ISO 9000:2000 Auditor Update Training - PowerPoint PPT Presentation

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ISO 9000:2000 Auditor Update Training

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ISO-9001 : 2000 Lessons learned from a Quality Registrar s Perspective Presented by Bea H. Ng - BVQi(NA) Lead Auditor ISO-9001:2000 Lessons Learned ... – PowerPoint PPT presentation

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Title: ISO 9000:2000 Auditor Update Training


1
ISO-9001 2000 Lessons learned from a Quality
Registrars Perspective Presented by Bea H. Ng
- BVQi(NA) Lead Auditor
2
ISO-90012000 Lessons Learned

  • Major Topics
  • 8 Quality Management Principles
  • ISO-90012000 Interpretations by BVQi(NA)

3
Customer focused

Determine customer needs expectations
Customer focused Organisations depend on
customers.
Requirements
Principle 1
Customer satisfaction
4
Leadership
  • Leaders establish unity of purpose, direction
    and internal environment in which people become
    fully involved.

Principle 2
5
Involvement of people
  • People are the essence of the organisation.
  • Their full involvement enables using their
    abilities to the benefit of the organisation.

Principle 3

6
Process approach
A desired result is more efficiently achieved
when resources and activities are managed as a
process.
Principle 4

7
Process approach
  • New structure
  • Familiar 20 elements are gone but are
    identifiable
  • New structure is process based and more generic
  • Clearly based on Plan - Do - Check - Act
    principle
  • Major clauses
  • Management responsibilities
  • Resource management
  • Product realisation
  • Measurement, analysis improvement
  • Alignment with ISO-14000

8
Process approach
C U S T O M E R
C U S T O M E R
Quality Management System Continual Improvement
S a t i s f a c t i o n
Management responsibility
R e q u i r e m e n t s
Resource management
Measurement, analysis, improvement
Product realisation
Product
Input
Output
9
System approach

Identifying, understanding and managing a system
of interrelated processes for a given objective
contributes to effectiveness and efficiency.
Principle 5

10
Continual improvement
  • Continual improvement is a permanent objective of
    the organisation

Quality improvement part of quality management
focusing on increasing effectiveness and
efficiency (ISO-90002000)
Principle 6
11
Factual approach to decision making

Effective decisions are based on the logical and
intuitive analysis of data and information.
Principle 7
12
Mutually beneficial supplier relationship
Mutually beneficial relationship between
organisation and its suppliers enhance the
ability of both organisations to create value.
Principle 8

13
ISO-90012000 Lessons Learned
  • ISO-90012000 INTERPRETATIONS
  • from a
  • Quality Registrars Perspective

14
ISO-90012000 Lessons Learned
  • 1) Standard Requirements - Justifiable
    Exclusions
  • 4.2.2 Quality Manual
  • a) the scope of the quality management system,
    including details of and justification for any
    exclusions
  • 1.2 Application
  • Where any requirements of this standard can not
    be applied due to the nature of an organisation
    and its product, this can be considered for
    exclusion
  • Where exclusions are made, claims of conformity
    to this standard are not acceptable unless they
    are limited to requirements in clause 7, and such
    exclusions do not affect the organisations
    ability, or responsibility, to provide product
    that meets customer and applicable regulatory
    requirements.

15
ISO-90012000 Lessons Learned
  • BVQi Interpretation - Justifiable Exclusions
  • Must be adequately stated in the quality manual
    if exclusions are taken.
  • Typical exclusions
  • - 7.3 Design and Development
  • - 7.5.2 Validation of processes for production
    or service
  • - 7.5.4 Customer property
  • - 7.6 Control of monitoring and measuring
    devices
  • Discussion Topics
  • Any others that may be applicable to your
    company?
  • What is a typical statement of exclusion?
  • Is it OK just to say not applicable to our
    method of operation?

16
ISO-90012000 Lessons Learned
  • 2) Standard Requirements - Documentation
  • 4.2 Documentation requirements
  • Quality management systems documentation shall
    include
  • a) documented statements of a quality policy and
    quality objectives
  • b) a quality manual
  • c) documented procedures required by the
    standard
  • d) documents needed by the organisation to
    ensure the effective planning, operation and
    control of its processes
  • e) records required by this standard
  • 4.2.3 Control of documents
  • b) to review and update as necessary and
    re-approve documents

17
ISO-90012000 Lessons Learned
  • BVQi Interpretations - Documentation
  • Manual content and design
  • Structure of the manual and form
  • Documentation structure
  • Document control
  • Discussion Topics
  • Acceptable form and structure of manuals - Manual
    reviews
  • Process interaction description
  • Flow charts - not a requirement, preferred
    approach
  • Review of existing documents, frequency and
    evidence
  • Measurable objectives

18
ISO-90012000 Lessons Learned
  • 3) Standard Requirement - Measurable Objectives
  • 5.4.1 Quality objectives
  • Top management shall ensure that the quality
    objectives, including those needed to meet
    requirements for product are established at
    relevant functions and levels within the
    organisation. The quality objectives shall be
    measurable and consistent with the policy.
  • 5.4.2 Quality Management system planning
  • a) the planning of the QMS is carried out in
    order to meet the requirements given in 4.1, as
    well as the objectives, and
  • b) the integrity of the QMS is maintained when
    changes to the QMS are planned and implemented

