Iso9001 2008-VG

ISO 9001:2008
Quality Management System

By: Vincent Gaspersz
Lean Six Sigma Master Black Belt

CMQ/OE, CQE, CQA, CSSBB/MBB, CFPIM, CSCP, QMS-A
Professor of Total Quality and Operations Management, Program MM Universitas Trisakti

Doktor Teknik Sistem dan Manajemen Industri, Institut Teknologi Bandung (ITB)
Doctor of Science in Management of Engineering and Technology, SCUPS
APICS (www.apics.org) Certified Fellow in Production and Inventory Management (CFPIM)
APICS (www.apics.org) Certified Supply Chain Professional (CSCP)
International Quality Federation (www.iqfnet.org) Six Sigma Master Black Belt (SSMBB)
American Society for Quality (www.asq.org) Certified Six Sigma Black Belt (CSSBB)
American Society for Quality (www.asq.org ) Certified Manager of Quality/Organizational Excellence
(CMQ/OE)
American Society for Quality (www.asq.org) Certified Quality Engineer (CQE)
American Society for Quality (www.asq.org ) Certified Quality Auditor (CQA)
RABQSA (www.rabqsa.com) Quality Management System Auditor (QMS-A)
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Part 1
Purpose and Structure of a QMS, PDCA
and the 8 Principles of Quality
Management
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1
What is ISO 9001:2008 QMS?
• ISO = International Organization for
Standardization
• 9001 = code to denote QMS Series
• 2008 = year of last revision
• Is a family of standards for implementing a
Quality Management System (QMS)
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Evolution of Quality Standards
ISO 9001 ISO 9001 ISO 9001 ISO 9001

1987 1994 2000 2008
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2
The ISO 9001:2008 Model
Continual
ContinualImprovement
Improvementof
ofthe
theQMS
QMS
clause 4
CUSTOMER REQUIREMENTS
CUSTOMER SATISFACTION
info. flow management
management
responsibility
responsibility
clause 5
clause 6 clause 8
resource
resource meas,
meas,analysis
analysis info. flow
management
management improvement
improvement
clause 7
Input product
product Output
realization product
product
value realization value
adding adding
activities activities
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Clauses/Requirements
Clause 4. Quality Management System
Clause 5. Management Responsibility
Clause 6. Resource Management
Clause 7. Product Realization
Clause 8. Measurement, Analysis and
Improvement
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3
Eight Quality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
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1. Customer Focus
• Organizations depend on their
customers; therefore they should

– Know their current and future needs
– Meet their requirements
– Exceed their expectations
– Get their feedback
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4
2. Leadership
management
management
• Leaders create common responsibility
responsibility
purpose and direction;

therefore they should
– Maintain a healthy internal
environment
– Inspire workforce to excel
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3. Involvement of People
resource
resource
• People are the essence of an management
management
organization; therefore
– They should be fully involved
– Their abilities should be used for
organization benefits
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5
4. Process Approach
Manage activities and related

resources as a PROCESS
Review Purchase Design Make Deliver
Order Product
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Process Approach
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6
“Turtle” Approach
WITH WHAT ?
(Materials /
WITH WHO?
Equipment) (Competence / Skills
/ Training)
PROCESS
OUTPUTS
INPUTS
HOW? OBJECTIVES/MEASURES?
(Support Processes, (Performance Indicators)
Procedures & Methods)
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Example: Management Responsibility

with what with who
Management Review Management team
forum Quality manager
Previous year’s results Team leaders
inputs
Internal audits Management outputs
Customer satisfaction responsibility Annual plan
trends & objective Improvement
Process/Product setting objectives
measures
Faults/Complaints data
how
measures support Implementation plan
Results vs plan
Customer surveys processes Resource allocation
Roles & responsibilities
Milestones IT systems
Communications
Purchasing
HR, Training
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7
5. System Approach to Management
• Managing interrelated processes as a
system helps the organization in achieving
its objectives in an effective and efficient
manner
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8
6. Continual Improvement: PDCA Cycle
Continual
ContinualImprovement
Improvementof
ofthe
theQMS
QMS
management
management
responsibility
responsibility
Plan Act
resource
resource meas.,
meas.,analysis
analysis
management
management improvement
improvement
Do Check
product
product
realization
realization
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7. Factual Approach to Decision-Making

• Effective decisions are based on
the analysis of data and
information
info. flow management

management
responsibility
responsibility
meas.,
meas.,analysis
analysis info. flow
improvement
improvement
product
product
realization
realization
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9
8. Mutually Beneficial Supplier Relationship
• Interrelated
• Win-Win
product
product
Supplier realization
realization
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Part 2
ISO 9000 Series
Explored and
Understood
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10
Structure of ISO 9001:2008
• 0.1 General
• 0.2 Process approach
• 0.3 Relationship with ISO 9004
• 0.4 Compatibility with other management systems
• 1 Scope
• 2 Normative References
• 3 Terms and Definitions
• 4. Quality management system
• 5. Management responsibility
• 6. Resource management
• 7. Product realization
• 8. Measurement, analysis and improvement
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4: Quality Management System

