Iqa Training - Tuv Sud PSB

Internal Quality Audit Training
Using ISO 19011:2011 Guidelines

Resource Speaker: Mr. Edison Yap Pike
TV SD PSB Philippines
House Rules
NO mobile phones switched on during training

sessions (or turn to silent mode) please
Delegate Introductions
Name (introduce the person to your right)

Involvement in QMS
Hobbies, interest
Expectation
Course Objectives
Interpret the requirements of QMS in the context of an

audit;
Describe the roles and responsibilities of auditors and lead
auditors;
Understand the concept of an audit and its purpose as a
management tool;
Plan and conduct an audit (in accordance with ISO 19011);
Understand the benefits of conducting an audit.
Course Overview
Tutorial
Group Work
Presentation
Course Outline
I.
II.
III.
IV.
V.
VI.
VII.
Introduction to Auditing
ISO 19011:2011 Updates
Audit Objectives, Principles, and Concepts
Audit Planning
Conducting On-site Audit
Audit Reporting
Auditor Selection and Evaluation
Introduction to Auditing
Why do we Audit?
Certification or internal audit
Assess effectiveness, doubtful performance
Verify compliance
Regulatory or contractual requirements
After significant changes
Needs from supplier evaluation

Identify opportunities for improvement
Internal Auditing
Audits must be at planned intervals
Audits check that QMS
Is being followed
Is effective
Meets requirements of ISO 9001:2008
Audits must be objective
Audit Types
Audits carried out by a
company on its own systems.
Your own
Organization
Audits carried out by

independent accredited
organizations.
1st Party
Certification
Body
3rd Party
Subcontractor
or Supplier
2nd Party
Audits carried out by one organization on another prior to
or after contract placement.
Difference Between 1st and 2nd and 3rd Party Audits

Elements
First Party (Internal Audit)
2nd and 3rd Party
Offers of advice
Usually expected
Never in 3rd Party, rarely

In 2nd Party
Audit Style
Can be relaxed although

Sometimes inhibiting if
auditee is senior mgt.
Much formal
Opening meeting
Optional
Required
Closing meeting
Optional
Required
Auditee Reaction
Depends on culture
Usually taken very seriously

Due to implications of audit
Result.
3.0 Terms and definitions

3.1 AUDIT
Systematic, independent and documented process for
obtaining audit evidence (3.3) and evaluating it
objectively to determine the extent to which the audit
criteria (3.2) are fulfilled.
3.2 AUDIT CRITERIA
Set of policies, procedures or requirements used as a
reference against which audit evidence (3.2) is
compared

3.3 AUDIT EVIDENCE
Records, statement of facts or other information which
are relevant to the audit criteria (3.3) and verifiable
3.4 AUDIT FINDINGS
Results of the audit evaluation of the collected audit
evidence (3.3) against audit criteria (3.2)
3.5 AUDIT CONCLUSION
Outcome of an audit, after consideration of the audit
objectives and audit findings (3.4)

3.6 AUDIT CLIENT
Organization or person requesting an audit (3.1)
Note 1: In the case of the internal audit, the audit client
can also be the auditee (3.7)
3.7 AUDITEE
Organization being audited
3.8 AUDITOR
Person conducting the audit (3.1)

3.9 AUDIT TEAM
One or more auditors (3.8) conducting an audit (3.1),
supported if needed by technical experts (3.10)
Note 1: One auditor of the audit team is appointed as
audit team leader.
Note 2: The audit team may include auditors-in-training.
3.10 TECHNICAL EXPERT
Person who provides specific knowledge or expertise to
the audit team (3.9)
Note 1: Specific knowledge or expertise is that which
relates to the organization, process or activity to be
audited, or language and culture.

3.11 OBSERVER
Person who accompanies the audit team but does
not audit.
Note 1: Not part of the audit team and does not
influence or interfere with the conduct of the audit
Note 2: Can be from the auditee, a regulator or
other interested party who witnesses the audit.
3.12 GUIDE
Person appointed by the auditee to assist the audit
team

3.13 AUDIT PROGRAMME
Arrangements for a set of one or more audits planned for a
specific time frame and directed towards a specific purpose.
3.14 AUDIT SCOPE
Extent and boundaries of an audit
Note 1: The audit scope generally includes a description of
the physical locations, organizational units, activities and
processes, as well as time period covered.
3.15 AUDIT PLAN
Description of the activities and arrangements for an audit

