Handout Training Iso 9001 2015

for  ISO  9001:2015 2  DAYS  TRAINING

GIC  Indonesia  Training  Division

Agenda   DAY  ONE   Introduction   Rationale  for  changes   Salient  Points  on  ISO  9001:2015   Comparison  with  ISO  9001:2008   Clause  4  -­‐  Context  of  the  Organization   Clause  5  -­‐  Leadership  

DAY  TWO   Clause  6  -­‐  Planning  for  the  Quality   Management  System   Clause  7  -­‐  Support   Clause  8  -­‐  Operation   Clause  9  -­‐  Performance  Evaluation   Clause  10  -­‐  Improvement  

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Objective

This  training  has  been  developed  to  provide  basic   information  and  updates  on  the  revision  to  ISO   9001  to  interested  parties  and  will  be  updated   periodically  until  the  final  version  is  published.

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Disclaimer

The  is  possibility  that  you  have  already  implemented   beyond  the  ISO  9001:2008  requirements  and   accidentally  cover  the  ISO  9001:2015  DIS  requirements   But  you  have  to  pay  attention  to  the  NEW  approach   that  may  not  be  implemented  yet  by  your  organisation

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Disclaimer Any  claims  or  statements  made  by  the  presenter  based  on   this  presentation  represent  their  own  opinions  and/or   interpretation,  and  are  not  formally  endorsed  by  GIC.  

! This  presentation  includes  information  related  to  the   status  of  the  revision  process  as  of  April  2015  

! Further  changes  are  likely  as  the  revision  process   progresses,  so  you  should  NOT  make  changes  to  your   management  system  at  this  stage  until  the  new  revision   has  been  published  officially. Copyright  GIC  2014

Introduction  –  Review  of  ISO  Standards   • Every  five  years,  ISO  Standards  are  reviewed  to  ensure  they   are  up-­‐to-­‐date.       • ISO  Technical  Committee  176  is  responsible  for  the   development  of  the  ISO  9001  and  ISO  9004  International   Standards  as  other  International  Standards  and  documents  in   the  ISO  9000  Family.       • A  formal  global  review  of  ISO  9001  was  completed  in  2012   among  ISO  member  bodies.    This  resulted  in  a  decision  to   revise  the  standard

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Introduction  –  Review  of  ISO  Standards   • As  with  all  ISO  standards,  this  will  be  a  consensus  process   • All  ISO’s  National  Member  Bodies  (NMBs)  and  official  liaison   members  nominate  experts  to  participate  in  the  drafting   process  

• Work  on  the  revision  has  already  begun  and  the  Draft   International  Standard  (DIS)  has  been  released  and  voting   shall  start  on  2014-­‐07-­‐10  and  voting  ends  on  2014-­‐10-­‐10.

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Introduction  -­‐  Key  Messages • According  to  ISO  Survey  2012  —   more  than  1.1  million  certificates   around  the  globe   • 73%  of  all  MSS  (Management   System  Standards)  certificates  are   ISO  9001  certificates   • ISO  14001  will  be  published   around  the  same  time   • ISO  9001:2015  —  the  changes   proposed  are  significant Copyright  GIC  2014

Introduction  –  The  ISO  9001  evolution 1987     • The  first  ISO  9000  series  was  published.     • It  was  based  on  BS5750.       • Focused  on  Quality  Control    

1994   • There  were  3  certification  standards  that   were  released  (i.e.  ISO  9001,  ISO  9002,  ISO   9003)   • Elemental  approach  (consisting  20   Elements)  focused  on  producing  products   at  a  consistent  level  of  quality. Copyright  GIC  2014

Introduction  –  The  ISO  9001  evolution 2000   There  is  a  significant  changes  or  leap  from  1994  version  to  2000   such  as:   • From  elemental  to  a  Process  Model  on  Quality  Management   System  using  the  PDCA  (Deming  Cycle)   • From  the  1994  with  3  Certification  Standards  to  2000  version   of  only  1  Certification  Standard  (but  with  exclusion  to  clauses   applicable  only  on  clause  7).  

2008   • No  significant  changes.  The  changes  are  mostly  clarifications. Copyright  GIC  2014

Introduction  –  The  ISO  9001  evolution

2015

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Introduction  –  The  ISO  9001  evolution !

2015   ▪ New  concepts  are  being  considered   ▪ The  customer  remains  the  primary  focus   ▪ A  new  common  ISO  format  has  been  developed  for  use  across   all  Management  System  Standards  

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Why  is  the  Standard  changing? ` of  “business  environment”   ▪• Evolution   ▪ Evolution  of  management  systems   ▪ Evolution  of  quality   ▪ ISO  scheduled  review

Rationale  for  Changes • In  the  last  25  years,  many  other  Management  Systems   Standards  have  come  into  use  world  wide.       • These  various  standards  have  different  format  or  structure.     Here  is  an  example  of  comparison  between  ISO  9001  and  ISO   14001: ISO  9001:2008  Structure 4.1  General  Requirements   4.2  Documentation  Requirements   5  Management  responsibility   6  Resource  Management   7  Product  Realization  

ISO  14001:2004  Structure 4.1  General  requirements   4.2  Environmental  policy   4.3  Planning   4.4  Implementation  and  operation   4.5  Checking  

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Rationale  for  Changes • Organizations  that  use  multiple  Management  System   Standards  are  increasingly  demanding  a  common   format  and  language  that  is  aligned  between  those   standards.   • Hence,  if  there  is  a  common  format,  integration  will  be   easier.    

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High  Level  Structure  -­‐  Common  Text   Annex  SL  

• Mandated  by  ISO’s  Technical  Management  Board  (TMB)   • High  level  structure,  identical  core  text  and  common  terms   and  core  definitions  for  use  in  all  Management  System   Standards   • Purpose  -­‐  Enhance  the  consistency  and  alignment  of   different  management  system  standards   • Organizations  who  implement  a  single  system  addressing   multiple  standards  (e.g.  QMS,  EMS,  ISMS  etc)  will  see  the   most  potential  benefit

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High  Level  Structure  (HLS) 1.   2.   3.   4.  

Scope     Normative  references     Terms  and  definitions     Context  of  the  organization    

• Understanding  the  organization  and   its  context     • Needs  and  requirements     • Scope     • Management  System     5.   Leadership     • General     • Management  commitment     • Policy     • Roles,  responsibility  and  authority     6.     Planning     • Actions  to  address  risks  &   opportunities     • Objectives  and  plans  to  achieve   them  

7.  Support    

• • • • •

Resources     Competence     Awareness     Communication     Documented  information     8.  Operation     • Operational  planning  and  control     9.  Performance  evaluation     • Monitoring,  measurement,  analysis   &  evaluation     • Internal  audit     • Management  review     10.  Improvement     • Non  conformity  and  corrective   action     • Continual  Improvement  

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Rationale  for  Changes ▪ Decrease  the  emphasis  on  Documentation   ▪ Increase  the  emphasis  on  Achieving  Value  for  the   Organization  and  its  customers   ▪ Increase  emphasis  on  Risk  Management  to  achieve   objectives  

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Salient  Points 1. Structure  and  Terminology   2. Product  and  Services   3. Context  of  the  Organization   4. Documented  Information   5. Risk-­‐based  Approach   6. Scope  and  Applicability   7. Organizational  Knowledge   8. Control  of  externally  provided  products  and  services Copyright  GIC  2014

Salient  Points 1. Structure and Terminology   ! ISO  9001:2008

ISO  9001:2015

Products

Products  and  services

Exclusions

Not  used  (See  Annex  A.4  for  clarification   of  applicability)

Documentation,  records

Documented  information

Work  environment

Environment  for  the  operation  of   processes

Purchased  product

Externally  provided  products  and  services

Supplier

External  provider

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Salient  Points 2. Products and Services   !

2008: The term “product” to include all output categories.  

2015: The term “products and services” includes all output categories (hardware, services, software and processed materials.   In most cases, the terms “products” and “services” are used together. Most output that organizations provide to customers, or are supplied to them by external providers, include both products and services.  

!

