Into Duct Ion to ISO 90012008 25.4.12

8/2/2019 Into Duct Ion to ISO 90012008 25.4.12

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W h a t i s I S O ?

ISO is the international

organization for

standardization based in

Geneva, Switzerland. It is thelargest standards organization

in the world and it develops

standards for use of companies

and organizations worldwide.


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ISO is a non governmental organization

and its membership comprises of

standardization bodies of the majorcountries of the world including India.

Bureau of Indian Standards representsIndia in ISO.

Continued.

What is ISO ?


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STANDARDSSTANDARDIZATION

SPECIFICATION


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Specification:Requirements for a product, service or system interms of dimension, tolerances, functions andperformance.

StandardizationStandardization is the process through which wearrive at an agreed and common performance

parameters or specification for a product, processor a system

Standard

A standard documents the specificationor therequirements for a product, process or a systemarrived through the standardization process. Itdefines the requirements in measurable terms.


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Quality management system is a set of policies,procedures and processes required for planning

and execution of the business activities of an

organization.

The activities of the quality management system is

designed to drive the organization to continuallyimprove the effectiveness and efficiency of itsperformance.

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PolicyProcedureProcess

PolicyAn organizations business

goals and objectives

Procedure

Specifies how a job has tobe done

ProcessA series of interlinked

activities aimed toproduce a planned result

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SYSTEM

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Driving system Computer operating system

Management system Design system

Can you name some other systems?

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Customerrequirements

QMS Regulatory & Legalrequirements

Continualimprovement

Process & proceduremanagementCustomer

satisfaction

WHY QMS IS REQUIRED

QMS is the framework for development of a qualitypolicy that drives the organization to continual

improvement and customer satisfaction, and alsoensure compliance to legal and regulatory requirements


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All these activities are directed towards implementation ofthe quality policy of the organization.

A set of procedures and processes are required to direct andcontrol the activities of the organization and improve its

effectiveness.

Quality management systems consistof,

quality planning,

quality assurance,

quality control, and

quality improvement.


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Quality plan is a framework of procedures and

processes that establish the objectives for quality,

and application of quality system elements.

It translates quality policy into measurable objectives

and requirements and lays down a sequence of steps

for realizing them within a specified timeframe.

It documents activity plans , resources required ,

responsibilities and all other requirements required

for the relevant project.


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Quality control is a technical function that includes all thescientific precautions, such as calibrations andduplications, that are needed to acquire data of knownand adequate quality.

Quality assurance is a management function; it deals withsetting policy and running an administrative system of

management controls that cover planning, implementation,and review of data collection activities and the use of datain decision making.


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Quality improvement is a planned andstructured approach to improve

performance through,1. systematic analysis of the activities,

2. measurement of performance,

3. prevention of errors,4. setting targets, and

5. identifying and applying improved methods to

achieve the targetted improvements.

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Quality

STATEDREQUIREMENT

HIGHQUALITY

LOWQUALITY

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ISO 9001:2008

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ISO 9001 is a quality management

system standard

The standard was issued in 1987,

revised in 1994, 2000 & 2008.

The standard ensures that quality

products are produced consistently.


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I S O 9 0 0 1 : 2 0 0 8 ISO 9001:2008 is the current version of the quality management

system standard issued by ISO. It provides a set of generic

requirements for all type of business activities.

The requirements

Apply to the processes that create and control the products and

services of an organization.

Prescribes systematic control of activities to ensure that the needs and

expectations of customers are met.

Is designed and intended to apply to virtually any product or service,

made by any process anywhere in the world.

It is a standard against which an organization can be certified.


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C e r t i f i c a t i o n

1. Certification is the formal recognition that an organization has the

proficiency to meet the specified requirements of a recognizedquality system standard.

2. Certification is given by an accredited body such as DNV, Bureau

Veritas, BIS etc. after assessment of the organization through audits,

and then issuing a certificate to show that the organization abides by

the principles set out in the standard (viz.ISO 9001),following

industry best practices

3. Certification communicates to the world that the company has

established a recognized quality system.

