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					QUALITY SYSTEM
& CE MARK
        QUALITY
 DEGREE TO WHICH A SET OF
 INHERENT CHARACTERISTICS
 FULFILS REQUIREMENTS
                 ISO 9000:2000
    DEVELOPMENT OF QA
        STANDARDS
 1963 MIL-Q-9858A        US MILITARY
 1969 AQAP               NATO
 1970 10 CFR50           US FED.REG.
 1971 ASME BOILER        MECH.ENGG
  CODE
 1973 DEF-STAN         UK MOD
 1979 BS 5750          BRITISH STANDARD
 1987 ISO 9001:1987    INTERNATIONAL
                         STANDARD
 ISO 9001:1994         INTERNATIONAL
                         STANDARD
 ISO 9001:2000         INTERNATIONAL
                         STANDARD
         BACKGROUND
ISO 9000 series standards developed in 1987 to
HELP EXPAND WORLD TRADE
PROVIDE CONFIDENCE TO THE CUSTOMERS
ON THE QUALITY OF PRODUCTS/ SERVICES
THEY BUY
HELP    THE    INDUSTRY   TO   REMAIN
COMPETITIVE BY CONTINUOUS IMPROVEMENT

STANDARDS ARE REVIEWED AND REVISED
ONCE IN FIVE YEARS.

PHASE I REVISION TOOK PLACE IN JULY 1994.


 PHASE II REVISION TOOK PLACE IN YEAR 2000
    BACKGROUND CONTD…
PHASE I REVISION
 A SHORT TERM CORRECTIVE ACTION
  INCORPORATING CHANGES TO
  REINFORCE REQUIREMENTS
 BROUGHT IN CLARITY AND UNIFORMITY,
 REMOVED ANOMALIES TO THE EXTENT
  POSSIBLE.
 PUBLISHED IN JULY 1994
     PHASE II REVISION
         CONTD…
PHASE – II REVISION
 WORK STARTED IN 1994
 METHOD ADOPTED WAS TO IDENTIFY ALL
  USERS AND IDENTIFY ALL THEIR NEEDS.
 PUBLISHED IN DECEMBER 2000
 EMPHASIS ON CUSTOMER SATISFACTION.
 ENCOURAGES ADOPTION OF PROCESS
  APPROACH
 ISO 9000 FAMILY OF STANDARDS

ISO 9000:2000  QUALITY MANAGEMENT
                SYSTEMS –
                FUNDAMENTALS AND
                VOCABULARY
ISO 9001:2000  QUALITY MANAGEMENT
                SYSTEMS:REQUIREMENTS


ISO 9004:2000  QUALITY MANAGEMENT
                SYSTEMS: GUIDELINES FOR
                PERFORMANCE
                IMPROVEMENTS
EIGHT QUALITY MANAGEMENT
        PRINCIPLES

 CUSTOMER FOCUS
 LEADERSHIP
 INVOLVEMENT OF PEOPLE
 PROCESS APPROACH
 SYSTEM APPROACH TO MANAGEMENT
 CONTINUAL IMPROVEMENT
 FACTUAL APPROACH TO DECISION MAKING
 MUTUALLY BENEFICIAL SUPPLIER
 RELATIONSHIP
   QUALITY MANGEMENT
       PRINCIPLES
 Customer focus: organizations depend on
  their customers and therefore should
  understand current and future customer
  needs; should meet customer requirements
  and strive to exceed customer expectations.
 Leadership: leadership establish unity of
  purpose and direction of the organization.
  They should create and maintain the internal
  environment in which people can become
  fully involved in achieving the organisation’s
  objectives.
         QUALITY MANGEMENT
         PRINCIPLES CONT….
 Involvement of people : people at all
  levels are the essence of an organization and
  their full involvement enables their abilities to
  be used of the organisation’s benefit.
 Process approach : a desired result is
  achieved more efficiently when and activities
  and related resources are managed as a
  process.
 System approach to management:
  identifying, understanding and managing
  interrelated     processes    as    a    system
  contributes to the organisation’s effectiveness
  and efficiency in achieving its objective.
         QUALITY MANGEMENT
         PRINCIPLES CONT….

