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