• General requirements (4.1)
– General requirements for approach & content of the
QMS (e.g. for the adoption of the process approach)
– Outsourcing
• Documentation requirements (4.2)
– Mandatory procedures
– Manual, Policy & Objectives
– General sufficiency of documentation and records
– System for Document Control
– System for Control of Records
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11
5: Management Responsibility
• The areas where direct Top Management
involvement is mandatory
– Demonstrating commitment
– Demonstrating customer focus
– Input into policy development & review
– Identification of objectives and input into the
planning process
– Defining responsibilities, providing resources
– Ensuring internal communications are effective
– Involvement in management review
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6: Resources
• Human Resources
– Ensuring adequacy particularly in respect of
training
• Infrastructure
– Buildings, work space, equipment, vehicles,
information systems etc
• Environmental controls (Aligned with
ISO14000)
– Heat, light, humidity, temperature, clean rooms
– In fact any controls that are applicable
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12
7: Product Realisation
• Think of this as “Production” or “Service Delivery”
– Control of the core day to day operations
– Operational planning (7.1)
– Handling contracts, enquiries & customer
communication systems (7.2)
– Design (7.3)
– Management of supplies and suppliers (7.4)
– Operational controls (7.5)
– Calibration (7.6)
• Exclusions may apply
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8: Measurement, Analysis & Improvement

• The collection and constructive use of data
– Measuring product (conformity checks and inspection)
– Measuring process (efficiency measures)
– Customer satisfaction (Survey, Feedback, Complaint)
– Internal audit
– Control of quarantine/isolation activities
– Analysis of data (you must do something with data)
– Continual improvement (the standard encourages the
application of the process approach to improvement)
– Corrective action (Correction + Corrective
Action)
– Preventive action
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13
Process Approach
• Process approach to quality management
encouraged
• An activity using resources, and managed
in order to enable the transformation of
inputs into outputs, can be considered as
a process.
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Processes:
Resources Controls
Input Output
Activities
or
set of activities
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14
Processes - Understand Interactions
Resources Controls
Input
Process A Process C
Output
Process B Process D
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Customer satisfaction
Continual Improvement of the
Quality Management System
C C
U U S
S R Management S a
t
e responsibility
T q T i
u s
O i O f
M r Measurement, M a
e Resource c
Analysis and
E m
management improvement E t
e i
R n R o
Input
S t Output S
n
s
Product Product
realisation
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15
1 Scope (1.1 General)
Standard specifies QMS requirements for use to:
• demonstrate organisation’s ability to consistently
provide product meeting customer & applicable
statutory & regulatory (legal) requirements
• enhance customer’s satisfaction through
effective application of the system including
processes for its continual improvement and
assurance of conformity to customer and
applicable statutory & regulatory requirements
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1.2 Application
• Requirements are generic
• Requirement may be excluded if cannot
be applied due to the nature of
organisation and its product
• Exclusions must:
– Not affect ability or responsibility to provide
conforming product
– Be limited to Clause 7
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16
2 Normative reference
• ISO 9000 : 2005, Quality management
systems - Fundamentals and vocabulary.
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3 Terms and definitions

• The term “product” also means “service”
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17
4.1 General requirements
• Establish, document, implement and
maintain a QMS and continually improve
its effectiveness in accordance with the
standard
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4.1 General Requirements

• Determine the processes necessary for QMS
• Determine the sequence and interaction of
processes
• Determine criteria & methods to ensure effective
operation & control of the processes
• Ensure availability of resources and information
needed to support the operation & monitoring of
the processes
• Monitor, measure where applicable and analyse
processes
• Implement actions necessary to achieve
planned results & continual improvement
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18
4.1 General Requirements
• Manage the processes in accordance with
the standard
• Ensure control of outsourced processes
affecting product conformity
• Define control of outsourced processes
within the QMS
• Control over outsourced processes does
not absolve the organization of its
responsibilities
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4.2 Documentation requirements

4.2.1 General
• QMS documentation:
– Quality policy, objectives
– Quality manual
– Documented procedures and records
– Documents, including records determined by
the organisation
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19
4.2.1 General
• Documented procedure means that it must
be established, documented, implemented
and maintained
• Extend of documentation may differ due to
– Size & type of organisation
– Complexity & interaction of processes
– Competence of personnel
• Documentation may be in any type of
media
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4.2.2 Quality Manual

• Quality manual must include as minimum:
– The scope of QMS including details of, and
justification for, any exclusions
– Documented procedures or reference thereto
– Description of the interaction between the
processes of the QMS
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4.2.3 Control of documents
• Documented procedures to:
– approve documents prior to issue
– review, update as necessary and re-approve documents
– to identify the changes and the current revision status of
documents
– to ensure documents remain legible, readily identifiable
– ensure relevant versions of applicable documents are available
at points of use
– ensure that documents of external origin necessary for planning
and operation of QMS are identified and distribution controlled
– obsolete documents are prevented from unintended use and
identified if kept for any reason
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Six Mandatory Procedures