3.16 RISK
Effect of uncertainty on objectives
3.17 COMPETENCE
Ability to apply knowledge and skills to achieve
intended results.
Note 1: Ability implies the appropriate application of
personal behavior during the audit process

3.18 CONFORMITY
Fulfillment of a requirement
3.19 NONCONFORMITY
Non-fulfillment of a requirement
3.20 MANAGEMENT SYSTEM
System to establish policy and objectives, and to
achieve those objectives
ISO 19011:2011 Updates
Topic
Changes
Terms and definitions
Added definition for Observer, Guide, Risk

Revised definition for Competence
Principles of auditing
Replaced Ethical conduct with Integrity

Added Confidentiality
5.0 Managing an audit

programme
Expanded and structured to follow a process flow:

5.1 General
5.2 Establishing the audit programme objectives
5.3 Establishing the audit programme
5.4 Implementing the audit programme
5.5 Monitoring the audit programme
5.6 Reviewing the audit programme
6.0 Performing an audit
No longer includes appointment of audit team and

audit team leader, defining audit objectives, scope
and criteria (transferred to 5.0 Managing an audit
programme)
Combined Conducting document review and

Preparing for the on-site audit activities to one
section Preparing audit activities
Topic
Changes
Conducting audit activities includes Performing

document review while conducting the audit
7.0 Competence and

evaluation of auditors
Added 7.2.3.3 Discipline and sector specific

knowledge and skills of management systems
auditor to cover knowledge and skills for auditing
different management systems (instead of Quality
and Environmental Management Systems only in
2002 version). Refers to Annex A
New section: Annex A

Illustrative examples of
discipline-specific
knowledge and skills of
auditors
Guidance on how to support the development of

auditor competence criteria and auditor selection
New section: Annex B

Additional guidance for
auditors planning and
conducting audits
Describes different audit methods and guidance on

how to conduct sampling audits, what to consider
when conducting document reviews, different
methods to gather information, considerations for
recording nonconformities, etc.
Auditing Objectives, Principles, and

Concepts
4.0 Principles of Auditing

PRINCIPLES
DETAILS
Integrity
Foundation of professionalism:
Honesty, diligence, responsibility,
demonstration of competence,
impartiality
Fair presentation
Obligation to report truthfully and

accurately:
Significant obstacles and unresolved
diverging opinions between auditor
and auditee are reported and
disclosed

PRINCIPLES
DETAILS
Due professional
care
Diligence and judgment in auditing

Exercise due care in accordance with
the importance of task performed.
Have the necessary competence
Confidentiality
Security of information
Exercise discretion in the use and
protection of information acquired
Info should not be used
inappropriately for personal gain or in
a manner detrimental to the legitimate
interest of the auditee

PRINCIPLES
DETAILS
Independence
Impartiality and objectivity of audit

conclusions
Free from bias and conflict of interest.
Maintain objectivity in the conduct of audit.
Evidencebased
approach
Reaching a reliable and

reproducible audit conclusions in
a systematic process
Audit evidence is verifiable
Based on samples of information available
Use of appropriate sampling that is closely
related to confidence of audit conclusions
5.0 Management of Audit Programme

Establishing the audit programme objectives
Establishing the audit programme
Assignment roles and responsibilities

Competence of person managing the audit programme
Extent of the audit programme
Identify and evaluate audit programme risks
Procedures for the audit programme
Identify audit programme resources
5.0 Management of Audit Programme

Implementing the audit programme
Define the objectives, scope, and criteria for the audit
Selecting audit methods
Selecting team members
Assigning responsibilities to audit team leader
Managing the audit programme outcome
Managing and maintaining audit programme records
Monitoring the audit programme

Reviewing and improving the audit programme
Competence
and evaluation
of auditors
Performing an
audit
6.0 Performing an Audit Audit Activities

INITIATING THE AUDIT (6.2)
PREPARING AUDIT ACTIVITIES (6.3)
CONDUCTING THE ON-SITE AUDIT (6.4)
Establish initial contact with auditee

Determine feasibility of audit
Review documents of mgt. systems to

prepare for audit
Preparing the audit plan
Assigning the audit team
Preparing work documents
Conducting opening meeting
Performing document review while
conducting the audit
Communicating during audit
Assigning roles and responsibilities of guides
& observers
Collecting and verifying information
Generating audit findings
Preparing audit conclusions
Conducting closing meeting
6.0 Performing an Audit Audit Activities
PREPARING AND DISTRIBUTING

