, RESPONSIBILITY AND AUTHORITY, MANAGEMENT REPRESENTATIVE,
INTERNAL COMMUNICATION, MANAGEMENT REVIEW, GENERAL MANAGEMENT REVIEW, REVIEW INPUT, REVIEW OUTPUT, RESOURCES MANAGEMENT, PROVISION OF RESOURCES, HUMAN RESOURCES, GENERAL, COMPETENCE, AWARENESS AND TRAINING, INFRASTRUCTURE, WORK ENVIRONMENT, PRODUCT REALIZATION, PLANNING OF PRODUCT REALIZATION, CUSTOMER-RELATED
PROCESSES, DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT, REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT, CUSTOMER COMMUNICATION, DESIGN AND DEVELOPMENT, DESIGN AND DEVELOPMENT PLANNING, DESIGN AND
DEVELOPMENT INPUTS, DESIGN AND DEVELOPMENT OUTPUTS, DESIGN AND DEVELOPMENT REVIEW, DESIGN AND DEVELOPMENT
VERIFICATION, DESIGN AND DEVELOPMENT VALIDATION, CONTROL OF DESIGN AND DEVELOPMENT CHANGES, PURCHASING, PURCHASING PROCESS, PURCHASING INFORMATION, VERIFICATION OF PURCHASED PRODUCT, PRODUCT AND SERVICE
PROVISION, CONTROL OF PRODUCTION AND SERVICE PROVISION, VALIDATION PROCESSES FOR PRODUCTION AND SERVICE PROVISION, IDENTIFICATION AND TRACEABILITY, CUSTOMER PROPERTY,
PRESERVATION OF PRODUCT, CONTROL OF MONITORING AND
MEASURING DEVICES, MEASUREMENT, ANALYSIS AND
IMPROVEMENT, GENERAL MEASUREMENT, ANALYSIS AND
IMPROVEMENT, MONITORING AND MEASUREMENT, CUSTOMER
SATISFACTION, INTERNAL AUDITS, MONITORING AND
MEASUREMENT OF PROCESSES, MONITORING AND MEASUREMENT OF
PRODUCT, CONTROL OF NONCONFORMING PRODUCT, ANALYSIS OF DATA, IMPROVEMENT, CONTINUAL
IMPROVEMENT, CORRECTIVE ACTION, PREVENTIVE ACTION,
ISO 9001 GUIDE |