ISO 9001:2008 identifies 6 mandatory procedures:
4.2.3 Control of Documents,

4.2.4 Control of Records,
8.2.2 Internal Audit,
8.3 Control of Non-Conforming Product,
8.5.2 Corrective Action and
8.5.3 Preventive Action
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4.2.4 Control of Records
• Records to provide evidence are
controlled
• Documented procedure to define the
controls needed for the identification,
storage, protection, retrieval, retention and
disposition of quality records.
• Records must be legible, readily
identifiable and retrievable.
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22
1. Quality Manual Why? Quality Policy, Quality Objectives
Organization’s Commitment,
1 System Description
2. Procedures What?, When?, Overall Procedures

2 Where?, Who?
3 3. Work Instructions How? Detailed instructions to do work
4. Records Objective Recorded Data, for example

4 Evidence filled-in forms
QMS Documentation Hierarchy

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5 Management Responsibility
• 5.5 Responsibility,
• 5.1 Management authority and
commitment communication
– 5.5.1 Responsibility &
• 5.2 Customer focus authority
• 5.3 Quality policy – 5.5.2 Management
representative
• 5.4 Planning
– 5.5.3 Internal communication
– 5.4.1 Quality objectives
– 5.4.2 QMS planning • 5.6 Management
review
– 5.6.1 General
– 5.6.2 Review input
– 5.6.3 Review output
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23
5.1 Management Commitment
• Provide evidence of commitment to the
development implementation and
continual improvement of QMS by:
– communicating the importance of meeting
customer and statutory and regulatory
requirements
– establishing quality policy & objectives
– management reviews
– provision of resources
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5.2 Customer Focus

Determine customer
requirements
Meet requirements
Customer satisfaction
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24
5.3 Quality Policy
• appropriate to the purpose of the organisation
• commitment to comply with requirements
• continually improve the effectiveness of the
QMS
• framework for establishing & reviewing quality
objectives
• communicated and understood
• reviewed for continuing suitability
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5.4.1 Quality Objectives

• establish quality objectives
• measurable & consistent with the quality
policy
• include those needed to meet
requirements for product
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25
5.4.2 Quality Management System
Planning
• planning of the QMS is carried out in order
to meet requirements given in 4.1, as well
as the quality objectives
• Maintain the integrity of the QMS integrity
when changes are planned and
implemented
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5.5 Responsibility, Authority and

Communication
5.5.1 Responsibility and authority
• define and communicate responsibilities
and authorities
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5.5.2 Management Representative
• Member of the organization’s management
• ensures that processes needed for the QMS are
established, implemented and maintained
• reports on performance of QMS including needs
for improvement
• promotes awareness of customer requirements
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5.5.3 Internal Communication

• Communication processes are established
• Communication takes place regarding the
effectiveness of QMS
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5.6 Management Review
5.6.1 General
• Review of the QMS by top management at
planned intervals to:
– ensure QMS suitability, adequacy & effectiveness
– assess opportunities for improvement
– evaluate the need for changes to QMS including
policy & objectives
• Records maintained.
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5.6.2 Review Input

audit results
customer feedback
process performance
product conformity
status of PAs and CAs Management
follow up actions from earlier Review
reviews
changes that could affect the
QMS
recommendations for
improvement
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5.6.3 Review Output
improved effectiveness of
Management the QMS
Review improvement of product
resource needs
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6 Resource Management
• 6.1 Provision of resources
• 6.2 Human resources
– 6.2.1 General
– 6.2.2 Competence, training and awareness
• 6.3 Infrastructure
• 6.4 Work environment
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6.1 Provision of Resources
• Determine & provide the resources
needed to:
– implement, maintain the QMS and continually
improve its effectiveness
– enhance customer satisfaction
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6.2 Human Resources

• 6.2.1 General
Personnel performing work affecting
conformity to product requirements must
be competent on the basis of :
• appropriate education
• training
• skills
• experience.
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6.2.2 Competence, Training and
Awareness
• Determine the necessary competence
• Provide training or take other action to
satisfy those needs
• Evaluate the effectiveness of actions taken
• Ensure staff aware of relevance and
importance of their activities and
contribution to achieving objectives
• Maintain appropriate records of education,
training, skills and experience
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6.3 Infrastructure
• Determine, provide & maintain the
infrastructure needed to achieve product
conformity. Infrastructure includes, as
applicable:
– buildings, workspace
– equipment
– supporting services
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6.4 Work Environment
• Determine and manage the work
environment needed to achieve product
conformity.
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7 Product Realization
7.1 Planning of product realization
7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production & service provision
7.6 Control of measuring & monitoring equipment
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7.1 Planning of Product Realization
• Planning must determine as appropriate:
– quality objectives and requirements for the
product
– the need for processes, documentation,
resources specific to the product
– verification and validation activities &
acceptance criteria
– Records to provide evidence
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7.2 Customer Related Processes