AUDIT REPORT (6.5)
Prepare the audit report

Distribute the audit report
COMPLETE AUDIT (6.6)
Documents pertaining to audit may be

retained or destroyed as agreed upon
Confidentiality must be observed
CONDUCTING
AUDIT FOLLOW-UP (6.7)
Verification of effectiveness of
corrective action
Audit Planning
Audit Team Leaders Responsibilities

Prepare an Audit Plan and working
documents
Protect the health and safety of the audit
team
Represent Audit team to Management
Organize and direct the audit team
Provide direction and guidance to
trainees
Resolve conflict
Lead the team to reach audit conclusions
Prepare and complete the audit report
Auditors Responsibilities
Comply with the audit requirement

Plan/carry out responsibility effectively
Remain within audit scope
Be able to identify availability and adequacy of
Documented System
Verify understanding and implementation of
Documented System
Gather, check and analyze evidence
Remain alert to further information/evidence
Auditors Responsibilities
Act in ethical manner

Documents audit findings
Report audit results
Require corrective and preventive action
Verify implementation and effectiveness of
Corrective and Preventive Action
Retain/safeguard audit documents
Support Audit Team Leader
Responsibilities of Auditees
Cooperate with lead auditor/team to ensure
that audit is conducted smoothly
Establish communication channels
Confirm the audit authority
Ensure staff availability for interview and
meetings
Arrange logistics and necessary support
Audit Preparation
Time and Resources

Auditors Contacts Dept heads
Prepare audit plan
Prepare checklist
Review documentation
(Quality Manual and 6 Mandatory Documented Procedures)
Control of documents
Control of records
Internal audit
Control of nonconforming
product
Corrective action
Preventive action
Advantages of Audit Plan

Clarifies Purpose of Audit
Use Time More Effectively
Ensure Important Elements Covered
Shows Open Approach if Copied Before Audit
Gives Framework of Audit
Gives Professional Impression
Provides Records of What Covered
Preparing An Audit Plan
Audit objectives, criteria and scope

Dates and places
Time required
Roles and responsibilities of audit
team and accompanying persons
Allocation of appropriate resources to
critical areas of audits
Audit Plan - Sample

Date
Time
Organizational
unit/Location
01/12/12
Process/Event/
Element
Auditors
ISO 9001 (Audit criteria)

9:00 9:30
Conference Room
9:30 10:30
Facility Tour
10:30 12:00
Office of the Top Mgt
12:00 1:00
Lunch
1:00 3:00
Technical/ Design
Section
Opening Meeting
AB
AB
4.1, 4.2, 5.1, 5.2, 5.3,

5.4.1, 5.4.2, 5.5.1, 5.5.2,
5.5.3, 5.6, 6.1, 8.2.1,
8.2.2, 8.5.1
AB
7.5.1, 7.5.2, 7.5.3, 7.5.4,

7.5.5, 7.6, 8.2.3, 8.2.4, 8.3,
8.4, 8.5.2, 8.5.3
AB
Preparing Work Documents

Auditor Toolkit
Clipboard
Logbook
Checklist
Audit plan
Report Forms
ISO 9001:2008 standard
Sources for the Creation of Checklist

ISO Standard (ISO 9001:2008) Requirements
Key elements of QMS Documentation
Known or Classic Problems of Organization
Ideas from Auditors
Knowledge of Industry
Previous Checklist
Sample Checklist for Auditing Warehouse

1. How are damaged goods dealt with upon receipt?
2. What are the packaging / storage criteria used?
3. How is it decided where items should be stored?
4. Is storage environment suitable, ex. Temperature, humidity & dust control?
5. Are there any items with limited shelf life, if so, how are they controlled?
6. Are there any items requiring special protection, ex. from electrostatic
damage?
7. How are items routinely checked for deterioration?
8. How are defective items identified & segregated?
9. Is there any evidence of poor product house keeping, handling or storage?
10.What training do Warehouse Personnel get?
Conducting On-Site Audit
Audit Communications
With Auditee
Opening meeting
Daily review
Informal communications
Closing meeting
Within Audit team
Regular communications (normally
each half day)
Internal meeting
Opening Meeting
Participants (attendance record)

Confirm agreement of all parties to the audit plan
Introduce audit team
Methods and procedures to conduct the audit
Communication channel and language used
Relevant safety, emergency and security procedures
Roles of a guide and observers
Methods and grading of nonconformities
Condition to terminate the audit
State the disclaimer
Appeal system
Invite questions
What do we Audit Against?

