Professional Documents
Culture Documents
ISO 9001:
2015 Requirement
Clause
Have you included the commitment to satisfy applicable requirements related to quality in the
quality policy?
Do you include quality policy to ensure commitment for continual improvement of the
Quality management system? How do you track the continual improvements? What
benefits are achieved by you by implementing this ISO 9001-2015 standards?
How do you plan actions to address these risks and opportunities? How do you integrate
and implement these actions into its Quality management system processes?
How do you evaluate actions for the effectiveness of the actions related to risk and
opportunity?
What do you evaluate to ensure the effectiveness action?
b) Is your Quality objective measurable? Show me. Are there any objectives not
measurable?
How do you establish, implement and maintain documented Quality objectives? How?
Have you considered compliance obligations and risk and opportunities in framing this
objectives?
Which type of objectives are defined? What parameters needs to be taken in to account
while establishing and reviewing objectives?
Have you done any planning for how to achieve the Quality 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 these objectives?
6.3 Planning of changes
Have you determines the needs and opportunities for change to the QMS?
How can you carried out the change in organization?
What are the things you consider at the time of change in organization?
Have you consider the availability of resources at the time of change in organization?
Have you consider the purpose of the change and their potential consequences?
Have you consider the allocation or reallocation of responsibilities and authorities at the
time of change in organization?
7. Supports
7.1 Resources
Have you determine and provide resources needed for
Establishment
What are the training provided by you to all employees? Show me your training records?
How do you plan and impart training? Are you having list of in house trainer? What is the
mechanism of providing induction training to new employees? What is the mechanism of
providing induction training to new employees? What is your training plan for next six
months?
7.3 Awareness
Do your employees are aware of quality policy and Quality objective? How do
a)
you contribute your work to implement the quality policy in your work area?
How do you contribute to Quality management system? What benefits are
b) achieved by implementing the QMS? What is your improved quality
performance?
Does the employee aware for what is the implication of not conforming with QMS
c) requirements and for not fulfilling Quality obligations? How do you provide such
awareness to all concern persons?
7.4 communication
How do you determine the needs of internal and external communication relevant to
QMS? Do you have any communication plan?
a) What do you communicate related QMS?
b) When do you communicate related QMS?
c) Whom do you communicate related QMS?
d) How do you communicate related QMS?
e) Who will communicate related QMS?
Do you respond to relevant communication on its Quality management system? Is there
any documented information of this communication?
Have you internally communicate information relevant to QMS at various levels and
functions? How?
Do you ensure such communication enables persons to contribute for continual
improvement? How
Have you externally communicate information relevant to QMS? Show us what kind of
communication is done by you externally? Does it covers all information required by all
applicable compliance obligations?
7.5 Documented Information
7.5.1 General
a) Do you require information documented as per ISO 9001:2015?
b) How do you decide the need of the effective documentation information?
c) Do you documented requirement Paper copy or electronic copy?
1) What is your documented information for competence of person?
2) Have you documented related like quality policy and QMS objectives?
3) Have you documented scope of the QMS?
Have you any documented information compliance to ISO 9001:2015
5)
requirements?
7.5.2 Creating and Updating
Have you created and updated documented information covering proper
a)
identification and description of the title, date, author or reference number?
b) Do you made format for documented information including identification,
copyright @ Green World Group; E-mail: info@greenwgroup.com
ISO 9001 :2015 Clause Wise audit Questionnaire
ISO 9001:
2015 Requirement
Clause
language, software version, and graphics and media like paper copy and
electronic copy?
c) Who is reviewing and updating and re-approved documented, information?
Have you approved information for adequacy and suitability prior to issue ? Who
is authorized to approve and review the documented information? How do you
d) ensure documented information is adequate and suitable for the purpose?
Where did you defined such authority for approval and review of documented
information
7.5.3 Control of documented information
Have you defined any control mechanism for documented information? How do
a)
you ensure documented information is available for use when it is required?
How do you protect documented information? How do you adopt system like
b)
confidentiality, improper use, or loss of integrity?
Does the documents required by the QMS is protected and controlled? How?
Who is authorised to control QMS documents? How do you distribute the
c) documented information? Have you prepared authorized copy holder list to
understand who is having access of information? How do you retrieve
documented information and use it?
Are documented information established and maintained to provide evidence of
conformity to requirements and the effective operation of the QMS? How do you
d)
store and preserve the documented information? How do you ensure it is
legible?
Is it protected and controlled? How do you change the documented information?
How do you establish version control for your documented information? Are you
e)
using any automated tool for such version control and configuration
management?
Is there a documented information define the controls needed for the
identification, storage, protection, retrieval, retention time and disposition of
f) documented information? Have you define the retention period for various types
of documented information? How do you dispose of such documented
information in hard copy as well as soft copy?
Does the master list for documented information with revision no. Made and updated?
