ISO9001-2015 Departmentwise Audit Questionnaire

ISO 9001:2015, Department Wise Audit Questionnaire
1.
QMS & GENERAL PROCEDURES:-
(1)
How do you measure effectiveness of system for working of your company? How do
you collect necessary information for the same? Are you getting information for
corrective action taken and its effectiveness for discussion in the management review
meeting?
(2)
Have you considered the context of the organizations overall business activities and issues
and environmental conditions affected by your activities? To whom you have identified your
interested parties?
(3)
What are the needs and expectations of interested parties in Environment management
system? What procedure or process is followed to understand interested parties requirements?
How do you establish the EMS? How do you bring continual improvement in
Environment management system in accordance of ISO 9001-2015?
(4)
How do you plan for management review meeting and who are committee member?
Do you circulate agenda for Management review meetings in advance? Do you
prepare minutes of Management review meeting with the actions decided in
management review meeting? How do you monitor effectiveness of the system? Are
you having any quantifiable objectives for management review? When do you review
it?.
(5)
Have you done any planning for how to achieve the environmental objectives? Does this plan
cover what will be done, resource details and responsibilities, target date? How the results are
evaluated including indicators for achievement of this objective?
(6)
Have you update risks based on investigation and opportunities determined during planning?
How do you ensure corrective action taken is appropriate to the effects of the Non conformities
encountered?
(7)
How do you improve the suitability, adequacy, and effectiveness of the QMS to enhance
performance? Have you determined is there needs or opportunities that are addressed as a
part of continual improvement?
(8)
Are you doing follow-up for completion of action decided in Management review
meetings? How? What is input and output of Management review meetings?
(9)
Does the master list for documented information? Show us latest revision of Quality
Manual and other documented information? How do you inform all the persons for
changes in any documents? Who is responsible for approval and control of different
types of documents? How do you get information for changes in the procedure /
documented information? How do you inform to all the concerned person?
(10)
How documents are identified for control/uncontrolled & obsolete?
(11)
Do you preserve obsolete documents? Where do you preserve it?
(12)
Do you have list of trained auditors? Who has given training to them as per ISO
9001:2015? How many days? Have you made audit plan & audit schedule? During
auditing do the auditor check and monitor results of Quantifiable criteria reported by the
functional heads? Does all the NCRs communicate to respective function heads? Are
they closed? Have you prepared plan for internal quality audit for whole year? How do
auditors carry out internal quality audit? Explain us how do you use audit checklist?
Have you done any audit summary for department-wise / Clause-wise audit findings?
How do you close NCR?
ALKAFAA COMPANY www.alkafaa.com
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(13)
How do you carryout audit for Purchase department? Have you checked effectiveness
of training given and competence of auditors? How?
(14)
Do you maintain documented information for the actual audit carried out against audit
planned as well as summary of audit done? Where do you maintain such documented
information?
(15)
How do you ensure that all departments are covered for all the clauses applicable to
that department are audited in internal quality audit? How do you see effectiveness of
action taken on audit NCR? Where is it documented?
(16)
Is the Quality Policy well understood at all levels? Have you arrange training on Quality
policy?
(17)
Have you documented customer requirements based on the customer need? Have you
documented statutory and regulatory requirements applicable to your product? How do
you ensure that it is fulfilled at all the levels? How do you promote customer
requirements within the organisation?
(18)
How do you identify maintain & store documented information? Are they legible?
Where do you document information retention period? How do you establish control for
computerised documented information?
(19)
Who is responsible for control of data? How is it controlled? How do you establish
control on computerised data?
(20)
Are you taking corrective for process, product, and system and customer complaint?
When do you take corrective actions? Who review the effectiveness of corrective and
action taken by concerned department? Explain details of corrective and action
procedure? How do you monitor it? Have you done analysis of audit NCRs? Based on
that have you taken any corrective and action?
(21)
Show us master copy of format with approval for all the formats and exhibits applicable
in QMS area? Have you made Quality Plan for different activities and inter-linkage of
your various departments?
(22)
Have you prepared job description specification for different level of employees in the
company? How do you communicate the same to the various employees?
(23)
Who will identify need for statistical techniques? How it is identified and implemented?
(24)
Have you identified the process needed for the Quality Management System? How is it
applied throughout the organisation? Have you identified critical processes? How do
you identify interaction of processes as well as criteria and methods needed to ensure
that both the operation and control of the processes are effective? How do you monitor,
measure and analyse the processes?
(25)
Have you identified any exclusion? What justifications are given for the same? Have
you documented the same? Where?
(26)
Can you show any evidence that top management has given commitment for the
development and implementation of the Quality Management System? Has he
communicated for the importance of meeting customer as well as statutory and
regulatory requirements?
(27)
Have you made any mechanism for ensuring availability of resources vs. further
requirements? How do you identify resource requirements? How do you fulfil the
same?
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(28)
Have you identified customer requirements to enhance the customer satisfaction? How
do you ensure promotion of awareness of customer requirements throughout the
organisation?
(29)
What kind if communication process is established within the organisation? How the
communication takes place regarding the effectiveness of Quality Management
System? Have you made any procedure for the same? How is it implemented?
(30)
How do you ensure competence of persons performing work affecting conformity of the
product? What kind of infrastructure do you provide? How do you identify and convey
your need for the resources?
(31)
How do you ensure customer satisfaction? Have you done any customer survey? Have
you analyse data for the Questionnaire submitted by the customer? Have you taken
actions based on the same?
(32)
How do you measure effectiveness of training? How do you ensure training given to the
auditor is effective?
(33)
Have you analysed date for:
a).
Customer satisfaction.
b).
Product conformities like inspection for incoming, inprocess and final stage inspection.
c).
Process trends and opportunities for the improvement for example yield control, time
cycle reduction etc.
d).
Suppliers.
(34)
When do you carry out corrective actions? How do you identify causes of
nonconformity? Have you documented results of actions taken? Where? How do you
review the effectiveness of the action taken?
(35)
Have you fixed any action plan for the achievement of Quantifiable criteria? By which
data and how it will be achieved? Show us action plan for achieving the same.
2.
QUALITY CONTROL: -
(1)
Are acceptance & rejection criteria specified for different process parameters and
product tested by your company? Have you prepared overall inspection test plan
covering references of work instruction, acceptance criteria, format and parameters
tested for different types of products for incoming, in process and final stage of
inspection?
(2)
Are you inspecting / verifying all the critical products, new developed products or
purchased material? How? Any documented information are kept for the same? Are
you testing raw materials? How?
(3)
Have you trained staff for follow up of operating procedures & work instruction of Q.A.,
Laboratory & test methods for testing of various products? Have you received any test
method given by your customer?
(4)
How do you carry out calibration of laboratory instruments used by your personnel for
department testing work? How do you maintain calibration status? How do you control
& maintain instruments in your department?
(5)
Have you done calibration of equipment like laboratory instruments, weighing balance,
etc? Is it traceable to approved national /International standards? If such traceability is
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not available then is it calibrated against documented method or established
methodology?
(6)
How do you identify un-inspected, inspected & non-conforming samples in your