7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
7.2.3 Customer communication
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7.2.1 Determination of
Requirements Related to Product
• Organisation must determine:
– requirements specified by the customer
– requirements not specified but necessary
– statutory and regulatory requirements
applicable to product,
– any additional requirements
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7.2.2 Review Requirements

Related to the Product
• Review requirements before commitment to supply
product & ensure that:
– product requirements are defined
– difference between contract requirements from those previously
expressed resolved
– organisation has ability to meet the requirements
• Record the results of review and actions
• Confirm requirements, when customer does not provide
documented requirements
• When requirements are changed ensure that documents
are amended and relevant persons are made aware
of the changes.
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7.2.3 Customer Communication
• Effective arrangements for communication
with customers relating to :
– product information
– enquiry, contract & order handling including
amendments
– customer feedback including complaints
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7.3 Design & Development

7.3.1 Design & development planning
7.3.2 Design & development inputs
7.3.3 Design & development outputs
7.3.4 Design & development review
7.3.5 Design & development verification
7.3.6 Design & development validation
7.3.7 Control of design & development changes
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7.3.1 Design & Development (D&D)
Planning
• Plan & control D&D of the product.
• Planning to include:
– D&D stages
– required review, verification and validation
activities
– responsibilities & authorities for D&D
• Interfaces between groups must be
managed
• Planning to be updated as the D&D
progresses Vincent Gaspersz 71
7.3.2 Design & Development Inputs

• Determine & record product requirements
including:
– functional & performance requirements
– applicable statutory and regulatory requirements
– information from previous similar designs
– any other essential requirements
• Review input for adequacy
• Requirements must be complete, unambiguous
and not in conflict with each other
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7.3.3 Design & Development
Outputs
• D&D output in a form suitable for verification
• D&D output must
– meet the input requirements
– provide information for purchasing, production and
service provision
– contain or reference acceptance criteria
– define characteristics essential for proper & safe use
• Approve output prior to release
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Review
• At suitable stages systematic reviews of
D&D to:
– evaluate the ability to meet requirements
– identify problems and propose follow up
• Involve all functions concerned
• Record the results and any necessary
actions
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Verification
• Verify D&D to ensure that output meets
the input requirements
• Record the results of verification and
necessary actions
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Validation
• Perform D&D validation to confirm that
product is capable of meeting the
requirements for the specified or intended
use
• Whenever applicable to be completed
prior to delivery
• Results of validation and necessary
actions must be recorded
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7.3.7 Control of Design and
Development Changes
• Design & development changes must be
identified and records maintained
• Changes must be reviewed, verified and
validated as appropriate and approved
before implementation
• Record results of review of changes and
any necessary actions
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7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
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7.4.1 Purchasing Process
• Ensure that purchased product meets
requirements
• Type & extend of control depends on effect
purchased product may have on the final
product
• Evaluate and selects suppliers based on their
ability to supply conforming product
• Establish criteria for selection, evaluation and re-
evaluation of suppliers
• Results of evaluation and any necessary actions
must be recorded
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7.4.2 Purchasing Information

• Purchasing information must include
where appropriate:
– requirements for approval of product,
procedures, processes and equipment
– requirements for qualification of personnel
– quality management system requirements
• Ensure adequacy of specified purchase
requirements prior to their communication
to supplier
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7.4.3 Verification of Purchased
Product
• Establish & implement inspection or other
activities needed to ensure purchased
product conformity
• Where organisation or its customer
propose verification at supplier’s premises,
organisation must specify in purchasing
information:
– verification arrangements
– method of product release
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7.5 Production and Service

Provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for
production and service provision
7.5.3 Identification & traceability
7.5.4 Customer property
7.5.5 Preservation of product
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41
7.5.1 Control of Production and
Service Provision
• Plan and carry out production & service
provision under controlled conditions. Controlled
conditions include as applicable:
a) availability of information describing product
characteristics
b) availability of work instructions, as necessary
c) the use of suitable equipment
d) availability & use of monitoring and measuring
equipment
e) implementation of monitoring and measurement
f) the implementation of product release, delivery and
post delivery activities
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7.5.2 Validation of Processes

• Validate processes where outcome is not verified and as
a consequence, deficiencies may become apparent after
delivery
• Validation shall demonstrate the ability of processes to
achieve results
• For these processes establish:
– criteria for review and approval of the process
– approval of equipment and qualification of personnel
– use of defined methods & procedures
– requirements for records
– revalidation
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7.5.3 Identification and Traceability
• Where appropriate identify product by
suitable means throughout product
realization
• Identify status with respect to
measurement & monitoring requirements
throughout product realization
• Where traceability is required control the
unique identification of product
• Maintain records
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7.5.4 Customer Property