4. Certification provides evidence that the organization has

implemented an effective business management system, and that

they are serious about quality and ensuring that the customer'sexpectations are met.

5. It gives buyers confidence that the organization would be able to

supply quality products consistently.


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An organization to survive and grow must satisfy its customers.

Customers are satisfied when products

and services meet their expectations.

ISO 9001: 2008 provides the framework

of process models that turn out products

to satisfy customer expectations.

ISO 9001:2008 being a QMS standard, its implementation

enables an organization to ensure that its business processes

interact efficiently and effectively to produce qualitygoods and

services.

Why an organization should implement

ISO 9001: 2008?


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ISO 9001:2008 requires a documented qualitymanagement system.

The standard allows flexibility to an organization todecide as to what documentation they will include intheir quality management system.

The objective of the quality management system is to

support development and implementation of effectivebusiness processes. As such, documents not requiredfor the business should not be included in the qualitysystem.

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Documented statements of a quality policy andquality objectives.

A quality manual.

Documented procedures required by the standard. Documents needed by the organization to ensure the

effective planning, operation and control of itsprocesses.

Records required by the standard. All the documents that form part of the QMS have to

be controlled in accordance with clause 4.2.3 of ISO9001:2008, or, for the particular case of records,according to clause 4.2.4.

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An organizations policy is a statement that enunciates

the organizations business goals and objectives andbroadly outlines the means to achieve them. It may alsoinclude a plan of action to gain competitive advantage.

A quality policy related to the overall corporate policy,defines the organizations commitment to quality. It sets

up quality plans through which it aspires to achieve

business leadership.

A quality policy is a framework of quality objectives andaction plans to drive continual performanceimprovement throughout the organization.

Q u a l i t y p o l i c y


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The quality policy should be aligned to the organizationsbusiness needs.

The quality policy should include a commitment to comply tothe requirements of the quality management systemrequirements.

The effectiveness of the quality management system shall becontinually improved.

Quality policy should provide aframeworkfor establishingand reviewing of quality objectives.

The quality policy shall be communicated at all levels withinthe organization and it shall be reviewed for continuingsuitability.

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ISO 9000:2005 defines quality objective as a qualityoriented goal - something to aim for or try to achieve.

To understand quality objective we must understandthe difference between a Goal and Objective.

A goal generally implies an intention, something thatwe would like to achieve.

Objective goes a step further. It is a goal withmeasurable target, that is achievable within aspecified timeframe. Quality objective converts a goalto an effective action plan.

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Quality objectives to be measurable and

consistent with the quality policy.

The clause also requires quality objectivesto be established at all relevant functionsand levels.

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Q alit Objecti es


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1. In practice quality objectives are selected from the day

to day work functions of an organization with the

intention of carrying out a specific targetedimprovement which is measurable.

2. Quality objectives must be reviewed and tracked to

ensure that there is progress towards the targeted

improvement.

3. While quality objectives should be consistent with thequality policy, from the business perspective they can

relate to the strategic business needs of the

organization.

4. Since quality policy itself relates to the strategic

business objectives of an organization, there is unlikely

to be any conflict with quality policy when quality

objectives are derived from thestrategic needs.

Quality Objectives


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Strategy guides the nature and direction of an

organization. It is about gaining business advantage

over the competitors by differentiating and increasing

the value of its products and services in the eyes of the

customer. Strategy can be expressed in three differentforms,

1. General Strategy2. Corporate Strategy, and

3. Competitive Strategy

St t


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1. General strategy is concerned with courses of action, the relationship

between ends and means.

2. Corporate strategy is concerned with choices and commitments

regarding markets, business and the very nature of the company itself.

3. Competitive strategy is concerned with competitors and competition

Cost, Differentiaton and Focus, as also Operating excellence, Customer

intimacy and Product leadership.

Strategy


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An organization having a well defined strategy, the salient points of

which has been communicated to its employees will be in an

advantageous position in terms of competition in the market place.

A well understood statement of the company strategy aligns employee

behaviour with the business requirements.

