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1. Explain in brief the clauses of ISO/TS 16949.

January 10, 2013 By: Meliza Category: 1st SEM

Answer  : The ISO/TS16949 standard specifies eight different Clauses which have to be followed by the organization to meet the objectives and confirm customer requirements as follows.

Table 5.1: The eight clauses of ISO/TS 16979

The first four clauses i.e. Clause 0-Introduction to Clause 3-Terms and Definitions does not provide requirements to the Quality Management System (QMS). Instead they give a brief overview of the standard like the concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. The remaining five clauses i.e. Clause
4-Quality Management System to Clause 8-Measurement, Analysis and Improvement provide the quality management requirements that must be implemented by the QMS. Each major clause will contain its sub clauses as explained below:

Clause 4 — Quality management system

  • With addition to the conformance of customer requirements the organization must retain the responsibility of the outsourced processes [4.1.1]
  • The organization must have a process that performs a periodic review, distribution and implementation of all customer standards as per the customer requirement schedule [4.2.3.1]
  • The organization must maintain a record of customer requirements [4.2.4.1]

Clause 5 — Management responsibility

  • The top management should review the product realization on a periodic basis that must be documented [5.1.1]
  • The Top management must describe the quality objectives and measurements to be incorporated in the business plan and their use to set up a quality policy [5.4.1.1]
  • The Top management shall appoint ‘customer representatives’ with specific responsibility to guarantee conformity with customer requirements [5.5.2.1]

Clause 6 — Resource management

  • The management must choose a personnel with product design responsibility to achieve design requirements and skilled in application tools and techniques [6.2.2.1]
  • The organization must establish and sustain documented procedures for identifying training needs and achieving competency for all personnel performing activities that affect compliance to product requirement [6.2.2.2]
  • The organization must provide on-the-job training to the personnel affecting compliance to product requirements [6.2.2.3]

Clause 7 — Product realization

  • The organization must determine all customer specific requirements for designation, documentation etc [7.2.1.1]
  • The organization must have different approaches to prepare for product awareness [7.3.1.1]
  • The organization must identify, document, review and review the product design including customer requirements ,identification etc [7.3.2.1]
  • The organization must identify, document and review the manufacturing process design inputs like product design data, customer requirements if any, specific experience from previous developments [7.3.2.2]
  • Identify special characteristics such as product requirement and process parameters [7.3.2.3]
  • All system changes must be reflected in the control plan [7.5.1.1]

Clause 8 — Measurement, analysis and improvement

  • The appropriate statistical tools must be selected during quality planning and include it in the control plan [8.1.1]
  • The statistical concepts like variation, control must be understood and used in the organization [8.1.2]
  • Audit the quality management system to ensure conformity to the standard [8.2.2.1]
  • The organization must audit each manufacturing process to determine its effectiveness [8.2.2.2]
  • The organization must perform product audit at every stage of the production to confirm to all specified requirements [8.2.2.3]

 

2. Describe the different CMM levels.

3. Write a brief note on ISO 10002.

 

Q4. What is IT Service Management? Write a brief note on ISO 20000.

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