????? 2 Overview of ISO 9000

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????? 2 Overview of ISO 9000

• requirements of ISO 9001200

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ISO

• ISO 90002000 Concepts and terminology
• ISO 90012000 Requirement for quality
  management
• ISO 90042000 Guidance for quality management
  of organisations.
• ISO 19011 Guidelines on quality and environment
  auditing.

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Overview of the ISO 9001
Continual Improvement of the Quality Management
System
CUSTOMERS
CUSTOMERS
Satisfaction
Requirement
Management responsibility
Measurement, analysis improvement
Resource management
Product realisation
Product
Input
Output
4
ISO 9001

• 0 Introduction
• 1 Scope
• 2 Normative reference
• 3 Terms and definitions
• 4 Quality management system

5 Management responsibility 6 Resource
management 7 Product realisation 8 Measurement,
analysis and improvement
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0 Introduction

• ISO 9001 aim at achieving effectiveness of the
  quality management system
• ISO 9004 look at it efficiency
• Compatible with ISO 14001

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1 Scope

• 1.1 General
• Standard specifies QMS requirement for use to
• Demonstrate organisations ability yo
  consistently provide product meeting customer
  applicable regulatory requirements
• Enhance customers satisfaction through effective
  application of the system including processes for
  its continual improvement and assurance of
  conformity to customer and applicable regulatory
  requirements

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1 Scope

• 1.2 Application
• Requirement are generic
• Requirement may be excluded if cannot be applied
  due to the nature of organisation and its product
• Exclusions must
• Not affect ability or responsibility to provide
  conforming product
• Be limited to clause 7
• Conformity to ISO 9001 may not be stated if
  exclusions go beyond above.

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2 Normative reference

• Amendment or revisions of cited standard do not
  apply
• User encouraged to use most recent revision
• ISO 84021994 replaced by ISO 90002000
  Fundamentals and vocabulary.

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3 Terms and definitions

• ISO 90002000 applies new supply chain terminology

Supplier
Organisation
Customer
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3 Terms and definitions

• Product Result of process
• Note four generic product categories
• Hardware
• Software
• Services
• Processed materials

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4 Quality management system

• 4.1 General requirement
• Establish, document, implement and
  maintain a QMS and continually improve its
  effectiveness in accordance with the standard
• Identify the process necessary for QMS
• Determine the sequence and interaction of process
• Determine criteria methods to ensure effective
  operation control of the process

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4 Quality management system

• Ensure availability of resource and information
  needed to support the operation monitoring of
  the processes
• Measure, monitor and analyse processes
• Implement actions necessary to achieve planned
  results continual improvement
• Manage the processes in accordance with the
  standard
• Ensure control of outsourced processes affecting
  product conformity
• Identify control of outsourced processes within
  the QMS

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4 Quality management system

• 4.2 Documentation requirements
• 4.2.1 General
• QMS documentation must include
• Quality policy
• Quality objective
• Document procedures required by standard
• Document required by organisation to ensure
  effective planning, operation control process
• Records required by the standard

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4 Quality management system

• Note 1 Term documented procedure means that it
  must be established, documented, implemented and
  maintained
• Note 2 Extend of documentation may differ due to
• Size and type of organisation
• Complexity interaction of processes
• Competence of personel
• Note 3 Documentation may be in any type of media

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4 Quality management system

• 4.2.2 Quality manual
• must include as minimum
• The scope of QMS including detail of, and
  justification for, and exclusions
• Documented procedures or reference thereto
• Description of the interaction between the
  processes of the QMS

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4 Quality management system

• 4.2.3 Control of the documents
• Documented procedures to
• Approve documents prior to issue
• Review, update as necessary and re-approve
  documents
• To identify the changes and the current revision
  status of documents
• To ensure documents remain legible, readily
  identifiable

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4 Quality management system

• ensure relevant versions of applicable documents
  are available at points of use
• Ensure that documents of external origin are
  identified and distribution controlled
• Obsolete documents are prevented from unintended
  use and identified if kept for any reason

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4 Quality management system

• 4.2.4 Control of records
• Records must be established and maintained
• Records must be legible, readily identifiable and
  retrievable
• Documented procedure for control of
  identification, storage, retrival, retention time
  and disposition of quality records.

