ISO 9001 Training Guide

ISO 9001:2008 Awareness Training
WelcomeWelcome
ISO 9001:2008
Awareness Trainingg
Issue: TUVME/QM 002/02 Date:
24.02.09
1TUV Middle East

Course
Course Duration: 8 Hours
IQBAL ALI Course Structure:
Tutorials, Discussions, … etc.
24.02.09
2TUV Middle East

Course Introd ction
Delegates will be:
• Able to understand concepts & historic evolution of quality;
Course Introduction
• Able to understand concepts & historic evolution of quality;
• Able to understand Quality Management System (brief overview);
• Able to understand requirements of ISO 9001:2008 QMS standard inAble to understand requirements of ISO 9001:2008 QMS standard in
detail;
24.02.09
3TUV Middle East

Concepts of Quality and Historic Evolution?Concepts of Quality and Historic Evolution?
Definitions for Quality?
Fitness for the Purpose
Conformance to Requirements
C S i f i /D li hCustomer Satisfaction /Delight
ISO Definition:
“Degree to which a set of characteristics fulfils requirements”
24.02.09
4TUV Middle East

Which Car is of better Quality?
Toyota - Camry or Toyota - Echo
Category Grade Quality
24.02.09
5TUV Middle East

Category is given to entities having same
functional use but different requirements forfunctional use but different requirements for
Quality.
Grade is inherent in the product and may bep y
altered by change in Specification.
“ Whereas Quality is dependent upon how well
the product satisfies the needs ”
24.02.09
6TUV Middle East

Quality Management SystemQuality Management System
Quality Assurance:
“ All the Planned and Systematic activities implemented within the“ All the Planned and Systematic activities implemented within the
Quality Management System and Demonstrated as needed to provide
adequate confidence for an entity to fulfill requirements for Quality ”
Two aspects of Quality Assurance are:
1. External - Quality Assurance provides Confidence to Customers.
2. Internal - Quality Assurance provides Confidence to The Management
to understand the customer’s needs at all times and that they have
established the capability to meet this requirements at lowest possible
24.02.09
7
cost & time, thus making profit.
TUV Middle East

Quality Control:
“ Operational Techniques and Activities that are used to
fulfill requirements for Quality ”
Quality Control is Reactive in nature.
Quality Assurance is Pro-active in nature.
Quality Management System uses both Quality Control &
Quality Assurance.
24.02.09
8TUV Middle East

Quality Management System:
“All activities of overall Management function
that determine Quality Policy, Objectives &
Responsibility, & Implement them by meansResponsibility, & Implement them by means
of Quality Planning, Quality Control, Quality
Assurance & Quality Improvement”.
24.02.09
9TUV Middle East

Quality Management System
Some of the elements of QMS are :
A sustained Management commitment to Quality;
A sustained Management commitment to Quality;
Preventing defects rather than detecting them;
A Continual Improvement approach;
Focusing on customer requirements &Focusing on customer requirements &
expectations;
Quality is everyone’s responsibility;
T k d Q litTeam work produces Quality;
Root cause Corrective /Preventive action;
24.02.09
10TUV Middle East

The effect of QMS in any organization is directly proportional to the profit
Why QMS is prominent in any organization?
and customer satisfaction.
A good QMS will reduce deficiencies, which will bring down the cost
(which will increase the profit) and increase customer satisfaction.(which will increase the profit) and increase customer satisfaction.
Other reasons are:
Competition;
Ch iChanging customer;
Availability of options;
Product complexity;
Higher Level of customer expectations;
24.02.09
11
Higher Level of customer expectations;
TUV Middle East

ISOISO
ISO (International Organization for Standardization) is a worldwide
federation of national standards bodies from approximately 140federation of national standards bodies from approximately 140
countries (1 from each);
ISO is a non-governmental organization established in 1947;
Objective – is to promote the development of standardization in the
world with a view to facilitate the international exchange of goods and
services and to develop cooperation in the spheres of intellectualservices, and to develop cooperation in the spheres of intellectual,
scientific, technological and economic activity;
ISO’s name – came from the Greek word “ isos ” means “equal ”.
24.02.09
12TUV Middle East

