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ISO 19011 - IAT V 1.0 Final
ISO 19011 - IAT V 1.0 Final
© DQS Group
Definition
Measures associated with goals or targets showing how well an organization is achieving its objectives or
Key Performance Indicator ( KPI) critical success factors for a particular project.KPIs are used to objectively define a quantifiable and
measurable indication of the organization’s progress toward achieving its goals
Web-based IAQG database containing information on participating IAQG member companies, National
Aerospace Industry Associations (NAIA), National Accreditation Bodies (NAB), accredited CBs,
Online Aerospace Supplier
authenticated Aerospace Experience Auditors (AEAs), Aerospace Auditors (AAs) certified suppliers,
Information System (OASIS)
certificates, and audit results.
The means, methods, and internal requirements by which the organization intends to achieve planned
Planned Activities
results of a given process to meet customer requirements. Planned activities include conformity to
process requirements and maintained documented information.
The intended performance of a process as determined and measured by the organization. Planned
results include product and service conformity and On-time Delivery (OTD) to meet customer
requirements, and may include other elements related to the process, as defined by the organization.
Planned Results
Quality Management System Terminology and Definitions
Contd
A combination of people, material, machines, tools,
environment, and methods that produce a product or
Process
service. Set of interrelated or interacting activities which
transforms inputs into outputs.
confirmation, through the provision of objective
Verification evidence, that specified requirements have been
fulfilled
When auditing each process identified by the organization, there are basic questions
that should be asked, for example:
• Companies
effectiveness
performance
• To identify deficiencies and
inaccuracies within the system
Internal Audit – 9.2
Conduct Audit
Review
Close NCR
Why Internal Audit?
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Audit Programme
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PDCA in Audit Program
Resources considerations
▪ Financial resources
▪ Auditing techniques
▪ Availability of trained auditors
▪ Customer specific auditor qualification requirements
▪ Complexity of processes
▪ Availability of process auditors / experts
▪ Scope and duration of audit
Managing an Internal Audit Program
▪ Implementation
▪ Review the feasibility of the audit
▪ Appointing the audit team & leader. Consider audit
objectives, scope & criteria, independence / conflict of
interest, team dynamics & comfort level of auditee,
language / social & cultural issues
▪ Provide necessary resources to audit teams
▪ Communicating the audit program, coordinating and
scheduling audits
▪ Ensuring conduct of audit in accordance to audit
program
Managing an Internal Audit Program
▪ Implementation
▪ Establishing and maintaining a process for auditor
evaluation
▪ Review / approval and distribution of audit reports
▪ Ensuring follow up
Evaluation of Auditor Competence
Personal attributes
▪ Ethical
▪ Perceptive
▪ Open minded
▪ Versatile
▪ Diplomatic
▪ Decisive
▪ Observant
▪ Self reliant
▪ Non argumentative
▪ Comprehensive
Evaluation of Auditor Competence
Personal attributes
Typical Internal Audit Program
▪ Off-site preparation
▪ Quality manual / Procedures review
▪ Establish process responsibilities
▪ Audit objectives, scope, criteria and reference
documents
▪ Responsibilities of team members
▪ Assignment of team responsibilities
Internal Audit
▪ Opening meeting
▪ Collecting and verifying information
▪ Do a “Process Audit”, interviews
▪ Begin each interview with management
▪ Follow the process – not the clause
▪ Follow the process – not the documentation
▪ Apply PDCA to process investigation
▪ Flowcharting / process mapping helpful
▪ Communication techniques
▪ Icebreaker ,open questions, closed questions,
leading questions, multiple questions, silent
questions
Internal Audit
With What?
(Materials, Who ?
Infrastructure, (Competent
Work Personnel)
Environment)
• The Second party audit is generally known as the vendor quality assuranceaudit
• Objectives
1. Qualification of vendors
2. Customer’s requirement shall audit their vendors
3. Improve their quality system
4. Resolve quality problems / issues
INTRODUCTION TO AUDITING
• External Third Party Audit
• Third party audits are conducted by an
independent body (certification body)
and can either be voluntary, as in the
case of a certification audit, or
compulsory, as required by laws and
regulations.