department? How do you downgrade the materials after lab testing? How do you
identify downgrade material? Are you putting remarks for O.K. / not O.K. in the test
reports/ who is authorised for the review and approval of test reports?
(7)
How do you get details for third party inspection or product approval by customers?
How do you get information for the statutory and product related regulatory
requirements? How do you ensure fulfilment of the same?
(8)
How do you get information for the customer requirements and ensure its fulfilment?
Are you inspecting reprocessed material? Show us documented information?
(9)
Are you carrying out testing of all the critical incoming material, in process and final
stages for each lot? How do you maintain documented information? How do you
maintain status of inspection?
(10)
What action have you taken after receiving customer complaints? How do you analyse
customer complaints?
(11)
How do you ensure that product has passed through all the inspection & meet
customer requirements? How do you carry out final inspection of product to be supplied
to different segment like replacement market, defence, exports etc.? Where are you
keeping documented information?
(12)
Have you attended management review meetings? Which was discussion related to
your areas? Have you completed actions decided in management review meeting in
your area?
(13)
How do you get special test requirements of customers and how it is carried out? Do
you get any test method for testing of product from the customer? How do you follow it?
(14)
How do you maintain master list of documented information with retention period? All
type of documented information including computerised documented information
maintained by you is covered in the master list of documented information? In your all
the files record name and format no. (If applicable) is written? Proper document control
is established by you?
(15)
Have you been audited? How many NCRs given to you? Have you taken actions to
close the same?
(16)
Are you using any subjective criteria for inspection and testing? How do you establish
control for the same?
(17)
What is the process approach in your department? What is the input and output in your
laboratory? Have you prepared Quantifiable criteria for you area? How do you monitor
it? Have you conveyed the same to the concerned person? Have you prepared any
action plan for the achievement of Quantifiable criteria?
(18)
How do you carryout process audit?
(19)
(20)
(21)
How do you prevent, or reduce, undesired effects related to risk?