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5 Management responsibility

• 5.1 Management commitment
• 5.2 Customer focus
• 5.3 Quality policy
• 5.4 Planning
• 5.4.1 Quality objectives
• 5.4.2 QMS planning

• 5.5 Responsibility, authority and communication
• 5.5.1 Responsibility authority
• 5.5.2 Management representative
• 5.5.3 Internal communication
• 5.6 Management review
• 5.6.1 General
• 5.6.2 Review input
• 5.6.2 Review output

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5.1 Management commitment

• Provide evidence of commitment to the
  development implementation and improvement of QMS
  by
• Communicating the importance of meeting customer
  and statutory and regulatory requirements
• Establishing quality policy objectives
• Management reviews
• Provision of resources

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5.2 Customer focus
Determine customer requirements
Meet requirements
Customer satisfaction
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5.3 Quality policy

1. Appropriate to the purpose of the organisation
2. Commitment to comply with requirement
   continually improve the effectiveness of the QMS
3. Framework for establishing _at_ reviewing quality
   objectives
4. Communicated and understood within the
   organisation
5. is reviewed for continuing suitability

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5.4.1 Quality objectives

• Establish quality objectives at relevant
  functions and levels
• Objectives must be measurable consistent with
  the quality policy
• Include those needed to meet requirements for
  product
• documented

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5.4.2 Quality management system planning

• Planning of the QMS is carried out in order to
  meet requirements in 4.1,as well as the quality
  objectives
• The integrity of the QMS integrity must be
  maintained when changes are planned and
  implemented

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5.5 Responsibility, authority and communication

• 5.5.1 Responsibility and authority .
• Responsibility and authority shall be defined
  and communicated within the organisation.

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5.2.2 Management RepresentativeMember of the
management who has responsibility and authority
that includes

• Ensuring that process needed for the QMS are
  established, implemented and maintained.
• Reporting on performance of QMS including needs
  for improvement
• Ensuring the promotion of awareness of customer
  needs requirements
• Note Responsibility may include liaison with
  external in relation to QMS

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5.5.3 Internal communication

• Ensure appropriate communication within the
  organisation regarding the processes of the QMS
  and their effectiveness.

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5.6 Management Review5.6.1 GeneralReview of the
QMS by top management at planned intervals to

• Ensure QMS suitability ,adequacy effectiveness
• Assess opportunities for improvement
• Evaluate the need for changes to QMS including
  policy objective

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5.6.2 Review inputReview performance and
improvement opportunities related to

• Audit results
• Customer feedback
• Process performance product conformity
• Status of preventive and corrective actions
• Follow up actions from earlier reviews
• Changes that could affect the QMS
• Recommendations for improvement

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5.6.3 Review outputOutput to include actions
related to

• Improvement of the effectiveness of the QMS and
  its processes
• Improvement of product
• Resource needs
• Results of management review must be recorded

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6. Resource Management

• 6.1 Provision of resources
• 6.2 Human resources
• 6.2.1 General
• 6.2.2 Competence, awareness and training
• 6.3 Infrastructure
• 6.4 Work environment

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6.1 Provision of resources

• Determine provide the resources needed to
• Implement, maintain the QMS and continually
• Improve its effectiveness
• Enhance customer satisfaction

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6.2 Human Resources

• 6.2.1 General
• Personnel performing work affecting product
  quality must be competent on the basis of
  appropriate education, training, skills and
  experience

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Competence considerations

• Future demands
• Anticipated management and workforce succession
  needs
• Changes in the processes and equipment
• Individual competencies needed
• Statutory and regulatory requirements, standards,
  directives, etc.

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6.2.2 Competence, awareness and training

• Determine the necessary competence
• Provide training or take other action to satisfy
  those needs
• ?Evaluate the effectiveness of actions taken
• ?Ensure staff aware of relevance and importance
  of their activities and contribution to achieving
  objectives
• Maintain appropriate records of educations,
  training, skills and experience

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Awareness
? Creativity ? Innovation ? Impact on society ?
Introductory programmes ? Refreshers

• ? The vision for future
• ? Policy objectives
• ? Organisational change
• development
• ? Improvement activities

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6.3 Infrastructure

• Identify, provide maintain the infrastructure
• Needed to achieve product conformity.
• Infrastructure includes, as applicable
• Buildings, workspace associated facilities
• Equipment (hardware software).
• Supporting service

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6.4 Work environment

• Determine and manage the work environment
• needed to achieve product conformity

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6.4 Work environment Human Factors