• Care for customer’s property while it is under
organisation’s control or being used by
organisation
• Identification, verification, protection &
safeguarding customer property provided for
use or incorporation
• Any customer property that is lost, damaged or
found unsuitable must recorded & reported to
customer
Customer property includes intellectual property & personal data
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7.5.5 Preservation of Product
• Preserve the product during internal
processing and final delivery to intended
destination
• Include identification, handling, packaging,
storage and protection
• This applies to constituent parts of a
product
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7.6 Control of Monitoring &

Measuring Equipment
• Determine monitoring and measurements to be
made & measurement & monitoring equipment
needed to provide evidence of conformity of
product
• Ensure measuring and monitoring is carried out
consistently with monitoring and measurement
requirements
• Suitability of measuring/monitoring software
must be confirmed prior to use and re-confirm as
necessary
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44
7.6 Control of Monitoring &
Measuring Equipment
• Calibrate or verify or both at specified intervals or prior to use
against international or national standards. Where no such standard
exist record the basis
• Adjust or re-adjust as necessary
• Have identification to determine calibration status
• Safeguard from adjustments invalidating calibration
• Protect from damage or deterioration during handling,
maintenance& storage
• record results of calibration
• assess and record validity of previous results when device found to
be out of calibration
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8 Measurement, Analysis and Improvement

• 8.3 Control of
nonconforming product
• 8.1 General
• 8.4 Analysis of data
• 8.2 Monitoring/measurement
– 8.2.1 Customer • 8.5 Improvement
satisfaction – 8.5.1 Continual
– 8.2.2 Internal Audit improvement
– 8.2.3 Monitoring & – 8.5.2 Corrective action
measurement of – 8.5.3 Preventive action
processes
– 8.2.4 Monitoring &
measurement of product
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45
8.1 General
• Plan & implement measurement,
monitoring analysis and improvement
processes needed to:
– demonstrate conformity to product
requirements
– ensure conformity of the QMS
– continually improve the effectiveness of the
QMS
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8.2.1 Customer Satisfaction

• Organisation shall monitor information
related to customer perception as to
whether the organisation has met
customer requirements.
• The methods for obtaining and using this
information must be determined
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46
8.2.2 Internal Audit
• Conduct internal audits at planned intervals to
determine if :
– QMS conforms to the planned arrangements,
requirements of the standard and organisation’s
requirements
– QMS is effectively implemented & maintained
• Plan the audit programme considering:
– status and importance of the processes and the areas
– results of previous audits
• Define audit criteria, scope, frequency &
methodologies
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8.2.2 Internal Audit

• Select auditors to ensure objectivity and
impartiality.
• Auditor must not audit own work.
• The documented procedure must cover:
– responsibilities & requirements for planning and
conducting audits
– reporting results and maintaining records
• Corrective actions without undue delay
• Follow up to verify actions taken & report
verification results
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47
8.2.3 Monitoring and Measurement
of Processes
• Apply suitable methods for monitoring and,
where applicable, measurement of QMS
processes
– These methods shall demonstrate the ability
of the processes to achieve planned results
– Where planned results are not achieved
corrections and corrective actions must be
taken
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8.2.4 Monitoring and Measurement

of Product
• Monitor & measure product characteristics to verify
conformity at appropriate stages
• Evidence of conformity with the acceptance criteria must
be maintained.
• Records must indicate the person(s) authorising release
of the product for delivery to the customer
• Release or delivery must not proceed until all the
planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant
authority, and where applicable by the customer
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48
8.3 Control of Nonconforming
Product
• Nonconforming product must be identified
and controlled to prevent unintended use
or delivery
• Documented procedure to define controls,
responsibility and authority
• When the nonconforming product is
corrected it must be re-verified to
demonstrate conformity
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8.3 Control of Nonconforming

Product
• Organisation must deal with nonconforming
product by one or more of the following ways:
– action to eliminate detected nonconformity
– concession
– preclude original intended use or application
– Taking actions appropriate to the effects,
when nonconformity is detected after delivery
• Records of the nature of nonconformity and any
subsequent action including concessions must
be maintained
Vincent Gaspersz 98
49
8.4 Analysis of Data
• Determine, collect & analyse appropriate data to
demonstrate the suitability and effectiveness of QMS
and to evaluate where continual improvement of the
QMS can be made
• Data from measurement & monitoring & other relevant
sources
• Analyze data to provide information on:
– customer satisfaction
– conformity to product requirements
– process, product characteristics and their trends including
opportunities for preventive action
– suppliers
Vincent Gaspersz 99
8.5 Improvement
8.5.1 Continual improvement
• Organisation shall continually improve the effectiveness
of the QMS through use of:
– quality policy
– quality objectives
– audit results
– analysis of data
– corrective actions
– preventive actions
– management review
Vincent Gaspersz 100