SOISO
Origin
International Electro-technical Commission (1906)
International Federation of the National Standardizing Associations (1926International Federation of the National Standardizing Associations (1926
- 1942) -> Mech. Field
I i l O i i f S d di i (1947)International Organization for Standardization (1947)
24.02.09
13TUV Middle East

ISOISO
Standard Purpose Remarks
E t bli h th t ti p i t t
ISO 9000:2008
Establishes the starting point to
understand the standards and defines the
fundamental terms and definitions used in
the ISO 9000 family
Only for reference
ISO 9001:2008
This is the requirement standard used to
assess the ability to meet customer and
applicable regulatory requirements and
there by address customer satisfaction
Against which is
the third party
certification
there by address customer satisfaction
ISO 9004:2008
This provides guidelines for continual
improvement of QMS to all benefit all
parties through sustained customer
Only for reference
24.02.09
14
satisfaction
TUV Middle East

ISO
ISO 9000 is the most successful standard in ISO history and is accepted world
wide.
Nearly 400,000 registrations world-wide with registrants in over 150 countries
from all continents
Being applied in a wide variety of organizations
Over 40 “sectors” or industry classifications
l d b l t i l/ ti l i t t l d t t tiled by: electrical/optical equipment, metal products, construction,
machinery, wholesale/retail trade
but growing in acceptance by many others, including: engineering,
information technology, health/social work, utilities, transportation, public
24.02.09
15
information technology, health/social work, utilities, transportation, public
administration, education, other services.
TUV Middle East

ISOISO
B i Vi iBusiness Vision
Performance Excellence
Malcolm Baldrige Criteria CompetitiveMalcolm Baldrige Criteria
Performance Improvement
ISO 9004:2008
Competitive
Advantage
Efficient
Quality Management SystemISO 9004:2008
Baseline Performance:
ISO 9001:2008
Effective
24.02.09
16TUV Middle East

8 QM Principles8 QM Principles
ISO 9000:2008 is developed based on 8 Quality Management Principles
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach
6. Continual Improvement
7. Factual Approach to Decision Making
8 Mutually Beneficial Supplier Relationships
24.02.09
17
8. Mutually Beneficial Supplier Relationships
TUV Middle East

Customer Focus
Organizations depend on their Customers and
therefore should:
Understand current and future customer Needs;
Meet customer Requirements andq
Strive to exceed customer Expectations.
Issue: TUVME/QM 001/02
Date: 24.02.09
TUV Middle East
18

Leadership
Leaders should:
Establish unity of purpose and Direction of
the organization &
Create and maintain the internal environment
in which people can become fully Involved in
achieving the organization’s objectives.
Date: 24.02.09
TUV Middle East
19

Involvement of People
People at all levels are the essence of an
organization and
Their full involvement enables their abilities
to be used for the organization’s benefit.g
Date: 24.02.09
TUV Middle East
20

Process Approach
Organizations need to do more than simply monitor process outputs.
(typically through inspection activities):
They must also control all process inputs, (people, facilities, equipment,
material & methods) &
Th bli h i l h f iThey must establish appropriate controls over the transformation
activities (if desired results are to be achieved consistently and
efficiently).
Date: 24.02.09
TUV Middle East
21

What is a Process?
Activity that transforms Input into Outputy p p
Input Activity Outputp Activity p
Resources:
Results:
People
Facilities/Equipment
Material
M h d
Products
Services
Performance
Date: 24.02.09
TUV Middle East
22
Methods