• Creative work methods
• Opportunities for greater involvement of people
• Safety rules and guidance
• Ergonomics
• Special facilities for people
• Social interaction

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6.4 Work environmentPhysical factors
? Cleanliness ? Vibration ? Pollution ? Air flow

• ? Heat
• ? Noise
• ? Light
• ? Hygiene
• ? Humidity

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7.Product realisation

• 7.1 Planning of product realisation
• 7.2 Customer related processes
• 7.3 Design development
• 7.4 Purchasing
• 7.5 Production service provision
• 7.6 Control of measuring monitoring devices

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7.1 Planning of product realisationPlanning must
determine as appropriate

• ? quality objectives and requirements for the
  product
• ? the need for processes, documentation,
  resources specific to the product
• ? verification and validation activities
  acceptance critiria
• ? records

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7.2 Customer related processes

• 7.2.1 Determination of requirements related to
  product
• 7.2.2 Review of requirements related to product
• 7.2.3 Customer communication

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7.2.1 Determination of requirements related to
product

• Organisation must determine
• ? requirement specified by the customer including
  delivery post delivery activities
• ? requirements not specified but necessary for
  specified or intended use, where known
• ? statutory and regulatory requirements related
  to product,
• ? any additional requirements

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7.2.2 Review requirements related to the product

• Review identifies requirements before commitment
  to supply product and
• ensure that
• ? product requirements are defined
• ? differences between tender contract are
  resolved
• ? organisation has ability to meet the
  requirements
• Record the results
• Documentation to be amended un case of changes
  personnel made aware

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7.2.3Customer communication

• Determine and implement effective arrangements
  for communication with customers relating to
• ? product information
• ? enquiry, contract order handling including
  amendments
• ? customer feedback including complaints

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7.3 Design development

• 7.3.1 Design development planning (4.4.1,4.4.2
  4.4..3)
• 7.3.2 Design development inputs (4.4.4)
• 7.3.3 Design development outputs (4.4.5)
• 7.3.4 Design development review (4.4.6)
• 7.3.5 Design development verification (4.4.7)
• 7.3.6 Design development validation (4.4.8)
• 7.3.7 Control of design development changes
  (4.4.9)

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7.3.1 Design development planning

• ? Plan control DD of the product.
• ? Planning to include
• ? DD stages
• ? required review, verification and validation
  activities
• ? responsibilities authorities for DD
• ? Interfaces between groups must be managed
• ? Planning to be updated as the DD progresses

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7.3.2 Design development inputs

• ? Determine record product requirements
  including
• ? functional performance requirements
• ? application statutory and regulatory
  requirements
• ? information from previous similar designs
• ? any other essential requirements
• ? Review input for adequacy
• ? Requirements must be complete, unambiguous and
  not conflict with each other

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7.3.3 Design development outputs

• ? DD output in a form allowing verification.
• ? DD output must
• ? met the input requirements
• ? provide information for purchasing,
  production of service provision
• ? contain or reference acceptance criteria
• ? define characteristics essential for proper
  safe use
• ? Approve output prior to release

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7.3.4 Design development review

• ? At suitable stages systematic reviews of DD
  to
• ? evaluate the ability to meet requirements
• ? identify problems and propose follow up
• ? Involve all functions concerned
• ? Record the results and any necessary actions

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7.3.5 Design development verification

• ? Verify DD to ensure that output meets the
  input requirements
• ? Record the results of verification and
  necessary actions

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7.3.6 Design development validation

• ? Perform DD validation to confirm that product
  is capable of meeting the requirements for the
  specified or intended use, where known
• ? Whenever applicable to be completed prior to
  delivery
• ? Results of validation and necessary actions
  must be recorded

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7.3.7 Control of design development changes

• ? Design development changes must be identified
  and records maintained
• ? Changes must be reviewed, verified and
  validated as appropriate and approved before
  implementation
• ? Record results of review of review of changes
  and any necessary actions

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7.4 Purchasing

• 7.4.1 Purchasing process
• 7.4.2 Purchasing information
• 7.4.3 Verification of purchased product

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7.4.1 Purchasing process

• ? Ensure that purchase product meets requirements
• ? Type extend of control depends on effect
  purchased product may have on product realisation
  or the final product
• ? Evaluate and selects suppliers based on their
  ability to supply conforming product
• ? Establish criteria for selection, evaluation
  and re-evaluation of suppliers
• ? Results of evaluation and any necessary action
  must be recorded

