session 14 iso documentation

872019 Session 14 ISO Documentation

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Introduction

AccreditationBody

CertificationBodyRegistrar



InternationalAccreditationForum (IAF)

Association of Accreditation bodies to promoteconfidence and consistency in ISO-9001 accreditationand certification process

AccreditationBody

Provide confidence that certification body is competentenough to issue ISO 9001 certificate Accreditationmark appear on certificate

CertificationBody Registrar

Conduct an audit ( Third body audit) to see theconformity of organization as per ISO-9001amp issuecertificate if conformity is found

Your supplier Organization supplying you goods You can conduct 2nd party audit to see the conformity to ISO QMS

You You are purchasing goods and now safe to get qualityproduct

Introduction



ISOISO

bull The name ISO is derived from the Greek word isos

meaning equalbull The relation to standards is that if two objects meet the

same standard they should be equal

bull International Organization

for standardization

bullA network of national

standard institute of more

than 150 countries

bull Central office in Geneva

Switzerland that coordinates

the system and publish the

standards



ISO 9000bull Series of standards on quality management and assurancebull Applicable to all types and sizes of organizationsbull Prevents ldquonon-conformityrdquo at every stage from design to after-

sales-servicesbull ISO-9000 is a certificate awarded by independent

auditors attesting that your organization has met thequality management requirements determined by ISO-9000bull It is frame work for showing to customer how weproduce test product train employees keep records

and fix defects EtcISO 9000 Quality Management amp Assurance Standards GUIDELINES for Selection amp Use

ISO 9001 Model for Quality Assurance in Design Development Production

Installation and Servicing

ISO 9002 Model for Quality Assurance in Production Installation and Servicing

ISO 9003 Model for Quality Assurance in Final Inspection and Testing

ISO 9004 Quality Management and Quality System Elements ndash GUIDELINESISO-9001 and 9004 are designed to constitute a ldquoconsistent pair ldquo of standards

DefinitionsDefinitions



Benefits of ISOBenefits of ISO

Product Cost Reduction Better process control amp internal operational efficiency Better documentation of processes Greater Employees quality awarenessAs the result

Reduction in product scrap rework and rejection Time is saved

Consistency in Quality Quality Constantly Measured

Preventive approach to deal with potential threats to qualityAs the result The defect rate decreased Improve product reliability Avoid the penalties for quality failure Market share increased with access to new market




Others Customer Demand for ISO Registration Customer satisfaction through documented procedures Competitive price offer due to low cost of product Purchase of good quality raw materials to produce

quality products Good practices through following other ISO series like

14000 22000 27000 and so on Documented Procedure are easier for new employee to

follow

Training enhance the skill result the profitability Continual Improvement is followed by the setting of

objectives amp Goals targets achievements Collection Analysis of data and Management Review



bull Standard A standard is a document It is a set of rulesthat control how people develop and manage materials

products services technologies processes and systems

bull Audit An independent documented activity in accordance

with written checklists and procedures to verify byexamination and evaluation of objective evidence that

applicable elements of the QMS have been developed

documented and effectively implemented in accordance with

the specified requirements

First Party (Internal Audit) Second Party( External Audit)

Third Party Assessment Nonconformance Major-

Minor non conformance Existing potential non

conformance CAPA Request Gap analysis


O



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements

S a t i s f a c t i o n

Continual Improvement of

the Quality Management System

ConsumptionProduct

Overv ew overv ew oISOISO

9001200890012008

ISO 9001 ModelISO 9001 Model

KEY Value Added

ActivitiesModel of a Process BasedQuality Management System



Provision of

resources

Human

resources

Infrastructure

s

Workenvironment

6 ResourceManagement

General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews

5 ManagementResponsibility 8 MeasurementAnalysis amp

improvement

System Requirements Structure of theSystem Requirements Structure of the

StandardStandard

4 QualityManageme

nt System

7 ProductRealization

General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements



DefinitionsDefinitionsbull Document is information with its supportingmediumRecord is a document stating results achieved or

providing evidence of activities performed

bull All records are documents but not all documentsare records A written procedure is a document but

not a record

bull A record is just a special type of document A blankform with no data is a document Once data is

entered on the form it may become a record



What is a DocumentWhat is a DocumentISO 90002008 definitionISO 90002008 definition

Document Information and its supporting mediumDocument Information and its supporting medium

INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc

DOCUMENTATION CAN BE IN ANY FORMAT OR

MEDIUM



Objectives of DocumentationObjectives of Documentation Communicate InformationCommunicate Information

ndash Means to transmit and communicate informationMeans to transmit and communicate informationndash Type and amount depend onType and amount depend on

grade of formality of communication systemgrade of formality of communication system

level of communication skilllevel of communication skill

Organizational CultureOrganizational Culture

Nature of product and processNature of product and process

Evidence ConformityEvidence Conformityndash Provide evidence that what has been planned hasProvide evidence that what has been planned has

been achievedbeen achieved

Share KnowledgeShare Knowledgendash communicate and preserve the organizationrsquoscommunicate and preserve the organizationrsquos

KnowndashHowKnowndashHow Technical SpecificationsTechnical Specifications

Manufacturing TechnologyManufacturing Technology



Extension of DocumentationExtension of Documentation

The extent of the QMS documentation can vary from oneThe extent of the QMS documentation can vary from one

organization to the other because oforganization to the other because of

a) Size of the organization and type of its activitiesa) Size of the organization and type of its activities

b) Complexity of its processes and interactionsb) Complexity of its processes and interactions

c) Competence of personnelc) Competence of personnel



Control of DocumentationControl of Documentation

Define NeededDocument

DevelopDocument

Ensure that

document is andremains legible ampreadily identifiable

Review ampApprove

Prior to issue

Issue toPoints of use

General Rule

The right document must beavailable at the right time at rightplace

PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained

Identify RevisionStatus

Documents required by the QMS shall be controlled

(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)

