Introduction to

ISO 9001:2008

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  olution of quality standards

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2uality System Standard

u generic (ISO 9000)

u industry related (AS 9000, TL 9000)


ISO 9002 and 9003

u Prior to ISO 9001:2000, there were ISO 9002 and

ISO 9003 too. These were subsets of ISO 9001 with
certain exclusions.
u ISO 9002 & ISO 9003 (1987 and 1994) incorporated
in ISO 9001:2000 and withdrawn


Process approach

u Process approach to quality management encouraged

u An acti ity using resources, and managed in order to
enable the transformation of inputs into outputs, can
be considered as a process.

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Processes:

   

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 Processes - understand interactions

   
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 ustomer satisfaction
C Continual Improvement of the C
Quality Management System
U R
U S
a
S e S t
q Œ


T i
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  T s
O i
O f
r Π
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M e 
 

 M c
E m 

  

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e Input E i
R n Output
R o
t Product 

S s realisation S
n


elationship with ISO 9001 and ISO 9004
u Designed to complement each other
u an be used independently
u Different scope - similar structure
u ISO 9001 can apply for certification or contractual
purposes and focuses on effecti eness
u ISO 9004 pro ides wider focus on quality management


1 Scope (1.1 General)
Standard specifies 2 S requirements for use to:
u demonstrate organisation·s ability to consistently pro ide
product meeting customer & applicable statutory &
regulatory (legal) requirements
u enhance customer·s satisfaction through effecti e
application of the system including processes for its
continual impro ement and assurance of conformity to
customer and applicable statutory & regulatory
requirements
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1.2 Application
u equirements are generic
u equirement may be excluded if cannot be applied
due to the nature of organisation and its product
u xclusions must:
º Ñot affect ability or responsibility to pro ide conforming
product
º Be limited to lause 7

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2 Ñormati e reference

u ISO 9000 : 2005, 2uality management systems -

Fundamentals and ocabulary.

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3 Terms and definitions

u The term ´productµ also means ´ser iceµ

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4.1 General requirements

u stablish, document, implement and maintain a 2 S

and continually impro e its effecti eness in
accordance with the standard

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4.1 General equirements
u Determine the processes necessary for 2 S
u Determine the sequence and interaction of processes
u Determine criteria & methods to ensure effecti e operation &
control of the processes
u nsure a ailability of resources and information needed to
support the operation & monitoring of the processes
u onitor, measure where applicable and analyse processes
u Implement actions necessary to achie e planned results &
continual impro ement

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4.1 General equirements
u anage the processes in accordance with the standard
u nsure control of outsourced processes affecting product
conformity
u Define control of outsourced processes within the 2 S
u ontrol o er outsourced processes does not absol e the
organization of its responsibilities

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4.2 Documentation requirements

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u 2 S documentation:
º 2uality policy, objecti es
º 2uality manual
º Documented procedures and records
º Documents, including records determined by the organisation

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4.2.1 General
u Documented procedure means that it must be established,
documented, implemented and maintained
u xtend of documentation may differ due to
º Size & type of organisation
º omplexity & interaction of processes
º ompetence of personnel
u Documentation may be in any type of media

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4.2.2 2uality manual

u 2uality manual must include as minimum:

º The scope of 2 S including details of, and justification for, any
exclusions
º Documented procedures or reference thereto
º Description of the interaction between the processes of the
2 S

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4.2.3 ontrol of documents
u Documented procedures to:
º appro e documents prior to issue
º re iew, update as necessary and re-appro e documents
º to identify the changes and the current re ision status of documents
º to ensure documents remain legible, readily identifiable
º ensure rele ant ersions of applicable documents are a ailable at points of use
º ensure that documents of external origin necessary for planning and operation of 2 S
are identified and distribution controlled
º obsolete documents are pre ented from unintended use and identified if kept for any
reason
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4.2.4 ontrol of records

u ecords to pro ide e idence are controlled

u Documented procedure to define the controls needed for
the identification, storage, protection, retrie al, retention
and disposition of quality records.
u ecords must be legible, readily identifiable and retrie able.