Have you define a quality risk assessment process? Show me.
What are the things you consider in your department at the time of change in
organization?
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(22)
Is there necessary infrastructure and environment in your department for the operation
of process?
(23)
Do you implement action from risks and opportunities?
(24)
Have you update risks based on such investigation in documented information?
3.
MARKETING: -
(1)
How do you carryout marketing of your product? Are you having agents? How do you
select such channel of distribution? Who is authorised for selection of them? Are you
having list of approved Dealer / Agent list for the same?
(2)
Have you prepared your company brochure? Are you having price list? Who approve
it? How do you finalise price for the new product?
(3)
How do you participate in defining requirements for new products? How do you get
information for new products? How do you provide information for your product to you
customer as well as plant people?
(4)
Have you define customer expectations & product requirements? How do you
communicate it to Design, Manufacturing, Q.C., packing etc?
(5)
How do you sale your products? How do you understand requirements related to the
products as below:
1.
Requirements specified by the customer.
2.
Requirements not specified by the customer for intended use.
3.
Statutory and regulatory requirements applicable to the product.
4.
Any additional requirements considered necessary by the organisation.

Can you show us evidence that above 4 types of requirements is determined,
understood before execution of order? How do you ensure your capability for the above
requirements? How do you maintain contract review report? How do you keep tract for
completion of order and compilation of all such orders?
(6)
What are the Quantifiable criteria for your department? How do you monitor it? Have
you given any further criteria for your other sales staff? What process approach do you
adopt? What is input and output of your department? Have you done any analysis for
timely completion of orders or delay is delivery? How do you amend the order?
(7)
How do you monitor effectiveness of department? Can you show us your action plan
for achievement of your quantifiable criteria? How do you monitor your results for
achievement of Quantifiable criteria vs. planned action?
(8)
How do you know plant capability for manufacture of different types of product? How do
you given delivery schedule? Have you done internal contract review any time? Where
are contract review report? How do you convey the same to the plant? How do you
confirm capability for new product development with the customer as well as convey
the same to plant?
(9)
organization?
(10)
How do you handle customer complaints? Any documented information are

maintained? When do you close such complaints? How fast you close the customer
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complaints? Have you done any analysis for customer complaints and warranty claims
attended by the company? What corrective actions are taken for the same?
(11)
How do you convert customer inquiry in to contract? Does the total requirements laid
down?
(12)
(13)
(14)

of process?
(15)
(16)
Who has attended management review meeting? Have you decided any action for your
department? How? Does marketing monitor & report customer feedback in
management review meeting?
(17)
How do you maintain documented information in your area ? All type of documented
information including computerised documented information maintained by you is
covered and maintained?
(18)
Have you been audited? How many NCRs are given to you? Have you taken actions to
close the same?
(19)
(20)
How do you determine and implement effective arrangements for communicating

customers for product information (List of your brand products), order handling,
complaints etc. Have you fixed any timeframe for the effective communication with
customer?
(21)
How do you measure customer satisfaction? Have you defined methods for the same?
Have you analysed such data? Have you taken any corrective action for the same?
What is input for customer satisfaction survey? Have you fixed any criteria for customer
satisfaction?]
4.
PRODUCTION AREAS: -
(1)
Are production Head, In charge, supervisors & workers trained for the methods & skills
to perform their task as well as applicable ISO 9001:2015 documented information?
Are the operators aware of their work instructions for operation on respective work
area?
(2)
What is the process approach in your manufacturing activity? What is the input and
output in your various processes? Have you prepared Quantifiable criteria for your
process? How do you monitor it? Have you conveyed the same to the concerned
person like supervisors and workers?
(3)
of process?
(4)
Have you identified operational control points of your activities? Are you having documented
operational control plan? Are you maintaining documented information as per the requirements
of operational control plan? Show me documented information.
(5)
(6)