Show us latest revision of Quality Manual and other documented information? How do
you maintain master list of page-wise amendment? How do you inform all the persons
for changes in any documented information? Who is responsible for approval and
control of different types of documents? Are you changing whole document or page-wise
amendment? How do you get information for changes in the documented information?
How do you inform to all the concerned person?
How documented information are identified for control / uncontrolled and obsolete?
Do you preserve obsolete documents? Where do you preserve it?
8.0 Operation
8.1 Operational Planning and control
Have you plan, implemented processes as per ISO 9001:2015 QMS system Standard?
Dose the organization has capability and can meet the claims for the products and
services it offers? How do you ensure it?
How do you specify the characteristics of the product that are essential to its safe
and proper use?
8.3.6 Design and Development changes
Are design and development changes identified, reviewed and controlled by
organization to ensure that there is no adverse impact on conformity of requirements?
Is documented information of the results of the review of changes, authorization of the
changes and any necessary actions to prevent adverse impacts maintained?
8.4 Control of externally provided processes, products and services
8.4.1 General
How do you ensures that externally provided processes, products, and services conform
to specified requirements?
Have you determine the controls to be applied on externally provided products and
services when;
a) Products and services are provided by external providers for incorporation into the
Does the organisation deal with nonconforming product by one or more of the following
ways:
a) By correction?
b) By segregation, containment, return or suspension of provision of products and
services?
c) By informing the customer?
d) Obtaining authorization for acceptance under concession?
Are documented information of the nature of the nonconformities and any subsequent
actions taken including concessions obtained maintained? How it is maintained and who
is authorized for disposal of such nonconformity?
How do ensure during internal audit that ISO 9001 requirements as well as international
standard requirements are implemented by the organization?
How do you ensure during the audit that QMS is implemented & maintain effectively?
Have you any establish plan, implement & maintain audit programme? Who is the
authorised person reporting for audit and to whom it is reported? How do you ensure
Processes & Audits result mention in Internal audit is implemented effectively?
How do you define audit criteria and scope of internal audit?
How do you select auditors and conduct audits to ensure objectivity and impartiality of
the audit process? Are identified employees/ functional heads trained for internal
auditor? Are you having list of trained Auditor?
Who is authorised person to review results of the audits?
How do you maintain evidence of the audit programme and the audit results ? Where?
Who has access to such documented information?
Do you have list of trained auditors? Who has given training to them as per ISO 9001
QMS? How many days? Have you made audit plan? During auditing do the auditor
check and monitor results of Objectives reported by the functional heads? Does all the
NCR’s communicated to respective function heads? Are they closed? Have you
prepared plan for internal audit for whole year? How do auditors carry out internal 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?
Do you maintain records for the actual audit carried out against audit planned as well as
summary of audit done? Where do you maintain such records?
How do you ensure that all departments are covered for all the clauses applicable to that
department are audited in internal audit? How do you see effectiveness of action taken
on audit NCR? Where is it recorded?
9.3 Management Review
How Top management Review the organization’s Quality management system/ what is
the frequency of review to ensure its continuing suitability & adequacy? how do you
ensure its effectiveness? When Do you conduct such QMS reviews?
Does this review include assessing opportunities for improvement and the need for
changes to the QMS, including quality policy and quality objectives?
Do you have documented information and actions emerged from the QMS management
review meetings?
What action is taken from previous management reviews? Have you any status for
action monitoring of previous management reviews?
Do you report to Top Management for effectiveness of Quality Management System?
How do you measure effectiveness of system for working of your Organization? How do
you collect necessary information for the same? Are you getting information for
corrective action taken on the identified non–compliances and it’s effectiveness for
discussion in the management review meeting? What is the frequency of the
Management Review Meeting?
Do you review result of feedback for the quality? who is performing it? Do you take any
feedback, implemented any improvement based on nonconformities and corrective
action, monitoring and measurement of results, Results of QMS audits and reviews,
fulfillment of quality objectives etc in the management review meetings?
Have you define adequacy resources and discussed it in MRM? What do you measure
opportunities for continual improvement?
How do you plan for management review meeting and who are committee member? Do
you circulate agenda for Management review meeting 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 reviewing objectives
and targets in the management review? When do you review it?
Does the output of management review includes the following?
What is the base for taking corrective actions? Do you take corrective action for all the
non–conformities?
What is the mechanism to take corrective action?
Are you taking corrective action for process, product, system and interested parties
complaint? When do you take corrective actions? Who review the effectiveness of
corrective action taken by concerned department? How do you monitor it?
How do you maintain documented information for nature of the Non Conformity and
subsequent actions taken as well as result of corrective action? Who maintain it?
10.3 Continual improvement
How do you ensure that organization has continually improve the adequacy and
suitability and effectiveness of QMS?
How do you improve the suitability, adequacy, and effectiveness of the QMS to enhance
Quality performance? Have you determine is there needs or opportunities that is
addressed as a part of continual improvement ?