8 QM Principles
Monitor & Measure the Process
make sure the inputs are right, the transformation
ti iti i t tl k d th d i d lt
8 QM Principles
activities consistently work, and the desired results
are achieved, then - improve the process as needed
ActivityInput Output
Right Resources: Desired Results:
Qualified People
Right Facilities/Equipment
Correct Materials
Desired Results:
Quality Products
Quality Services
Customer Satisfaction
Date: 24.02.09
TUV Middle East
23
Proven Methods

How is a Process Measured?
Efficient
N W
Effective
D i d R l A hi dNo Waste Desired Results Achieved
Input
Activity
Output
Right Resources: Desired Results:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Quality Products
Quality Services
Date: 24.02.09
TUV Middle East
24

System Approach
Organizations must understand a system is a set of interrelated processes,
and
the output of one process is the input to one or more subsequent
processes, so ...
it is critical to manage the “white space” (or interface) between processes
to ensure that the overall system is effective
Date: 24.02.09
TUV Middle East
25

8 QM Principles
System:
Controls Controls
8 QM Principles
Input
Process
A
Output - A
Process
B
Output - B
Input
B
Output - A
Process
Controls
Date: 24.02.09
TUV Middle East
26
Process
C
Output - C

Continual Improvement
Continual improvement of the organization’s
overall performance should be a permanent
objective;objective;
Improvement must be a planned activity if
th iz ti d i t i llthe organization desires to improve overall
performance and capabilities.
Date: 24.02.09
TUV Middle East
27

Improve Process through PDCA Cycle
The QMS must be used for continual
Plan Do
improvement ...
Results
/
Act Check
Measure/Monitor Results
Against Objectives - Improve
Process and Change QMS as
N d d t A hi nd S t in
Improvement Objective
QMS
Baseline Performance
Needed to Achieve and Sustain
Desired Results
Date: 24.02.09
TUV Middle East
28

8 QM Principles
Factual Approach To Decision Making
8 QM Principles
Effective decisions are:
Based on the analysis of data and
information.
Date: 24.02.09
TUV Middle East
29

Mutually Beneficial Supplier Relationship
An organization and its suppliers are truly
inter-dependent and
A mutually beneficial relationship
enhances the ability of both to create value.
Date: 24.02.09
TUV Middle East
30

6 Resource5 Management 8 Measurement4 Quality 7 Product6 Resource
Management
M t
5 Management
Responsibility
8 Measurement
Analysis &
improvement
4 Quality
Management
System
7 Product
Realization
Provision of
resources
Human
resources
General
requirements
Documentation
Requirements
Planning
Customer
related
processes
Management
Commitment
Customer focus
General
Monitoring &
measurement
Infrastructures
Work
environment
Design &
development
Purchasing
Quality policy
Planning
Control of NCR
Analysis of data
Production &
service
provision
Responsibility,
authority &
communication
Management
Improvements
Date: 24.02.09
TUV Middle East
31
Management
Reviews

ISO 9001 StandardISO 9001 Standard
0 Introduction
0.1 General
Strategic Decision;
Standard can be used by internal & external parties;Standard can be used by internal & external parties;
QM principles in ISO 9000 & ISO 9004 are taken in to consideration;
0.2 Process approachpp
Promotes the adoption of process approach;
Date: 24.02.09
TUV Middle East
32

0.3 Relationship with ISO 9004
ISO 9001 & ISO 9004 – a consistent pair – complement each other;
Same structure;
0 4 C ibili i h h0.4 Compatibility with other management systems
Aligned with ISO 14001:1996 specially to enhance the compatibility for
the user;;
Integration of other management systems (EMS, OHSM, FM … etc)
is possible;
Date: 24.02.09
TUV Middle East
33

Date: 24.02.09
TUV Middle East
34

ISO 9001 Standard
1 Scope
Specifies requirements for QMS if an organization wants to:
ISO 9001 Standard
Specifies requirements for QMS, if an organization wants to:
demonstrate its ability and
enhance customer satisfaction.
All requirements are generic and are applicable for all types of
i tiorganizations.
If not applicable, requirement (s) can be excluded – but is limited to the
requirements within clause 7.
2 N rm ti R f r nc2 Normative References
3 Terms and definitions
Supplier – Organization – Customer
“ Product “ means “ service “ also.
Date: 24.02.09
TUV Middle East
35
product intended for, or required by, a customer,
any intended output resulting from the product realization processes.