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Salient  Points 3. Context of the organisation   • ! There are two new clauses relating to the context of the organization:   4.1 Understanding the organization and its context   4.2 Understanding the needs and expectation of interested parties.   The titles of clauses 4.1 and 4.2 provide for alignment with other management system standards. They do not imply extension of quality management system requirements beyond the Scope of this International Standard. Copyright  GIC  2014

Salient  Points 4. Documented Information ! The terms “documented procedure” and “record” have both been replaced throughout the requirements text by “documented information”.   Where ISO 9001:2008 would have referred to documented procedures (e.g. to define, control or support a process) this is now expressed as a requirement to maintain documented information.  

! Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information.

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Salient  Points 5. Risk-based Approach   It requires the organization to understand its context (clause 4.1) and determine the risks and opportunities that need to be addressed (clause 6.1).   With the inclusion of this approach, it has facilitated some reduction in prescriptive requirements and their replacement by performance-based requirements.   Although risks and opportunities have to be determined and addressed, the standard does not require for formal risk management or a documented risk management process. Copyright  GIC  2014

Salient  Points 6. Applicability   This Standard no longer makes specific reference to ‘exclusions’ when determining the applicability of its requirements to the organization’s quality management system. When a requirement can be applied within the scope of its QMS, the organization cannot decide that it is not applicable. Where a requirement cannot be applied (for example where the relevant process is not carried out) the organization can determine that the requirement is not applicable. However, this is non-applicability cannot be allowed to result in failure to achieve conformity of products and services or meet the organization’s aim to enhance customer satisfaction. Copyright  GIC  2014

Salient  Points 7. Organizational knowledge   Clause 7.1.6 Organizational knowledge addresses the need to determine and maintain the knowledge obtained by the organization, including by its personnel, to ensure that it can achieve conformity of products and services. The process for considering and controlling past, existing and additional knowledge needs to take account of the organization’s context, including its size and complexity, the risks and opportunities it needs to address, and the need for accessibility of knowledge. The balance between knowledge held by competent people and knowledge made available by other means is at the discretion of the organization, provided that conformity of products and services can be achieved. Copyright  GIC  2014

Salient  Points 8. Control of externally provided products and services This addresses all forms of external provision, whether it is by purchasing from a supplier, through an arrangement with an associate company, through the outsourcing of processes and functions of the organizations or by any other means.   The organization is required to take a risk-based approach to determine the type and extent of controls appropriate to particular external providers and externally provided products and services.

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COMPARISON

COMPARISON  (2  of  5)

COMPARISON  (3  of  5)

COMPARISON  (4  of  5)

COMPARISON  (5  of  5)

Clause  4  -­‐  Context  of  the  organisation 4.1  Understanding  the  organization  and  its  context     4.2  Understanding  the  needs  and  expectations  of    interested   parties     4.3  Determining  the  scope  of  the  quality    management  system     4.4  Quality  management  system  and  its  processes     !

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4.  Context  of  Organization 4.1  Understanding  the  organization  and  its  context   ! The  organization  shall  determine  external  and  internal  issues  that  are  relevant   to  its  purpose  and  its  strategic  direction  and  that  affect  its  ability  to  achieve  the   intended  result(s)  of  its  quality  management  system.  

! The  organization  shall  monitor  and  review  the  information  about  these  external   and  internal  issues.  

! NOTE  1  Understanding  the  external  context  can  be  facilitated  by  considering  issues   arising  from  legal,  technological,  competitive,  market,  cultural,  social,  and  economic   environments,  whether  international,  national,  regional  or  local.   
 NOTE  2  Understanding  the  internal  context  can  be  facilitated  by  considering  issues   related  to  values,  culture  knowledge  and  performance  of  the  organization. Copyright  GIC  2014

Context  of  Organization External  context  includes*   • cultural,  social,  political,  legal,  regulatory,  financial,  technological,  economic,   natural  and  competitive  environment,  whether  international,  national,   regional  or  local;   • relationships  with,  and  perceptions/values  of  external  stakeholders  

! Internal  context  includes*   • corporate  culture;   • governance,  organizational  structure,  roles  and  accountabilities;   • policies,  objectives,  and  strategies   • resources  (capital,  time,  people,  processes,  systems  technologies);   • information  systems,  information  flows  and  decision-­‐making  processes  (both   formal  and  informal)  

! *  (taken  from  ISO  31000)  

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Context  of  Organization

The  context  of  the  organisation  equates  to   the  business  environment  the  organisation   is  operating  in.    

!

It  is  about  the  organisation  understanding   its  place  in  the  universe.  

! Purpose: Clothing manufacturer ! Intended outcome: Production of men’s suits !Internal issues •Automation •Workforce •Design secrets •Capacity •Company culture •Innovation

!External issues •Customers •Fashion •New markets •Deadlines •Competition •Regulators •Utilities

!(Relevant) interested parties •Consumers •Employees •Owners/shareholders •Society •Suppliers and partners

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SWOT  Analysis

4.  Context  of  Organization 4.2  Understanding  the  needs  and  expectations  of  interested   parties   ! Due  to  their  impact  or  potential  impact  on  the  organisation’s  ability  to   consistently  provide  products  and  services  that  meet  customer  and  applicable   statutory  and  regulatory  requirements,  the  organization  shall  determine:   a) the  interested  parties  that  are  relevant  to  the  quality  management  system;   b) the  requirements  of  these  interested  parties  that  are  relevant  to  the   quality  management  system.  

! The  organization  shall  monitor  and  review  the  information  about  these   interested  parties  and  their  relevant  requirements.

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What  is  Interested  Party

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4.  Context  of  Organization 4.3  Determining  the  scope  of  the  quality  management   system   !

The  organizaeon  shall  determine  the  boundaries  and  applicability  of  the  quality   management  system  to  establish  its  scope.  

!

When  determining  this  scope,  the  organizaeon  shall  consider:   a) the  external  and  internal  issues  referred  to  in  4.1;   b) the  requirements    of  relevant  interested  parees  referred  to  in  4.2;   c) the  products  and  services  of  the  organizaeon.  

!

Where  a  requirement  of  this  Internalonal  Standard  within  the  determined   scope  can  be  applied,  then  it  shall  be  applied  by  the  organizalon.  

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4.  Context  of  Organization 4.3  Determining  the  scope  of  the  quality  management   system   !

If  any  requirement(s)  of  this  Internaeonal  Standard  cannot  be  applied,  this  shall   not  affect  the  organizaeon’s  ability  or  responsibility  to  ensure  conformity  of   products  and  services.  

!

The  scope  shall  be  available  and  be  maintained  as  documented  informalon   staeng  the:   • products  and  services  covered  by  the  quality  management  system;   • juseficaeon  for  any  instance  where  a  requirement  of  this  Internaeonal   Standard  cannot  be  applied.

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4.  Context  of  Organization 4.4  Quality  management  system  and  its  processes   !

The  organizaeon  shall  establish,  implement,  maintain  and  conenually  improve  a   quality  management  system,  including  the  processes  needed  and  their   interaceons,  in  accordance  with  the  requirements  of  this  Internaeonal   Standard.  

!

The  organizaeon  shall  determine  the  processes  needed  for  the  quality   management  system  and  their  applicaeon  throughout  the  organizaeon  and   shall  determine:   a) the  inputs  required  and  the  outputs  expected  from  these  processes;   b) the  sequence  and  interaclon  of  these  processes;   c) the  criteria,  methods,  including  measurements  and  related  performance   indicators  needed  to  ensure  the  effeceve  operaeon,  and  control  of  these   processes;   d) the  resources  needed  and  ensure  their  availability; Copyright  GIC  2014

4.  Context  of  Organization 4.4  Quality  management  system  and  its  processes   !

e) the  assignment  of  the  responsibililes  and  authoriles  for  these  processes;   f) the  risks  and  opportuniles  in  accordance  with  the  requirements  of  6.1,  and   plan  and  implement  the  appropriate  aceons  to  address  them;   g) the  methods  for  monitoring,  measuring,  as  appropriate,  and  evalualon  of   processes  and,  if  needed,  the  changes  to  processes  to  ensure  that  they   achieve  intended  results;   h) opportuniles  for  improvement  of  the  processes  and  the  quality   management  system.  