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(7)
Are you having any special processor? What do you mean by is? Are you operator for
special process? How do you monitor such special process? Do you keep any
documented information for the same? Are you doing periodic process Qualification?
Before finalising process parameters have you done study for your past process data
to consider the process parameters?
(8)
How do you identify the material and for what parameters at incoming, in process, and
final storage area?
(9)
Are equipments / instruments used by your departments are calibrated? What is your
mechanism for calibration?
(10)
How can you ensure that implemented control of the processes is as per defined criteria? How
do you Control planned changes and review the consequences of unintended changes? Who is
responsible for the same?
(11)
How do you ensure that outsourced process is controller or influenced. What type and extent of
control or influence is applied to the Process is defined within the QMS for such outsourced
process? Have you established system for selection of vendors and outsourced activities and
how do you communicate such controls to them?
(12)
(13)
(14)
What are the things you consider in your department at the time of change ?
(15)
Have you established any traceability system to recall defective product based on
customer complaint or production feedback for particular lot? How do you identify
finished materials as well semi finish lot? Have you established any codification system
for the lot numbering?
(16)
Is production planned for all the different departments? Do you carryout production
planning and product realisation? How do you monitor plan vs. actual? How do you
carryout routine work? What processor do you follow for internal communication?
(17)
Have you define a risk and opportunity? How risk assessment process is followed?
Show me.
Is there appropriate control of materials, equipments & critical parameters of process?
How do you monitor and control your Processes? Are you maintaining documented
information for process control monitoring? How do you get the information for the
mixing of various products?
(18)
What methods for monitoring, measurement, analysis and evaluation are followed to ensure
valid results?
(19)
Is there inspection & test status given for downgrade materials? How? Are there
appropriate documented information for disposal of non-conforming materials & who is
authorised for the same?
(20)
Have you finalised critical limits for you processes? Have you documented the same?
Where? How do you control process parameters? How do you monitor the same? Do
you maintain the documented information for the same? Are adequate equipment used
for storage & Handling?
(21)
Is training provided at all levels of workman in the company? Where are documented
information? Does management evaluate training effectiveness? Based on training
effectiveness documented information are you giving retraining?
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(22)
Do you analyse your documented information to find out route cause for taking
corrective actions to product and process nonconformity? Where do you documented
results of effectiveness of corrective actions?
(23)
Are you following methods for process control, process qualification & process
monitoring on manufacturing machines? What are the control parameters during the
manufacturing processes? What are std. Values & tolerances? Are you using any
subjective criteria for inspection or process control? How do you maintain documented
information for the same? Have you done eye checking of the persons doing the
checking?
(24)
How do you receipt and issue materials within and outside your department? Where is
it documented?
(25)
What are the steps followed for identifying & disposal of non-conforming materials?
How do you identify uninspected, conforming & not O.K. material?
(26)
Have you been audited? How many NCRs are given to you? Have you taken actions
to close the same?
(27)
Have you attended management review meetings? What was discussion related to
your area?
(28)
What kind of communication process is established within the organisation? How the
System? How is it implemented?
(29)
How do you ensure competence of persons performing work affecting the Quality?
Have you identified competence level for employees? What kind of infrastructure do
you provide? How do you identify and convey your need for the resources?
(30)
When do you take actions for the effect of the potential problems? How do you
determine potential nonconformity and their causes? How do you document results of
action taken? How do you review the effectiveness of the action taken? How do you
review actions in the management review meetings?
(31)
Have you analysed documented information for the conformity of product requirements
of characteristics and trends of processes and products including opportunities for
improvement?
(23)
How do you ensure achievement of Quantifiable criteria? By which date you will
achieve it? How? Where is action plan for the same?
5.
ENGINEERING (UTILITY AND MAINTENANCE): -
(1)
Have your documented preventive maintenance schedule? Is it based on

manufacturers suggestions? Are you timely following it? Where is it documented? Are
you having equipment history data? Are you maintaining breakdown maintenance
data? Are you doing analysis of breakdown maintenance and taking necessary
corrective actions?
(2)
Are you following methods for process control and process monitoring on utility
equipment? What is the control parameter during the processes? What is std. Values &
Tolerances?
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(3)
Is there appropriate control of materials, equipment and critical parameters of utility

process? How do you monitor and control your processes? Are you maintaining
documented information for process control monitoring?
(4)
Have you been audited? How many NCRs are given to you? Have you taken actions
to close the same?
(5)
your area?
(6)
What is the process approach in your maintenance activity? What is the input and
output in your various processes of your utilities as well as plants? Have you prepared
Quantifiable criteria for your department to monitor the effectiveness? How do you
monitor it? Have you conveyed the same to the concerned person like supervisors and
workers? What is action plan for achievement of quantifiable criteria? How do you
achieve it?
(7)
How do you ensure competence of persons performing work affecting the Quality?
What kind of infrastructure do you provide? How do you identify and convey your need
your need for the resources?
(8)
(9)

