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THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT


BEAR UPON ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS
Fitness for use
Conformance to requirements
Accuracy
Perfection
Zero Defect
Adequacy
Cost Effectiveness


A group of interacting, interrelated, or
interdependent elements forming a
complex whole
Set of detailed methods ,procedures and
routines established or formulated to
carry out a specific activity , perform a
duty , or solve a problem

Quality Management System
A System of coordinated activities which is meant to direct
and control an organization with regard to quality.
International Organization for Standardization
Founded in 1946 in Geneva , Switzerland
ISO is a non-governmental organization that forms a bridge between
the public and private sectors.
"ISO", derived from the Greek. ISO, meaning "equal". Whatever the
country, whatever the language, the short form of the organization's
name is always ISO.
"ISO", is a system audit not for product audit
ISO is composed of more than 90 members countries
World's largest developer and publisher of International Standards.
ISO 9001:2008 - Quality Management Systems Requirements

ISO 9000:2000 - Quality Management Systems fundamentals
and vocabulary

ISO 9004:2000 - Quality Management System guidelines for
performance improvements

ISO 19011:2000- Guide for Auditing Management System

ISO 9000 series evolution:
1987- initial publishing
1994- first revision
2000- Second revision
2008- Current edition

Principle 1
Principle 2
Leaders must set the direction of the organization

Leaders must create and maintain internal environment
that encourages people to achieve the organizations
objectives
Principle 3
Must help people to develop and use their abilities

Must encourage the involvement of people at all level
Principle 4
Activities
+
Resources
Input
Output
A desired result is more efficiently achieved when
resources and activities are managed as a process
Control
Process A
Process B Process D
Input
Output
Control
Process C
Processes understand interaction
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

Performance Measurements
Delivery status On-time, On spec,
etc
Supplier evaluation
Outputs
Receipt of
Material on right
condition
Right Quality
Right Quantity
Right Time

Purchasing
Procedure
Interactions to
Storage
Inspection and Testing
Manufacturing
Finance
Inputs
Demand for
material
Item specs and
Date
Supplier source
Suppliers
capability to
meet our
requirements
Principle 5
Identifying , understanding
and managing a system of
interrelated process for a
given objective improves the
organization effectiveness
and efficiency

Demings
wheel
(P.D.C.A.)
ISO
9000
PLAN DO

ACT CHECK

Continual
Improvement
Customer Focus
Continual improvement of the organization's overall performance
should be a permanent objective of the organization.
Principle 6
The Plan-Do-Check-Act Cycle
(Demings Cycle)
Principle 7
Effective decisions are based on the analysis
of data and information
Principle 8
An organization and its suppliers are interdependent,
and a mutually beneficial relationship enhances the
ability of both to create value
Continual improvement of the
Quality Management System
C
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T
O
M
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R
S

Management
Responsibility
Measurement,
Analysis and
Improvement
Resource
Management
Product /
Service
Realization
Input
Data
Product
Service
Output
Data
R
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m
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t
s

S
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C
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S

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
Provision of
resources(6.1)
Human
resources(6.2)
Infrastructures(6.3
)
Work
environment(6.4)
6 Resource
Management
General
requirements (4.1)
Documentation
Requirements(4.2)
Management
Commitment(5.1)
Customer focus
(5.2)
Quality policy(5.3)
Planning(5.4)
Responsibility,
authority &
communication(5.
5)
Management
Reviews (5.6)
5 Management
Responsibility
8 Measurement
Analysis &
improvement
4 Quality
Management
System
7 Product
Realization
General (8.1)
Monitoring &
measurement(8.2)
Control of NCP(8.3)
Analysis of data(8.4)
Improvements(8.5)
Planning(7.1)
Customer
related
processes(7.2)
Design &
development(7.3)
Purchasing(7.4)
Production &
service
provision(7.5)
Control of monitoring &
measuring devices(7.6)

4.1 General requirements

Establish , document , implement and maintain a QMS
and continually improve its effectiveness in
accordance with the standard

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
Measure , monitor and analyze processes
Implement action necessary to achieve planned results &
continual improvement



4.2 Documentation Requirements
Extent
Size and type of
organization
Complexity and
interaction of processes
Competence of personnel

Note3 (Documentation
may be in any type of
media)
To Include
Documented procedures
required by standard
Documents required by
organization to ensure
effective operation and
control process

Note 1 (Where the term
documented procedure
appears)
General
4.2.2 Quality Manual
The organization shall establish a Quality Manual that
include:
Scope of QMS
Documented procedures or reference to them
Description of interaction between the process of QMS
4.2 Documentation Requirements
4.2 Documentation Requirements
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 the documents of external origin are identified and
distribution controlled
Obsolete documents are prevented from unintended use and
identified if kept for any reason
Documents required by the quality management system shall be controlled
4.2 Documentation Requirements
4.2.4 Control of Records
Records must be established and maintained
Records must be legible , readily identifiable and retrievable
Documented procedure for control of identification , storage ,
retrieval ,retention time and disposition of quality records
5.1 Management
Commitment