!

The  organizaeon  shall  maintain  documented  informalon  to  the  extent   necessary  to  support  the  operaeon  of  processes  and  retain  documented   informalon  to  the  extent  necessary  to  have  confidence  that  the  processes  are   being  carried  out  as  planned. Copyright  GIC  2014

Clause  5  -­‐  Leadership 5.1  Leadership  and  commitment     5.1.1  Leadership  and  commitment  to  the  quality    management  system     5.1.2  Customer  focus    

5.2  Quality  policy     5.3  Organisation  roles,  responsibilities  and    authorities     !

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Management  Vs  Leadership

!

What  is  TOP  MANAGEMENT DEFINITIONS (ANNEX SL)   a person or group of people who directs and controls an organisation at the highest level ! Note  1  Top  management  has  the  power  to  delegate  authority  and  provide   resources  within  the  organization.     Note  2  If  the  scope  of  the  management  system  (3.04)  covers  only  part  of  an   organization  then  top  management  refers  to  those  who  direct  and  control  that   part  of  the  organization.    

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5.1  Leadership  and  Commitment 5.1.1  Leadership  and  commitment  for  the  quality  management   system   Top  management  shall  demonstrate  leadership  and  commitment  with  respect   to  the  quality  management  system  by:   a)  taking  accountability  of  the  effectiveness  of  the  quality  management   system;   b)  ensuring  that  the  quality  policy  and  quality  objectives  are  established  for   the  quality  management  system  and  are  compatible  with  the  strategic   direction    and  the  context  of  the  organization  ;   c)  ensuring  that  the  quality  policy  is  communicated,  understood  and  applied   within  the  organization;   d)  ensuring  the  integration  of  the  quality  management  system  requirements   into  the  organisation’s  business  processes;   e)  promoting  awareness  of  the  process  approach; Copyright  GIC  2014

5.1  Leadership  and  Commitment f)  ensuring  that  the  resources  needed  for  the  quality  management  system  are   available;   g)  communicating  the  importance  of  effective  quality  management  and  of   conforming  to  the  quality  management  system  requirements;   h)  ensuring  that  the  quality  management  system  achieves  its  intended     results;   i)  engaging,  directing  and  supporting  persons  to  contribute  to  the   effectiveness  of  the  quality  management  system;   j)  promoting  continual  improvement;   k)  supporting  other  relevant  management  roles  to  demonstrate  their   leadership  as  it  applies  to  their  areas  of  responsibility.  

! NOTE  Reference  to  “business”  in  this  International  Standard  can  be  interpreted   broadly  to  mean  those  activities  that  are  core  to  the  purposes  of  the   organization’s  existence;  whether  the  organization  is  public,  private,  for  profit   or  not  for  profit. Copyright  GIC  2014

5.1  Leadership  and  Commitment 5.1.2  Customer  Focus   !

Top  management  shall  demonstrate  leadership  and  commitment  with  respect   to  customer  focus  by  ensuring  that:   a) customer  requirements  and  applicable  statutory  and  regulatory   requirements  are  determined  and  met;   b) the  risks  and  opportuniles  that  can  affect  conformity  of  products  and   services  and  the  ability  to  enhance  customer  saesfaceon  are  determined   and  addressed;   c) the  focus  on  consistently  providing  products  and  services  that  meet   customer  and  applicable  statutory  and  regulatory  requirements  is   maintained;   d) the  focus  on  enhancing  customer  saesfaceon  is  maintained.

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5.  Leadership 5.2  Quality  policy   !

5.2.1  Top  management  shall  establish,  review  and  maintain  a  quality  policy  that:   a) is  appropriate  to  the  purpose  and  context  of  the  organizalon;   b) provides  a  framework  for  sejng  and  reviewing  quality  objeceves;   c) includes  a  commitment  to  saesfy  applicable  requirements;   d) includes  a  commitment  to  conenual  improvement  of  the  quality   management  system.  

!

5.2.2  The  quality  policy  shall:   a) be  available  as  documented  informaeon;   b) be  communicated,    understood  and  applied  within  the  organizaeon;   c) be  available  to  relevant  interested  parles,  as  appropriate.  

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5.  Leadership 5.2  Organizational  roles,  responsibilities  and  authorities   !

Top  management  shall  ensure  that  the  responsibiliees  and  authoriees  for   relevant  roles  are  assigned,  communicated  and  understood  within  the   organizaeon.  

!

Top  management  shall  assign  the  responsibility  and  authority  for:   a)  ensuring  that  the  quality  management  system  conforms  to  the  requirements   of  this  Internaeonal  Standard;   b)  ensuring  that  the  processes  are  delivering  their  intended  outputs;   c)  reporlng  on  the  performance  of  the  quality  management  system,  on   opportuniles  for  improvement  and  on  the  need  for  change  or  innovalon,  and   especially  for  reporlng  to  top  management;   d)  ensuring  the  promoeon  of  customer  focus  throughout  the  organizaeon;   e)  ensuring  that  the  integrity  of  the  quality  management  system  is  maintained   when  changes  to  the  quality  management  system  are  planned  and   implemented. Copyright  GIC  2014

Clause  6  -­‐  Planning  for  the  QMS ! 6.1  Actions  to  address  risks  and  opportunities     6.2  Quality  objectives  and  planning  to  achieve  them     6.3  Planning  of  changes     ! !

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What  is  RISK DEFINITIONS (ANNEX SL)   effect of uncertainty  

! Note  1  An  effect  is  a  deviation  from  the  expected  —  positive  or  negative.     Note  2  Uncertainty  is  the  state,  even  partial,  of  deficiency  of  information  related   to,  understanding  or  knowledge  of,  an  event,  its  consequence,  or  likelihood.     Note  3  Risk  is  often  characterised  by  reference  to  potential  events  (ISO  Guide   73,  3.5.1.3)  and  consequences  (ISO  Guide  73,  3.6.1.3),  or  a  combination  of   these.     Note  4  Risk  is  often  expressed  in  terms  of  a  combination  of  the  consequences  of   an  event  (including  changes  in  circumstances)  and  the  associated  likelihood  (ISO   Guide  73,  3.6.1.1)  of  occurrence.    

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6.1  Action  to  address  risks  and  opportunities ! 6.1  Actions  to  address  risks  and  opportunities   6.1.1  When  planning  for  the  quality  management  system,  the  organization   shall  consider  the  issues  referred  to  in  4.1  and  the  requirements  referred   to  in  4.2  and  determine  the  risks  and  opportunities  that  need  to  be   addressed  to:   a)  give  assurance  that  the  quality  management  system  can  achieve  its   intended    result(s);   b)  prevent,  or  reduce,  undesired  effects;   c)  achieve  continual  improvement.  

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6.1  Action  to  address  risks  and  opportunities 6.1.2  The  organization  shall  plan:   a)  actions  to  address  these  risks  and  opportunities;   b)  how  to:   1)  integrate  and  implement  the  actions  into  its  quality  management   system  processes  (see  4.4);   2)  evaluate  the  effectiveness  of  these  actions.   Actions  taken  to  address  risks  and  opportunities  shall  be  proportionate  to  the   potential  impact  on  the  conformity  of  products  and  services.  

! NOTE  Options  to  address  risks  and  opportunities  can  include:  avoiding  risk,   taking  risk  in  order  to  pursue  an  opportunity,  eliminating  the  risk  source,   changing  the  likelihood  or  consequences,  sharing  the  risk,  or  retaining  risk  by   informed  decision. Copyright  GIC  2014

Risk  Analysis

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Risk  Analysis

6.2  Quality  objectives  and  planning     to  achieve  them 6.2.1  The  organizaeon  shall  establish  quality  objeceves  at  relevant  funceons,   levels  and  processes.  

!

The  quality  objeceves  shall:   a) be  consistent  with  the  quality  policy,   b) be  measurable;   c) take  into  account  applicable  requirements;   d) be  relevant  to  conformity  of  products  and  services  and  the  enhancement  of   customer  saesfaceon;   e) be  monitored;   f) be  communicated;   g) be  updated  as  appropriate.  