50
8.5.2 Corrective Action
• Take actions to eliminate the causes of nonconformities
to prevent recurrence.
• Corrective actions appropriate to the impact of the
problem
• Documented procedure shall define requirements for:
– reviewing nonconformities (including customer complaints)
– determining the causes of nonconformities
– Evaluating the need for corrective action
– determining & implementing action needed
– recording results of action taken
– reviewing the effectiveness of the corrective action taken

8.5.3 Preventive Action

• Determine action to eliminate the causes of
potential nonconformances to prevent
occurrence.
• Actions appropriate to the impact of the potential
problem
• Documented procedure must define the requirements for
– determining potential nonconformances & their causes
– evaluating the need for preventive action
– determining and implementing action needed
– recording the results of action taken
– reviewing the effectiveness of the preventive action taken

51
Part 3
Internal Quality Audit

What is Quality?
• Q is fitness for use.
• Q is conformance to requirements.
• Q is conformance to customer/user
requirements.
– Meet/satisfy customer/user requirements,
needs, and expectations.
• Degree to which a set of inherent

characteristics fulfills requirements.
(ISO 9000 : 2005)

52
What is 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

What is Audit Evidence?

• Records, statements of fact or other
information, which are relevant to
the audit criteria and verifiable

53
What is Audit Findings?
• Results of the evaluation of the

collected audit evidence against
audit criteria.

What is Audit Client?
• organization or person requesting

an audit.

54
What is Auditee?
• Organization being audited

What is Auditor?
• Person with the competence to
conduct an audit.

55
What is Technical Expert?
• person who provides specific
knowledge or expertise to the audit
team.

What is Audit Plan?

• Description of the activities and
arrangements for an audit.

56
What is Audit Scope?
• extent and boundaries of an audit.

What is Nonconformance?
Non‐fulfillment of a requirement

57
What is Correction, and C & P Actions?
Correction:
Action to eliminate a detected nonconformity
Corrective Action:
Action to eliminate the cause of a detected
nonconformity
Preventive Action:
Action to eliminate the cause of a potential
nonconformity or other undesirable potential
situation
What is Ident., Trac. And Status?

Identification:
To describe product/ raw material/ semi finish
product etc. Example Batch #, Lot #, Code etc
Traceability:
Ability to trace the history, application or location of
that which is under consideration
Status:
To identify the current status of product/ raw material with regard
to inspection and test results. Tag/ sticker of HOLD, REWORK,
SCRAP Identified areas.

58
Types of Audits
• First-party (internal audit)
• Second-party (external audit done by customer or
other interested party)
• Third-party (external audit performed by
independent (disinterested) external organization,
e.g. audit by registrars or certification bodies

The Purpose of an Audit is ...

to collect objective evidence to
permit an informed judgment about
the status of the quality
management system

59
Objectivity of Auditing
AUDIT AUDIT
CRITERIA EVIDENCE
AUDIT FINDINGS
Improvement Conformance Non-Conformance
Major Minor
AUDIT CONCLUSION
RECOMMENDATION
FOR AUDIT

Audit Methods &

Techniques
FORWARD TRACE
RECEIVE
INSPECT STORES
GOODS
BACKWARDS TRACE

60
Internal Quality Audit Steps
Initiation
Preparation
Evaluation
Reporting
Fixing

Initiation STEPS RESPONSIBILITY

1. Request Audit Program Manager
2. Identify Lead Auditor Program Manager
3. Define Audit Scope Program Manager
& Lead Auditor

61
Importance of Preparation

Exercise: Initiation
• Who is responsible for scheduling the
audits?
• When are internal audits scheduled?
• How often are audits performed?
• Who is responsible for selecting the
auditors?
• What criteria are important for
selecting auditors?

62
Annual Audit Plan
• Considerations
• Approvals

Exercise: Auditing the Training Activity
• Why is the audit performed?

• What is being audited?
• Which requirements?

63
SOLUTION:
• Purpose:
– To verify compliance with Quality
Manual and ISO 9001:2008
• Audit Scope:
– Training Activity
• Requirements:
– As specified in
• ISO 9001:2008
• etc

Internal Quality Audit

Steps
Initiation
STEPS RESPONSIBILITY
4. Select Audit Team Lead Auditor
Preparation
5. Understand Org. Audit Team
6. Review Documentation Audit Team
7. Plan the Audit Lead Auditor
8. Prepare Checklist &
Working Papers Audit Team

64
Audit Team
• Consider team member qualifications
• Consider activities being audited
• Consider type and degree of
experience of the auditors
• Create a balanced team

Preparation Steps
review
initiation
documents
get plan
approvals audit

65
Exercise: Review Documentation
For the Training activity, which specific
documents would you request to
prepare your team for the audit?

