Iso 9001 2008 awareness training-slides

ISO 9001:2008 Awareness Training

WelcomeWelcome

ISO 9001:2008 Awareness Trainingg

Issue: TUVME/QM 002/02 Date: 24.02.09

1TUV Middle EastISO 9001:2008 Awareness Training


CourseCourse Duration: 8 Hours

IQBAL ALI Course Structure:

Tutorials, Discussions, … etc.




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;




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”





Which Car is of better Quality?

Toyota - Camry or Toyota - Echo

Category Grade Quality





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 be p yaltered by change in Specification.

“ Whereas Quality is dependent upon how well the product satisfies the needs ”




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


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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.





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”.




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;





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;


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Higher Level of customer expectations;

TUV Middle EastISO 9001:2008 Awareness Training


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 ”.




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)




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


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satisfaction



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 classificationsl 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 tradebut growing in acceptance by many others, including: engineering,

information technology, health/social work, utilities, transportation, public


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information technology, health/social work, utilities, transportation, public administration, education, other services.



ISOISO

B i Vi iBusiness Vision

Performance ExcellenceMalcolm Baldrige Criteria CompetitiveMalcolm Baldrige Criteria

Performance Improvement ISO 9004:2008

CompetitiveAdvantage

EfficientQuality Management SystemISO 9004:2008

Baseline Performance:ISO 9001:2008


EffectiveQuality Management System




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


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8. Mutually Beneficial Supplier Relationships




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 001/02Date: 24.02.09


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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.



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Involvement of People

People at all levels are the essence of an organization and

Their full involvement enables their abilitiesto be used for the organization’s benefit.g



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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).



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What is a Process?Activity that transforms Input into Outputy p p

Input Activity Outputp Activity p

Resources:Results:

PeopleFacilities/EquipmentMaterialM h d

ProductsServicesPerformance



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Methods


8 QM Principles

Monitor & Measure the Processmake 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 resultsare achieved, then - improve the process as needed

ActivityInput Output

Right Resources: Desired Results:

Qualified PeopleRight Facilities/EquipmentCorrect Materials

Desired Results:

Quality ProductsQuality ServicesCustomer Satisfaction



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Proven MethodsCustomer Satisfaction



How is a Process Measured?EfficientN W

EffectiveD i d R l A hi dNo Waste Desired Results Achieved

InputActivity Output

Right Resources: Desired Results:

Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Quality ProductsQuality ServicesCustomer Satisfaction



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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



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8 QM Principles

System:Controls Controls

8 QM Principles

InputProcess

AOutput - A

Process B

Output - B

Input

B

Output - A

Process

Controls



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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.



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Improve Process through PDCA Cycle

The QMS must be used for continual

Plan Doimprovement ...

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 ObjectiveQMS

Baseline Performance

Needed to Achieve and Sustain Desired Results



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8 QM Principles

Factual Approach To Decision Making

8 QM Principles

Effective decisions are:

Based on the analysis of data and information.



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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.



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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



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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;



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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;



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ISO 9001 Standard1 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 andenhance 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 References3 Terms and definitions

Supplier – Organization – Customer“ Product “ means “ service “ also.



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product intended for, or required by, a customer,any intended output resulting from the product realization processes.


ISO 9001 Standard4 Quality management system

4 1 General requirements

ISO 9001 Standard

4.1 General requirementsThe organization shallDetermine 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



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, 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 the p ocesses. Co t o o suc outsou ced p ocesses s a be de t ed w t t equality 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.



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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.



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ISO 9001 Standard

4.2 Documentation requirements

ISO 9001 Standard

4.2.1 Generala) quality policy and quality objective;b) quality manual;c) documented procedures required;c) documented procedures required;d) other documents needed; ande) records.

4 2 2 Q li l4.2.2 Quality manuala) the scope & and justification for any exclusions;b) procedures, or reference to them; andc) interaction between the processes.



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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 areidentified;

• 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



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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 toprovide evidence of conformity to requirementsand of the effective operation of the qualitymanagement system;

Records shall remain legible, readilyidentifiable and retrievable;

A doc mented proced re shall be establishedA documented procedure shall be establishedto define the controls needed for theidentification, storage, protection, retrieval,retention time and disposition of records.



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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; ande) ensure the availability of resources.



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5.2 Customer focus

Top management shall ensure that customer requirements aredetermined and are met with the aim of enhancing customersatisfaction (see 7.2.1 and 8.2.1).



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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.



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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



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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; andb) communicate.)

5.5.2 Management representativeTop 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



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improvement; andc) promote awareness of customer requirement.



5.5.3 Internal communication

a) top management shall ensure thatappropriate communication processesare established; and

b) that communication takes placeregarding the effectiveness of the QMS.



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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 itscontinuing suitability, adequacy and effectiveness.

2. Maintain records.



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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; andg) results of audit.g)



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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.



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6 Resource management6.1 Provision of resources

a) to implement and maintain the QMS andcontinually improve its effectiveness; and

b) to enhance customer satisfactionb) to enhance customer satisfaction.

6.2 Human resources6.2.1 General

Personnel performing work affecting conformity to product requirementsshall be competent on the basis of appropriate education, training, skillsand experience.