!

The  organizaeon  shall  retain  documented  informalon  on  the  quality  objeceves.

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6.2  Quality  objectives  and  planning     to  achieve  them 6.2.2  When  planning  how  to  achieve  its  quality  objeceves,  the  organizaeon  shall   determine:   a) what  will  be  done;   b) what  resources  will  be  required;   Nothing’s  new  but  easier  to   c) who  will  be  responsible;   be  understood d) when  it  will  be  completed;   e) how  the  results  will  be  evaluated.

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6.3  Planning  of  changes Where  the  organizaeon  determines  the  need  for  change  to  the  quality   management  system  (see  4.4)  the  change  shall  be  carried  out  in  a  planned  and   systemaec  manner.  

!

The  organizaeon  shall  consider:   a) the  purpose  of  the  change  and  any  of  its  potenlal  consequences;   b) the  integrity  of  the  quality  management  system;   c) the  availability  of  resources;   d) the  allocaeon  or  reallocaeon  of  responsibiliees  and  authoriees.  

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Clause  7  -­‐  Support 7.1  

Resources  

7.1.1   General   7.1.2   People   7.1.3   Infrastructure   7.1.4   Environment  for  the  operation  of  processes   7.1.5   Monitoring  and  measuring  resources   7.1.6   Organizational  knowledge  

7.2   Competence   7.3     Awareness   7.4   Communication   7.5.     Documented  Information   7.5.1   General   7.5.2        Creating  and  Updating  

!

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7.1  Resources 7.1.1  General  

The  organizaeon  shall  determine  and  provide  the  resources  needed  for  the   establishment,  implementaeon,  maintenance  and  conenual  improvement  of   the  quality  management  system.  

! !

The  organizaeon  shall  consider:   a) the  capabiliees  of,  and  constraints  on,  exiseng  internal  resources;   b) what  needs  to  be  obtained  from  external  providers.  

! 7.1.2  People  

To  ensure  that  the  organizaeon  can  consistently  meet  customer  and  applicable   statutory  and  regulatory  requirements,  the  organizaeon  shall  provide  the   persons  necessary  for  the  effeceve  operaeon  of  the  quality  management   system,  including  the  processes  needed.

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7.1  Resources 7.1.3  Infrastructure  

!

The  organizaeon  shall  determine,  provide  and  maintain  the  infrastructure  for   the  operaeon  of  its  processes  to  achieve  conformity  of  products  and  services.   NOTE  Infrastructure  can  include:   a) buildings  and  associated  ueliees;   b) equipment  including  hardware  and  solware;   c) transportaeon;   Previously   Work  Environment d) informaeon  and  communicaeon  technology.  

! 7.1.4  Environment  for  the  operalon  of  processes  

The  organizaeon  shall  determine,  provide  and  maintain  the  environment   necessary  for  the  operaeon  of  its  processes  and  to  achieve  conformity  of   products  and  services.   NOTE  Environment  for  the  operaeon  of  processes  can  include  physical,  social,   psychological,  environmental  and  other  factors  (such  as  temperature,  humidity,   ergonomics  and  cleanliness). Copyright  GIC  2014

7.1  Resources 7.1.5  Monitoring  and  measuring  resources   !

Where  monitoring  or  measuring  is  used  for  evidence  of  conformity  of   products  and  services  to  specified  requirements  the  organizaeon  shall   determine  the  resources  needed  to  ensure  valid  and  reliable  monitoring  and   measuring  results.  

!

!

The  organizaeon  shall  ensure  that  the  resources  provided:   a) are  suitable  for  the  specific  type  of  monitoring  and  measurement  aceviees   being  undertaken;   b) are  maintained  to  ensure  their  conlnued  fitness  for  their  purpose.  

!

The  organizaeon  shall  retain  appropriate  documented  informalon  as  evidence   of  fitness  for  purpose  of  monitoring  and  measurement  resources.

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7.1  Resources

!

Where  measurement  traceability  is:  a  statutory  or  regulatory  requirement;  a   customer  or  relevant  interested  party  expectaeon;  or  considered  by  the   organizaeon  to  be  an  esseneal  part  of  providing  confidence  in  the  validity  of   measurement  results;  measuring  instruments  shall  be:   • verified  or  calibrated  at  specified  intervals  or  prior  to  use  against  measurement   standards  traceable  to  internaeonal  or  naeonal  measurement  standards.  Where   no  such  standards  exist,  the  basis  used  for  calibraeon  or  verificaeon  shall  be   retained  as  documented  informaeon;   • idenlfied  in  order  to  determine  their  calibralon  status;   • safeguarded  from  adjustments,  damage  or  deterioralon  that  would  invalidate   the  calibraeon  status  and  subsequent  measurement  results.  

!

The  organizaeon  shall  determine  if  the  validity  of  previous  measurement  results   has  been  adversely  affected  when  an  instrument  is  found  to  be  defeclve  during   its  planned  verificaeon  or  calibraeon,  or  during  its  use,  and  take  appropriate   correceve  aceon  as  necessary. Copyright  GIC  2014

7.1  Resources 7.1.6   O rganizalonal   k nowledge   !

!

The  organizaeon  shall  determine  the  knowledge  necessary  for  the  operalon  of   its  processes  and  to  achieve  conformity  of  products  and  services.   ! This  knowledge  shall  be  maintained,  and  made  available  to  the  extent   necessary.   ! When  addressing  changing  needs  and  trends,  the  organizaeon  shall  consider  its   current  knowledge  and  determine  how  to  acquire  or  access  the  necessary   addieonal  knowledge.   ! NOTE  1  Organizaeonal  knowledge  can  include  informaeon  such  as  intellectual   property  and  lessons  learned.   ! NOTE  2  To  obtain  the  knowledge  required,  the  organizaeon  can  consider:   a)  internal  sources  (e.g.  learning  from  failures  and  successful  projects,  capturing   undocumented  knowledge  and  experience  of  topical  experts  within  the   organizaeon);   b)  external  sources  (e.g.  standards,  academia,  conferences,  gathering   knowledge  with  customers  or  providers).   Copyright  GIC  2014

7.2  Competence

!

The  organizaeon  shall:   a) determine  the  necessary  competence  of  person(s)  doing  work  under  its   control  that  affects  its  quality  performance;   b) ensure  that  these  persons  are  competent  on  the  basis  of  appropriate   educaeon,  training,  or  experience;   c) where  applicable,  take  aceons  to  acquire  the  necessary  competence,  and   evaluate  the  effeceveness  of  the  aceons  taken;   d) retain  appropriate  documented  informaeon  as  evidence  of  competence.  

!

NOTE  Applicable  aceons  can  include,  for  example,  the  provision  of  training  to,   the  mentoring  of,  or  the  re-­‐assignment  of  currently  employed  persons;  or  the   hiring  or  contraclng  of  competent  persons.  

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7.3  Awareness

!

Persons  doing  work  under  the  organization’s  control  shall  be  aware  of: a)  the    quality  policy;   b)  relevant  quality  objectives;   c)  their  contribution  to  the  effectiveness  of  the  quality  management   system,  including  the  benefits  of  improved  quality  performance;   d)  the  implications  of  not  conforming  with  the  quality  management   system  requirements.  

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7.4  Communication The  organizaeon  shall  determine  the  internal  and  external  communicaeons   relevant  to  the  quality  management  system  including:   a) on  what  it  will  communicate;   b) when  to  communicate;   c) with  whom  to  communicate;   d) how  to  communicate.  

!

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7.5  Documented  Information 7.5.1  General   !

The  organizaeon’s  quality  management  system  shall  include   a) documented  informaeon  required  by  this  Internaeonal  Standard;   b) documented  informaeon  determined  by  the  organizaeon  as  being  necessary   for  the  effeceveness  of  the  quality  management  system.  

!

!

NOTE  The  extent  of  documented  informaeon  for  a  quality  management  system   can  differ  from  one  organizalon  to  another  due  to:   a) the  size  of  organizaeon  and  its  type  of  aceviees,  processes,  products  and   services;   b) the  complexity  of  processes  and  their  interaceons;   c) the  competence  of  persons.  