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7.4.2 Purchasing information

• Purchasing information must describe the product
  to be purchased including
• where appropriate
• ? requirements for approval of product, processes
  and equipment
• ? requirements for qualification of personnel
• ? quality management system requirements
• Ensure adequacy of specified purchase
  requirements prior to their
• communication to supplier

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7.4.3 Verification of purchased product

• ? Establish implement inspection or other
  activities needed to ensure purchased product
  conformity
• ? Where organisation or its customer propose
  verification at suppliers premises, organisation
  must specify in purchasing information
• ? verification arrangements
• ? method of product release

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7.5 Product and service provision

• 7.5.1 Control of production and service provision
• 7.5.2 Validation of processes for production and
  service provision
• 7.5.3 Identification traceability
• 7.5.4 Customer property
• 7.5.5 Preservation of product

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7.5.1 Control of production and service provision

• Plan and carry out production service provision
  under controlled conditions. Controlled
  conditions include as applicable
• a) Availability of information describing product
  characteristics
• b) Availability of work instructions, as
  necessary -4.9 (a)
• c) The use of suitable equipment -4.9(b)
• d) Availability use of measuring monitoring
  devices -4.11(a)
• e) Implementation of monitoring and measurement
  -4.9(d)
• f ) the implementation of release, delivery and
  post delivery activities -4.10.4 4.15.6 and 4.19

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7.5.2 Validation of processes

• Processes where outcome is not verified and/or
  where deficiencies may become
• apparent after delivery must be validated to
  demonstrate ability to achieve
• planned results
• Arrangements must be established for these
  process including, as applicable
• ? criteria for review and approval of the process
• ? approval of equipment
• ? qualification of personnel
• ? use of defined methods procedures
• ? requirements for records
• ? re-validation

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7.5.2 Validation of processes

• Considerations
• ? High value products
• ? Where deficiency will only be apparent when
  product is in use
• ? Where process can not be repeated
• ? Where product verification is not possible

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7.5.2 Validation of processes

• Example of risk assesment
• ? FMEA
• ? Fault tree analysis
• ? Relationship diagrams
• ? Reliability prediction
• ? Simulation techniques

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7.5.3 Identification and traceability

• ? Where appropriate identity product by suitable
  means throughout realisation
• ? Identify status with respect to measurement
  monitoring requirements
• ? Where traceability is required control record
  unique identification of product

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7.5.4 Customer Property

• ? Care for customers property while it is under
  organisation's control or being used by
  organisation
• ? Identifications verification, protection
  safeguarding customer property provided for use
  or incorporation
• ? Any customer property that is lost, damaged or
  found unsuitable must recorded reported to
  customer
• Note Customer property includes intellectual
  property

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7.5.5 Preservation of product

• ? Preserve conformity of product during internal
  processing and final delivery to intended
  destination
• ? Include identification, handling. Packaging,
  storage and protection
• ? This applies to constituent parts of a product

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7.6 Control of monitoring measuring device

• ? Determine monitoring and measurements to be
  made measurement monitoring devices needed to
  provide evidence of conformity of product
• ? Ensure measuring and monitoring is carried out
  consistently with monitoring and measurement
  requirements
• ? Suitability of measuring/monitoring software
  must be confirmed prior to use

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7.6 Control of monitoring measuring device

• ? Calibrate or verify measuring and monitoring
  devices (MMD) at specified intervals or prior to
  use against internationals or national standards.
  Where no such standard exist record the basis
• ? Adjust or re-adjust as necessary
• ? Identify to enable the determination of
  calibration status
• ? Safeguard MMD from adjustments invalidating
  calibration
• ? Protect MMD from damage or deterioration during
  handling, maintenance storage
• ? record result of calibration
• ? assess and record validity of previous results
  when device found to be out of calibration
• Note See ISO 10012 for guidance

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8.Measurment, analysis and improvement
8.1General 8.2 Monitoring/measurement 8.2.1
Customer satisfaction 8.2.2 Internal
Audit 8.2.3 Monitoring measurement of
processes 8.2.4 Monitoring measurement of
product
8.3 Control of nonconforming product 8.4
Analysis of data 8.5 Improvement 8.5.1 Continual
improvement 8.5.2 Corrective action 8.5.3
Preventive action
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8.1 general

• Plan implement measurement, monitoring analysis
  and improvement process
• needed to
• ? demonstrate conformity of the product
• ? ensure conformity of QMS
• ? continually improve the effectiveness of the
  QMS
• This includes determination of applicable
  methods, including statistical techniques and the
  extent of their use

