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Awareness to

ISO 9001:2000
Tutor’s Introduction
Course Objectives

z Be able to understand and


interpret the requirements of the
standard

z Planning to implement the


requirements of the standard
Course Structure

z Lectures and value added


discussions on each topic.
z Workshops to enable
delegates to increase their
understanding regarding ISO
9001:2000 version and to
experience Quality
Management System
implementation practices.
ISO

ISO14
001
ISO 9000
International SA8 0
00

Organization for OHSAS1


8001
9
1694
Standardization ISO/ TS
INTRODUCTION
Origin
ISO 9000:87
ISO 9000:94
ISO 9001:2000
BS5750
1979
AQAP1
(NATO)
1970’s
MIL-STD-9858
(1940’s)
What is ISO?
z International Organization for Standardization
z Develops standards do not certify companies
z Around 140 countries members
z Around 13000 standards produced
z Technical Committees are formed to produce
standards
z TC 176 for ISO 9000
z International Organization for Standardization
Email: central@iso.ch
Web: http://www.iso.ch
http://www.bsi.org.uk/iso-tc176-sc2.
ISO 9000:2000
Family of Standards
z CORE STANDARDS
z ISO 9000:2000 Fundamentals and Vocabulary
z ISO 9001:2000 QMS Requirements
z ISO 9004:2000 Guidelines for Performance Improvement

z SUPPORTING STANDARDS
z ISO 10005:1995 Guidelines for Quality Plans
z ISO 10006:1997 Guidelines for Project Management
z ISO 10007:1995 Guidelines for Configuration Mgt
z ISO 10011-1, -2, -3 on Auditing
z ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt.
z ISO 10013:1995 Guidelines for Quality manuals
ISO 9000:2000 Family of
Standards

z ISO/TR 10014:1998 Guidelines for


managing economics of quality
z ISO 10015 Guidelines for Training
z ISO/TR 10017:1999 Guidelines on
Statistical techniques
What’s New?
1. New Standard
z ISO 9002 and 9003 dropped
z ISO 9001 modified

2. New Structure
z 20 clauses abandoned
z Now 8 sections
QMS

Quality
Management System
A System of coordinated activities which
is meant to “direct” and “control” an
organization with regard to quality.
or
(satisfying your customer by managing your resources,
through a standardized system)
Corrective &
Preventive
Actions Production &
Design Control Process Controls

Management
Material, Equipment
Human Resource &
Controls Records, Facility Controls
Documents, &
Change Controls
QUALITY MANAGEMENT
PRINCIPLES
What are they?

The basic principles on


which the ISO 9000:2000
standards are based

Quality Management
Principles
Principles of new Standard
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PRINCIPLE 1
CUSTOMER-FOCUSED
ORGANISATION

Organization depend on their customers and


therefore should understand current and
future customer needs, meet customer
requirements and strive to exceed customer
expectations.
PRINCIPLE 2
LEADERSHIP
z Leaders establish unity of purpose and
direction of the organization. They should
create and maintain the internal
environment in which people can become
fully involved in achieving the
organization's objectives.
PRINCIPLE 3
INVOLVEMENT OF PEOPLE
People at all levels are the essence of an
organisation and their full involvement
enables their abilities to be used for the
organisation’s benefit.
PRINCIPLE 4
PROCESS APPROACH
z A desired result is
achieved more efficiently
when related resources
and activities are
managed as a process.
PRINCIPLE 5
SYSTEM APPROACH TO
MANAGEMENT
z Identifying, understanding
and managing a system of
interrelated processes for
a given objective improves
the organization’s
effectiveness and
efficiency.
PRINCIPLE 6
CONTINUAL IMPROVEMENT

z Continual improvement
should be a permanent
objective of the
organization.
PRINCIPLE 7
FACTUAL APPROACH
TO DECISION MAKING
z Effective decisions are based on the
analysis of data and information.
PRINCIPLE 8
MUTUAL BENEFICIAL
SUPPLIER RELATIONSHIPS
z An organization and its
suppliers are
interdependent, and a
mutually beneficial
relationship enhances the
ability of both to create
value.
Process
Any activity that takes “inputs”
and converts them to “outputs”
Process Approach