(10)
(11)
(12)

Are you analysing breakdown data? How? Are you taking any corrective actions based
on it? When do you take actions for the effect of the potential problems? How do you
determine potential nonconformity and their causes? How do you document results of
actions taken? How do you review actions in the management review meetings?
(1)
What competence, education and experience are required for your employees? What
have your documented it? Based on that any gap is found in your department? How do
you maintain the documented information for the same?
organization?
(2)
(3)
of process?
6.
PURCHASE: -
(1)
Have you selected vendor and suppliers? Have you prepared Approved Vendor List?
What is a selection criterion? Do you maintain documented information for AVL &
Vendor selection/ evaluation?
(2)
(3)
(4)

organization?
(5)
(6)
Have you prepared any questionnaire for selection of vendor? Can you show the
same?
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(7)
Have you prepared clear specification for all the purchase items? How do you get
information on purchasing data form user department? Have you prepared purchase
specification for raw materials and are you referring the same document in the
purchase order? How are you getting details for the spares and hardware and job work
items? How are you getting specification for the same? How do you give codification for
part number?
(8)
Have you made agreement for quality assurance with your subcontractor? Have you
established any control on them? How do you select subcontractor for job contract?
How do you establish control on them?
(9)
Can you show me documented information for the trial run or sample approval for the
vendor selection/evaluation?
(10)
How do you ensure that outsourced process is controller or influenced. What type and extent of
control or influence is applied to the Process is defined within the QMS for such outsourced
process? Have you established system for selection of vendors and outsourced activities and
how do you communicate such controls to them?
(11)
(12)
Have you done periodic evaluation and vendor rating of your supplier? Which items are
included for the same?
(13)
How do you carry out cash purchase? Who is authorised to purchase against letter of
indent?
(14)
of process?
(15)
Who is reviewing and approving purchase order for adequacy of the specified
requirements prior to release? Where is the list of authorised person for the same?
(16)
How do you carry out purchase of service like labour contract, calibration of instrument,
transport etc.? Do you prepare P.O.? Contract / work order for the same?
(17)
Are you going to vendors place for inspection of the product and are you conveying
vendors for test certificate requirement as required by you?
(18)
How do you keep track for requirement vs. purchase order release vs. materials receipt
and monitor your purchase activity? How do you keep track for pending requirements
and describe purchase order cancellation procedure? How do you keep track for
pending purchase order? How do you amend the purchase order? Show us
documented information?
(19)
Are you using any vendors standard documents or master sample and who is
controlling the same?
(20)
Do you Out sourced any of the processes?
(21)
How do you control the subcontracted processes?
(22)
Have you been audited? How many NCRs are given to you? Have you take actions to
close the same?
(23)
(24)
your area?
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(25)
Have you documented job description with authority and responsibility to all the
concerned persons in your department?
(26)
What is the process approach in your department? What is the input and output in your
various activities done by you? Have you prepared Quantifiable criteria for your
department to monitor the effectiveness? How do you monitor it? Have you conveyed
the same to the concerned person staff members in your department? What is action
plan for achievement of quantifiable criteria? By which data? What is action plan for the
same?
(27)
What kind of communication process is established within the organisation? How the
System? Have you made any documented information for the same? How is it
implemented?
7.
STORES (RAW MATERIAL AND SPARES): -
(1)
(2)
(3)