Review Documentation
• Quality Manual • Past audit
• Procedures performance
• Forms • Customer feedback
• Organization chart • Number of
• Facility floor plan employees
• Working hours

66
Plan Audit
• Confer with audit team members
• Don’t forget the approvals

Audit Plan: June 22-23, 2011
Purpose: To verify compliance with Quality Manual and ISO 9001:2008

Audit Scope: Training
Requirements: As specified in
- ISO 9001:2008
- Quality Manual,
- HR Procedure
Overall Schedule:
June 22, 2011 June 23, 2011
8:00-8:30 Opening Meeting 8:00-11:00 Field Activities
8:30-9:00 Audit Team Meeting 11:00-12:00 Audit Team Meeting
9:00-12:00 Field Activities 12:00-1:00 Exit Meeting
12:00-1:00 Audit Team Meeting
1:00-3:00 Field Activities
3:00-3:30 Daily Auditee Briefing
Audit Team Members: Ms. Yenny, Lead Auditor

Mr. Willy, Auditor
Mr. Robert, Auditor
Approved: ________________ Approved: ________________

Ms. Yenny Mr. Budi

67
Initiation
Preparation
9. Conduct Opening Meeting Lead Auditor
Evaluation 10. Meet with Management Audit Team
11. Interview & Observe Audit Team
12. Assess Evidence Audit Team

An auditor’s memory is
as sharp as his pencil.

68
Focus of the Audit
To collect objective evidence to
permit an informed judgment about
the status of the quality
management system.

Objective evidence may be ...

• documented
• based on interview
• based on observation
• quantitative
• qualitative
• verifiable

69
Checklists & Working Papers
Checklists
Audit Questions
Audit Investigation
Audit Findings

Checklists
Checklists plan
the flow of
questions

70
Checklists
Checklists
guide the course
of the audit

Checklists
Checklists
define
the sample

71
Checklists
Checklists
help in writing
the report

Checklist should …
• Be based on information available
before the audit
• Be modified when necessary
• Allow follow-up
• Be balanced to cover priority areas
• Be created by individual auditors

72
Who do I talk to?
• Talk to the right people
– Those responsible for the activity
– Those doing the activity

Audit Team Meeting

• Informal briefings
• Opportunity to share
information
• Discuss necessary
adjustments to plan
• Develop report
• Helps keep
communication lines open
among audit team
members
73
Opening Meeting
• Conduct before start of field activities
• Audit team members must be present
• Auditee contacts should be present
• Creates an atmosphere of
cooperation between auditors and
auditee

Opening Meeting
• Sign-in sheet
• Distribute detailed audit schedule
• Address any auditee scheduling
concerns
• Revise schedule, if necessary

74
Daily Auditee Briefing
• Review potential findings regularly
with auditee
• Opportunity for auditee to close a
finding before the end of the audit
• Helps strengthen communications
• Audit becomes constructive

Interview & Observe

• Asking questions
• Observing activities
• Examining documents & records
• Examining facilities

75
Observing Activities
Confirm that
procedures are
being followed
how?
how?

Look for
undocumented
activities
what?
what?

76
Confirm answers
who?
who?

• Auditee Reactions
– Take over conversations
– Play “show & tell”
– Blame someone
– Act defensively
– Waste time
– Interrupt
– etc

77
Interviewing

Interviewing
• Introduce yourself
• Explain why you are there
• Investigate to depth
necessary
• Ask, Listen, Verify
• Interview the right people
– Those responsible for the
activity
– Those doing the activity
• Rumors is not evidence
78
Interviewing
• Interview for:
– elaboration
– corroboration
– perspective
– basis for
evidence

Interviewing
• Two eyes
• Two ears
• One mouth
• Ratio of use:
– One of
speaking to
four receiving

79
Interviewing
why
why
when
when
what
what how
how
who
who where
where

When Something Seems Wrong

80
When Something Seems Wrong
• Is it really wrong?
• Does he know it is wrong?
• What is his explanation?
• Is it an isolated event, or a
symptom of a deeper problem?
• Why didn’t quality system detect
it?

Nonconformity
Nonconformity refers to a
failure to meet a
specified requirement:
– Quality Manual Policies
– Procedures
– ISO 9001:2008 req.
– Government Regulations

81
85% or more of processes can be improved
by modifying organizational systems
(a management responsibility) rather
than attempting to modify an
individual employee’s performance.
W. Edwards Deming

What if nothing seems to be wrong?
• No problems …
don’t panic
• Move on
• Don’t keep
looking for
something wrong

82
ROLE PLAY:
•Auditing role
play

Initiation
Preparation
Evaluation
13. Write Nonconformities Audit Team
Reporting 14. Conduct Closing Meeting Audit Team
15. Write a Summary Report Lead Auditor

83
Do I have a Nonconformity?
YES
if you have objective evidence that:
• A requirement is not addressed
• Practice differs from defined system
• System is not effective

Major or Minor Nonconformity

• Major
– System element is missing
– System element is not implemented
– System element is not effective
• Minor
– A single/isolated lapse in the system

84
EXERCISE: Nonconformity or Not
• For each situation, identify whether

– major nonconformity,
– Minor nonconformity, or
– nothing.