The systematic identification and


management of these activities and the
interaction between activities.
Example - Purchasing
Process
Purchasing
Purchasing Outputs
Outputs
Inputs
Inputs Procedure
Procedure •• Receipt
Receiptof
of
•• Demand
Demandforfor Material
material Materialon
onright
right
material condition
condition
•• Item
Itemspecs
specsand
and •• Right
Date RightQuality
Quality
Date Right
RightQuantity
Quantity
•• Supplier Interactions
Interactionsto
to
Suppliersource
source •Storage •• Right
RightTime
Time
•• Suppliers •Storage
Suppliers •Inspection
capability •Inspectionand
andTesting
Testing
capabilityto
to •Manufacturing
meet •Manufacturing
meetour
our •Finance
requirements •Finance
requirements

Performance
PerformanceMeasurements
Measurements
•Delivery
•Deliverystatus
status––On-time,
On-time,On
Onspec,
spec,
etc
etc
•Supplier
•Supplierevaluation
evaluation
Process Approach Model
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM

C R
e Management C S
a
U q
responsibility U
t
i
u
S i
S s
r Measurement, f
T e Resource
analysis and T a
c
O m management improvement
e O t
M n
t M
i
o
Input
E s Service Output
E
n

R realization Product
R
Important changes
•More emphasis on customer satisfaction
•Commitment to comply with legal and statutory requirements
•Need to review suitability of quality policy
•Need to define quantified and measurable quality objective at
different functions and levels
•More emphasis on human resource management
•Re-evaluation of suppliers on the basis of their performance
•Analysis of data for continual improvement
•Need to maintain suitable work environment
•Term “Subcontractor” replaced with “Supplier” and “Supplier”
replaced with “organization”
•Exclusions defined
The Structure
0 Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 Quality management system
requirements
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
System Requirements /
Structure of the Standard
4 Quality 5 Management 6 Resource 7 Product 8
Management Responsibility Management Realization Measurement
System Analysis &
improvement

Management
General Provision of Planning(7.1)
Commitment(5. General (8.1)
requirements (4.1) resources(6.1)
1)
Customer
Documentation Customer focus related
Requirements(4.2) (5.2) Human Monitoring &
processes(7.2
resources(6.2) measurement(8.2)
)
Quality Design &
policy(5.3) development(7.3)
Infrastructures(6.3 Control of NCP(8.3)
)
Planning(5.4)
Purchasing(7.4)
Work
Analysis of data(8.4)
environment(6.4)
Responsibility,
Production &
authority &
service
communication(
provision(7.5) Improvements(8.5)
5.5)

Management Control of monitoring &


measuring devices(7.6)
Reviews (5.6)
0.4 Compatibility with
other Management
Systems
z Standard is intended to be compatible with
other management systems
z It is aligned with ISO 14000 to enhance
compatibility
z Standard does not include requirements
for other management system such as
EMS, OHSM or Financial management
1.2 Applications
z Requirements may be excluded if not
appropriate due to :
z nature of product

z customer requirements

z applicable regulatory requirements

z Exclusions must:
z Not affect ability to provide conforming
product
z Be limited to clause 7
4 Quality Management
System
4.1 General Requirements
z Establish, document, implement,
maintain and continually improve QMS in
accordance with the standard.
4.2 General
Requirements
z To implement the QMS the Organization shall

z Identify and manage processes necessary for QMS


z Determine the sequence and interaction of processes
z Determine criteria and methods to ensure effective
operation and control of the process
z Ensure availability of information needed to support the
operation and monitoring of processes
z Measure, monitor, analyze processes and act as
necessary to achieve planned results and continual
improvements
z Manage the process in accordance with the standard
4.2 Documentation
Requirements General
z Extent z To Include
z Size and type of z Documented procedures
organization required by standard
z Complexity and z Documents required by
interaction of processes organization to ensure
z Competence of personnel effective operation and
control process
z Note3 (Documentation
may be in any type of z Note 1 (Where the term
media) “documented procedure”
appears)
4.2 Documentation
Requirements
z 4.2.2 Quality Manual
z The organization shall establish a
Quality Manual that include:
z Scope of QMS

z Documented procedures or reference


to them
z Description of interaction between the
process of QMS
4.2 Documentation
Requirements
z 4.2.3 Control of Documents
z Documents required by the QMS shall be controlled
z Approve, Review, Ensure current & relevant version,
Identification of external origin documents, Prevent
unintended use of obsolete documents.
z 4.2.4 Control of Quality Records
z Documented Procedure shall be established for
identification, storage, protection, retrieval, retention
time and disposition.
z Records shall be:
ƒ Established and maintained to provide evidence.
ƒ Legible, readily identifiable and retrievable.
5 Management Responsibility
z 5.1 Management z 5.5 Responsibility, authority
Commitment and communication
z 5.2 Customer Focus z 5.5.1 Responsibility &
authority
z 5.3 Quality policy
z 5.5.2 Management
z 5.4 Planning
representative
z 5.4.1Quality
z 5.5.3 Internal
objectives
communication
z 5.4.2 Quality
z 5.6 Management Review
Planning
z 5.6.1 General