5.2 Customer Focus

5.3 Quality policy

5.4 Planning
5.4.1Quality
objectives
5.4.2 Quality
Planning

5.5 Responsibility,
authority and
communication
5.5.1 Responsibility &
authority
5.5.2 Management
representative
5.5.3 Internal
communication
5.6 Management Review
5.6.1 General
5.6.2 Review input
5.6.3 Review output

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

Communicating the importance of meeting
customer and legal/regulatory requirements.
Establishing quality policy and objectives.
Management Reviews
Provision of resources.
5.2 Customer Focus
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
Appropriate to the purpose of
organization.
Commitment to meeting
requirements and continual
improvements
Frame work for establishing and
reviewing quality objectives
Communicated and understood at
appropriate levels
Is reviewed for continuing suitability
Establish quality objectives at relevant
functions and levels
Objectives must be measurable and consistent
with the quality policy including the
commitment to continual improvement
Include those needed to meet requirements
for product
5.4 Planning
5.4.1 Quality Objectives (Cont)
5.4 Planning
5.4.1 Quality Objectives (Cont)
Quality Objectives should be:
Set
Measurable
Achievable
Realistic
Timed
5.4.2 Quality Management System Planning
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

Functions and their interaction,
responsibilities and authorities
shall be defined and
communicated to facilitate
effective quality management

5.5.2 Management Representative
Member of the management who has responsibility
and authority for
ensuring that processes of the QMS are established
and maintained
Reporting on performance of QMS including needs for
improvement
Promoting awareness of customer needs and
requirements
Note: Responsibilities may include liaison with
external parties in relation to QMS
5.5.3 Internal Communication
Ensure communication between various
levels and functions regarding the
processes of the QMS and their
effectiveness
5.6 Management Review
5.6.1 General
Review of QMS by top
management at planned
interval to;
ensure QMS suitability,
adequacy and effectiveness
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
Review performance and improvement
opportunities related to:
Audit results
Customer feedback
Process performance and product conformance
Status of preventive and corrective actions
Follow up actions from earlier reviews
Change that could affect the QMS
Recommendations for improvement
5.6.3 Review Output
Output to include actions related to
improvement of the effectiveness QMS and its
processes
improvement of product related to customer
requirements
resource needs
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
6.1 Provision of Resources
The organization shall determine and determine
the resources needed for :
implement and maintain the QMS and
continually improve its effectiveness.
Enhance customer satisfaction by meeting
customer requirements.
6.2 Human Resources
6.2.1 General
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
Identify competency needs
Provide required training
Evaluate the effectiveness of
training provided
Ensure staff is aware of
relevance and importance of
their activities and contribution
to achieving quality objectives
Maintain appropriate records of
education, training, qualification
and experience
6.3 Infrastructure
Identify, provide and maintain the infrastructure
needed to achieve product conformity
This shall include :
Workspace & associated utilities
Equipment, hardware and software
Supporting services (transport or
communication)
6.4 Work Environment
The organization shall determine and manage the
work environment needed to achieve conformity
to product requirements.
7.1 Planning of product realization
7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production & service operation
7.6 Control of measuring & monitoring devices
7 Product Realization
7.1 Planning of Product Realization
Sequence of process to achieve product
Consistent with QMS and documented to suit
method of operations
Quality objectives and requirements for the
product
The need for processes, documentation, resources
and facilities specific to the product
Verification and validation activities and
acceptance criteria
Records
7.2 Customer Related Processes
7.2.1 Determination of requirements related to the
product
7.2.2 Review of product requirements
7.2.3 Customer communication
7.2.1 Determination of requirements related
to the product
Product requirements specified by the customer
including requirements for delivery and post-
delivery activities
Requirements not specified but necessary for
intended or specified use
Obligations related to product, including
regulatory and legal requirements
any additional requirements determined by the
organization
7.2.2 Review of requirements related to the product
Review identified requirements and ensure before
commitment to supply product that;
Product requirements are defined
For verbal orders requirements are confirmed
Difference between tender and contract are
resolved
Organization has ability to meet the
requirements

Records of the results arising from the review
shall be recorded.
7.2.3 Customer Communication
Identify and implement arrangements for
communication with customers relating to:
product information
inquiry, contract or order handling, including
amendments
Customer feedback including complaints
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 and development
changes

7.4 Purchasing
7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased product
7.4.1 Purchasing Process
Purchased product meets requirements
Type & extend of control depends on effect
purchased product may have on realization
processes and their output
Selects suppliers based on their ability to supply
conforming product
Define criteria for selection and periodic
evaluation and re-evaluation of suppliers
Results of evaluation and follow up actions must
be recorded
7.4.2 Purchasing
Information
Purchasing information shall describe the
product to be purchased, including where
appropriate:
Requirements for approval of
product,procedures, processes and
equipment.
Requirements for qualification of personnel.
Quality management system requirements.