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8.2.1 Customer satisfaction

• ? Organisation shall monitor information related
  to customer perception as to whether the
  organisation has met customer requirements.
• ? The method for obtaining and using this
  information must be determined

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8.2.2 Internal audit

• Conduct internal audits at planned intervals to
  determine if
• ? QMS conforms to the planned arrangement,
  requirements of the standard and organisations
  requirements
• ? QMS is effectively implemented maintained
• Plan the audit programme considering
• ? status and importance of the processes and the
  areas
• ? results of previous audits
• Define audit criteria, scope, frequency
  methodologies
• Select auditors to ensure objectivity and
  impartiality.
• Auditor must not audit own work.

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8.2.2 Internal audit

• ? The documented procedure must cover
• ? responsibilities requirements for planning
  and conducting audits
• ? reporting results and maintaining records
• ? Corrective actions without undue delay
• ? Follow up to verify actions taken report
  Verification results
• Note
• See ISO 19011 for guidance

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8.2.3 Monitoring and measurement of processes

• ? Apply suitable methods for monitoring and ,
  where applicable, measurement of QMS processes
• ?These methods shall demonstrate the ability of
  the processes to achieve planned results
• ?Where planned results are not achieved
  corrections and corrective actions must be taken
  to ensure conformity of the product

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8.2.4Monitoring and measurement of product

• ? monitor measure product characteristics to
  verify conformity at appropriate stages of
  realisation processes in accordance with planned
  arrangements
• ? Evidence of conformity with the acceptance
  criteria must be maintained. Records must
  indicate the person(s) authorising release of the
  product
• ? Release or delivery must not proceed until all
  the planned arrangement have been satisfactorily
  completed, unless otherwise approved by a
  relevant authority, and where applicable by the
  customer

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8.3 Control of nonconforming product

• ? Nonconforming product must be identified and
  controlled to prevent unintended use or delivery
• ? Documented procedure to define control,
  responsibility and authority
• ? When nonconformance detected after delivery
  take appropriate action

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8.3 Control of nonconforming product

• ? Oraganisation must deal with nonconforming
  product by one or more of the following ways
• ? action to eliminate detected nonconformity
• ? concession
• ? preclude original intended use or application
• ? When the nonconforming product is corrected it
  must be re-verified to demonstrate conformity
• ? Record of the nature of nonconformity and any
  subsequent action including concessions must be
  maintained

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8.4 Analysis of data

• ? Determine, collect analyse appropriate data
  to demonstrate the suitability and effectiveness
  of QMS and to evaluate where continual
  improvement of the QMS can be made
• ? Data from measurement monitoring other
  relevant sources
• ? Analyse data to provide info on
• ? customer satisfaction
• ? conformity to product requirements
• ? process, product characteristics and their
  trends including opportunities for preventive
  action
• ? Suppliers

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8.5 Improvement

• 8.5.1 Continual improvement
• Organisation shall continually improve the
  effectiveness of the QMS though use of
• ? quality policy
• ? quality objectives
• ? audit results
• ? analysis of data
• ? corrective actions
• ? preventive actions
• ? management review

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Continual improvement

• SPC
• Benchmarking
• Quality Circles
• Risk Assessment
• Teamwork for Quality
• Quality Function Deployment

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Continual Improvement

• Problem Solving Techniques
• ? Cause effect diagram
• ? Pareto analysis
• ? Flowcharting
• ? Brain storming

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8.5.2 Corrective action

• Organisation shall take actions to eliminate the
  causes of nonconformities to
• prevent recurrence.
• Corrective actions appropriate to the impact of
  the problem
• Documented procedure shall define requirements
  for
• ? reviewing nonconformities (including customer
  complaints)
• ? determining the causes of nonconformities
• ? evaluating the need for corrective action
• ? determining implementing action needed
• ? recording results of action taken
• ? reviewing corrective action taken

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8.5.3 Preventive action

• Organisation shall determine action to eliminate
  the causes of potential
• nonconformances to prevent occurrence.
• Actions appropriate to the impact of the
  potential problem
• Documented procedure must define the requirements
  for
• ? determining potential nonconformances their
  causes
• ? evaluating the need for preventive action
• ? determining implementing action needed
• ? recording results of action taken
• ? reviewing preventive action taken