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 5 anagement responsibility
u 5.1 anagement  

    
commitment   



    
u 5.2 ustomer focus


 
u 5.3 2uality policy 

  
u 5.4 Planning  
 
º 5.4.1 2uality objecti es 

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º 5.4.2 2 S planning 

   


  
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5.1 anagement commitment
u Pro ide e idence of commitment to the de elopment
implementation and continual impro ement of 2 S by:
º communicating the importance of meeting customer and statutory
and regulatory requirements
º establishing quality policy & objecti es
º management re iews
º pro ision of resources

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5.2 ustomer focus


 










  

 
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5.3 2uality policy
u appropriate to the purpose of the organisation
u commitment to comply with requirements
u continually impro e the effecti eness of the 2 S
u framework for establishing & re iewing quality objecti es
u communicated and understood
u re iewed for continuing suitability

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5.4.1 2uality objecti es

u establish quality objecti es

u measurable & consistent with the quality policy
u include those needed to meet requirements for
product

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5.4.2 2uality management system planning

uplanning of the 2 S is carried out in order to meet

requirements gi en in 4.1, as well as the quality
objecti es
u aintain the integrity of the 2 S integrity when
changes are planned and implemented

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5.5 esponsibility, authority and communication

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u define and communicate responsibilities and
authorities

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5.5.2 anagement epresentati e
u ember of the organization·s management
u ensures that processes needed for the 2 S are established,
implemented and maintained
u reports on performance of 2 S including needs for
impro ement
u promotes awareness of customer requirements

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5.5.3 Internal communication

u ommunication processes are established

u ommunication takes place regarding the
effecti eness of 2 S


5.6 anagement e iew

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u e iew of the 2 S by top management at planned
inter als to:
º ensure 2 S suitability, adequacy & effecti eness
º assess opportunities for impro ement
º e aluate the need for changes to 2 S including policy & objecti es
u ecords maintained.
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 5.6.2 e iew input
audit results
customer feedback
process performance
product conformity 
status of PAs and As 
follow up actions from earlier re iews
changes that could affect the 2 S
recommendations for impro ement

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 5.6.3 e iew output

impro ed effecti eness of the 2 S


impro ement of product

resource needs


6 esource anagement

u 6.1 Pro ision of resources

u 6.2 Human resources
º 6.2.1 General
º 6.2.2 ompetence, training and awareness
u 6.3 Infrastructure
u 6.4 Work en ironment

6.1 Pro ision of resources

u Determine & pro ide the resources needed to:

º implement, maintain the 2 S and continually impro e its
effecti eness
º enhance customer satisfaction

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6.2 Human esources
u 6.2.1 General
Personnel performing work affecting conformity to product
requirements must be competent on the basis of :
appropriate education
training
skills
experience.

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6.2.2 ompetence, training and awareness
uDetermine the necessary competence
uPro ide training or take other action to satisfy those needs
u aluate the effecti eness of actions taken
unsure staff aware of rele ance and importance of their
acti ities and contribution to achie ing objecti es
u aintain appropriate records of education, training, skills
and experience


6.3 Infrastructure

u Determine, pro ide & maintain the infrastructure

needed to achie e product conformity. Infrastructure
includes, as applicable:
º buildings, workspace
º equipment
º supporting ser ices


6.4 Work en ironment

u Determine and manage the work en ironment

needed to achie e product conformity.


7 Product realization

7.1 Planning of product realization

7.2 ustomer related processes
7.3 Design & de elopment
7.4 Purchasing
7.5 Production & ser ice pro ision
7.6 ontrol of measuring & monitoring equipment

7.1 Planning of product realization

u Planning must determine as appropriate:

º quality objecti es and requirements for the product
º the need for processes, documentation, resources specific to
the product
º erification and alidation acti ities & acceptance criteria
º ecords to pro ide e idence

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7.2 ustomer related processes

7.2.1 Determination of requirements related to

product
7.2.2 e iew of requirements related to product
7.2.3 ustomer communication

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7.2.1 Determination of requirements related to product

u Organisation must determine:

º requirements specified by the customer
º requirements not specified but necessary
º statutory and regulatory requirements applicable to product,
º any additional requirements


7.2.2 e iew requirements related to the product
u e iew requirements before commitment to supply product & ensure
that:
º product requirements are defined
º difference between contract requirements from those pre iously expressed
resol ed
º organisation has ability to meet the requirements
u ecord the results of re iew and actions
u onfirm requirements, when customer does not pro ide documented
requirements
u When requirements are changed ensure that documents are
amended and rele ant persons are made aware of the changes.