Writing a Nonconformity: The 4 C’s

• Clear … Simple language
• Correct … Objective
• Complete … Traceable
• Concise …… Summary
– What happened?
– What should happen?

85
Writing Nonconformity: Steps
1. Write (informally) the
nonconformity on the spot.
2. Explain to auditee manager
promptly.
3. Review with team members.
4. Write nonconformity statement on
the NCR (Non-Conformity Report).
5. Get auditee manager signature.

Closing Meeting Keys

• Informal setting
• Report the results to management
• Agree on follow-up
• Questions and clarification

86
Agenda of Closing Meeting
1. Introduction & purpose of meeting
2. Thanks for cooperation
3. Distribute list of attendees
4. Review audit purpose and scope
5. Explain nature of sampling
6. Summarize results: Good observations, no. of
nonconformities, overall weakness, recommendations
7. Summary from each auditor
8. When to expect written report
9. Agreement on follow-up
10. Questions & Clarifications

Audit Summary Report

• Prepared by Lead Auditor
• Sent promptly to Management Representative
• Sent promptly to Heads of audited area
Audit Report Content

• Audited area
• Lead Auditor and members
• Audit date
• Audit scope
• Audit criteria (list of key documents)
• Summary of findings
• Good practices
• Total number of nonconformities
• Descriptions and discussion of nonconformities
• Conclusion

87
Initiation
Preparation
Evaluation
Reporting
Fixing 16. Take Corrective Actions Auditee
17. Verify Corrective Actions Audit Team
Follow-Up Flowchart
Identify
Identify Agree
Agreeononneed
need
NC,
NC,issue
issueNCR
NCR for
for CA,sign
CA, signitit
Propose
ProposeCACA
Agree?
Agree? plan
plan
not OK
OK
Verify
VerifyCA
CA Implement
Implement
&&
CA
CA
Close
CloseNCR
NCR
NC = Non-Conformance
NCR = Non-Conformance Report
CA = Corrective Action Vincent Gaspersz 176
88
Part 4
Auditor’s Skills & Responsibilities

Auditor’s Responsibilities
• Communicating
• Planning and executing
• Documenting
• Reporting
• Verifying
• Safeguarding
• Cooperating

89
Auditor’s Qualifications
• Education
• Training
• Experience
• Personal Attributes
• Management Skills

Auditor Skills
• Communication skills
• Interpersonal skills
• Analytic skills

90
Internal Auditor
• Acts as a consultant

Contact: The End SMARTER

Specific Goals
Measurable
Vincent Gaspersz
Phone: 0251-8332933 or Achievable
0813-1940-6433 Result-oriented
E-mail: vincentgaspersz@yahoo.com Timely
Empowerment
Reward & Recognition
Smarter:
• Shorter Cycle Time
• Smoother processes
• Simpler rules or procedures

91

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ISO 9001:2008

Quality Management System

Lean Six Sigma Master Black Belt

Professor of Total Quality and Operations Management, Program MM Universitas Trisakti

Evolution of Quality Standards

ISO 9001 ISO 9001 ISO 9001 ISO 9001

customers; therefore they should

purpose and direction;

 Manage activities and related

Review Purchase Design Make Deliver

Example: Management Responsibility

7. Factual Approach to Decision-Making

info. flow management

4: Quality Management System

8: Measurement, Analysis & Improvement

3 Terms and definitions

4.1 General Requirements

4.2 Documentation requirements

4.2.2 Quality Manual

Six Mandatory Procedures

4.2.3 Control of Documents,

2. Procedures What?, When?, Overall Procedures

3 3. Work Instructions How? Detailed instructions to do work

4. Records Objective Recorded Data, for example

QMS Documentation Hierarchy

5.2 Customer Focus

5.4.1 Quality Objectives

5.5 Responsibility, Authority and

5.5.3 Internal Communication

5.6.2 Review Input

6.2 Human Resources

7.2 Customer Related Processes

7.2.2 Review Requirements

7.3 Design & Development

7.3.2 Design & Development Inputs

7.3.4 Design & Development

7.3.6 Design & Development

7.4.2 Purchasing Information

7.5 Production and Service

7.5.2 Validation of Processes

7.5.4 Customer Property

Customer property includes intellectual property & personal data

7.6 Control of Monitoring &

8 Measurement, Analysis and Improvement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.4 Monitoring and Measurement

8.3 Control of Nonconforming

Vincent Gaspersz 100

Vincent Gaspersz 101

8.5.3 Preventive Action

Vincent Gaspersz 102

Internal Quality Audit

Vincent Gaspersz 103

• Degree to which a set of inherent

Vincent Gaspersz 104

Vincent Gaspersz 105

What is Audit Evidence?

Vincent Gaspersz 106

• Results of the evaluation of the

Vincent Gaspersz 107

What is Audit Client?

• organization or person requesting

Manage activities and related

Approved: Approved: