Lead Auditor

Topics: Quality management system, Measurement, Quality assurance Pages: 7 (851 words) Published: March 18, 2011

Prior to coming for Lead Auditor course, read each of the following questions carefully and answer with reference to ISO 9001:2008. Try to identify the applicable clause number in each case. .

1. Does the standard require Quality objectives to be measured?

Yes the Standard requires Quality Objectives to be mesured. For the continual improvement of the organisation we require the Quality Objectives to be measured. The Quality Objectives shall be measurable and consistent with the quality policy. ____________________________________________________________





2. -------------------------------------------------
Does this standard require maintaining records of education, training, skills & experience? -------------------------------------------------

Yes this standard requires maintaining records of education, training, skills and experience
because it ensures the effective planning , operation and control of the organizations processes. -------------------------------------------------



3. Do we require identifying the process?

Yes whenever required the organization shall identify the process by suitable means throughout the product realization. ____________________________________________________________





4. Do we need to maintain documented procedure for control of records?

The organization shall establish documented procedure to define the controls needed for the -------------------------------------------------
Identification, storage , protection, retrieval, retension and disposition of records. -------------------------------------------------


5. Does this standard require Quality Policy to be communicated & understood throughout the organization?

Yes the top management in the organization should ensure that the quality policy is -------------------------------------------------
Communicated and understood within the organization and is reviewed for continual suitability. -------------------------------------------------


6. What are the minimum output requirements of Management review?

The minimum output requirements of Management review are as follows: -------------------------------------------------
-improvement of the effectivenessof the quality management system and its processes, -------------------------------------------------
-improvement product related to customer requirements and
-resource needs

7. At what stage of design & development validation shall be performed?

Validation will be perfomed at sucha stage where the resulying product is capable of meeting the ____________________________________________________________

requirements for the specified application or intended use. Wherever practicable, validaion will
be completed prior to the delivery or implementation of the product. -------------------------------------------------


8. Does this standard require statuary & regulatory requirements related to the product be Determined?

Yes, the organization shall dtermine statutory and regulatory requirements applicable to the...
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