z 5.6.2 Review input

z 5.6.3 Review output


5.1 Management
Commitment
z Provide evidence of commitment to the
development and improvement of QMS by:

z Communicating the importance of


meeting customer and legal/regulatory
requirements.
z Establishing quality policy and objectives.
z Management Reviews
z Provision of resources.
5.2 Customer Focus
z Top Management shall ensure that
customer needs & expectations are
determined, converted into requirements
& fulfilled with the aim of achieving
customer satisfaction
5.3 Quality Policy
z Appropriate to the purpose of
organization.
z Commitment to meeting
requirements and continual
improvements
z Frame work for establishing and
reviewing quality objectives
z Communicated and understood
at appropriate levels
z Is reviewed for continuing
suitability
5.4 Planning
5.4.1 Quality Objectives
z Establish quality objectives at relevant
functions and levels
z Objectives must be measurable and
consistent with the quality policy including
the commitment to continual improvement
z Include those needed to meet
requirements for product
5.4 Planning
5.4.1 Quality Objectives (Cont)
Quality Objectives should be:
• Specific
• Measurable
• Achievable
• Realistic / Related
• Time Bound
5.4.2 Quality Management
System Planning
z Identify and plan
processes needed to
achieve quality objectives

• Plan the development


of QMS
• Plan the
implementation of QMS
• Plan the improvement
of QMS
5.5 Responsibility, Authority
and Communication
5.5.1 Responsibility and
authority
z Functions and their
interaction, responsibilities
and authorities shall be
defined and communicated
to facilitate effective quality
management
5.5.2 Management
Representative
z Member of the management who has
responsibility and authority for
z ensuring that processes of the QMS are
established and maintained
z Reporting on performance of QMS
including needs for improvement
z Promoting awareness of customer needs
and requirements
z Note: Responsibilities may include liaison
with external parties in relation to QMS
5.5.3 Internal Communication
z Ensure communication between various
levels and functions regarding the
processes of the QMS and their
effectiveness
5.6 Management Review
5.6.1 General
z Review of QMS by top
management at planned
interval to;
z ensure QMS suitability,
adequacy and effectiveness
z Evaluate the need for
changes to QMS including
policy and objectives

Records from Management


Reviews shall be
maintained (see 4.2.4).
5.6.2 Review Input
z Review performance and improvement
opportunities related to:
z Audit results
z Customer feedback
z Process performance and product
conformance
z Status of preventive and corrective
actions
z Follow up actions from earlier reviews
z Change that could affect the QMS
z Recommendations for improvement
5.6.3 Review Output
z Output to include actions related to
z improvement of the effectiveness QMS
and its processes
z improvement of product related to
customer requirements
z resource needs
6 Resource Management
z 6.1 Provision of resourses
z 6.2 Human resources
z 6.2.1 General

z 6.2.2 Competence, awareness and


training
z 6.3 Infrastructure
z 6.4 Work environment
6.1 Provision of Resources

z The organization shall determine and


determine the resources needed for :
z implement and maintain the QMS and
continually improve its effectiveness.
z Enhance customer satisfaction by
meeting customer requirements.
6.2 Human Resources
6.2.1 General

z Those who have responsibilities defined in


the QMS must be competent on the basis
of appropriate education, training, skills
and experience
6.2.2 Competency, Awareness
and Training
z Identify competency needs
z Provide required training
z Evaluate the effectiveness of
training provided
z Ensure staff is aware of
relevance and importance of
their activities and contribution
to achieving quality objectives
z Maintain appropriate records of
education, training, qualification
and experience
6.3 Infrastructure
z Identify, provide and maintain the
infrastructure needed to achieve product
conformity
z This shall include :
z Workspace & associated utilities

z Equipment, hardware and software

z Supporting services (transport or


communication)
6.4 Work Environment
z The organization shall determine and
manage the work environment needed to
achieve conformity to product
requirements.
7 Product Realization