How do you maintain account for job work materials send with gate pass?
(4)
Which methods are followed for receipt and issue of materials form store? Are you
having persons list for the issue of materials for the same? How do you maintain
documented information for the issue and receipt of material?
(5)
Is the method for Preserving material adequate? How do you take care for the
preservation of materials?
(6)
organization?
(7)
of process?
(8)
(9)
Do you maintain proper inspection and test status for materials lying in store area?
(10)
How do you identify uninspected, O.K. & not O.K. materials? How do you inform
concern department person for arrival of materials to carry out necessary inspection?
How do you control shelf life material?
(11)
How do you maintain stock documented information? Have you specified location for
the storage of different items? How do you keep track for the same?
(12)
Have you specified minimum inventory level at any place for critical items? Are you
involved in raising the indent for follow up of indent for the indent raised by various
departments? How do you keep tack for the pending indents?
(13)
What types of controls are established to avoid deterioration of Quality of material

during storage? What controls are followed for self-life material used?
(14)
How do you dispose off non-confirming materials?
(15)
(16)
Do you verify Quality, brand and type of materials with respect to purchase order on
receipt in the store
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(17)
What is the process approach in your department? What is the input in the various
activities done by you? Have you prepared Quantifiable criteria for your department to
monitor the effectiveness? How do you monitor it? Have you conveyed the same to the
concerned staff members in your departments?
(18)
Are you having MSDS for all the chemicals stored in the raw materials stores? How do
you take care for the various symbols put on the packing of raw materials and what is
the meaning of the same? Have you got any training for the safety issues?
8.
PACKING AND DESPATCH: -
(1)
(2)
(3)
Are you putting identification label as per contract made with customer?
Are you control-packaging materials and follow same packing method as per
agreement with customer?
Are you inspecting and testing the packing materials? Show the documented
information of same.
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
How do you get information for packing and despatch of different types of pigments?
How do you get carrying out a blending of materials? Are you inspecting the blended
lot? What is the system of giving the lot number?
How do you get information form the Q.C for the inspection test status and who is
authorised to release the materials based on final inspection and testing? How are you
getting the information for lot ready for despatch?
How do you get information for customer requirements for example packing materials,
Shipping mark, Packing weight etc.? How do you establish proper control for the
same? What care is taken for the same?
Have you define a risk assessment process? Show me.
Are adequate instructions provided for packing and how do you take care for quality of
materials for delivery to destination or customer s place.
What care are taken for product quality during packing?
How do you control and store materials in the packing area? Have you identified areas
for storage of different materials? How do you maintain stock for the same?
What is input to your department? What is output form your department? Have you
identified any Quantifiable criteria? How do you monitor the same?
What are the things you consider in your department at the time of change and what is
the change management process followed by you?
of process?
9. ADMINISTRATIONS AND TRAINING: (1)

(2)
(3)
Have you determine competence of personnel performing work affecting conformity to

the product requirements? How? Based on that how do you identify training needs or
recruitment of new person for the various levels of employees?
Are you having competence chart for the various levels of employees? How do you
ensure the competence and are you having annual appraisal to ensure competence of
employee?
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(4)
of process?
(5)
How do you provide the training or necessary actions to achieve necessary

competence competency need for the various levels of employees?
What mechanism if followed by you so that all the personnel are aware for the
relevance and importance of their activities and how can they contribute to the
achievements of the quality objectives?
Can you show us the documented information for the education, skill, experience and
training of your various levels of the employees? Who is recently recruited? Does he
fulfil you requirements? Show us his degree certificate?
What is input to your department? What is output from your department? How do you
control it? Have you made any quantifiable criteria for your department? How do you
monitor it?
(6)
(7)
(8)
(9)
(11)
Can you show us documented information for annual training as well as routine
training? How do you prepare training calender? Can you shoe us the same?
How do you ensure effectiveness of training given? Based on that in any case have
you given retraining?
(12)
(13)
organization?
(10)
(14)
(15)
Have you identified any training need for special activity based on multi skill analysis?
Do you get timely resources or delay to get resources? What are the step at the time
of un availability of resources?
(16)
Do you provide training or take other actions to achieve the necessary competence? Have
you define what is appropriate education, training and experience for different category of
persons? Where do you maintain such documented information?
Have you ensure that the necessary competence has been achieved? What actions are taken
to acquire the necessary competence? How do you evaluate the effectiveness of action taken
for example written test, mock trail, review of effectiveness of training etc? What action was
taken to upgrade the competence of people?
Are you maintaining appropriate information and documented information of education,
training, skills and experience and qualifications as an evidence of competence?
(17)
(18)
10.
RESEARCH AND DEVELOPMENT: -
(1)
How do you get information for the new R & D work and product or process related
development work? Are you carrying out any design and development planning?
How do you identify various design and development stages covering design review,
verification and validation? How do you maintain he documented information for the
same?
How do you carryout interfaces with different department for R & D work? How do you
assign responsibility for R & D work to various team members?
How do you get input for the design and development activities? Where do you
maintain documented information for the new products as well as application related
changes in the existing product or input for all the modification projects? How do you
document design input?
(2)
(3)
(4)
(5)
Page 13 of 15