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7.5  Documented  Information 7.5.2  Creating  and  updating   !

!

Nothing’s  new  but  easier  to  be  understood

When  creaeng  and  updaeng  documented  informaeon  the  organizaeon  shall   ensure  appropriate:   a) idenlficalon  and  descriplon  (e.g.  a  etle,  date,  author,  or  reference   number);   b) format  (e.g.  language,  solware  version,  graphics)  and  media  (e.g.  paper,   electronic);   c) review  and  approval  for  suitability  and  adequacy.  

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7.5  Documented  Information 7.5.3  Control  of  documented  information   !

!

Nothing’s  new  but  easier  to   be  understood

7.5.3.1  Documented  informaeon  required  by  the  quality  management  system   and  by  this  Internaeonal  Standard  shall  be  controlled  to  ensure:   a) it  is  available  and  suitable  for  use,  where  and  when  it  is  needed;   b) it  is  adequately  protected  (e.g.  from  loss  of  confideneality,  improper  use,  or   loss  of  integrity).

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7.5  Documented  Information 7.5.3  Control  of  documented  information   !

!

Nothing’s  new  but  easier  to   be  understood

7.5.3.2  For  the  control  of  documented  informaeon,  the  organizaeon  shall   address  the  following  aceviees,  as  applicable:   a) distribulon,  access,  retrieval  and  use;   b) storage  and  preservalon,  including  preservaeon  of  legibility;   c) control  of  changes  (e.g.  version  control);   d) retenlon  and  disposilon.  

!

Documented  informaeon  of  external  origin  determined  by  the  organizaeon  to   be  necessary  for  the  planning  and  operaeon  of  the  quality  management  system   shall  be  idenefied  as  appropriate,  and  controlled.  

!

NOTE  Access  can  imply  a  decision  regarding  the  permission  to  view  the   documented  informaeon  only,  or  the  permission  and  authority  to  view  and   change  the  documented  informaeon. Copyright  GIC  2014

Clause  8  -­‐  Operation 8.1     8.2  

Operational  planning  and  control   Determination  of  requirements  for  products  and  services  

8.2.1        Customer  communication   8.2.2   Determination  of  requirements  for  products  and  services   8.2.3   Review  of  requirements  related  to  products  and  services  

8.3  

Design  and  development  of  products  and  services  

8.3.1   General   8.3.2     Design  and  development  planning   8.3.3   Design  and  development  inputs   8.3.4     Design  and  development  controls   8.3.5   Design  and  development  outputs   8.3.6   Design  and  development  changes  

! ! Copyright  GIC  2014

Clause  8  -­‐  Operation 8.4  

Control  of  externally  provided  products  and  services  

8.4.1   General   8.4.2   Type  and  extent  of  control  of  external  provision   8.4.3   Information  for  external  providers  

8.5  

Production  and  service  provision  

8.5.1   Control  of  production  and  service  provision   8.5.2   Identification  and  traceability   8.5.3   Property  belonging  to  customers  or  external  providers   8.5.4   Preservation   8.5.5   Post-­‐delivery  activities   8.5.6   Control  of  changes  

8.6   Release  of  products  and  services   8.7   Control  of  nonconforming  process  outputs,  products  and   services   Copyright  GIC  2014

8.1  Operational  Planning  and  Control

!

The  organizaeon  shall  plan,  implement  and  control  the  processes,    as  outlined  in   4.4,  needed  to  meet  requirements    for  the  provision  of  products  and  services  and   to  implement  the  aceons  determined  in  6.1,  by:   a) determining  requirements  for  the  product  and  services;   b) establishing  criteria  for  the  processes    and  for  the  acceptance  of  products  and   services;   c) determining  the  resources  needed  to  achieve  conformity  to  product  and   service  requirements;   d) implemeneng  control  of  the  processes  in  accordance  with  the  criteria  ;   e) retaining  documented  informaeon  to  the  extent  necessary  to  have  confidence   that  the  processes  have  been  carried  out  as  planned    and  to  demonstrate   ! conformity  of  products  and  services  to  requirements.   The  output  of  this  planning  shall  be  suitable  for  the  organizaeon's  operaeons.  

!

The  organizaeon  shall  control  planned  changes  and  review  the  consequences  of   unintended  changes,  taking  aclon  to  milgate  any  adverse  effects,  as  necessary.   The  organizaeon  shall  ensure  that  outsourced  processes  are  controlled    in   accordance  with  8.4. Copyright  GIC  2014

8.2  Determination  of  Requirements  for  Products   and  Services 8.2.1  Customer  communicalon   !

!

The  organizaeon  shall  establish  the  processes  for  communicaeng  with  customers   in  relaeon  to:   a) informalon  relaeng  to  products  and  services;   b) enquiries,  contracts  or  order  handling,  including  changes;   c) obtaining  customer  views  and  perceplons,  including  customer  complaints;   d) the  handling  or  treatment  of  customer  property,  if  applicable;   e) specific  requirements  for  conlngency  aclons,  when  relevant

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8.2  Determination  of  Requirements  for  Products   and  Services 8.2.2  Determinalon  of  requirements  related  to  products  and   services   !

The  organizaeon  shall  establish,  implement  and  maintain  a  process  to  determine   the  requirements  for  the  products  and  services  to  be  offered  to  poteneal   customers.  

! !

The  organizaeon  shall  ensure  that:   a) product  and  service  requirements  (including  those  considered  necessary  by  the   organisaeon),  and  applicable  statutory  and  regulatory  requirements,  are   defined;   b) it  has  the  ability  to  meet  the  defined  requirements  and  substanlate  the  claims   for  the  products  and  services  it  offers.

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8.2  Determination  of  Requirements  for  Products   and  Services 8.2.3  Review  of  requirements  related  to  products  and  services   !

!

The  organizaeon  shall  review,  as  applicable:   a) requirements  specified  by  the  customer,  including  the  requirements  for   delivery  and  post-­‐delivery  aceviees;   b) requirements  not  stated  by  the  customer,  but  necessary  for  the  customers'   specified  or  intended  use,  when  known;   c) addieonal  statutory  and  regulatory  requirements  applicable  to  the  products   and  services;   d) contract  or  order  requirements  differing  from  those  previously  expressed.  

!

NOTE  Requirements  can  also  include  those  arising  from  relevant  interested   parles.

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8.2  Determination  of  Requirements  for  Products   and  Services 8.2.3  Review  of  requirements  related  to  products  and  services   !

This  review  shall  be  conducted  prior  to  the  organizaeon’s  commitment  to  supply   products  and  services  to  the  customer  and  shall  ensure  contract  or  order   requirements  differing  from  those  previously  defined  are  resolved.  

! !

Where  the  customer  does  not  provide  a  documented  statement  of  their   requirements,  the  customer  requirements  shall  be  confirmed  by  the  organizalon   before  acceptance.  

!

Documented  informalon  describing  the  results  of  the  review,  including  any  new   or  changed  requirements  for  the  products  and  services,  shall  be  retained.  

!

Where  requirements  for  products  and  services  are  changed,  the  organizaeon  shall   ensure  that  relevant  documented  informaeon  is  amended  and  that  relevant   personnel  are  made  aware  of  the  changed  requirements. Copyright  GIC  2014

8.3  Design  and  Development  of  Products  and   Services 8.3.1  General   !

Where  the  detailed  requirements  of  the  organizalon’s  products  and  services  are   not  already  established  or  not  defined  by  the  customer  or  by  other  interested   parles,  such  that  they  are  adequate  for  subsequent  produclon  or  service   provision,  the  organizalon  shall  establish,  implement  and  maintain  a  design  and   development  process.  

!

!

NOTE  1  The  organizaeon  can  also  apply  the  requirements  given  in  8.5  to  the   development  of  processes  for  produceon  and  services  provision  

!

NOTE  2  For  services,  design  and  development  planning  can  address  the  whole   service  delivery  process.  The  organizaeon  can  therefore  choose  to  consider  the   requirements  of  clauses  8.3  and  8.5  together.