Obsolete if previousdoc available

Changethe Doc



Documentation StructureDocumentation Structure

1

2

3

4

Vision

MissionQualityPolicy

TYPICAL STRUCTURE

Levelndash1 Quality Manual

Scope Exclusion

Description of processesinterrelationships

Levelndash2 Procedures Documentation of process

activities could include workinstructions

Levelndash3 Standardized FormsConvertible into records

External DocumentsCustomer Specifications

etc

Levelndash4 RecordsEvidence of conformance



Quality PolicyQuality Policy

is the statement which defines or describesis the statement which defines or describes

an organizations commitment towardsan organizations commitment towards

qualityquality

Quality Policy should beQuality Policy should be

ndash developed and authorized normally by Topdeveloped and authorized normally by Top

Management in consultation with seniorManagement in consultation with senior

executives and managementexecutives and management

ndash understood and implemented at all levels in theunderstood and implemented at all levels in the

organizationorganization

ndash and be relevant to the organizational goals andand be relevant to the organizational goals and

the needs and the expectations of its customersthe needs and the expectations of its customers



Quality ManualQuality ManualISO 90002008 Definition ldquoDocument specifying the QMS of anISO 90002008 Definition ldquoDocument specifying the QMS of an

organizationrdquoorganizationrdquo Quality manual is the first step in building a Quality ManagementQuality manual is the first step in building a Quality Management

SystemSystem At a minimum the Quality Manual is required to address the applicableAt a minimum the Quality Manual is required to address the applicable

ISO Series that the company plans to become registered against ISOISO Series that the company plans to become registered against ISO9001200890012008

The Quality Manual must include (ISO 90012008 ndash 422)The Quality Manual must include (ISO 90012008 ndash 422)

ndash Scope of QMS including details and justification of exclusionsScope of QMS including details and justification of exclusionsndash Documented procedures for QMS or Reference to themDocumented procedures for QMS or Reference to themndash Description of the interaction between processes of QMSDescription of the interaction between processes of QMS

The Quality Manual could also includeThe Quality Manual could also includendash A description of the organizationA description of the organizationndash The Quality PolicyThe Quality Policy

ndash Global Quality ObjectivesGlobal Quality Objectivesndash The Structure of the OrganizationThe Structure of the Organization

Quality Manual StructureQuality Manual Structurendash Three possible formats or structuresThree possible formats or structures

By ClausesBy Clauses By FunctionsBy Functions OthersOthers





Documented ProceduresDocumented Procedures

ISO 90012008 requires the following ldquodocumentedISO 90012008 requires the following ldquodocumented

proceduresrdquoproceduresrdquondash Control of Documents (423)Control of Documents (423)

ndash Control of Records (424)Control of Records (424)

ndash Internal Audit (822)Internal Audit (822)

ndash Control of Nonconforming Products (83)Control of Nonconforming Products (83)

ndash Corrective Actions (852)Corrective Actions (852)

ndash Preventive Actions (853)Preventive Actions (853)

PROCEDURE (ISO 90002008 Definition)

ldquoSpecified way to carry out an activity or a processrdquo

PLUS

ldquoDocuments needed by the organizationhelliprdquo



QUESTIONQUESTION

SS



Introduction

AccreditationBody

CertificationBodyRegistrar





AccreditationBody






Introduction



ISOISO





for standardization



than 150 countries




standards


























follow

















O



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements




ConsumptionProduct


9001200890012008


KEY Value Added




Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS





AccreditationBody






Introduction



ISOISO





for standardization



than 150 countries




standards


























follow

















O



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements




ConsumptionProduct


9001200890012008


KEY Value Added




Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS



ISOISO





for standardization



than 150 countries




standards


























follow

















O



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements




ConsumptionProduct


9001200890012008


KEY Value Added




Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS


























follow

















O



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements




ConsumptionProduct


9001200890012008


KEY Value Added




Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS















O



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements




ConsumptionProduct


9001200890012008


KEY Value Added




Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5Management

Responsibility

7 Product

Realization

6 Resource

Management

8 Measurement

Analysis and

Improvement

Requirements




ConsumptionProduct


9001200890012008


KEY Value Added




Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS



Provision of

resources

Human

resources

Infrastructure

s

Workenvironment


General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design amp

development

Purchasing

Production amp

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility

authority amp

communication

Management

Reviews


improvement


StandardStandard

4 QualityManageme

nt System


General

Monitoring amp

measurement

Control of NCR

Analysis of data

Improvements






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS






not a record







INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS





INFORMATION

Procedure

Specification

Record

Drawing

Report

Standard

MEDIUM

Paper

Electronic

Photographic

Magnetic

etc


MEDIUM


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS


























DevelopDocument

Ensure that


Review ampApprove

Prior to issue


General Rule


PreventUnintende

d Use

UpdateDocument

IdentifyIf Retained



(ISO 90012008) (Clause 423)


(ISO 90012008) (Clause 423)


Changethe Doc




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS




1

2

3

4

Vision


TYPICAL STRUCTURE


Scope Exclusion






etc







qualityquality



































PLUS




QUESTIONQUESTION

SS






qualityquality



































PLUS




QUESTIONQUESTION

SS



























PLUS




QUESTIONQUESTION

SS



QUESTIONQUESTION

SS