7.4.3 Verification of
Purchased Product
Identify and implement activities needed to
verify purchased product
Where organization or its customer purpose
verification at supplier premises, organization
must specify in purchasing information:
verification arrangements
method of product release.
7.5 Production & 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 and traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.5.1 Control of production and
service provision
Control production & services operations
through:
Availability of information
specifying product characteristics
Work instructions available where
necessary
Use and maintenance of suitable
equipment
Availability & use measuring and
monitoring devices
Implementation of monitoring
activities
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
qualification of the process
qualification of equipment and personnel
use of defined methodologies & procedure
requirements for record
re-valuation
7.5.3 Identification &
Traceability
Where appropriate identify product through all
stages of operations
Identify status with respect to measurement &
monitoring requirements
Where traceability is required control & record
unique identification of product
I can not
remember
7.5.4 Customer Property
Care for customers property being under
organizations control or being used by
organization
Identification, verification, protection &
maintenance of customer property provided for use
or incorporation
Any customer property that is lost, damaged or
found un- suitable must be recorded & reported to
customer
Customer Property -
tangible / intangible
7.5.5 Preservation of Product
Preserve conformity of product during internal
processing and final delivery to intended
destination
Include identification, handling, packaging,
storage and protection
This applies to constituent parts of product
7.6 Control of monitoring &
measuring devices
Calibrate & adjust measuring and monitoring
devices at specified intervals as prior to use
Traceability to international or national
standards. Where no such standard exist record
the basis
Safeguard MMD from adjustments invalidating
calibration
Protect MMD from damage or deterioration during
handling, maintenance or storage
Record results of calibration
Assess validity of previous results when devices
found to be out of calibration
8 Measurement, Analysis and
Improvement
8.1 General
8.2 Monitoring &
Measurement
8.2.1 Customer
satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and
measurement of
processes
8.2.4 Monitoring and
measurement of
product
8.3 Control of non-
conforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual
improvement
8.5.2 Corrective action
8.5.3 Preventive action
8.1 General

Define, plan & implement measurement and
monitoring activities needed to assure
conformance and achieve improvement

This include determination of the need and use
of applicable methodologies and statistical
techniques
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Organization shall monitor information on
customer satisfaction and /or dis-satisfaction

The methodologies for obtaining and utilizing
such information must be determined
8.2.2 Internal Audit
Conduct periodic internal audit to
determine if QMS:
Conforms to the requirements of the
standard
Has been effectively implemented &
maintained
Plan the audit program considering:
Status and importance of the activity
results of previous audits
Define audit scope, frequency and
methodologies performed by personnel
not performing audited work
The documented procedure must
cover:
Responsibilities & authorities
for conducting audits
Ensuring independence
Recording results and reporting
to management
Timely corrective actions
Follow up to verify & report
implementation of verification
results
8.2.2 Internal Audit
8.2.3 Measurement and
Monitoring of Processes
Apply suitable methods for measurement and
monitoring of those realization processes
necessary to meet customers requirements.

Measure & monitor product
characteristics to verify
conformance at appropriate stages
of realization processes
Evidence of conformity with the
acceptance criteria must be
documented, records must indicate
the authority responsible for release
of product
Release or delivery must not
proceed until all the specified
activities have been completed
unless otherwise approved by the
customer
8.2.3 Measurement and
Monitoring of Product
8.3 Control of Non conforming
Product
Documented procedures
for control of non
conforming product to
prevent unintended use
or delivery
Non conforming product
shall be corrected
Re-verify after
correction
If non-conformance
detected after delivery
take appropriate action
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
Collect & analyze data, determine suitability and
effectiveness of QMS and to identify
improvements that can be made
Data from measurement & monitoring & other
related sources
Analyze data provide info on:
Customer satisfaction and/or dissatisfaction
Conformance to customer requirement
Process, product characteristics and their
trends
Suppliers
8.5 Improvement
8.5.1 Continual improvement
Planning for Continual Improvement
The organization must plan and manage
processes necessary for continual improvement
of the QMS
Facilitate continual improvement using:
quality policy
objectives
audit results
analysis of data
corrective actions
preventive actions
Management Review
8.5.2 Corrective Action
Organization must take corrective action to
eliminate the causes of non-conformance to
prevent recurrence
Action appropriate to the impact of problem
Documented procedures shall define
requirements for:
identifying non conformities
determine the causes
evaluating the need for corrective action
determine corrective action needed and
implemented
Recording results of action
Organization must identify preventive action to
eliminate the causes of potential non
conformances to prevent occurrences
Actions appropriate to the impact of potential
problem
Documented procedures must define the
requirements for
Identification of potential non-conformances
and their causes
Determining and ensuring implementation of
preventive action needed
Recording results of action taken
8.5.3 Preventive Action
Situation Warranting
Corrective Action
Identification of major non-conformance.
Large number of minor non-conformities.
The reoccurrence of a problem with a process or
activity.
Non-conformities observed during audits.
Customer Complaints.
Non-conforming deliveries from vendors.
Stages of Corrective & Preventive Action
REPORTING
INVESTIGATION
ACTION
FOLLOWUP
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






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