 Continual        improvement:       Continual
  improvement of the organisation’s overall
  performance should be a permanent objective
  of the organization.
 Factual approach to decision making:
  effective decisions are based on the analysis
  of data and information.
 Mutually           beneficial        supplier
  relationships: an organization and its
  suppliers are interdependent and mutually
  beneficial relationships enhance the ability of
  both to create value.
             QMS APPROACH
 Determining the needs and expectations of the
    customer and other interested parties;
   Establishing the quality policy and quality objectives
    of the organization;
   Determining the processes and responsibilities
    necessary to attain the quality objectives;
   Determining and providing resources necessary to
    attain the quality objectives;
   Establishing methods to measure the effectiveness
    and efficiency of each process’
   Applying these measures to determine the
    effectiveness and efficiency of each process;
    Determining means of preventing non conformities
    and eliminating their causes;
    Establishing and applying a process for continual
    improvement of the quality management system.
 ISO 9001:2000 – STANDARD
      REQUIREMENTS
CLAUSE No: 4.1.GENERAL
               REQUIREMENTS
 Identify the processes
 Determine sequence and interaction
 Determine criteria and methods for
  effective control
 Ensure availability of resources and
  information
 Monitor, measure and analyse process
 Implement actions for continual
  improvement
  ISO 9001:2000 – STANDARD
   REQUIREMENTS CONTD…
CLAUSE No: 4.2.DOCUMENTATION
  REQUIREMENTS

The QMS Documentation shall include:
 Documented statements of a policy
  and quality objectives
 A quality manual
 Documented procedures
 Documents to ensure effective
  planning, operation and control
 Records
   ISO 9001:2000 – STANDARD
    REQUIREMENTS CONTD…

CLAUSE No: 5.1.MANAGEMENT COMMITMENT

Top management – commitment to the QMS by:
 Communicating the importance of meeting customer
  & regulatory requirements
 Establishing the quality policy
 Establish quality objectives
 Conduct management reviews
 Ensuring availability of resources
  ISO 9001:2000 – STANDARD
   REQUIREMENTS CONTD…
CLAUSE No: 5.2.CUSTOMER FOCUS
 Customer expectations and needs
 Customer requirements
 Steps taken to ensure the above
 Customer satisfaction measurement
   ISO 9001:2000 – STANDARD
    REQUIREMENTS CONTD…
Clause No:5.3 QUALITY POLICY

Quality policy is the overall intentions and
direction of an organization related to
quality as formally expressed by top
management.
Quality policy shall be
o Appropriate to the organization
o Commitment to comply with requirements
o Commitment to continually improve
o Frame work for establishing and reviewing
   quality objectives
   ISO 9001:2000 – STANDARD
    REQUIREMENTS CONTD…
Clause No:5.4 PLANNING
5.4.1 Top management shall ensure that          quality
   objectives are
established at relevant functions and levels.
* Quality objectives shall be
       $ Measurable
       $ Consistent with the quality policy

5.4.2 Quality Management system planning: Top
   management shall ensure that
 Planning of QMS is carried out to meet the
   requirements given in 4.1
 Integrity is maintained when changes are planned &
  ISO 9001:2000 – STANDARD
   REQUIREMENTS CONTD…
Clause No:5.5 RESPONSIBILITY, AUTHORITY &
 COMMUNICATION
5.5.1.Top      Management     shall    ensure   that
   responsibilities and authorities are defined and
   communicated

5.5.2.Management Representative
Top management shall appoint a MR whose
responsibility and authority includes:
 Establishing, implementing & maintaining processes
   required for QMS
 Reporting to top management on performance of
   QMS
 Ensuring the promotion of awareness of customer
  ISO 9001:2000 – STANDARD
   REQUIREMENTS CONTD…
Clause No: 5.6 MANAGEMENT REVIEW


Top Management hall review the QMS at
planned intervals. The review includes
 Opportunities for improvement
 Quality policy and objectives
 Needs for changes to QMS
  ISO 9001:2000 – STANDARD
   REQUIREMENTS CONTD…


Clause No: 6 RESOURCE MANAGEMENT
 6.1 Provision of resources
 6.2 Human resources
 6.3 Infrastructure
 6.4 work environment
     ISO 9001:2000 – STANDARD
      REQUIREMENTS CONTD…
Clause No: 7 PRODUCT REALIZATION
  (PERMISSIBLE EXCLUSIONS)
The organization shall plan and develop process needed for product
 realisation.
 7.1 Planning of product realization
 7.2 Customer-related processes
 7.3 Design and development
 7.4 purchasing
 7.5 Production and service provision
 7.6 Control of monitoring and measuring devices
 EXCLUSIONS
The exclusions to the standard are limited to requirements of
 clause 7 only and subject to the condition that