Conformance to the Documented System /
Quality Manual
Conformance to ISO 9001:2008
Effectiveness and appropriateness of system?
Environment, Health and Safety?
Company Rules?
Evidence
Results of interview with employees/others

Observation of activities, work environment, etc.
Review of documents and records
Review of physical samples, photos taken, etc.
Could be positive or negative
?
The Audit Triangle

Question
( ask them what they do)
Observe
Check
( see what they actually do)
( what the process says

they should do)
Interviewing Process
Identify individual to be audited

Introduce yourself
Explain why you are there
Ask open question(s)
Do show me please
Check facts and make notes
Thank auditee
Identify next auditee on trail
Interview Technique
Avoid sitting in an opposing manner

Develop rapport with a small talk, eye contact
Explain the reason why you are here, take taking
Spend more time listening
Good idea to have an audit at the auditees office
?
Open Questions
Encourage Auditee to talk freely
ex. set the scene
Use what, where, why, who, when & how?
Take care to prevent Auditee from talking to much
?
Probing Questions
Follow-up or Focusing questions
Search for information in greater depth
Cornerstone of audit techniques
?
Closed Questions
Used to established specific facts

ex. Do you?
Normally receives a yes / no answer
Do not use too often
?
Counter Productive Questions

Type of questions to be avoided
Moves away from purpose of audit

Examples includes:
Tricky questions
Leading questions
Ambiguous questions
Multiple questions
Nonconformity
Non-fulfillment of a requirement, e.g.
Customer requirements
Statutory and regulatory requirements
System requirements
Nonconformity Classification
NONCONFORMANCE (NC):
A nonconformance relates to the absence, or total
failure, of a process to meet the internal requirements
resulting in an actual or potential adverse effect on
customer satisfaction and quality of the product or
service.
A number of lapses against one clause of guidelines
when acting together reduce the effectiveness of a
process to the extent that there are actual adverse
effects on customer satisfaction and product quality
which can represent a nonconformance.
Nonconformity Classification
OBSERVATION (O):
Single observed lapse or failure to comply with a
requirement of the guidelines or an internal
requirement which however, as based on objective
evidence, does not jeopardize product quality.
HINTS FOR IMPROVEMENT (H):
Findings which is a best practice observed by the
auditor which the organization may or may not
consider them. This practices are sort of
recommendation in improving the quality system of the
organization.
Nonconformities Must
Be factual / objective
Be clear and concise
Give clause number of Quality Standard /
Company Document
Be locatable by the Auditors
Define the exact instance
Be given a unique identifier
Be categorized (ex. NC / O / I)
Be accepted / signed by the audited
company
Nonconformity Format
Clause No.
Criteria statement
However
Factual description (Audit Evidence)
When
Where
Who
What
Generating audit findings / Audit conclusions
NONCONFORMANCE REPORT
Company:
Area:
Reference:
XYZ Co.
Warehouse
Classification:
ISO Clause:
NC
Detail of Nonconformance:
Auditor:
Corrective Action:
Remarks:
By:
Verified by:
Element -Specific Objective Evidences

4 Quality Management System
4.1 General Requirements
Determination of processes for QMS and their application
throughout the organization,
Determination of sequence of these processes,
Determination of criteria and methods for the effectiveness
of these processes,
Availability of resources,
Process monitoring, measurement and analysis,
Actions for continuous improvement,
Control of outsourced processes as part of QMS.

4.2 Documentation Requirements
4.2.1 General
Documented statements of Quality Policy and Quality
Objectives
Quality Manual
Documented procedures and records required by the
standard
Documents and records required by the organizational
process control.

4.2.2 Quality Manual
Scope of the system including justification of

exclusions;
Documented procedures or reference there to;
Organizational charts;
QMS process descriptions and interactions.

4.2.3 Control of documents
Documented procedure for control of documents;

Approval for adequacy prior to issue;
Review, update and re-approval;
Identification of changes and current revision status;
Relevant applicable documents are available at point of
use;
Legible and readily identifiable;

4.2.3 Control of documentscont.
Identification and controlled distribution of external
documents relevant to QMS;
Suitable identification of obsolete documents.

4.2.4 Control of records
Documented procedure for control of records
Identification
Storage
Protection
Retrieval
Retention
Disposition
Methods of control.