ISO 9001 Standard
4 Quality management system
4 1 General requirements
ISO 9001 Standard
4.1 General requirements
The organization shall
Determine the processes needed for the quality management system and their
application throughout the organization,application throughout the organization,
determine the sequence and interaction of these processes,
determine criteria and methods needed to ensure that both the operation and
control of these processes are effective,control of these processes are effective,
ensure the availability of resources and information necessary to support the
operation and monitoring of these processes and
monitor, measure where applicable and analyze these processes, and
Date: 24.02.09
TUV Middle East
36
, pp y p ,
implement actions necessary to achieve planned results and continual
improvement.

ISO 9001 Standard
These processes shall be managed by the organization in accordance with the
requirements of this International Standard;
ISO 9001 Standard
Where an organization chooses to outsource any process that affects product
conformity with requirements, the organization shall ensure control over such
processes. Control of such outsourced processes shall be identified within thep ocesses. Co t o o suc outsou ced p ocesses s a be de t ed w t t e
quality management system. The type and extent of control to be applied to
these outsourced processes shall be defined within the quality management
system.
NOTE Processes needed for the quality management system referred to above
should include processes for management activities, provision of resources,
product realization and measurement, analysis and improvement.
Date: 24.02.09
TUV Middle East
37

ISO 9001 Standard
4.1 General requirements
NOTE 3 E i l d d b l h
ISO 9001 Standard
NOTE 3 Ensuring control over outsourced processes does not absolve the
organization of the responsibility of conformity to all customer, statutory and
regulatory requirements. The type and extent of control to be applied to the
outsourced process can be influenced by factors such as
) h i l i f h d h i i 'a) the potential impact of the outsourced process on the organization's
capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared,) g p ,
c) the capability of achieving the necessary control through the application of
7.4.
Date: 24.02.09
TUV Middle East
38

ISO 9001 Standard
4.2 Documentation requirements
ISO 9001 Standard
4.2.1 General
a) quality policy and quality objective;
b) quality manual;
c) documented procedures required;c) documented procedures required;
d) other documents needed; and
e) records.
4 2 2 Q li l4.2.2 Quality manual
a) the scope & and justification for any exclusions;
b) procedures, or reference to them; and
c) interaction between the processes.
Date: 24.02.09
TUV Middle East
39
c) interaction between the processes.

4.2.3 Control of documents
A documented procedure required:A documented procedure required:
• approve;
• review and update;
h d h i i• changes and the current revision status are
identified;
• relevant versions are available at points of use;
• documents remain legible and readily
id tifi blidentifiable;
• documents of external origin are identified and
their distribution controlled; and
• to prevent the unintended use of obsolete
d t
Date: 24.02.09
TUV Middle East
40
documents.

4.2.4 Control of records
R d h ll b t bli h d d i t i d tRecords shall be established and maintained to
provide evidence of conformity to requirements
and of the effective operation of the quality
management system;
Records shall remain legible, readily
identifiable and retrievable;
A doc mented proced re shall be establishedA documented procedure shall be established
to define the controls needed for the
identification, storage, protection, retrieval,
retention time and disposition of records.
Date: 24.02.09
TUV Middle East
41

5 Management responsibility
5.1 Management commitment
a) communicate the importance of meeting
customer as well as statutory and regulatorycustomer as well as statutory and regulatory
requirements;
b) establish the quality policy;
c) ensure that quality objectives are established;
d) d i dd) conduct management reviews; and
e) ensure the availability of resources.
Date: 24.02.09
TUV Middle East
42