Think of a business as a collection of 1000 iron filings,

each filing representing an employee. If you pick up the

filings and drop them onto a piece of paper, they will lie

spread out all pointing in different directions. This will besomething like 1000 employees working hard with

different objectives in mind. If you now bring a magnet

over the filings, they change their positions and line up

in the same direction

The concept of strategy has been borrowed from the military and


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The concept of strategy has been borrowed from the military andadapted for use in business.

In the military, troops are maneuvered into positions before the

actual engagement takes place.

How the troops have to be deployed prior to engagement withthe enemy is a matter strategy.

During actual battle various type of actions are involveddepending on the progress and situation of the battle.

These actions which could keep on changing are termed tactics.

Together, strategy and tactics bridge the gap between ends andmeans.

Many businesses have adopted the techniques of strategy andtactics to gain competitive advantage in the market place.


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As a competitive strategy an organization can think of three core

values that it can deliver.

They are, Operational excellence (the lowest price), Productleadership (the best product), or Customer intimacy (the best

solution & service).

Of the three above the organization may have to decide which

value proposition they are best equipped to offer.

Mission&

Strategy

BusinessObjectives

QualityPolicy

QualityObjectives

Quality objectives are part of the continual

improvement activities within the organization.


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A quality manualdocuments an organization's qualitymanagement system . Clause 4.2.2 of ISO 9001:2008 definesthe minimum content of the quality manual as follows,

Scope of the QMS

Exclusions with their justifications

Interaction of the QMS processes

Quality procedures or reference to them

The format and structure of the manual is a decision for eachorganization, and will depend on the organizations size,culture and complexity.

The quality manual has to be controlled in accordance withthe requirements of clause 4.2.3.

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Establish, document, implement and maintain a quality management system

and continually improve its effectiveness.

a. Identify theprocesses required for the quality management system

b. Determine and document the sequence and interaction between the processesc. Identify and establish appropriate criteria and methods needed to operate and control

them.

d. Ensure that resources and supporting information are provided for process operation

e. Monitor, measure where applicable, and analyze the processes

f. Implement actions to achieve planned results and continual process improvement

These processes shall be managed by the organization in accordance with ISO

9001 . Organization should control outsourced processed. Type and extent

control on outsourced processes should be defined.


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A series of

interlinked activities

that use resources to transform

inputs into outputs.

ACTIVITY 3ACTIVITY 1 ACTIVITY 2 OUTPUTINPUT


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Processes must be planned and controlledto achieve the desired results.

Process planning requires control of inputs,resources and activities, and ensuring thatthe activities are arranged in the rightsequence.

Since the activities are also processes, theymust also be controlled.

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PROCESS

OUTPUT

RESOURCEPROCESS

CONTROL

INPUT

A process has to be

controlled to ensure

that the output

achieved is the

desired one

ACTIVITIES

A1 A2 A3

EACH PROCESS HAS A

SPECIFIC PURPOSE

PROCESS

A process requires

certain resources to

be able to function.


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As one of the measurements of theperformance of the quality management

system, the organization shall monitorinformation relating to customer perceptionas to whether the organization has metcustomer requirements.

The methods for obtaining and using thisinformation shall be determined.


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Continuous Continual


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Continual improvement is a set of activities that anorganization routinely carries out in order to improve itsability to meet requirements.

Continual improvement is achieved by carrying out internalaudits, performing management reviews, analyzing data,and implementing corrective and preventive actions.

Continual Improvement is a process ofincremental

improvement (step by step improvement) and is appliedcompany wide so that both managers and workmen areinvolved in this process of improvement.


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Breakthrough improvement is a majorimprovement that is achieved all at once.

Such improvements can be achieved throughinnovative changes of the process ortechnology, new advanced equipment or

complete overhaul of the working methodsto achieve a large jump in improvement.


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As opposed to continual improvement inwhich both managers and workmen are

involved and work together,

Breakthrough improvement is in the preserveof managers alone as this require technical

knowledge and out of the box thinking(innovation).


