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ISO 9000 Certification

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ISO 9000 Certification ISO 9001 and ISO 9000.3 ISO 9000 There are 5 Standards in the basic ISO 9000 series: conformance models or guides. A conformance model is a ... – PowerPoint PPT presentation

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Title: ISO 9000 Certification


1
ISO 9000 Certification
  • ISO 9001
  • and
  • ISO 9000.3

2
ISO 9000
  • There are 5 Standards in the basic ISO 9000
    series conformance models or guides.
  • A conformance model is a Standard to which your
    organisation must conform in order to be
    certified.
  • A guide is a set of recommendations concerning
    the establishment of an effective quality system
    in order to be certified in one of the
    conformance models.

3

ISO 9000
  • Guides
  • ISO 9000
  • ISO 9004
  • Conformance Models
  • ISO 9001
  • ISO 9002
  • ISO 9003

4
Guides
  • ISO 9000
  • Guidelines for selection and use of the standards
    on quality management, quality system elements,
    and quality assurance.
  • ISO 9004
  • Guidelines for quality management and quality
    system elements.

5
Conformance models
  • ISO 9001
  • Quality assurance in design/development,
    production, installation, and servicing.
  • ISO 9002
  • Quality assurance in production, installation,
    and servicing.
  • ISO 9003
  • Quality assurance in final inspection and test.

6
Quality system
  • A quality system is the organisational structure,
    responsibilities, procedures, processes, and
    resources needed to implement quality management.
    It should only be as comprehensive as needed to
    meet quality objectives.

7
What is certified?
  • Your quality system must conform to the ISO 9000
    Standard that your organisation selects.
  • It is the quality system that becomes certified
    (registered) during the certification process.

8
Terms
  • Product The material or service provided.
  • Applies in the Standard to
  • Incoming material/service
  • In-process product/service
  • Finished product/service
  • Supplier Your organisation
  • Subcontractor Your supplier
  • Customer The organisation that receives your
    product/service.

9
Selecting a conformance model
10
Quality Audits
  • An audit is an evaluation of your quality system
    and documentation.
  • Your organisation may undergo several types of
    audits
  • First-party audits
  • Second-party audits
  • Third-party audits

11
Third-party audits
  • The third-party audit is a quality system audit
    performed by an auditor on the supplier in order
    to achieve certification for one of the ISO 9000
    Standards. The third-party auditor must be
    independent of both the customer and the
    supplier.
  • Third-party audits cannot be performed by the
    customer or the supplier.

12
What is looked for?
  • Do your documents conform to the requirements of
    the Standard?
  • Do your operations conform to the documents?
  • Do your records show past conformance to your
    documents?

13
9 stages to certification
  • Strategic planning
  • Gap analysis
  • Corrective action
  • Documentation and records
  • Implementation
  • Pre-certification audit
  • Registrar documentation review
  • Site preparation
  • Certification audit

14
Strategic planning
  • Management
  • Displays strong commitment to the certification
    effort
  • Selects a registrar
  • Selects a conformance model for which
    organisation may seek certification
  • Forms a project team
  • Establishes a timeline
  • Assesses training needs regarding ISO 9000 and
    organisational background.

15
Gap analysis
  • Corrective action teams
  • Evaluate the existing quality system against the
    selected conformance model
  • Evaluate the documentation against the quality
    system and the selected conformance model.

16
Corrective action
  • Corrective action teams institute changes in
    quality system as identified in stage 2.

17
Documentation and records
  • Corrective action teams
  • Implement a document structure and control system
  • Institute a control of quality records process
  • Revise documents as necessary
  • Provide training about changes, additions, and
    other topics as identified in stage 1.

18
Implementation
  • Management
  • Implements and monitors all changes in the
    quality system
  • Ensures all gaps identified in stage 2 are closed
  • Maintains records of all changes.

19
Pre-certification audit
  • Pre-assessment auditor ensures that all
    operations and documentation are according to the
    selected conformance model.

20
Registrar documentation review
  • Registrar reviews quality manual (and any other
    requested documents) as advance organiser to the
    organisation and the supporting documentation.

21
Site preparation
  • Management prepares organisation for the
    registrar and certification audit.

22
Certification audit
  • Registrar reviews quality system and
    documentation to determine if quality system
    meets the selected conformance model and can be
    certified as such.