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8.3  Design  and  Development  of  Products  and   Services 8.3.2  Design  and  development  planning   !

!

In  determining  the  stages  and  controls  for  design  and  development,  the   organizaeon  shall  consider:   a) the  nature,  duraeon  and  complexity  of  the  design  and  development  aceviees;   b) requirements  that  specify  parecular  process  stages,  including  applicable  design   and  development  reviews;   c) the  required  design  and  development  verificaeon  and  validaeon;   d) the  responsibiliees  and  authoriees  involved  in  the  design  and  development   process;   e) the  need  to  control  interfaces  between  individuals  and  parees  involved  in  the   design  and  development  process;   f) the  need  for  involvement  of  customer  and  user  groups  in  the  design  and   development  process;   g) the  necessary  documented  informaeon  to  confirm  that  design  and   development  requirements  have  been  met. Copyright  GIC  2014

8.3  Design  and  Development  of  Products  and   Services 8.3.3   Design  and  development  inputs   !

The  organizaeon  shall  determine:   a) requirements  esseneal  for  the  specific  type  of  products  and  services  being   designed  and  developed,  including,  as  applicable,  funceonal  and  performance   requirements;   b) applicable  statutory  and  regulatory  requirements;   c) standards  or  codes  of  pracece  that  the  organizaeon  has  commioed  to  implement;   ! d) internal  and  external  resource  needs  for  the  design  and  development  of  products   and  services;   e) the  poteneal  consequences  of  failure  due  to  the  nature  of  the  products  and   services;   f) the  level  of  control  expected  of  the  design  and  development  process  by   ! customers  and  other  relevant  interested  parees.   Inputs  shall  be  adequate  for  design  and  development  purposes,  complete,  and   unambiguous.   ! Conflicts  among  inputs  shall  be  resolved. Copyright  GIC  2014

8.3  Design  and  Development  of  Products  and   Services 8.3.4  Design  and  development  controls   !

!

The  controls  applied  to  the  design  and  development  process  shall  ensure  that:   a) the  results  to  be  achieved  by  the  design  and  development  aceviees  are  clearly   defined;   b) design  and  development  reviews  are  conducted  as  planned;   c) verificaeon  is  conducted  to  ensure  that  the  design  and  development  outputs   have  met  the  design  and  development  input  requirements;   d) validaeon  is  conducted  to  ensure  that  the  resuleng  products  and  services  are   capable  of  meeeng  the  requirements  for  the  specified  applicaeon  or  intended   use  (when  known).

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8.3  Design  and  Development  of  Products  and   Services 8.3.5  Design  and  development  outputs   !

!

The  organizaeon  shall  ensure  that  design  and  development  outputs:   a) meet  the  input  requirements  for  design  and  development;   b) are  adequate  for  the  subsequent  processes  for  the  provision  of  products  and   services;   c) include  or  reference  monitoring  and  measuring  requirements,  and  acceptance   criteria,  as  applicable;   d) ensure  products  to  be  produced,  or  services  to  be  provided,  are  fit  for  intended   purpose  and  their  safe  and  proper  use.  

!

The  organizaeon  shall  retain  the  documented  informaeon  resuleng  from  the   design  and  development  process.

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8.3  Design  and  Development  of  Products  and   Services 8.3.6  Design  and  development  changes   !

The  organizaeon  shall  review,  control  and  idenefy  changes  made  to  design  inputs   and  design  outputs  during  the  design  and  development  of  products  and  services   or  subsequently,  to  the  extent  that  there  is  no  adverse  impact  on  conformity  to   requirements.  

! !

Documented  informaeon  on  design  and  development  changes  shall  be  retained.

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8.4  Control  of  Externally  Provided  Products  and   Services 8.4.1  General   !

The  organizaeon  shall  ensure  that  externally  provided  processes,  products,  and   services  conform  to  specified  requirements.  

! !

The  organizaeon  shall  apply  the  specified  requirements  for  the  control  of   externally  provided  products  and  services  when:   a)  products  and  services  are  provided  by  external  providers  for  incorporaeon  into   the  organisaeon’s  own  products  and  services;   b)  products  and  services  are  provided  directly  to  the  customer(s)  by  external   providers  on  behalf  of  the  organizalon;   c)  a  process  or  part  of  a  process  is  provided  by  an  external  provider  as  a  result  of  a   decision  by  the  organizaeon  to  outsource  a  process  or  funceon.

Copyright  GIC  2014

8.4  Control  of  Externally  Provided  Products  and   Services 8.4.1  General   !

The  organizaeon  shall  establish  and  apply  criteria  for  the  evalualon,  seleclon,   monitoring  of  performance  and  re-­‐evalualon  of  external  providers  based  on  their   ability  to  provide  processes  or  products  and  services  in  accordance  with  specified   requirements.  

! !

The  organizaeon  shall  retain  appropriate  documented  informalon  of  the  results   of  the  evaluaeons,  monitoring  of  the  performance  and  re-­‐evaluaeons  of  the   external  providers.

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8.4  Control  of  Externally  Provided  Products  and   Services 8.4.2   Type  and  extent  of  control  of  external  provision   !

In  determining  the  type  and  extent  of  controls  to  be  applied  to  the  external   provision  of  processes,  products  and  services,  the  organisaeon  shall  take  into   consideraeon:   a) the  potenlal  impact  of  the  externally  provided  processes,  products  and  services   on  the  organizaeon’s  ability  to  consistently  meet  customer  and  applicable   statutory  and  regulatory  requirements;   ! b) ! the  perceived  effeclveness  of  the  controls  applied  by  the  external  provider.   The  organizaeon  shall  establish  and  implement  verificalon  or  other  aclviles   necessary  to  ensure  the  externally  provided  processes,  products  and  services  do  not   adversely  affect  the  organisaeon's  ability  to  consistently  deliver  conforming  products   and  services  to  its  customers.   Processes  or  funceons  of  the  organizaeon  which  have  been  outsourced  to  an   external  provider  remain  within  the  scope  of  the  organizaeon’s  quality  management   system;  accordingly,  the  organizaeon  shall  consider  a)  and  b)  above  and  define  both   the  controls  it  intends  to  apply  to  the  external  provider  and  those  it  intends  to  apply   to  the  resuleng  process  output. Copyright  GIC  2014

8.4  Control  of  Externally  Provided  Products  and   Services 8.4.3  Informalon  for  external  providers   !

The  organizaeon  shall  communicate  to  external  providers  applicable  requirements   for  the  following:   a) the  products  and  services  to  be  provided  or  the  processes  to  be  performed  on   behalf  of  the  organizaeon;   b) approval  or  release  of  products  and  services,  methods,  processes  or  equipment;   c) competence  of  personnel,  including  necessary  qualificaeon;   ! d) their  interaceons  with  the  organizaeon's  quality  management  system;   e) the  control  and  monitoring  of  the  external  provider’s  performance  to  be  applied   by  the  organizaeon;   f) verificaeon  aceviees  that  the  organizaeon,  or  its  customer,  intends  to  perform  at   the  external  provider’s  premises.  

!

The  organizaeon  shall  ensure  the  adequacy  of  specified  requirements  prior  to  their   communicaeon  to  the  external  provider. Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.1  Control  of  produclon  and  service  provision   !

The  organizaeon  shall  implement  controlled  condieons  for  produceon  and  service   provision,  including  delivery  and  post-­‐delivery  aceviees.  

!

Controlled  condieons  shall  include,  as  applicable:   a) the  availability  of  documented  informalon  that  defines  the  characterisecs  of  the   products  and  services;   ! b) the  availability  of  documented  informalon  that  defines  the  aceviees  to  be   performed  and  the  results  to  be  achieved;   c) monitoring  and  measurement  aceviees  at  appropriate  stages  to  verify  that   criteria  for  control  of  processes  and  process  outputs,  and  acceptance  criteria  for   products  and  services,  have  been  met.   d) the  use,  and  control  of  suitable  infrastructure  and  process  environment;   e) the  availability  and  use  of  suitable  monitoring  and  measuring  resources; Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.1  Control  of  produclon  and  service  provision   !