z 7.1 Planning of product realization


z 7.2 Customer related processes

z 7.3 Design & development

z 7.4 Purchasing

z 7.5 Production & service operation

z 7.6 Control of measuring &


monitoring devices
7.1 Planning of Product
Realization
z Sequence of process to achieve product
z Consistent with QMS and documented to suit
method of operations
z Quality objectives and requirements for the
product
z The need for processes, documentation,
resources and facilities specific to the product
z Verification and validation activities and
acceptance criteria
z Records
7.2 Customer Related
Processes
z 7.2.1 Determination of requirements
related to the product
z 7.2.2 Review of product requirements
z 7.2.3 Customer communication
7.2.1 Determination of
requirements related to the
product
z Product requirements specified by the
customer including requirements for
delivery and post-delivery activities
z Requirements not specified but necessary
for intended or specified use
z Obligations related to product, including
regulatory and legal requirements
z any additional requirements determined by
the organization
7.2.2 Review of requirements
related to the product
z Review identified requirements and ensure
before commitment to supply product that;
z Product requirements are defined

z For verbal orders requirements are confirmed

z Difference between tender and contract are


resolved
z Organization has ability to meet the
requirements
Records of the results arising from the review
shall be recorded.
7.2.3 Customer Communication
z Identify and implement arrangements for
communication with customers relating to:
z product information

z inquiry, contract or order handling,


including amendments
z Customer feedback including complaints
7.3 Design & Development

z 7.3.1 Design & development planning


z 7.3.2 Design & development inputs
z 7.3.3 Design & development outputs
z 7.3.4 Design & development review
z 7.3.5 Design & development verification
z 7.3.6 Design & development validation
z 7.3.7 Control of design and development
changes
7.4 Purchasing

z 7.4.1 Purchasing process

z 7.4.2 Purchasing information

z 7.4.3 Verification of purchased product


7.4.1 Purchasing Process

z Purchased product meets requirements


z Type & extend of control depends on effect
purchased product may have on realization
processes and their output
z Selects suppliers based on their ability to
supply conforming product
z Define criteria for selection and periodic
evaluation and re-evaluation of suppliers
z Results of evaluation and follow up actions
must be recorded
7.4.2 Purchasing Information

z Purchasing information shall describe the


product to be purchased, including where
appropriate:
z Requirements for approval of
product,procedures, processes and
equipment.
z Requirements for qualification of
personnel.
z Quality management system
requirements.
7.4.3 Verification of
Purchased Product
z Identify and implement activities needed to
verify purchased product
z Where organization or its customer
purpose verification at supplier premises,
organization must specify in purchasing
information:
z verification arrangements

z method of product release.


z 7.5.1 Control of production and
service provision
z 7.5.2 Validation of processes for
production and service provision
z 7.5.3 Identification and traceability
z 7.5.4 Customer Property
z 7.5.5 Preservation of Product
7.5.1 Control of production and
service provision
Control production & services operations
through:
z Availability of information specifying product
characteristics
z Work instructions available where necessary
z Use and maintenance of suitable equipment
z Availability & use measuring and monitoring
devices
z Implementation of monitoring activities
z Implementation of defined processes for
release, delivery and post delivery activities
7.5.2 Validation of Processes
Validation arrangements must be defined
and must include as applicable
z qualification of the process
z qualification of equipment and personnel
z use of defined methodologies &
procedure
z requirements for record
z re-valuation
7.5.3 Identification &
Traceability
z Where appropriate identify product through
all stages of operations
z Identify status with respect to
measurement & monitoring requirements
z Where traceability is required control &
record unique identification of product

I can not remember


7.5.4 Customer Property
z Care for customer’s property being under
organization’s control or being used by
organization
z Identification, verification, protection &
maintenance of customer property
provided for use or incorporation
z Any customer property that is lost,
damaged or found un- suitable must be
recorded & reported to customer
z Customer Property -
tangible / intangible
7.5.5 Preservation of Product
z Preserve conformity of product during
internal processing and final delivery to
intended destination
z Include identification, handling, packaging,
storage and protection
z This applies to constituent parts of product
7.6 Control of monitoring &
measuring devices
z Calibrate & adjust measuring and monitoring
devices at specified intervals as prior to use
z Traceability to international or national
standards. Where no such standard exist record
the basis
z Safeguard MMD from adjustments invalidating
calibration
z Protect MMD from damage or deterioration
during handling, maintenance or storage
z Record results of calibration
z Assess validity of previous results when devices
found to be out of calibration
8 Measurement, Analysis
and Improvement
z 8.1 General z 8.3 Control of non-
z 8.2 Monitoring & conforming product
Measurement z 8.4 Analysis of data
z 8.2.1 Customer z 8.5 Improvement
satisfaction
z 8.5.1 Continual
z 8.2.2 Internal audit
improvement
z 8.2.3 Monitoring and
measurement of z 8.5.2 Corrective action
processes z 8.5.3 Preventive action
z 8.2.4 Monitoring and
measurement of
product
8.1 General