INTRODUCTION TO AUDITING
• Stage 1 Audit
• Stage 2 Audit
• Re-Certification Audit
• Surveillance Audit
❖ Surveillance audits are on-site audits
❖ Certified management system continues to fulfil
requirements
• Extensions to Scope
❖ May be conducted in conjunction with a
surveillance audit
INTRODUCTION TO AUDITING
• Short-notice Audits
investigate complaints
❖ In response to changes
❖ As follow up on suspended clients
. Multi-site Audits
❖ Client’s management system covering the
same activity in various locations
❖ A sampling programme
INTRODUCTION TO AUDITING
• Audit Trails
❖ Step by step with sequential process from
beginning to the end
❖ Reviewing again by various cross – references
procedures/Documents
❖ Forward and backward direction of process
sequence
❖ Audit follows a trail through the business from
origination to completion.
Introduction to AS9100:2016 Audit
Trails
• Each on-site audit, except for nonconformity follow-up and special audits shall include the
following, as applicable:
a. a review of the changes to the QMS, since the last audit (including certification structure);
b.a review of requirements from new aviation, space, and defense customers, since the last
audit;
c. a review of customer satisfaction information and requested corrective actions and associated
responses;
e.an audit of the organization's processes, including their performance and effectiveness, as
identified in the audit plan
NOTE: If there is more than one surveillance audit during a year (e.g., every six months), some
activities (e.g., interview with top management) may be spread over these audits.
INTRODUCTION TO AUDITING
• Benefits
– Globally harmonized certification scheme that is recognized by major
Aviation, Space and Defense companies
– Supports supplier approval activities with a recognized quality
management system certification
– Process approach to conformance assessment
– Focus on exceeding customer expectations
• Risks
– Does not prevent procurement from poor performing suppliers
– It is not certification of product
OPMT - Sector Management Structure
• Sector Management Structure (SMS)
– The organization established in an IAQG sector that
manages the application and oversight of the ICOP
scheme as defined by this standard.
– Each sector may use a different name for this
organization
» i.e., Registration Management Committee (RMC) in the
Americas and Asia/Pacific,
Mission:
Management and oversight of the 9100 series Aviation, Space and Defense
Quality Management System certification program.
Strategic Objectives:
Continually improve the globally harmonized Industry Control Other Party
quality management system certification program to be efficient,
recognized, and bring measurable benefits to stakeholders.
Accreditation
Process IAW AS
9101 F:2016 and
AS 9104/1 for
CB(CRB) provide
certification for
AS 9100 AS 9110
AS 9120
ACCREDITATION AND CERTIFICATION
3. Certification Body
Document Review
& Contract
Agreements
Audit and
Certification
ACCREDITATION AND CERTIFICATION
ACCREDITATION AND CERTIFICATION contd..
ACCREDITATION AND CERTIFICATION
– Operational Efficiency: The focus on process management and improvement means that
implementing AS9100 in your business can help improve your organization's efficiency.
Find new ways to save money by producing more product at a lower cost.
– Stakeholder Relationships: If you want to improve your company's image in the eyes of
your staff, customers and suppliers, demonstrating compliance with a respected industry
standard is a good place to start.
– Minimize Operational Risk: Risk-based thinking like that required by AS9100 helps your
organization develop and implement the best practices for the aerospace industry,
improving process quality and product traceability to help reduce risk and improve
product safety.
ACCREDITATION AND CERTIFICATION
❑ organizational objectives
❑ risks and opportunities associated with the audit programme (see 5.3) and the actions to address
them
❑ scope (extent, boundaries, locations) of each audit within the audit programme
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Principles of Auditing
❑ Confidentiality
❑Auditors should exercise discretion in the use and protection of information
acquired in the course of their duties.
❑Audit information should not be used inappropriately for personal gain by the
auditor or the audit client, or in a manner detrimental to the legitimate interests
of the auditee.
❑This concept includes the proper handling of sensitive or confidential
information.
Principles of Auditing
❑ Independence
❑Auditors should be independent of the activity being audited wherever
practicable, and should in all cases act in a manner that is free from bias and
conflict of interest.
❑For internal audits, auditors should be independent from the operating
managers of the function being audited.
❑Auditors should maintain objectivity throughout the audit process to ensure that
the audit findings and conclusions are based only on the audit evidence.