4.2.4 Control of records cont.

Shall remain:
Legible
Readily identifiable
Easily retrievable.
5 Management Responsibility
5.1 Management Commitment
Evidence of quality system effectiveness and continual
improvement by:
Communication on meeting customer, statutory and
regulatory requirements;
Established quality policy and quality objectives;
Management reviews;
Availability of resources.
5.2 Customer Focus
Customer requirements determined and met
Enhancing customer satisfaction.
5.3 Quality Policy
Commitment to comply w/ requirements and continual
improvement
Reviewed for continuing suitability
Framework for establishing/reviewing quality objectives
Communication and understanding with in the organization.
5.4 Planning
5.4.1 Quality objectives
- Aligned with quality policy
- Aligned with requirements
- Established at relevant functions and levels
- Measurable.
5.4.2 Quality management system planning
- Business Planning, Strategic Planning, Project plans,
quality assurance agreements
- Quality planning
5.5 Responsibility, Authority & Communication
5.5.1 Responsibility and Authority
- Job/function/requirement profiles
- Responsibilities & authorities communicated
5.5.2 Management Representative
- Level of authority
- Appointment letter
- Job/Function profile
- Must be a member of the organizations own management.
5.5.3 Internal Communication
- Established suitable communication processes within the organization
- Communication on QMS effectiveness.
5.6 Management Review
5.6.1 General
- Regular review of quality system
5.6.2 Review Input
- Audit results
- Customer feedback
- Process performance & product conformity
- Status of corrective and preventive action
- Follow-up action from previous management reviews
- Changes that could affect the QMS
- Recommendations for improvement.
5.6 Management Review
5.6.3 Review Output
- Improvement of the effectiveness of the QMS and the
processes
- Product improvement
- Resource needs.
6 Resource Management
6.1 Provision of Resources
- Implement, maintain for continually
- Ensure customer satisfaction.
improvement
6.2 Human Resources
6.2.1 General
Must be competent on the basis of:
- Education
- Training
- Skills
- Experience
- Competence requirements are relevant for any personnel
involved in QMS.
6.2 Human Resources
6.2.2 Competence, Awareness and Training
- Define training needs;
- Provide appropriate training/training program;
- Evaluation of training effectiveness;
- Awareness of personnel on their activities and contribution
on the quality objectives achievement;
- Maintain relevant records.
6.3 Infrastructure
- Determination, provision and maintenance of infrastructure
- Buildings, workplace and associated utilities
- Process equipment hardware and software
- Support services
- Information systems.
6.4 Work Environment
- Determine and control work-environment and other factors for
product conformity such as physical, environmental, noise,
temperature, humidity, lighting or weather.
7 Product Realization
7.1 Planning of Product Realization
- Planning of the quality objectives and product
requirements including resources;
- Quality planning;
- Project development plans;
- Maintain records.
7.2 Customer- Related Processes
7.2.1 Determination of product requirements
- Product requirements including delivery and post delivery
activities such as warranty provisions, maintenance services
and supplementary services (recycling)
- Statutory & regulatory requirements applicable to the
products.
7.2.2 Review of product requirements
- Capability checked
- Agreement before acceptance

- Statutory and regulatory requirements
- Differences resolved
- Amendments documented and communicated
- Determine requirements not specified by the customer but
necessary for use
- Maintain records.
7 Product Realization cont.

7.2.3 Customer Communication
- Define and implement communication with customers

on:
Product information
Inquiries, contracts or order handling including

amendments
Customer feedback, customer complaints
7 Product Realization cont.

7.3 Design and Development
7.3.1 Design and Development Plan
- Review, verification and validation
- Interfaces and effective communication
- Clarity of responsibilities and authorities
7.3.2 Design and Development Inputs
- Customer/market performance requirements
- Statutory and regulatory requirements
- Previous design and development results obtained

- Other requirements
- Adequate, clear-cut requirements
7 Product Realizationcont.
7.3.3 Design and Development Outputs
- Meet input requirements