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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 ofythe quality objectives; and

5. maintain appropriate records of education,training, skills and experience.



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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 workenvironment needed to achieve conformity to productrequirements.



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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 andresulting product meet requirements (see 4.2.4).



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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 orintended use, where known;

c) statutory and regulatory requirements applicable to the product ; and

d) any additional requirements considered necessary by the organization.



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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 previouslyexpressed 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 beforeacceptance.if product requirements are changed, ensure that relevant documentsare amended and that relevant personnel are made aware.



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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.



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7.3 Design and development7.3.1 Design and development planning

The organization shall plan and control the design and development ofproduct.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; andc) responsibilities & authorities for design & develop.

Manage the interfaces between different groups involved in design & developmentManage the interfaces between different groups involved in design & developmentto ensure effective communication & clear assignment of responsibility.

Planning output shall be updated, as appropriate, as the design and developmentprogresses



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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;

andd) other requirements essential for design and development.

These inputs shall be reviewed for adequacy.



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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 forverification against the design and development input and shall beapproved 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; andd) specify the characteristics of the product that are essential for its safe

and proper use.



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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. Recordsshall 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



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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; andd) records shall be maintained.

7.3.7 Control of design and development changes

a) identified and records maintained; andb) reviewed, verified and validated, as appropriate, and approved before

implementation.



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ISO 9001 StandardISO 9001 Standard7.4 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 lpp y pp p p p

the effect of the purchased product on product realization or the finalproduct

• evaluate and select suppliers based on their ability;pp y• criteria for selection, evaluation and re-evaluation shall be established;

and• maintain records.



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7.4.2 Purchasing information

a) requirements for approval of product. procedures, processes andequipment;

b) requirements for qualification of personnel; andc) 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 forensuring; and

b) verification at the supplier premises.



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7.5 Production & service provision

7.5.1 Control of production and service provision

Plan and carry out production and service provision under controlledconditionsconditions.

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; andf) the implementation of product release, delivery and post-delivery



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f) the implementation of product release, delivery and post deliveryactivities.



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; ande) revalidation.

7.5.3 Identification and traceability.

Where appropriate shall identify & trace the product by suitable means



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Where appropriate, shall identify & trace the product by suitable meansthroughout product realization .



7.5.4 Customer property

Exercise care with customer property while it is under the organization’scontrol or being used by the organization.

identify;ifverify;

protect; andsafeguard

If any customer property is lost, damaged or otherwise found to beunsuitable for use, this shall be reported to the customer.

maintain records.



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maintain records.



7.5.5 Preservation of product

identification;

handling;

packaging;

delivery;y;

storage; and

protection



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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; andestablish processes to ensure that monitoring and measurement areconsistent 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; andd) be protected from damage and deterioration during handling,

maintenance and storage.



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8 Measurement, analysis and improvement8.1 General1 to demonstrate conformity of product requirements;1. to demonstrate conformity of product requirements;2. to ensure conformity of the QMS; and3. to continually improve the effectiveness of the quality management

system.

• determine applicable methods.

8.2 Monitoring and measurement8.2 Monitoring and measurement8.2.1 Customer satisfaction

Monitor information relating to customer perception as to whether the



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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; andb) 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 bedefined; andauditors and conduct of audits shall ensureobjective and impartiality of the audit process.



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Define in a procedure:

• Responsibilities;• Responsibilities;• requirements for planning;• requirements for conducting;• requirements for reporting; and• maintain records.

Ensure that actions are taken without undue delay .

Follow-up activities shall include:

• verification of the actions taken; andh i f ifi i l



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• 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 toachieve planned results;

• when planned results are not achievedwhen planned results are not achieved,correction and corrective action shall be taken;and

• maintain records.



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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 correctiveaction shall be taken; and;

maintain records.



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8.3 Control of nonconforming product

identify and control to prevent its unintended use or deliveryresponsibilities and authorities for dealing with nonconformingproduct 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



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g pp p pnonconformity when nonconforming product is detected after deliveryor 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 hasstarted, the organization shall take action appropriate to the effects,or potential effects of the nonconformity.

Procedure requiredProcedure required.



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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 ofprocesses.

This shall provide information relating to:

• Customer satisfaction;• Conformity to product requirement;• Characteristics and trend of processes; and• Suppliers.



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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.



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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 preventrecurrence.

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; and6. reviewing the effectiveness of the corrective action taken



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8.5.3 Preventive action

Determine action to eliminate the causes of potential nonconformities inorder 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; and5) reviewing the effectiveness of the preventive action taken.



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ISO 9001:2008 Awareness TrainingTo meet the requirements you must:

Continually Improve EffectivenessUse corrective action to improve your service to your customers.

Continually Improve EffectivenessUse corrective action to improve your service to your customers.

MaintainShow evidence that you are doing what you said you were doing.

MaintainShow evidence that you are doing what you said you were doing.

DocumentDocument

ImplementDo what you wrote down.ImplementDo what you wrote down.

Document Write down what you do.Document Write down what you do.

Iso 9001 2008 awareness training-slides

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