5.2 Customer focus
Top management shall ensure that customer requirements are
determined and are met with the aim of enhancing customer
satisfaction (see 7.2.1 and 8.2.1).
Date: 24.02.09
TUV Middle East
43

5.3 Quality policy
a) appropriate;
b) commitment to comply and continually improve;
c) provides a framework for establishing and reviewing quality objectives;
d) communicated and understood; and) ;
e) reviewed.
Date: 24.02.09
TUV Middle East
44

5.4 Planning
5 4 1 Quality objectives5.4.1 Quality objectives
a) establish quality objectives at relevant function &
levels; and
b) these shall be measurable and consistent with the
quality policy.
5.4.2 Quality management system planningQ y g y p g
a) planning of the QMS is carried out in order to meet
the requirements as well as the quality objectives; and
b) integrity of the QMS is maintained
Date: 24.02.09
TUV Middle East
45
b) integrity of the QMS is maintained.

5.5 Responsibility, authority & communication
5 5 1 Responsibilit and a thorit5.5.1 Responsibility and authority
a) define; and
b) communicate.)
5.5.2 Management representative
Top management shall appoint a member of the organization's
management who irrespective of other responsibilities shall havemanagement who, irrespective of other responsibilities, shall have
responsibility and authority that includes;
a) ensure QMS is established, implemented & maintained;
b) report to top management on the performance & need for
improvement; and
Date: 24.02.09
TUV Middle East
46
improvement; and
c) promote awareness of customer requirement.

5.5.3 Internal communication
a) top management shall ensure that
appropriate communication processes
are established; and
b) that communication takes place
regarding the effectiveness of the QMS.
Date: 24.02.09
TUV Middle East
47

5.6 Management reviewg
5.6.1 General
1 T t h ll i QMS t l d i t l t it1. Top management shall review QMS, at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness.
2. Maintain records.
Date: 24.02.09
TUV Middle East
48

5.6.2 Review input
a) customer feedback;
b) process performance and product conformity;
c) status of preventive and corrective actions;
d) f ll i f i id) follow-up actions from previous management reviews;
e) change that could affect the quality management system;
f) recommendation for improvements; and
g) results of audit.g)
Date: 24.02.09
TUV Middle East
49

5.6.3 Review output
The output from the management review shall include any decisions and
actions related to:
a)impro ement of the effecti eness of the QMS and its processes;a)improvement of the effectiveness of the QMS and its processes;
b)improvement of product related to customer requirements; and
c)resource needs.
Date: 24.02.09
TUV Middle East
50

6 Resource management
6.1 Provision of resources
a) to implement and maintain the QMS and
continually improve its effectiveness; and
b) to enhance customer satisfactionb) to enhance customer satisfaction.
6.2 Human resources
6.2.1 General
Personnel performing work affecting conformity to product requirements
shall be competent on the basis of appropriate education, training, skills
and experience.
Date: 24.02.09
TUV Middle East
51
p

6.2.2 Competence, training and awareness
1. determine the competence;
2. Where applicable, provide training or take
other actions to satisfy these needs;
3. evaluate the effectiveness of the actions3. evaluate the effectiveness of the actions
taken;
4. ensure that its personnel are aware of the
relevance & importance of their activities &
how they contribute to the achievement ofy
the quality objectives; and
5. maintain appropriate records of education,
training, skills and experience.
Date: 24.02.09
TUV Middle East
52

6.3 Infrastructure
a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software);
and
) i i ( hc) supporting services (such as transport or
communication or information system).
6.4 Work environment
The organization shall determine and manage the work
environment needed to achieve conformity to product
requirements.
Date: 24.02.09
TUV Middle East
53

7 Product realization
7.1 Planning of product realization
a) quality objectives and requirements;
b) the need to establish processes and documents, and provide resources;
c) required verification, validation, monitoring, measurement, inspection) q , , g, , p
& test activities & the criteria for acceptance; and
d) records needed to provide evidence that the realization processes and
resulting product meet requirements (see 4.2.4).
Date: 24.02.09
TUV Middle East
54
g p q ( )

7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
a) requirements specified by the customer;
b) requirements not stated by the customer but necessary for specified or
intended use, where known;
c) statutory and regulatory requirements applicable to the product ; and
d) any additional requirements considered necessary by the organization.
Date: 24.02.09
TUV Middle East
55

ISO 9001 Standard
7.2.2 Review of requirements related to the product
a) product requirements are defined;
ISO 9001 Standard
a) product requirements are defined;
b) contract or order requirements differing from those previously
expressed are resolved; and
c) the organization has the ability to meet the defined requirements.
maintain records of review.
if no documented statement of requirements, then confirm before
acceptance.
if product requirements are changed, ensure that relevant documents
are amended and that relevant personnel are made aware.
Date: 24.02.09
TUV Middle East
56
p

ISO 9001 Standard
7.2.3 Customer communication
ISO 9001 Standard
The organization shall determine and implement
effective arrangements for communicating with
customers in relation to
a) product information;
b) enquiries, contracts or order handling, including
d t damendments; and
c) customer feedback, including customer
complaints.
Date: 24.02.09
TUV Middle East
57

7.3 Design and development
7.3.1 Design and development planning
The organization shall plan and control the design and development of
product.
a) the design and development stages;
b) the review verification & validation that are appropriate to each design &b) the review, verification & validation that are appropriate to each design &
development stage; and
c) responsibilities & authorities for design & develop.
Manage the interfaces between different groups involved in design & developmentManage the interfaces between different groups involved in design & development
to ensure effective communication & clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development
progresses
Date: 24.02.09
TUV Middle East
58
progresses.

7.3.2 Design and development inputs
Inputs relating to product requirements:
a) functional and performance requirement;
b) applicable statutory and regulatory requirements;b) applicable statutory and regulatory requirements;
c) where applicable, information derived from previous similar designs;
and
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy.
Date: 24.02.09
TUV Middle East
59

7.3.3 Design and development outputs
Th f d i d d l h ll b i f i bl fThe output of design and development shall be in a form suitable for
verification against the design and development input and shall be
approved prior to release.
D i d d l h llDesign and development outputs shall:
a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production and for) p pp p p g, p
service provision;
c) contain or reference product acceptance criteria; and
d) specify the characteristics of the product that are essential for its safe
and proper use.
Date: 24.02.09
TUV Middle East
60
p p

7.3.4 Design and development review
a) to evaluate the ability of the results of design and development to meeta) to evaluate the ability of the results of design and development to meet
requirements; and
b) to identify any problems and propose necessary actions.
P i i h ll i l d i f f i d R dParticipants shall include representatives of functions concerned. Records
shall be maintained.
7.3.5 Design and development verification7.3.5 Design and development verification
a) planned arrangements;
b) have met the design and development input; and
) d h ll b i i d
Date: 24.02.09
TUV Middle East
61
c) records shall be maintained.

7.3.6 Design and development validation
) l da) planned arrangements;
b) product is capable of meeting the requirements for the specified
application / intended use;
c) validate prior to the delivery / implementation; and
d) records shall be maintained.
7.3.7 Control of design and development changes
a) identified and records maintained; and
b) reviewed, verified and validated, as appropriate, and approved before
implementation.
Date: 24.02.09
TUV Middle East
62

7.4 Purchasing
7 4 1 Purchasing process7.4.1 Purchasing process
• ensure purchased product conforms to specified requirements; and
• apply control on the supplier and purchased product dependents on
h ff f h h d d d li i h fi l
pp y pp p p p
the effect of the purchased product on product realization or the final
product
• evaluate and select suppliers based on their ability;pp y
• criteria for selection, evaluation and re-evaluation shall be established;
and
• maintain records.
Date: 24.02.09
TUV Middle East
63

