BSCIC

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QMS- QUESTIONNAIRE (ISO 9001:2015)

1. What is context of Organization?

Context of the organization is the business environment determined by external

factors like legal, financial, social, regulatory and cultural, etc. and organization's
internal environment determined by internal factors like internal structures,
governance, resource capabilities. _
_
_
_

2. What all is to be considered for the scope of QMS of an organization?

_
Maximum customer satisfaction, continuous efficiency on a regular basis _

3. What are Risks and Opportunities?

_
Risks could have a negative impact and opportunities could have a positive impact
unplanned _
_

4. What is measurement traceability?

_
Validation of documents and equipment used to measure products and resources
_

Issue No 06 Jan 2016 Page 1 of 7

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E-mail :- training1@bsc-icc.com, training2@bsc-icc.com
website :- www.bsc-icc.com

5. What is organizational Knowledge?

The information that is necessary to obtain the achievements and goals of the
organization _
_

6. What are Documented Information?

_
The important information of an organization which should be organized in
documents and records _
_

7. What are externally provided processes?

_
A process, or part of a process, is provided by an external provider as a result of a
decision by the organization _
_

8. What is the difference between design review, design verification & design
validation as per Clause 8.3.4?

Reviews indicate that stated design objectives are being achieved, Reviews show
that the design objectives are being achieved, verification shows that requirements
are being met/ identified, validation shows that the organisation is ready to finalize
the requirements _

_
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9. Explain Continual Improvement.

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E-mail :- training1@bsc-icc.com, training2@bsc-icc.com
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The effort of an organization to constantly improve its quality and performance _

_

10.Give four examples of analysis of data & information required in ISO

9001:2015.

_
Document Control

Management Review

Education, Training, Skills and Experience

Product Realization _

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