PROGRAM - MBA - SEMESTER - 4

SUBJECT CODE & NAME - QM0023:

UNDERSTANDING ISO 9001:2008
1.
Describe the TQM and ISO 9000 family of
standards, also explain the usage and certification
of ISO 9000 standards.
Usage and certification of ISO 9000 standards
The ISO 9000 contains requirements for quality management systems in
organisations. The certification is not actually a requirement of ISO 9000
standards but customers started demanding it and made it part of their
contract requirements.
The ISO 9000 standards are originally meant to be used in contractual
situations where suppliers need to demonstrate their capability to meet the
requirements. The idea is that if suppliers can show that they adhere to the
requirements of ISO 9001, then only conforming products would be shipped to

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2. Explain - Factual approach to decision

making. What are the benefits and application
of mutually beneficial supplier relationships

Factual approach to decision making

Effective decisions are based on the analysis of data and information. ISO
Family of Standards
Let us understand the factual approach to decision makingwith the help of an
example.
The sales department of TQR Ltd. wanted to determine the expected future
sales of products in order to frame an effective sales strategy. For this, the
sales manager required the last five years sales data for different products.
Based on this data, he estimated the future sales of the organisation. This
further helped the manager to formulate effective sales strategies; thereby
promoting the organisations products

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3.
What do you understand by control of
documents and what are the main function for
which control of document is needed.
Control of documents

All the documents (that are used in a process or generated by a process) required
for the implementation and maintenance of QMS should be controlled as per
the requirements stated in the standard.
The control of documents involves functions, such as preparation, approval,
issuance, distribution, maintenance, usage, storage, security, or disposal of
documents. A controlled document is one where any or all of the above
functions are regulated as per the rules framed in this regard.

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4. What kind of work environment should you

provide to your employees as per ISO 9001:2008?
Work Environment
Work environment is a set of conditions under which work is
performed that includes work conditions related to physical,
social, psychological, and environmental factors. ISO 9000
Family of Standard The clause 6.4 of the standard provides
requirements withregard to work environment. Work environment

refers to those conditions under which work is performed by

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5. What are the requirements of sub-clause

7.5.3? Explain them
Requirements of Sub-clause 7.5.3
The sub-clause 7.5.3 lays emphasis on the identification
of product status
throughout product realisation. Below figure shows the requirements of the subclause 7.5.3:

The aforementioned requirements are discussed as follows:

Identification of the product by suitable means throughout product
realisation: When there are several products being manufactured or different
variants of the same products are manufactured,

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6. Write short notes on the following: (a) SelfAssessment (b) QMS Checklists
(a) Self-Assessment
After designing and implementing QMS as per the requirements of ISO
9001:2008, the next step for an organisation is to get the QMS
certified
through a carefully selected Certification Body (CB). Before
certification, the organisation may want to assess the readiness of the
QMS. For this, the organisation needs to conduct a self-assessment
exercise through an internal audit.
System assessment or self-assessment is a carefully considered evaluation
that consists of a comprehensive and systematic review resulting in an
opinion or judgment of the

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