(6)
(7)
Have you define risk assessment process? Show me? What are the risk and
opportunity related to your activities?
What are the things you consider in your department at the time of change and how
change management is followed by you?
(8)
(9)
Are you considering all the statutory and regulatory requirements like use of Banned
products, process limitation, and Maximum pressure limits? ASTM or IS standards?
Where of you maintain the documented information for the same?
How do you make design calculations? How so you document design outputs?
How do you plan for trial production, R & D experiments and new jig development
during R & D stage? Where do you maintain the documented information? How do you
monitor performance of the trial run?
Hoe do you document design output covering information related to purchase,
production etc. Where do you document acceptance criteria for the products? How do
you ensure product application for example paper, textile, plastic etc. for the various
pigments developed by you?
Where do you document stages of design review in the design plan? How do you carry
out design review? Who are the team members for the design review? Are you making
any action plan? Where do you documented information results of review?
How do you carry our design and development verification? Before releasing the
product from laboratory are you documenting product specification in documented
form? How do you monitor the same?
How do you validate the design? Where do you maintain the documented information
for the same?
of process?
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(20)
What is the different document generated form your departments? How do you
establish control for design and development changes?
What is the process approach made by you? What is input to your department? What
is output from your department? How do you monitor your quantifiable criteria? How do
you analyse results? What is action plant for achieving the same?
When do you take corrective actions for the effect of the potential problems? How do
you determine potential nonconformities and their casues? How do you documented
information results of action taken?
11.
TOP MANAGEMENT: -
(1)
How do you made your Quality Policy? How do you demonstrate leadership & commitment
with QMS?How? Have you documented your Quality Policy objectives? Where? How do
you ensure that it is implemented by all the employees? Does the QMS objectives are in
(18)
(19)
line with strategic direction of the organization?
(2)
(3)
How do you provide evidence of your commitment to the development and

implementation of the Quality Management System and continually improving its
effectiveness?
How do you ensure customer requirement are determined (Stated product related,
Application related or intended use, statutory and regulatory and additional) and met
with the aim of enhancing customer satisfaction as a part of customer focus? How do
you communicate the same to all the employees /
Page 14 of 15

(4)
Have you determine external and internal issues in the Quality management system (QMS)?
Does this issues are relevant to its purpose and ability to achieve intended outcome of QMS?
(5)
Is there Quantifiable objectives defined from Quality Policy? How do you measure
Quality Policy objectives? Where? Is it supported with objective evidence?
What are the prime objectives for going for ISO 9001:2015 Quality Management
System? What is your experience after implementing ISO: 9000 systems in last four
months?
(6)
(7)
(8)
Have you determine the boundaries and applicability of the Quality management system?
(9)
Have you considered the context of the organizations overall business activities and issues
and conditions affected by your activities? Based on that have you identified risk and
opportunity and what actions are planned? What is your next 5 years vision and to achieve
goals how do you see organization commitment for Quality management system?
(10)
Are regular Management Review Meetings held to review Quality system? How Many
management review meetings are held? Any agenda or circular for the same? How do
you review effectiveness of system with respect to Quality objectives and ISO: 9001
requirements? Do you receive any report from HOD for review on effectiveness of
system? Which points are discussed in Management Review Meeting?
How do you get information for requirement of resources? Does management provided
adequate resources for installation of Quality Management System like (1). Human
resources (Competence, awareness and training) (2) Skills (3) Infrastructure (Building,
workspace, Machinery, storages area, supporting cervices etc. (4) Inspection & test
equipment (5). Work Environment.
(11)
(12)
What are the advantages gain by the company after implementation of ISO 9001:2015
Quality Management System?
What are the needs and expectations of interested parties in Quality management system?
What process is followed to understand interested parties requirements?
(13)
Have you define authority and responsibility for all personnel? Is delegation of authority
and responsibility clearly defined?
(14) Have you define any growth rate %? How do you see future of your industries? What
will be companys role in your industry? What is your future plan?
(15) How do you identify training need for senior personnel?
(16) How do you give feedback for new product development to R & D? How do you get
such information?
Page 15 of 15

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ISO 9001:2015, Department Wise Audit Questionnaire

QMS & GENERAL PROCEDURES:-

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