23
Time taken depends on
  • The amount of existing documentation
  • The complexity and size of the organisation
  • The ISO 9000 conformance model chosen for
    certification
  • The commitment of management
  • The documentation skills of the project teams
  • The project management skills of the project
    teams
  • The availability of certification auditors.
  • Typically 12 to 18 months

24
The 20 Sections of ISO 9001
  • ISO 9001 Standard contains 20 sections (known as
    4.1 4.20.)
  • ISO 9002 Standard contains 19 of the 20.
  • ISO 9003 Standard contains 16 of the 20.

25
Management responsibility
  • Your organisations management shall provide for
  • A quality policy
  • Assignment of responsibility and authority to
    personnel
  • Resources for identification and verification
  • Appointment of a management representative
  • A management review for the suitability and
    effectiveness of your quality system.

26
Quality system
  • Your organisation shall
  • Plan, establish, maintain, and document your
    quality system to ensure that your product and/or
    service conforms to specified requirements
  • Provide an outline of the documentation structure
    and reference to immediate supporting documents
    in a quality manual
  • Provide quality plans.

27
Contract review
  • Your organisation shall review each contract or
    accepted order with your customer to ensure that
  • Customer requirements are adequately defined
  • Your organisation has the capability to meet
    these needs.

28
Design control
  • Your organisation shall control and verify the
    design of its product to ensure that it meets
    specified requirements.
  • Not 9002
  • Not 9003

29
Document and data control
  • Your organisation shall control all your quality
    system documents and data to ensure availability
    of documented information to those requiring it.

30
Purchasing
  • Your organisation shall ensure that purchased
    product conforms to specified requirements.
  • Not 9003

31
Control of customer-supplied product
  • Your organisation shall provide for
    verification, storage, and maintenance of
    customer-supplied product provided for
    incorporation into your product.

32
Product identification and traceability
  • Your organisation shall provide any necessary
    identification and traceability of incoming
    materials, in-process product, and finished
    product.

33
Process control
  • Your production, installation, and servicing
    processes are operated under controlled
    conditions.
  • Not 9003

34
Inspection and testing
  • Your organisation shall ensure that
  • Incoming product is verified for conformance to
    specified requirements
  • In-process product is inspected and tested as
    necessary
  • Finished product is verified as conforming to
    specified requirements prior to release.

35
Control of inspection, measuring, and test
equipment
  • Your organisation shall
  • control, calibrate, and maintain inspection,
    measuring, and test equipment and software used
    in your quality system to demonstrate the
    conformance of product to specified requirements
  • ensure that measurement uncertainty is known and
    consistent with the required measurement
    capability.

36
Inspection and test status
  • Your organisation shall ensure identification of
    inspection and test status of product throughout
    production, installation, and servicing.

37
Control of non-conforming product
  • Your organisation shall ensure that
    non-conforming product is prevented from
    unintended use or installation.

38
Corrective and preventive action
  • Your organisation shall
  • Investigate the cause of non-conforming product
    and consider corrective action needed to prevent
    recurrence
  • Analyse your quality system to detect and
    eliminate potential causes of non-conforming
    product.

39
Handling, storage, packaging, preservation, and
delivery
  • Your organisation shall provide adequate
    handling, storage, preservation, packaging, and
    delivery of your product to ensure that it meets
    specified requirements.

40
Control of quality records
  • Your organisations control of quality records
    process shall ensure that your quality records
    demonstrate that
  • Your quality system operates effectively
  • Required product quality is achieved.

41
Internal quality audits
  • Your organisations internal quality audit plan
    shall verify that your quality activities and
    related results meet requirements, and determine
    the effectiveness of your quality system.

42
Training
  • Your organisation shall identify training needs
    and train personnel to meet these needs.

43
Servicing
  • When servicing is a specified requirement in the
    contract, your organisation shall control that
    servicing and verify that it meets specified
    requirements.
  • Not 9003

44
Statistical techniques
  • Your organisation shall identify and use
    appropriate statistical techniques as necessary
    to verify the acceptability of process
    capability, product characteristics, and
    service.

45
The Certification Audit
  • The registrar visits your site(s) to
  • Meet with upper management to provide an overview
    of what will occur while they are there and
    answer any of managements questions
  • Determine whether or not your quality system is
    implemented according to the selected conformance
    model and the quality system documentation. To
    assess your quality system, the registrar asks
    your employees questions and observes employees
    performing their jobs.

46
The outcome?You cannot fail certification. The
worst that can happen is that you quit!
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