Clause No Questions Answer Objective Evidence NC

How are resource needs identified AND provided, for

all areas of the quality management system? Is there
only one way to get resources?
How often does it occur over the year? Is it
systematic?
Are resources directed towards improving the
effectiveness of the quality management system?
How? (Obtain examples)
How have resources been provided to enhance
Customer satisfaction levels? (Obtain examples)
Are resources used to respond to Customer
feedback? (Obtain examples)
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Is there a plan on how existing products/services will
be produced or supplied? Is there a flowchart of the
main steps?
Is a plan in place for introducing: New products? New
services? New contracts? New processes? New
projects? New locations? New computer systems?
Any examples of these new activities in the past 12
months? If so, was a plan followed? Is a checklist
used? How was implementation of all the critical
steps managed?
How is the transition from new to normal
operations managed?
How are new processes monitored and measured?
How are any new records identified? What is the
result/output of any planning activities?
7.3.1 How are the stages of design planned? Updated?
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7.3.2 How are input requirements identified/documented?
7.3.3 Where do design outputs go? Are they approved?
7.3.4
How often are reviews done? How are all input
requirements checked?
7.3.5 How is the design verified? When? Documented?
7.3.6 How is the design validated? When? Documented?
7.3.7
How are design changes reviewed? How is impact
evaluated? Record kept?
7.5.1
How are controls applied to the processes to ensure
that products & services are supplied to the
Customer correctly?
7.5.2
Have any processes whose output cannot be
checked? If so, how are these processes controlled?
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7.5.3
How are items identified? How do you indicate
whether products/services are good (or not) to use?
Can traceability information (if asked) be found on
what was delivered?
7.5.4
Does the Customer supply any product, property or
information? If so, is it checked for suitability? Is
Customer advised of any problems?
7.5.5
How is incoming, in-process and final product/service
handled? Stored? How are products/services
protected?
Is there a procedure in place that outlines the
activities in this Clause?
Are all identified processes being monitored and
measured? (check what processes were identified
under Clause 4.1)
Are both product and service processes covered?
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How Is monitoring and measurement being done?
Same approach used for each process?
How often Is the data collected? Who looks at it?
How Is it analysed?
Are process targets defined? Do they link to higher
level objectives? How is this communicated?
What are the results showing? If process
performance is below targets, what actions are
taken? Who decides? Who takes the action?
?
Did the actions taken work? How Do you know they
worked? Are there any repeat problems occurring in
the process?
Is there a procedure or program or plan in place to
monitor and measure the product/service being
supplied to the Customer?
Has the entire plan or procedure been followed?
(check product examples as well as service examples)
Is it consistent in all cases? Is the same approach
used for each product or service?
Will the monitoring and measurement methods show
whether the product/service has met Customer
requirements?
How often Is the data collected? Who looks at it?
How Is it analysed?
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Are there targets defined? How Is this
communicated?
what Are the results showing? If performance Is
below targets, what actions are taken? Who decides?
Who takes the action?
Did the actions taken work? How Do you know they
worked? Are there any repeat problems occurring?
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