 Such exclusions do not effect the organization’s ability or
  responsibility, to provide a product that fulfils customer
  and applicable regulatory requirements
    ISO 9001:2000 – STANDARD
     REQUIREMENTS CONTD…
Clause No: 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT

   8.1   General
   8.2   Monitoring and measurement
   8.3   control of non conforming product
   8.4   Analysis of data
   8.5   Improvement
            MAJOR CHANGES TO ISO
         9001:2000 COMPARED TO 1994
    The clause structure & terminology
§      Common system principles with EMS
§      9001 & 9004 clause number compatibility
§      Generic requirements to all industries
§      9004 taking it ‘beyond’ 9001
§      Process approach
§      Visible top management involvement
§      Planning of product realization
§      Effectiveness of training
§      Fewer documented procedures
§      Customer satisfaction
§      Monitoring and measurement of processes and products
§      Continual improvement
             QMS BENIFITS
# Better   Management
 Better planning including proficiency in
  developing global strategic skills and bringing
  ideas into action.
 Systematic /organized action.
 Reduction in rework, leading to less
  manufacturing cost.
 Availability of reliable, accurate, updated data
  facilitating effective decision-making.
 More emphasis on the systems rather than
  the individual.
 Better versatility and adaptability to change
  and transition.
 Institutionalisation of CAP.
        QMS BENIFITS CONT…
# Transparency in Operation
 Standardization of all operative procedures.
 Documentation of procedures in simple           and easily
  understandable language.
 Storage of these documents in conveniently accessible
  locations.
 Clearly defined targets/expectations for the outcome/result
  of each activity.
 Recording of the actual results.


# Clarity of purpose
 Awareness at all levels and at every stage, that is, vendor,
  supplier or
   customer.
 All operations/activities have become more focussed in
  term of what, when, where, how, by whom and at what
  cost:
   QMS BENIFITS CONT…
# Consistency in Quality
 Effective process control
 Customer      orientation    at     each
  operational area.

# Better Customer Satisfaction
 Improved product acceptance
 Translation of distinct act of skills and
  resources into added value to the
  customer in terms of product/delivery
  attributes.
 Improved customer faith
      QMS BENIFITS CONT…
# Continuous Growth

 Increased share in market segment.
 Penetration into new markets.
 Ability   to    sustain    competitive
  advantages by resisting erosion due to
  competitor behaviour.
CE MARKING OF MEDICAL
DEVICES
WHAT IS CE MARKING
 "CE" marking is the Symbol
 CE is the abbreviation of “Conformité
Européene" meaning "European Conformity”
 Implies manufacture’s declaration of
  conformance of essential requirements
 Is a "Passport to Europe“
 Is a "Symbol of Quality."
 Is not a product quality standard
NEED FOR CE MARKING
 Required to export to 15 European Union(EU)
  and 3 EFTA member states for 23 groups of
  products

 CE mark ensures that product placed on the
  EU market are safe as they follow the laws,
  regulations and administrative provisions as
  per directive requirement.

 CE Marking is a measure that the EU has
  adopted to establish single market and foster
  economic development for the member states
NEED FOR CE MARKING
Cont…
• Indicates that the product may be
 legally placed on the market in EU
 countries.

• Ensures the free movement of the
 product within the EU single market
DEFINITIONS
 A "MEDICAL DEVICE" is defined in
  Directive (93/42/EEC) as:
 Any instrument, apparatus, appliance,
  material or other article, whether used alone
  or in combination, including the software
  necessary for the proper application, intended
  by the manufacturer to be used for human
  beings for the purpose of :

• diagnosis, prevention, monitoring, treatment
  or alleviation of a disease
       DEFINITIONS Cont…
• diagnosis, monitoring, treatment , alleviation
  of or compensation for an injury or a
  handicap.
• investigation, replacement or modification of
  the anatomy or of a physiological process.
• control of conception &
• which does not achieve its principal intended
  action in or on the human body by
  pharmacological, immunological or metabolic
  means, but which may be assisted by such
  means.

Eg: Blood Bag, Condoms
DEFINITIONS Cont…
 ACTIVE IMPLANTABLE MEDICAL
  DEVICES
Active medical device means any medical device relying
  for its functioning on a source of electrical energy or
  any source of power other than that directly
  generated by the human body or gravity.
The "active implantable medical device" means
  any active medical device which is intended to
  be totally or partially introduced, surgically or
  medically, into the human body or by medical
  intervention into a natural orifice, and which is
  intended to remain after the procedure.

Eg:Heart pace makers

				
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