7.4.2 Purchasing information
a) requirements for approval of product. procedures, processes and
equipment;
b) requirements for qualification of personnel; and
c) quality management system requirements.c) quality management system requirements.
7.4.3 Verification of purchased product
) bli h d i l h i i h i i i fa) establish and implement the inspection or other activities necessary for
ensuring; and
b) verification at the supplier premises.
Date: 24.02.09
TUV Middle East
64

7.5 Production & service provision
7.5.1 Control of production and service provision
Plan and carry out production and service provision under controlled
conditionsconditions.
a) information that describes the characteristics;
b) the availability of work instructions, as necessary;
c) the use of suitable equipment;
d) the availability and use of monitoring and measuring equipment;
e) the implementation of monitoring & measurement; and
f) the implementation of product release, delivery and post-delivery
Date: 24.02.09
TUV Middle East
65
f) the implementation of product release, delivery and post delivery
activities.

7.5.2 Validation of processes for production and service provision
Validation shall demonstrate the ability of these processes to achieveValidation shall demonstrate the ability of these processes to achieve
planned results.
a) defined criteria for review and approval;
b) approval of equipment and personnel;
c) use of specific methods and procedures;
d) requirements for records; and
e) revalidation.
7.5.3 Identification and traceability.
Where appropriate shall identify & trace the product by suitable means
Date: 24.02.09
TUV Middle East
66
Where appropriate, shall identify & trace the product by suitable means
throughout product realization .

7.5.4 Customer property
Exercise care with customer property while it is under the organization’s
control or being used by the organization.
identify;
ifverify;
protect; and
safeguard
If any customer property is lost, damaged or otherwise found to be
unsuitable for use, this shall be reported to the customer.
maintain records.
Date: 24.02.09
TUV Middle East
67
maintain records.

7.5.5 Preservation of product
identification;
handling;
packaging;
delivery;y;
storage; and
protection
Date: 24.02.09
TUV Middle East
68
protection.

7.6 Control of monitoring and measuring equipment
d i h i i d b d kdetermine the monitoring and measurement to be undertaken;
determine monitoring and measuring equipment needed; and
establish processes to ensure that monitoring and measurement are
consistent with requirements.
a) be calibrated or verified or both at specified intervals, or prior to use;
b) be identified to enable the calibration status to be determined:
c) be safeguarded from adjustments that would invalidate thec) be safeguarded from adjustments that would invalidate the
measurement result; and
d) be protected from damage and deterioration during handling,
maintenance and storage.
Date: 24.02.09
TUV Middle East
69

8 Measurement, analysis and improvement
8.1 General
1 to demonstrate conformity of product requirements;1. to demonstrate conformity of product requirements;
2. to ensure conformity of the QMS; and
3. to continually improve the effectiveness of the quality management
system.
• determine applicable methods.
8.2 Monitoring and measurement8.2 Monitoring and measurement
8.2.1 Customer satisfaction
Monitor information relating to customer perception as to whether the
Date: 24.02.09
TUV Middle East
70
organization has met customer requirements.

8.2.2 Internal audit
To determine whether the QMS:
a) conforms to the requirements of this standard
and to the QMS requirements established; and
b) is effectively implemented and maintainedb) is effectively implemented and maintained.
An audit program shall be:
planned - consider the status and importance;
criteria, scope, frequency & methods shall be
defined; and
auditors and conduct of audits shall ensure
objective and impartiality of the audit process.
Date: 24.02.09
TUV Middle East
71

Define in a procedure:
• Responsibilities;• Responsibilities;
• requirements for planning;
• requirements for conducting;
• requirements for reporting; and
Ensure that actions are taken without undue delay .
Follow-up activities shall include:
• verification of the actions taken; and
h i f ifi i l
Date: 24.02.09
TUV Middle East
72
• the reporting of verification results.