- Provide information for purchasing, production and
service provision
- Product acceptance criteria
- Specify product characteristics essential for its safe and
proper use
- Preservation of product
- Approve before release.
7 Product Realizationcont.
7.3.4 Design and Development Review
- Evaluate capability at suitable stages
- Identify problem, prepare necessary actions
- Document review results & the necessary actions
7.3.5 Design and Development Verification
- Plan and perform to ensure that output satisfy input
requirements
- Follow-up action is defined
- Document verification results.
7.3 Design and development
7.3.6 Design and Development Validation
- Ensure fitness for use
- Validation prior to product delivery
- Partial Validation, if applicable
7.3.7 Control of Design and Development Changes
- Review, identify and document changes
- Review, verification, validation and approval prior to
implementation
- Review the effect of changes
- Review follow-up action on the product
- Document review results.
7.4 Purchasing
7.4.1 Purchasing Process
- Criteria for supplier selection, evaluation and re-evaluation
- Regular evaluation and re-evaluation of suppliers
- Documentation of evaluation
- List of approved suppliers.
7.4 Purchasing
7.4.2 Purchasing information
- Ensure adequacy of the requirements prior to communication to
supplier
- Product approval, procedures, facilities and equipment.
7.4.3 Verification of purchased products

- Supplier verification
- Verification plans
- Incoming inspection
7.5 Production and service provision
7.5.1 Control of production & service provision
- Define product characteristics
- Available work instructions
- Suitable equipment and environment
- Comply with reference standards
- Control/ monitor process parameters and product
characteristics
- Approve & maintain process & equipment
- Workmanship criteria clearly stipulated
- Post-delivery activities must be implemented.
7.5.2 Validation of Processes for production and service provision
- Criteria for review and approval
- Approval of equipment and personnel qualification
- Process control data
- Validation specification.
7.5.3 Product identification and traceability
- Identified product at all stages

- Identified status with respect to measurement and
verification activities
- Traceability for critical items recorded
- Applied to component and parts.
7.5 production and service provision
7.5.4 Customer property
- Identification, verification, protection and maintenance
- Procedure and documentation in cases involving damage or loss
(notification to customer)
- Inventory of customer property
- Organization exercise care for customer property
- Intellectual property
- Personal data.
7.5 Production and Service Provision
7.5.5 Preservation of product
Handling methods to prevent damage or deterioration
Stipulate methods of receipt and dispatch to/from stock
Regularly assess condition of product in stock
Packing, packaging and marking

Preservation and segregation
Protect product after final inspection and test
Apply to parts and components
Product release and/or service delivery
Activities satisfactorily completed

Documentation available and authorized
7.6 Control of monitoring & measuring equipment
Determine required monitoring and measuring equipment and its ability

Calibrate and adjust at regular intervals
Traceability to recognized standards
Define calibration process -acceptance criteria and action for
unsatisfactory results
Identification of calibration status
Out of calibration-assess & document affected products
Test software or comparative references check to prove capability of
verifying the acceptability of product
Software validation
Suitable environmental conditions
Safeguard from adjustments.
8 Measurement, Analysis & Improvement

8.1 General
- Determination, planning and implementation of measurement,
monitoring, analysis & improvement processes
- Type, location, timing and frequency of measurements
- Periodically review effectiveness of measures
- Use of suitable statistical techniques
- The results of analysis and improvements shall be an input to the
management review
- Determine, establish process for measurement of QMS
performance.

8.2 Monitoring and measurement
8.2.1 Customer Satisfaction
- Customer satisfaction survey
- User opinion surveys,
- Customer on product delivery,
- Lost business analysis,
- Compliments,
- Warranty claims and
- Dealer reports.

8.2 Monitoring and Measurement
8.2.2 Internal Audit
- Documented procedure for Internal Audit
- Internal Audit shall be used as a tool for evaluating ongoing
system compliance
- Cover quality activities and related results
- Schedule-based on status and importance
- Auditors qualification
- Independence
- Record and report findings

8.2.2 Internal Auditcont.
- Follow-up audit -verify implementation and effectiveness
- Auditors performance evaluation- Determine if QMS is
effectively implemented and maintained
- Determine if QMS conform to relevant standard
- Correction and corrective action
- Identify potential opportunities for improvement
- Maintain records.

8.2.3 Monitoring & Measurement of Process
- Suitable methods for monitoring and measurement with impact to
the conformity of product and quality system processes
- Implementation of correction and corrective action for
nonconformity.