Controlled  condieons  shall  include,  as  applicable:   f) the  competence  and,  where  applicable,  required  qualificaeon  of  persons;   g) the  validalon,  and  periodic  revalidalon,  of  the  ability  to  achieve  planned  results   of  any  process  for  produceon  and  service  provision  where  the  resuleng  output   cannot  be  verified  by  subsequent  monitoring  or  measurement;   h) the  implementalon  of  products  and  services  release,  delivery  and  post-­‐delivery   ! aceviees.

Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.2  Idenlficalon  and  traceability   !

Remain  the  same

Where  necessary  to  ensure  conformity  of  products  and  services,  the  organizaeon   shall  use  suitable  means  to  idenefy  process  outputs.  

!

The  organizaeon  shall  idenefy  the  status  of  process  outputs  with  respect  to   monitoring  and  measurement  requirements  throughout  produceon  and  service   provision.  

!!

Where  traceability  is  a  requirement,  the  organizaeon  shall  control  the  unique   ideneficaeon  of  the  process  outputs,  and  retain  any  documented  informaeon   necessary  to  maintain  traceability.  

!

NOTE  Process  outputs  are  the  results  of  any  aceviees  which  are  ready  for  delivery  to   the  organisaeon’s  customer  or  to  an  internal  customer  (e.g.  receiver  of  the  inputs  to   the  next  process);  they  can  include  products,  services,  intermediate  parts,   components,  etc. Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.3  Property  belonging  to  customers  or  external  providers   !

The  organizaeon  shall  exercise  care  with  property  belonging  to  the  customer  or   external  providers  while  it  is  under  the  organizaeon's  control  or  being  used  by  the   organizaeon.  The  organizaeon  shall  idenefy,  verify,  protect  and  safeguard  the   customer’s  or  external  provider’s  property  provided  for  use  or  incorporaeon  into  the   products  and  services.  

!!

When  property  of  the  customer  or  external  provider  is  incorrectly  used,  lost,   damaged  or  otherwise  found  to  be  unsuitable  for  use,  the  organizaeon  shall  report   this  to  the  customer  or  external  provider.  

!

NOTE  Customer  property  can  include  material,  components,  tools  and  equipment,   customer  premises,  intellectual  property  and  personal  data. Previous   Customer  Property Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.4  Preservalon   !

Remain  the  same

The  organizaeon  shall  ensure  preservaeon  of  process  outputs  during  produceon  and   service  provision,  to  the  extent  necessary  to  maintain  conformity  to  requirements.  

!

NOTE  Preservaeon  can  include  ideneficaeon,  handling,  packaging,  storage,   transmission  or  transportaeon,  and  proteceon.

!

Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.5  Post-­‐delivery  aclviles   !

As  applicable,  the  organizaeon  shall  meet  requirements  for  post-­‐delivery  aceviees   associated  with  the  products  and  services.  

!

In  determining  the  extent  of  post-­‐delivery  aceviees  that  are  required,  the   organisaeon  shall  consider:   ! a) the  risks  associated  with  the  products  and  services;   b) the  nature,  use  and  intended  lifelme  of  the  products  and  services;   c) customer  feedback;   d) statutory  and  regulatory  requirements.  

!

NOTE  Post-­‐delivery  aceviees  can  include  aceons  under  warranty  provisions,   contractual  obligaeons  such  as  maintenance  services,  and  supplementary  services   such  as  recycling  or  final  disposal. Copyright  GIC  2014

8.5  Production  and  Service  Provision 8.5.6  Control  of  changes   !

The  organizaeon  shall  review  and  control  unplanned  changes  esseneal  for   produceon  or  service  provision  to  the  extent  necessary  to  ensure  conenuing   conformity  with  specified  requirements.  

!

The  organizaeon  shall  retain  documented  informaeon  describing  the  results  of  the   ! review  of  changes,  the  personnel  authorizing  the  change,  and  any  necessary  aceons.

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8.6  Release  of  Products  and  Services The  organizaeon  shall  implement  the  planned  arrangements  at  appropriate  stages   to  verify  that  product  and  service  requirements  have  been  met.  Evidence  of   conformity  with  the  acceptance  criteria  shall  be  retained.  

!

The  release  of  products  and  services  to  the  customer  shall  not  proceed  unel  the   planned  arrangements  for  verificaeon  of  conformity  have  been  saesfactorily   completed,  unless  otherwise  approved  by  a  relevant  authority  and,  as  applicable,   by  the  customer.    

!!

Documented  informalon  shall  provide  traceability  to  the  person(s)  authorizing   release  of  products  and  services  for  delivery  to  the  customer.

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8.7  Control  of  Nonconforming  Process  Outputs,   Products  and  Services The  organizaeon  shall  ensure  process  outputs,  products  and  services  that  do  not   conform  to  requirements  are  idenefied  and  controlled  to  prevent  their  unintended   use  or  delivery.  

!

The  organizaeon  shall  take  appropriate  correceve  aceon  based  on  the  nature  of  the   nonconformity  and  its  impact  on  the  conformity  of  products  and  services.  This   applies  also  to  nonconforming  products  and  services  detected  aler  delivery  of  the   products  or  during  the  provision  of  the  service.  

!!

As  applicable,  the  organizaeon  shall  deal  with  nonconforming  process  outputs,   products  and  services  in  one  or  more  of  the  following  ways:   a)  correceon;   b)  segregaeon,  containment,  return  or  suspension  of  provision  of  products  and   services;   c)  informing  the  customer; Copyright  GIC  2014

8.7  Control  of  Nonconforming  Process  Outputs,   Products  and  Services d)  obtaining  authorizaeon  for:   • use  “as-­‐is’;   • release,  conenuaeon  or  re-­‐provision  of  the  products  and  services;   • acceptance  under  concession.  

!

Where  nonconforming  process  outputs,  products  and  services  are  corrected,   conformity  to  the  requirements  shall  be  verified.  

! !The  organizaeon  shall  retain  documented  informalon  of  aceons  taken  on  

nonconforming  process  outputs,  products  and  services,  including  on  any   concessions  obtained  and  on  the  person  or  authority  that  made  the  decision   regarding  dealing  with  the  nonconformity.

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Clause  9  -­‐  Performance  Evaluation 9.1  

Monitoring,  measurement  analysis  and  evaluation  

9.1.1   General   9.1.2   Customer  satisfaction   9.1.3   Analysis  and  evaluation  

9.2   9.3   ! !

Internal  audit   Management  review  

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9.1  Monitoring,  Measurement,  Analysis  and   Evaluation 9.1.1  General   !

The  organizaeon  shall  determine:   a)  what  needs  to  be  monitored  and  measured;   b)  the  methods  for  monitoring,  measurement,  analysis  and  evaluaeon,  as   applicable,  to  ensure  valid  results;   c)  when  the  monitoring  and  measuring  shall  be  performed;   d)  when  the  results  from  monitoring  and  measurement  shall  be  analysed  and   evaluated.  

!

The  organizaeon  shall  ensure  that  monitoring  and  measurement  aceviees  are   implemented  in  accordance  with  the  determined  requirements  and  shall  retain   appropriate  documented  informaeon  as  evidence  of  the  results.  

!

The  organizaeon  shall  evaluate  the  quality  performance  and  the  effeceveness  of   the  quality  management  system. Copyright  GIC  2014

9.1  Monitoring,  Measurement,  Analysis  and   Evaluation 9.1.2  Customer  Satisfaction   !

Remain  the  same

The  organizaeon  shall  monitor  customer  percepeons  of  the  degree  to  which   requirements  have  been  met.  

!

The  organizaeon  shall  obtain  informaeon  relaeng  to  customer  views  and  opinions   of  the  organisaeon  and  its  products  and  services.  

!

The  methods  for  obtaining  and  using  this  informaeon  shall  be  determined.  

!

NOTE  Informaeon  related  to  customer  views  can  include  customer  saesfaceon  or   opinion  surveys,  customer  data  on  delivered  products  or  services  quality,  market-­‐ share  analysis,  compliments,  warranty  claims  and  dealer  reports.

