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Introduction to

ISO 9001:2008

 olution of quality standards

m m m m

m m › ›

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in ISO 9001:2000 and withdrawn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.





Processes - understand interactions


ustomer satisfaction
C Continual Improvement of the C
Quality Management System
S e S t
q Π 
T i
  T s
O i
O f
r Π a
M e 
     M c
E m     
e Input E i
R n Output
R o
t Product 

S s realisation S

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
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
º Be limited to lause 7

2 Ñormati e reference

u ISO 9000 : 2005, 2uality management systems -

Fundamentals and ocabulary.

3 Terms and definitions

u The term ´productµ also means ´ser iceµ

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

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

4.1 General equirements
u anage the processes in accordance with the standard
u nsure control of outsourced processes affecting product
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

4.2 Documentation requirements

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

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

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
º Documented procedures or reference thereto
º Description of the interaction between the processes of the
2 S

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
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.

5 anagement responsibility
u 5.1 anagement    
u 5.2 ustomer focus
u 5.3 2uality policy       
u 5.4 Planning     
º 5.4.1 2uality objecti es  !
º 5.4.2 2 S planning     
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

5.2 ustomer focus


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

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

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

5.5 esponsibility, authority and communication

½ ½ 
u define and communicate responsibilities and

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

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

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.
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

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

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

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

7.2 ustomer related processes

7.2.1 Determination of requirements related to

7.2.2 e iew of requirements related to product
7.2.3 ustomer communication

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
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
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

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

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

7.3.5 Design & de elopment erification

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

u ecord the results of erification and necessary

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
u Whene er applicable to be completed prior to deli ery
u esults of alidation and necessary actions must be

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

7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information
7.4.3 Verification of purchased product

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
7.4.2 Purchasing information
u Purchasing information must include where appropriate:
º requirements for appro al of product, procedures, processes and
º requirements for qualification of personnel
º quality management system requirements
u nsure adequacy of specified purchase requirements prior
to their communication to supplier

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
º erification arrangements
º method of product release
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
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
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

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

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

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
u This applies to constituent parts of a product

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
u Suitability of measuring/monitoring software must be
confirmed prior to use and re-confirm as necessary
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

8 easurement, analysis and impro ement
u 8.1 General   "#  $$ 
u 8.2 onitoring/measurement 
º 8.2.1 ustomer satisfaction   "%&  $ 
º 8.2.2 Internal Audit   " 
º 8.2.3 onitoring & measurement of  " #   
 " #  
º 8.2.4 onitoring & measurement of
product  " '  

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

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

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

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

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

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

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

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

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

8.5.2 orrecti e action
u Take actions to eliminate the causes of nonconformities to pre ent
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