z Define, plan & implement measurement


and monitoring activities needed to assure
conformance and achieve improvement

z This include determination of the need and


use of applicable methodologies and
statistical techniques
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction

z Organization shall monitor information on


customer satisfaction and /or dis-
satisfaction

z The methodologies for obtaining and


utilizing such information must be
determined
8.2.2 Internal Audit
z Conduct periodic internal audit to
determine if QMS:
z Conforms to the requirements of the
standard
z Has been effectively implemented &
maintained
z Plan the audit program considering:
z Status and importance of the activity
z results of previous audits
z Define audit scope, frequency and
methodologies performed by personnel
not performing audited work
8.2.2 Internal Audit

z The documented procedure


must cover:
z Responsibilities & authorities
for conducting audits
z Ensuring independence
z Recording results and
reporting to management
z Timely corrective actions
z Follow up to verify & report
implementation of
verification results
8.2.3 Measurement and
Monitoring of Product

z Apply suitable methods for measurement


and monitoring of those realization
processes necessary to meet customer’s
requirements.
8.2.3 Measurement and
Monitoring of Product
z Measure & monitor product characteristics
to verify conformance at appropriate stages
of realization processes
z Evidence of conformity with the acceptance
criteria must be documented, records must
indicate the authority responsible for release
of product
z Release or 01deliveryPmust not proceedLuntil
D
19/ 5/ A SS HO
allIFthe
IED specified activities ED have been
ER
Vcompleted unless otherwise approved by the
customer
8.3 Control of Non conforming
Product
z Documented procedures for control of
non conforming product to prevent
unintended use or delivery
z Non conforming product shall be
corrected
z Re-verify after correction
z If non-conformance detected after
delivery take appropriate action
z It is often required that the proposed
rectification be reported for concession
to the customer, the end user,
regulatory or other body
8.4 Analysis of Data
z Collect & analyze data, determine suitability
and effectiveness of QMS and to identify
improvements that can be made
z Data from measurement & monitoring & other
related sources
z Analyze data provide info on:
z Customer satisfaction and/or dissatisfaction
z Conformance to customer requirement
z Process, product characteristics and their
trends
z Suppliers
8.5 Improvement
8.5.1 Continual improvement
z Planning for Continual Improvement
z The organization must plan and manage
processes necessary for continual
improvement of the QMS
z Facilitate continual improvement using:
z quality policy
z objectives
z audit results
z analysis of data
z corrective actions
z preventive actions
z Management Review
8.5.2 Corrective Action
z Organization must take corrective action to
eliminate the causes of non-conformance to
prevent recurrence
z Action appropriate to the impact of problem
z Documented procedures shall define
requirements for:
z identifying non conformities
z determine the causes
z evaluating the need for corrective action
z determine corrective action needed and
implemented
z Recording results of action
8.5.3 Preventive Action
z Organization must identify preventive action
to eliminate the causes of potential non
conformances to prevent occurrences
z Actions appropriate to the impact of potential
problem
z Documented procedures must define the
requirements for
z Identification of potential non-
conformances and their causes
z Determining and ensuring implementation
of preventive action needed
z Recording results of action taken
Situation Warranting
Corrective Action

z Identification of major non-conformance.


z Large number of minor non-conformities.
z The reoccurrence of a problem with a
process or activity.
z Non-conformities observed during audits.
z Customer Complaints.
z Non-conforming deliveries from vendors.
Stages of Corrective &
Preventive Action

z REPORTING
z INVESTIGATION
z ACTION
z FOLLOWUP
z CLOSING
EXPECTED BENEFITS
‘ Transparency in working at all level
‘ Data availability : Hidden Factors are open
‘ Creates Accountability
‘ Planning & scheduling improved
‘ Rework & Rejection are known and being
controlled
‘ Customer feedback through regular
surveys
‘ Employees Participation enhanced
‘ Continuos Improvements Program launched
‘ Market Reputation
Thank
You