8.2.4 Monitoring & Measurement of Product
- Product characteristics monitoring, measuring, verification and
documentation
- Responsible person identified for release of product
- Record evidence of implementation of required
measurement and monitoring and conformance with the acceptance
criteria

8.3 Control of nonconforming Product
- Documented procedure for control of nonconformance
- Identify, record and review the nature & extent of the non-conformity
- responsibility for disposition - defined and implemented
- Concerned functions notified
- Review in accordance with documented procedure
- Report use of non-conforming product to customer
- Record description of accepted non-conformity
- Re-inspect repaired and/or reworked product
- Determine and implement verification requirements for repaired or
reworked product

8.4 Analysis of Data
Determine, collect, analyze appropriate data to demonstrate
quality system suitability & effectiveness
Provide information on:
Customer satisfaction/dissatisfaction
Conformity of product requirements
Process and product characteristics
Suppliers

8.5 Improvement
8.5.1 Continual Improvement
Continual Improvement through:
- Quality policy
- Quality objectives
- Audit results
- Data analysis
- Corrective and preventive action
- Management review

8.5.2 Corrective action
- Documented procedure for corrective action
- Review non-conformities (incl. Customer complaints)
- Determine the causes of non-conformities
- Required measures to prevent recurrence
- Corrective action
- Monitoring and evaluation of corrective action
- Documentation
- Submit for management review.

8.5.3 Preventive Action
- Documented procedure for preventive action
- Determine potential non-conformities
- Determine potential root cause
- Planning of preventive action
- Implementation of preventive action
- Evaluation of preventive action taken
- Documentation
- Submit for management review.
Discuss and Agree Findings

Dont raise nonconformities / findings in front of staff,
if possible
Raise, at first opportunity, with Guide/Dept Heads
Resolve problems by discussion
Agree corrective action timetable
Closing Meeting
Thanks for cooperation, etc

Summary of good findings / points
Nonconformities / finding(s) and recommendation(s)
Corrective actions
Report details
What happens next
Any questions
Audit Reporting
Preparing Audit Report
Audit objectives
Audit Scope
Audit client
Audit team and auditees participants
Dates and locations of audit
Audit criteria
Audit findings and relevant evidence
Audit conclusions
Statement on the degree on which the
audit criteria have been fulfilled
Corrective vs. Preventive Action
Nonconformity Detected
Eliminate itself
(fixing NC)
CORRECTION
Prevent
recurrence
CORRECTIVE
ACTION
NC NOT YET Detected

Eliminate cause of
Potential NC
PREVENTIVE
ACTION
Corrective Action Steps
Confirm NC
Identify Root Cause/s
Identify Solution
Propose, review, accept
Implement , close
Follow up Action
Report circulated
Audit program updated
Checklist filed
Corrective action performed
Trends/findings fed to management review
Corrective action verified
Auditor Selection and Evaluation
Selecting Audit Team Members
Identify knowledge and skills required based on

audit objectives
Ensure all necessary knowledge and skills are
present in the audit team
Ensure impartiality and independence (not audit
own work)
Experts may be appointed to support
competence
The Ideal Auditor?
Relaxed and Friendly

Good Listener/Communicator
Interested, Objective and
Logical
Positive attitude and Enquiring
Mind
Explains the process and
Understand the Technicality.
Gives good feedback
Excellent Interpersonal Skills
Can communicate at all levels
of the organization
Personal Behavior
Ethical fair, truthful, sincere, honest, discreet

Open minded willing to consider alternative ideas
Diplomatic tactful in dealing with people
Observant actively observing surroundings and activities
Perceptive aware and able to understand situations
Versatile able to readily adapt to situations
Tenacious persistent and focused on achieving objectives
Decisive able to reach timely logical conclusions
Self-reliant able to act and function independently
Personal Behavior
Acting with fortitude able to act responsible and
ethically even though this actions may not always be
popular / may result in disagreement or confrontation
Open to improvement willing to learn from
situations and striving for better audit results
Culturally sensitive observant and respectful to the
auditees culture
Collaborative effectively interacting with others
(auditee and audit team)
Auditor Knowledge
Generic Knowledge
Audit principles,
procedures and methods
Must know how to collect information, use

work documents to support audit findings
and conclusions, document audit findings,
communicate effectively, etc.
Management System
requirements and
reference documents
Must be able to audit within the audit scope

and apply audit criteria using ISO standards,
procedure manuals, etc.
Organizational context
Must understand auditees structure, and

business and management practices
Applicable legal,
contractual, and other
requirements
Must know applicable laws and regulations

related to the business
Auditor Knowledge
Discipline and Sector Specific Knowledge
Discipline Specific
Knowledge
Ex. ISO 9001 requirements, terminologies

relating to QMS
Sector Specific Knowledge Ex. Transportation/ Education / Construction

sector terminologies, processes and
practices
Achieving Auditor Competence
Education
Auditors should have:

Formal education / training
contributing to development of
knowledge and skills in the
management system discipline /
sector that the auditor intends to
audit
Achieving Auditor Competence

Training
Auditors training should cover:
Knowledge and understanding of the standard

including legal and other requirements
Assessment techniques
Skills required for managing an audit
Experience
Should be in a position where the activities undertaken

helped develop skills and knowledge in MS.
Audit experience gained as auditor trainee
Possible Evaluation Methods
EVALUATION
METHODS
Review of
records
OBJECTIVES
To verify the background of the

auditor
EXAMPLES
Analysis of records of
education, training,
employment and audit
experience
Positive and
negative
feedback
To provide information about how Surveys, questionnaires,

the performance of the auditor is personal references,
perceived
testimonials, complaints,
performance evaluation,
peer review
Interview
To evaluate personal attributes

and communication skills, to
verify information and test
knowledge and to acquire
additional information
Face to face and

telephone interviews
Possible Evaluation Methods

EVALUATION
METHODS
Observation
Testing
OBJECTIVES
EXAMPLES
To evaluate personal
attributes and the ability to
apply knowledge and skills
Role-playing, witnessed
audits, on-the-job performance
To evaluate personal
attributes and knowledge
and skills and their
application
Oral and written exams,

psychometric testing
Post-audit review To provide information

where direct observation
may not be possible or
appropriate
Review of the audit report and

discussion with the audit
client, auditee, colleagues and
with the auditor
TV SD PSB Philippines Inc.

1808 The Orient Square, F. Ortigas Jr. Rd., Ortigas Center, Pasig City
Trunkline: +63 2 687 5673
Facsimile: +63 2 687 2651
For inquiries on Certification, please contact:
MARLON PALISOC Account Consultant (South Luzon)
THANK
YOU
JAMES SABANDAL Account Consultant (North Luzon)
!!!
MARK KHRIS SANTIAGO Account Consultant (Metro Manila)
FAITH PEDRIGAL Account Consultant (Cebu)
ANNA LIZA SAMORRO Account Consultant (Davao)
For inquiries on Trainings, please contact:

ANN RINGOL MCS Assistant

Iqa Training - Tuv Sud PSB

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Internal Quality Audit Training

Using ISO 19011:2011 Guidelines

NO mobile phones switched on during training

Name (introduce the person to your right)

Interpret the requirements of QMS in the context of an

Needs from supplier evaluation

Audits carried out by

Difference Between 1st and 2nd and 3rd Party Audits

First Party (Internal Audit)

2nd and 3rd Party

Never in 3rd Party, rarely

Can be relaxed although

Usually taken very seriously

3.0 Terms and definitions

3.0 Terms and definitions

3.0 Terms and definitions

3.0 Terms and definitions

3.0 Terms and definitions

3.0 Terms and definitions

3.0 Terms and definitions

3.0 Terms and definitions

ISO 19011:2011 Updates

Terms and definitions

Added definition for Observer, Guide, Risk

Replaced Ethical conduct with Integrity

5.0 Managing an audit

Expanded and structured to follow a process flow:

6.0 Performing an audit

No longer includes appointment of audit team and

6.0 Performing an audit

Combined Conducting document review and

6.0 Performing an audit

Conducting audit activities includes Performing

7.0 Competence and

Added 7.2.3.3 Discipline and sector specific

New section: Annex A

Guidance on how to support the development of

New section: Annex B

Describes different audit methods and guidance on

Auditing Objectives, Principles, and

4.0 Principles of Auditing

Obligation to report truthfully and

4.0 Principles of Auditing

Diligence and judgment in auditing

4.0 Principles of Auditing

Impartiality and objectivity of audit

Reaching a reliable and

5.0 Management of Audit Programme

Establishing the audit programme

Assignment roles and responsibilities

5.0 Management of Audit Programme

Monitoring the audit programme

6.0 Performing an Audit Audit Activities

PREPARING AUDIT ACTIVITIES (6.3)

CONDUCTING THE ON-SITE AUDIT (6.4)

Establish initial contact with auditee

Review documents of mgt. systems to

6.0 Performing an Audit Audit Activities

PREPARING AND DISTRIBUTING

Prepare the audit report

COMPLETE AUDIT (6.6)

Documents pertaining to audit may be