8.2.3 Monitoring & measurement of processes
h d f i i QMS• methods for monitoring QMS processes;
• measurement of the QMS processes ;
• demonstrate the ability of the processes to
achieve planned results;
• when planned results are not achievedwhen planned results are not achieved,
correction and corrective action shall be taken;
and
Date: 24.02.09
TUV Middle East
73
maintain records.

8.2.4 Monitoring & measurement of product
methods for monitoring product;methods for monitoring product;
measurement of the product ;
demonstrate the ability of the processes to achieve planned results;
when planned results are not achieved, correction and corrective
action shall be taken; and;
maintain records.
Date: 24.02.09
TUV Middle East
74

8.3 Control of nonconforming product
identify and control to prevent its unintended use or delivery
responsibilities and authorities for dealing with nonconforming
product shall be defined
Deal with NCP :
1. by taking action to eliminate the detected non-conformity;
2 d i b l h i d h li bl b h2. under concession by a relevant authority and, where applicable, by the
customer;
3. by taking action to preclude its original intended use or application.
4. by taking action appropriate to the effects, or potential effects, of the
f i h f i d i d d f d li
Date: 24.02.09
TUV Middle East
75
g pp p p
nonconformity when nonconforming product is detected after delivery
or use has started.

Maintain records;
When nonconforming product is corrected, it shall be subject to re-
verification; and
When nonconforming product is detected after delivery or use hasWhen nonconforming product is detected after delivery or use has
started, the organization shall take action appropriate to the effects,
or potential effects of the nonconformity.
Procedure requiredProcedure required.
Date: 24.02.09
TUV Middle East
76

ISO 9001 Standard
8.4 Analysis of data
ISO 9001 Standard
Determine, collect & analyze data – to demonstrate the suitability &
effectiveness of QMS. Collect data from monitoring & measurement of
processes.
This shall provide information relating to:
• Customer satisfaction;
• Conformity to product requirement;
• Characteristics and trend of processes; and
• Suppliers.
Date: 24.02.09
TUV Middle East
77

8.5 Improvement
8 5 1 C ti l i t h h8.5.1 Continual improvement - through
• quality policy;
• quality objectives;quality objectives;
• audit result;
• analysis of data;
• corrective and preventive actions; and
• management review.
Date: 24.02.09
TUV Middle East
78

8.5.2 Corrective action
T k ti t li i t th f f iti i d t tTake action to eliminate the causes of nonconformities in order to prevent
recurrence.
A documented procedure shall be established to define requirements for:p q
1. reviewing nonconformities;
2. determining the cause of nonconformities;
3. evaluating the need for action;g ;
4. determining and implementing action needed;
5. records of the results of action taken; and
6. reviewing the effectiveness of the corrective action taken
Date: 24.02.09
TUV Middle East
79

8.5.3 Preventive action
Determine action to eliminate the causes of potential nonconformities in
order to prevent their occurrence.
Establish procedures to define requirements for:Establish procedures to define requirements for:
1) determining potential non-conformities and their causes;
2) evaluating the need for action to prevent occurrence of non-conformities;
3) d i i d i l i i d d3) determining and implementing action needed;
4) records of results of action taken; and
5) reviewing the effectiveness of the preventive action taken.
Date: 24.02.09
TUV Middle East
80

To meet the requirements you must:
Continually Improve Effectiveness
Use corrective action to improve your service to your
customers.
Continually Improve Effectiveness
Use corrective action to improve your service to your
customers.
Maintain
Show evidence that you are doing what you said you were
doing.
Maintain
Show evidence that you are doing what you said you were
doing.
DocumentDocument
Implement
Do what you wrote down.
Implement
Do what you wrote down.
Document
Write down what you do.
Document
Write down what you do.

ISO 9001 Training Guide

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

En vedette

En vedette (20)

Similaire à ISO 9001 Training Guide

Similaire à ISO 9001 Training Guide (20)

Plus de umar farooq

Plus de umar farooq (20)

Dernier

Dernier (20)

ISO 9001 Training Guide