7.2.3 ustomer communication

u ffecti e arrangements for communication with

customers relating to :
º product information
º enquiry, contract & order handling including amendments
º customer feedback including complaints

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7.3 Design & de elopment
7.3.1 Design & de elopment planning
7.3.2 Design & de elopment inputs
7.3.3 Design & de elopment outputs
7.3.4 Design & de elopment re iew
7.3.5 Design & de elopment erification
7.3.6 Design & de elopment alidation
7.3.7 ontrol of design & de elopment changes
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7.3.1 Design & de elopment (D&D) planning
u Plan & control D&D of the product.
u Planning to include:
º D&D stages
º required re iew, erification and alidation acti ities
º responsibilities & authorities for D&D
u Interfaces between groups must be managed
u Planning to be updated as the D&D progresses

7.3.2 Design & de elopment inputs
u Determine & record product requirements including:
º functional & performance requirements
º applicable statutory and regulatory requirements
º information from pre ious similar designs
º any other essential requirements
u e iew input for adequacy
u equirements must be complete, unambiguous and not in
conflict with each other

7.3.3 Design & de elopment outputs

u D&D output in a form suitable for erification

u D&D output must
º meet the input requirements
º pro ide information for purchasing, production and ser ice pro ision
º contain or reference acceptance criteria
º define characteristics essential for proper & safe use
u Appro e output prior to release

7.3.4 Design & de elopment re iew

u At suitable stages systematic re iews of D&D to:

º e aluate the ability to meet requirements
º identify problems and propose follow up
u In ol e all functions concerned
u ecord the results and any necessary actions

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7.3.5 Design & de elopment erification

u Verify D&D to ensure that output meets the input

requirements
u ecord the results of erification and necessary
actions

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7.3.6 Design & de elopment alidation

u Perform D&D alidation to confirm that product is capable

of meeting the requirements for the specified or intended
use
u Whene er applicable to be completed prior to deli ery
u esults of alidation and necessary actions must be
recorded

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7.3.7 ontrol of design and de elopment changes

u Design & de elopment changes must be identified and

records maintained
u hanges must be re iewed, erified and alidated as
appropriate and appro ed before implementation
u ecord results of re iew of changes and any necessary
actions

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7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information
7.4.3 Verification of purchased product

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7.4.1 Purchasing process
u nsure that purchased product meets requirements
u Type & extend of control depends on effect purchased
product may ha e on the final product
u  aluate and selects suppliers based on their ability to
supply conforming product
u stablish criteria for selection, e aluation and re-e aluation
of suppliers
u esults of e aluation and any necessary actions must be
recorded
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7.4.2 Purchasing information
u Purchasing information must include where appropriate:
º requirements for appro al of product, procedures, processes and
equipment
º requirements for qualification of personnel
º quality management system requirements
u nsure adequacy of specified purchase requirements prior
to their communication to supplier

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7.4.3 Verification of purchased product

u stablish & implement inspection or other acti ities

needed to ensure purchased product conformity
u Where organisation or its customer propose erification at
supplier·s premises, organisation must specify in purchasing
information:
º erification arrangements
º method of product release
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7.5 Production and ser ice pro ision
7.5.1 ontrol of production and ser ice
pro ision
7.5.2 Validation of processes for production and
ser ice pro ision
7.5.3 Identification & traceability
7.5.4 ustomer property
7.5.5 Preser ation of product
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7.5.1 ontrol of production and ser ice pro ision
u Plan and carry out production & ser ice pro ision
under controlled conditions. ontrolled conditions
include as applicable:
a) a ailability of information describing product characteristics
b) a ailability of work instructions, as necessary
c) the use of suitable equipment
d) a ailability & use of monitoring and measuring equipment
e) implementation of monitoring and measurement
f) the implementation of product release, deli ery and post deli ery
acti ities
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7.5.2 Validation of processes
u Validate processes where outcome is not erified and as a consequence,
deficiencies may become apparent after deli ery
u Validation shall demonstrate the ability of processes to achie e results
u For these processes establish:
º criteria for re iew and appro al of the process
º appro al of equipment and qualification of personnel
º use of defined methods & procedures
º requirements for records
º re alidation

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7.5.3 Identification and traceability
u Where appropriate identify product by suitable means
throughout product realization
u Identify status with respect to measurement & monitoring
requirements throughout product realization
u Where traceability is required control the unique
identification of product
u aintain records

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7.5.4 ustomer property
u are for customer·s property while it is under
organisation·s control or being used by organisation
u Identification, erification, protection & safeguarding
customer property pro ided for use or incorporation
u Any customer property that is lost, damaged or found
unsuitable must recorded & reported to customer
ustomer property includes intellectual property & personal data

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7.5.5 Preser ation of product

u Preser e the product during internal processing and

final deli ery to intended destination
u Include identification, handling, packaging, storage and
protection
u This applies to constituent parts of a product