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To conduct internal audits at planned intervals to verify, conformance ofthe quality management system to the planned arrangements, and itseffective implementation and maintenance. The organization must:

a. Plan audit programs taking into consideration the status andimportance of the processes, areas and results of previous audits.

b. Define the audit criteria, scope, frequency, and methodsc. Select and use impartial and objective auditors, andd. Ensure that auditors do not audit areas of their own work, and

establish a documented procedure to define the responsibilitiesand requirements for,I. Planning and conducting audits.

II. Recording, reporting and maintenance of audit results.III. Ensuring that corrective actions are taken without delay toeliminate detected nonconformities and their causes.

IV. Following up of implementation of the correwctive actionsand reporting on the results of the corrective actions taken.

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An Audit is a fact finding mission. The

purpose is verification of compliance tospecified requirements. Internal audits are self auditing. Organizations audit themselves to verify that

operations, activities and processes are beingcarried out as per planned requirements.


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Internal audits must be conducted at plannedintervals to ensure compliance to requirements.

A documented procedure should define,1. How audits are to be planned including itsfrequency.

2. How they are to be recorded,and reported.3. For what periods audit records shall be

maintained.4. Ensuring timely corrective actions, and5. Verification of the results of corrective

actions.


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Internal audits verify, the effectiveness of the quality management system and its

implementation

Implementation and communicationof quality policy. Establishment, review and follow up of quality objectives. Implementation of continual improvement targets. Identification, implementation and improvements of processes

and procedures.

Achievement of customer satisfaction. Implementation of training requirements. Implementation of corrective anf preventive actions.


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The organization shall take corrective actions to eliminatenon conformities and their root causes to prevent theirrecurrence.

A documented procedure shall define requirements for:

a) reviewing non conformities and customer complaints,b) determining the causes of such nonconformities and

complaints,c) evaluating the need for action to ensure that non

conformities and complaints do not recur;

d) determining and implementing action needed;e) records of the results of action taken (see 4.2.4), andf) reviewing the effectiveness of the corrective action taken.


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A correction is an action taken to rectify a defective material throughre-working, reprocessing, assigning the defectives to some other usewhere they are acceptable; or totally destroying the defectives.

Corrections may not address the root cause of the problem.

Corrective actions address the root cause of the problem sothat the possibility of recurrence of the problem is eliminated.

Corrective action is a problem solving process, where theproblem is analyzed to identify the causes and then eliminatethem.


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Determine the actions to eliminate the causes of potentialnonconformities in order to prevent their occurrence.Ensure that preventive actions are appropriate to the

anticipated effects of the potential problem.

Establish a documented procedure to define the requirementsfor preventive action to:

Determine the potential nonconformities and their causes.

Evaluate the need for actions to prevent occurrence.

Determine and implement the needed actions .

Maintain records of the results of the actions taken., and

Review the effectiveness of preventive actions taken.


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Preventive actions are steps that are taken to removethe causes of potential nonconformitiessomething that

hasnt as yet occurred.

Preventive action is a risk analysis process.

While corrective actions prevent recurrence,preventive actions try to prevent future occurrences.


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QUALITYPOLICY

(5.3)

VERIFICATION

OF SYSTEM

INTERNALAUDIT(8.2.2)

QUALITY

OBJECTIVES

(5.4.1)

QUALITY

MANAGEMENTSYSTEM

(ISO 9001)

CUSTOMER

SATISFACTION

(8.2.1)

CONTINUAL

IMPROVEMENT

(8.5.1)

STARTING POINT


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Creation of an efficient and effective organization.

Well defined documented procedures and processes.

Consistent product quality.

Increased customer satisfaction.

Retention of customers.

Improved quality image, increased marketshare and profits.

Improved employee motivation, and awareness.

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1959

1972

1979

1987

1994

2000

2008

MIL-Q-9858: US defence qlty system standard

BS 4891: Quality Assurance Standard

BS 5750: Quality System Standard MIL-Q-9858ISO 9001: International Quality SystemStandard

Second revision: ISO 9001

First revision: ISO 9001

Current Version Of ISO 9001

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