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9.1  Monitoring,  Measurement,  Analysis  and   Evaluation 9.1.3  Analysis  and  evaluation   !

Remain  the  same

The  organizaeon  shall  analyse  and  evaluate  appropriate  data  and  informaeon   arising  from  monitoring,  measurement  and  other  sources.   ! The  output  of  analysis  and  evaluaeon  shall  be  used  to:   a) demonstrate  conformity  of  products  and  services  to  requirements;   b) assess  and  enhance  customer  salsfaclon;   c) ensure  conformity  and  effeclveness  of  the  quality  management  system;   d) demonstrate  that  planning  has  been  successfully  implemented;   e) assess  the  performance  of  processes;   f) assess  the  performance  of  external  provider(s);   g) determine  the  need  or  opportuniees  for  improvements  within  the  quality   management  system.  

!

The  results  of  analysis  and  evaluaeon  shall  also  be  used  to  provide  inputs  to   management  review. Copyright  GIC  2014

9.2.  Internal  Audit 9.2.  Internal  Audit   !

Remain  the  same

9.2.1  The  organizaeon  shall  conduct  internal  audits  at  planned  intervals  to  provide   informaeon  on  whether  the  quality  management  system;   a) conforms  to:   1. the  organizaeon’s  own  requirements  for  its  quality  management  system;   2. the  requirements  of  this  Internaeonal  Standard;   b) is  effecevely  implemented  and  maintained.

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9.2.  Internal  Audit 9.2.  Internal  Audit  

Remain  the  same

9.2.2  The  organization  shall:   a)  plan,  establish,  implement  and  maintain  an  audit  programme(s)  including  the   frequency,  methods,  responsibilities,  planning  requirements  and  reporting,  which   shall  take  into  consideration  the  quality  objectives,  the  importance  of  the   processes  concerned,  customer  feedback,  changes  impacting  on  the  organisation,   and  the  results  of  previous  audits;   b)  define  the  audit  criteria  and  scope  for  each  audit;   c)  select  auditors  and  conduct  audits  to  ensure  objectivity  and  the  impartiality  of   the  audit  process;   d)  ensure  that  the  results  of  the  audits  are  reported  to  relevant  management;   e)  take  necessary  correction  and  corrective  actions  without  undue  delay;   f)  retain  documented  information  as  evidence  of  the  implementation  of  the  audit   programme  and  the  audit  results. Copyright  GIC  2014

9.3  Management  Review 9.3.1  Top  management  shall  review  the  organizaeon's  quality  management   system,  at  planned  intervals,  to  ensure  its  conenuing  suitability,  adequacy,  and   effeceveness.  

!

The  management  review  shall  be  planned  and  carried  out  taking  into   consideraeon:   a) the  status  of  aceons  from  previous  management  reviews;   b) changes  in  external  and  internal  issues  that  are  relevant  to  the  quality   management  system  including  its  strategic  direceon;

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9.3  Management  Review c)  informaeon  on  the  quality  performance,  including  trends  and  indicators  for:   1.  nonconformiees  and  correceve  aceons;   2.  monitoring  and  measurement  results;   3.  audit  results;   4.  customer  saesfaceon;   5. issues  concerning  external  providers  and  other  relevant  interested  parees;   6. adequacy  of  resources  required  for  maintaining  an  effeceve  quality   management  system;   ! 7. process  performance  and  conformity  of  products  and  services;   d) the  effeceveness  of  aceons  taken  to  address  risks  and  opportuniees  (see   clause  6.1);   e) new  poteneal  opportuniees  for  conenual  improvement.

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9.3  Management  Review The  outputs  of  the  management  review  shall  include  decisions  and  aclons   related  to:   a)  conenual  improvement  opportuniees;   b)  any  need  for  changes  to  the  quality  management  system,    including  resource   needs.       The  organizaeon  shall  retain  documented  informalon  as  evidence  of  the  results   of  management  reviews.

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Clause  10  -­‐  Improvement 10.1   General   10.2   Nonconformity  and  corrective  action   10.3   Continual  improvement   ! ! ! !

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10.1  General The  organizaeon  shall  determine  and  select  opportuniles  for  improvement  and   implement  necessary  aclons  to  meet  customer  requirements  and  enhance   customer  saesfaceon.  

!

This  shall  include,  as  appropriate:   a) improving  processes  to  prevent  nonconformiees;   b) improving  products  and  services  to  meet  known  and  predicted  requirements   c) improving  quality  management  system  results.  

!

NOTE  Improvement  can  be  effected  reaclvely  (e.g.  correceve  aceon),   incrementally  (e.g.  conenual  improvement),  by  step  change  (e.g.  breakthrough),   crealvely  (e.g.  innovaeon)  or  by  re-­‐organisalon  (e.g.  transformaeon).

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10.2  Nonconformity  and  Corrective  Action 10.2  Nonconformity  and  corrective  action   10.2.1  When  a  nonconformity  occurs,  including  those  arising  from  complaints,   the  organization  shall:   a)  react  to  the  nonconformity,  and  as  applicable:   1)  take  action  to  control  and  correct  it;   2)  deal  with  the  consequences;   b)  evaluate  the  need  for  action  to  eliminate  the  cause(s)  of  the  nonconformity,  in   order  that  it  does  not  recur  or  occur  elsewhere,  by:   1)  reviewing  the  nonconformity;   2)  determining  the  causes  of  the  nonconformity;   3)  determining  if  similar  nonconformities  exist,  or  could  potentially  occur;   c)  implement  any  action  needed;   d)  review  the  effectiveness  of  any  corrective  action  taken;   e)  make  changes  to  the  quality  management  system,  if  necessary. Copyright  GIC  2014

10.2  Nonconformity  and  Corrective  Action 10.2  Nonconformity  and  corrective  action   ! Corrective  actions  shall  be  appropriate  to  the  effects  of  the  nonconformities   encountered.  

!

NOTE  1  In  some  instances,  it  can  be  impossible  to  eliminate  the  cause  of  a   nonconformity.   NOTE  2  Corrective  action  can  reduce  the  likelihood  of  recurrence  to  an  acceptable   level.  

! 10.2.2  The  organization  shall  retain  documented  information  as  evidence  of:    a)  the  nature  of  the  nonconformities  and  any  subsequent  actions  taken;    b)  the  results  of  any  corrective  action.

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10.3  Continual  Improvement The  organizaeon  shall  conenually  improve  the  suitability,  adequacy,  and   effeceveness  of  the  quality  management  system.  

!

The  organizaeon  shall  consider  the  outputs  of  analysis  and  evalualon,  and  the   outputs  from  management  review,  to  confirm  if  there  are  areas  of   underperformance  or  opportuniles  that  shall  be  addressed  as  part  of  conenual   improvement.  

!

Where  applicable,  the  organizaeon  shall  select  and  ullise  applicable  tools  and   methodologies  for  invesegaeon  of  the  causes  of  underperformance  and  for   supporeng  conenual  improvement.

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ISO  9001:2015  –  New  Structure

Figure  1  –  Model  of  a  process-­‐based  quality  management  system,   showing  the  links  to  the  clauses  of  this  International  Standard

What  should  we  do? ▪ Research  and  initiate  in  being  updated  on  what  is  going  on  and   be  ready  to  implement  the  new  requirements   ▪ Takes  full  advantage  of  the  revision  of  ISO  9001  to  improve   business  performance   ▪ Integrate  their  activities  within  the  scope  of  multiple   Management  System  Standards   ▪ Decrease  the  emphasis  on  documentation  when  this  is  not   mandated  or  does  not  add  value   ! ✓ Remember,  don’t  make  any  changes  yet!

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ISO  9001:2015  Timeline

Reference:  ISO/TC  176  presentation

Stay  Tuned! ! Additional updates and information will be made available as the change process proceeds. Meanwhile, you can check www.iso.org for details

! ! Guardian Independent Certification (GIC) Indonesia PT. Verifikasi Independen Indonesia Jakarta (021) 29704026 - Surabaya (031) 8479096 for more details email to [email protected]

! !

 

Acknowledgement and References: ISO / TC 176 presentation, DIS ISO 9001:2015, IRCA webinar