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7.6 ontrol of monitoring & measuring equipment
u Determine monitoring and measurements to be made &
measurement & monitoring equipment needed to pro ide
e idence of conformity of product
u nsure measuring and monitoring is carried out
consistently with monitoring and measurement
requirements
u Suitability of measuring/monitoring software must be
confirmed prior to use and re-confirm as necessary
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7.6 ontrol of monitoring & measuring equipment
u alibrate or erify or both at specified inter als or prior to use against international
or national standards. Where no such standard exist record the basis
u Adjust or re-adjust as necessary
u Ha e identification to determine calibration status
u Safeguard from adjustments in alidating calibration
u Protect from damage or deterioration during handling, maintenance& storage
u record results of calibration
u assess and record alidity of pre ious results when de ice found to be out of
calibration

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 8 easurement, analysis and impro ement
u 8.1 General   "
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u 8.2 onitoring/measurement 
º 8.2.1 ustomer satisfaction   "
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º 8.2.2 Internal Audit   "

º 8.2.3 onitoring & measurement of  "

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processes
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#  
º 8.2.4 onitoring & measurement of
product  "

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8.1 General

u Plan & implement measurement, monitoring analysis

and impro ement processes needed to:
º demonstrate conformity to product requirements
º ensure conformity of the 2 S
º continually impro e the effecti eness of the 2 S

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8.2.1 ustomer satisfaction

u Organisation shall monitor information related to

customer perception as to whether the organisation
has met customer requirements.
u The methods for obtaining and using this information
must be determined

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8.2.2 Internal audit
u onduct internal audits at planned inter als to determine if
:
º 2 S conforms to the planned arrangements, requirements of the standard
and organisation·s requirements
º 2 S is effecti ely implemented & maintained
u Plan the audit programme considering:
º status and importance of the processes and the areas
º results of pre ious audits
u Define audit criteria, scope, frequency & methodologies

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8.2.2 Internal audit
u Select auditors to ensure objecti ity and impartiality.
u Auditor must not audit own work.
u The documented procedure must co er:
º responsibilities & requirements for planning and conducting audits
º reporting results and maintaining records
u orrecti e actions without undue delay
u Follow up to erify actions taken & report erification
results

8.2.3 onitoring and measurement of processes

u Apply suitable methods for monitoring and, where

applicable, measurement of 2 S processes
º These methods shall demonstrate the ability of the processes
to achie e planned results
º Where planned results are not achie ed corrections and
correcti e actions must be taken

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8.2.4 onitoring and measurement of product
u onitor & measure product characteristics to erify conformity at
appropriate stages
u  idence of conformity with the acceptance criteria must be maintained.
u ecords must indicate the person(s) authorising release of the product
for deli ery to the customer
u elease or deli ery must not proceed until all the planned arrangements
ha e been satisfactorily completed, unless otherwise appro ed by a
rele ant authority, and where applicable by the customer

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8.3 ontrol of nonconforming product

u Ñonconforming product must be identified and

controlled to pre ent unintended use or deli ery
u Documented procedure to define controls,
responsibility and authority
u When the nonconforming product is corrected it
must be re- erified to demonstrate conformity

8.3 ontrol of nonconforming product
u Organisation must deal with nonconforming product by
one or more of the following ways:
º action to eliminate detected nonconformity
º concession
º preclude original intended use or application
º Taking actions appropriate to the effects, when nonconformity is
detected after deli ery
u ecords of the nature of nonconformity and any
subsequent action including concessions must be
maintained


8.4 Analysis of data
u Determine, collect & analyse appropriate data to demonstrate the
suitability and effecti eness of 2 S and to e aluate where continual
impro ement of the 2 S can be made
u Data from measurement & monitoring & other rele ant sources
u Analyze data to pro ide information on:
º customer satisfaction
º conformity to product requirements
º process, product characteristics and their trends including opportunities for
pre enti e action
º suppliers
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8.5 Impro ement
8.5.1 ontinual impro ement
u Organisation shall continually impro e the effecti eness of the 2 S
through use of:
º quality policy
º quality objecti es
º audit results
º analysis of data
º correcti e actions
º pre enti e actions
º management re iew
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8.5.2 orrecti e action
u Take actions to eliminate the causes of nonconformities to pre ent
recurrence.
u orrecti e actions appropriate to the impact of the problem
u Documented procedure shall define requirements for:
º re iewing nonconformities (including customer complaints)
º determining the causes of nonconformities
º  aluating the need for correcti e action
º determining & implementing action needed
º recording results of action taken
º re iewing the effecti eness of the correcti e action taken


8.5.3 Pre enti e action
u Determine action to eliminate the causes of potential
nonconformances to pre ent occurrence.
u Actions appropriate to the impact of the potential problem
u Documented procedure must define the requirements for
º determining potential nonconformances & their causes
º e aluating the need for pre enti e action
º determining and implementing action needed
º recording the results of action taken
º re iewing the effecti eness of the pre enti e action taken