19
ISO-90012000 Lessons Learned
  • BVQi Interpretations - Measurable Objectives
  • Established at relevant function and levels
  • relevant functions may include purchasing, RI,
    sales marketing, customer service, design/RD,
    servicing, etc.
  • Must be measurable and consistent with the policy
  • Process and Product related
  • Discussion Topics
  • Where have you seen objectives documented and
    controlled? If contained in meeting minutes, is
    this acceptable?
  • How do we determine if objectives are linked to
    the policy? How do people answer the policy
    questions? Do they know their objectives
    (Reference 6.2.2 d)?
  • Planning activities related to the achievement of
    objectives

20
ISO-90012000 Lessons Learned
  • 4) Standard Requirement - Continual Improvement
  • 8.5.1 Continual Improvement
  • The organisation shall continually improve the
    effectiveness of the quality management system
    through the use of the quality policy, quality
    objectives, audit results, analysis of data,
    corrective and preventive actions and management
    review.
  • ISO 9000-2000 definition
  • -- recurring activity to increase the ability
    to fulfil requirements
  • NOTE THE PROCESS OF ESTABLISHING OBJECTIVES AND
    FINDING OPORTUNITIES FOR IMPROVEMENT IS A
    CONTINUAL PROCESS THROUGH THE USE OF AUDIT
    FINDINGS AND AUDIT CONCLUSIONS, ANALYSIS OF DATA,
    MANAGEMENT REVIEWS OR OTHER MEANS AND GENERALLY
    LEADS TO CORRECTIVE ACTION OR PREVENTIVE ACTION.

21
ISO-90012000 Lessons Learned
  • BVQi Interpretations - Continual Improvement
  • Significant new requirement
  • Distinction between continuous and continual
  • Significant or sustained lack of improvement
    must be met with corrective action, unless the
    undesirable condition is expected/predicted,
    resulting from a conscious/deliberate decision be
    management.
  • Discussion topics
  • What if efforts do not result in improvement?
  • Does the improvement activity need to be
    documented?
  • Where and how deep into the organization do
    improvement efforts need to be made (drivers)?
  • If they are not showing improvement, can an
    organization stay certified?


22
ISO-90012000 Lessons Learned
  • 5) Standard Requirement - Process Approach
  • 4.1 The Organization shall
  • a) identify the processes needed for the QMS and
    their application throughout the organization
  • b) determine their sequence and interaction of
    these processes
  • c) determine criteria and methods needed to
    ensure that both the operation and control of
    these processes are effective
  • d) ensure availability of resources and
    information necessary to support the operation
    and monitoring of these processes
  • e) monitor, measure and analyse these processes,
    and
  • f) implement actions necessary necessary to
    achieve planned results and continual improvement
    of these processes

23
ISO-90012000 Lessons Learned
  • BVQi Interpretations - Process Approach
  • Process Identification
  • BVQi auditors will expect to see the process
    model that explains the key processes of the
    business and how each relates and links to
    others.
  • Sequence and interaction
  • The organization is not required to produce
    system maps, flow charts, lists of processes
    etc., as evidence to demonstrate that the
    processes and their sequence and interactions
    were identified. Such documents may be used by an
    organization should they deem them useful, but
    are not mandatory.
  • Discussion topics
  • What do we expect to see and how can we
    determine compliance? Minimum description
    requirements in the manual.
  • Referencing a separate document in the manual
    to describe/show sequence and interaction, is
    this acceptable?

24
ISO-90012000 Lessons Learned
  • 6) Standard Requirements - Competency
  • 6.2.1 General
  • Personnel performing work affecting product
    quality shall be competent on the basis of
    appropriate education, skills, and experience
  • 6.2.2 Competence, awareness and training
  • a) determine the necessary competence for
    personnel performing work affecting product
    quality
  • b) provide training or take other action to
    satisfy these needs
  • c) evaluate the effectiveness of the action taken


25
ISO-90012000 Lessons Learned
  • BVQi Interpretations - Competency
  • Determine the necessary competence
  • The organization should determine knowledge
    and/or skills an employee would need to be
    considered competent, in their opinion, to
    perform a particular job.
  • Evaluate the effectiveness of the actions
  • The new requirement is aimed at ensuring that the
    training or other activity has produced a
    competent employee. . Effectiveness of other
    actions may be evaluated by a variety of means
    organizations should select what best suits their
    needs.
  • Discussion topics
  • Job descriptions for competency determination.
  • Training effectiveness vs... competence
    decisions.
  • Operational personnel supervision/management
    expectations.
  • Do internal auditors need external training?

26
ISO-90012000 Lessons Learned
  • 7) Other Sub-Clauses
  • Customer Focus (5.2)
  • Customer Communication (7.2.3)
  • Customer Property (7.5.4)
  • Customer Satisfaction (8.2.1)
  • Analysis of Data (8.4)
  • Any others? Questions??

27
ISO-90012000 Lessons Learned
  • Thank you and Good Night !!
  • Happy Auditing
  • Drive Safely
  • from Bea H. Ng and Jim Rivas
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