Principles of Auditing
❑ Evidence based approach
❑ Audit evidence should be verifiable.
❑ It will in general be based on samples of the information available, since an
audit is conducted during a finite period of time and with finite resources.
❑ An appropriate use of sampling should be applied, since this is closely related to
the confidence that can be placed in the audit conclusions.
Personal Behaviour
❑ Ethical- fair, truthful, sincere, honest and discreet
❑Open-minded, i.e. willing to consider alternative ideas or points of
view
❑ Diplomatic, i.e. tactful in dealing with people
❑ Observant, i.e. actively observing physical surroundings and
activities
❑ Perceptive, i.e. aware of and able to understand situations
Personal Behaviour
❑ Versatile, i.e. able to readily adapt to different situations
❑ Tenacious, i.e. persistent and focused on achieving objectives
❑Decisive, i.e. able to reach timely conclusions based on logical
reasoning and analysis
❑ Self-reliant, i.e. able to act and function independently whilst
interacting effectively with others;
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Personal Behaviour
❑Acting with fortitude, respon and ethical even
though these actions may not always be popular and may sometimes
result in disagreement or confrontation;
❑Open to improvement, i.e. willing to learn from situations, and
striving for better audit results;
❑Culturally sensitive, i.e. observant and respectful to the culture of
the auditee;
❑Collaborative, i.e. effectively interacting with others, including audit
team members and the auditee’s personn
Negative Traits of Auditors
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AUDITOR RESPONSIBILITIES
1. The Roles and Responsibility of the TeamLeader
• Documenting observations
• Recording evidence
STATUS:
IMPORTANCE:
a. Review of previous audit points which includes Observations' or/and non conformity points.
b. Cover all the clauses as per the audit schedule for the department/Organization.
c. Note and discuss general observation and could be potential non conformity.
d. Suggestions' for Improvement.
Audit Objective:
a. Management priorities.
b. Commercial requirements
c. Management system requirements
d. Statuary, Regulatory and contractual requirements
e. Customer requirements
f. Risk Mitigation
Audit Scheduling:
Audit scheduling is a schedule prepared for that / any particular audit. This is
prepared based on the audit plan.
Considerations:
➢ Based on the frequency of the audit
➢ Based on the previous Audit results (Internal / External)
➢ Based on the customer complaints
➢ Changes to the quality System
➢ Scope of audit department involved
➢ Auditee availability
Audit Checklist:
2 Audit execution: The execution phase of an audit is often called the fieldwork. It is the data-gathering
portion of the audit and covers the time period from arrival at the audit location up to the exit meeting. It
consists of multiple activities including on-site audit management, meeting with the auditee, understanding
the process and system controls and verifying that these controls work, communicating among team
members, and communicating with the auditee.
3Audit reporting: The purpose of the audit report is to communicate the results of the investigation. The
report should provide correct and clear data that will be effective as a management aid in addressing
important organizational issues. The audit process may end when the report is issued by the lead auditor or
after follow-up actions are completed.
4 Audit follow-up and closure: According to ISO 19011, clause 6.6, "The audit is completed when all the
planned audit activities have been carried out, or otherwise agreed with the audit client." Clause 6.7 of ISO
19011 continues by stating that verification of follow-up actions may be part of a subsequent audit
Audit reports : Internal Audit Vs External Audit
Internal Audit reports
1 Opportunities for Improvement ( OFI ) , if applicable
2 Non- Conformity Report ( NCR), if applicable
External Audit reports ( Certification Body)
1 Form 1 ( Stage 1 Audit report)
2Form 2 QMS Process Matrix report
3 Form 3 PEAR Report
4 Form 4- Non-Conformity Report NCR
5Form5 – Audit report (Stage2, Surveillance, Re-certification)
6 Supplemental Audit report ( Optional)
Types of Audit reports
Non Conformity
In order words, a specified requirement is not being met.
This may be categorized as Major, Minor-Non Conformity
Closing Meeting
▪ review the audit findings and any other appropriate
information collected during the audit, against the audit
objectives
▪ agree on the audit conclusions, taking into account the
uncertainty inherent in the audit process
▪ prepare recommendations, if specified by the audit plan
▪ discuss audit follow-up, as applicable
AUDIT CONCLUSIONS AND CLOSING MEETING