Ceklist ISO 9001 - 2015
Ceklist ISO 9001 - 2015
Ceklist ISO 9001 - 2015
Clause 4 Contex
1 Has the organization determined the external and internal issues relevant to the
ability to achieve the intended results?
2 Does the organization monitor and review information about these external and
1 Has the organization determined the interested parties that are relevant to the Q
3 Does the organization monitor and review the information about these intereste
2 Has the organization determined the boundaries and applicability of the QMS?
3 While determining the scope, has the organization determined the external an
product and services of the organization?
5 Does the scope states the types of products and services covered?
6 Does the scope give justification for any requirements that the organization dete
4.4.1
1 Has the organization determined the processes needed for the QMS?
2 Has the organization determined the application of these process throughout the
3 Has the organization determined the sequence and the interaction of these proc
4 Has the organization determined and applied the criteria and methods nee
processes?
5 Does these methods include the monitoring, measurement and related performa
6 Has the organization determined the resources needed for these organization?
7 Has the organization ensured the availability of the resources needed for these p
8 Has the organization assigned the responsibilities and authorities for these proce
9 Has the organization addressed the risk and opportunities associated with these
10 Has the organization evaluated these processes and implemented any chang
results?
11 Has the organization made improvement in its processes and its QMS?
4.2.2
1 Has the organization maintained documented information to support the operati
Clause 5 Leadership
5.1 Leadership and commitment
5.1.1 General
1 Does the top management demonstrate leadership and commitment by taking a
2 Has the top management ensured that the quality policy and quality objective a
3 Are quality policy and quality objective compatible with the context and strategi
4 Has the organization integrated the requirements of QMS with the business proc
5 Is the organization promoting the use of process approach and risk based thinkin
6 Is the top management ensuring that the resources needed for the QMS are ava
8 Does the top management ensure that the QMS is achieving its intended results
9 Does Top Management engage, directs and supports the persons required to con
2 Are the risks and opportunities that can affect conformity of products and s
determined and addressed?
5.2 Policy
5.2.1 Establishing the Quality policy
1 Has the Top Management established, implemented and maintained a quality po
2 Is quality policy appropriate to the purpose and context of the organization and
3 Does Quality policy provide the framework for setting quality objective?
4 Does Quality policy include the commitment to satisfy applicable requirements a
1 Has the Top management ensured that the responsibilities and authorities for re
within the organization?
2 While assigning the responsibilities and authorities, do the top management ens
3 While assigning the responsibilities and authorities, do the top management ens
4 While assigning the responsibilities and authorities, do the top management ens
organization?
5 While assigning the responsibilities and authorities, do the top management ens
improvement are reported to them?
6 While assigning the responsibilities and authorities, do the top management ens
QMS are planned and maintained?
6 Planning
6.1 Actions to address risks and opportunities
1 While planning for QMS, does the organization considers the issues referred in c
6.1.1
1 Has the organization determined the risks and opportunities that has to be addr
desirable effects, prevent, or reduce undesired effects and achieve improvemen
6.1.2
1 Has the organization planned actions to address these risks and opportunities?
2 Have these actions implemented and integrated into its QMS processes?
6.2.1
1 Has the organization established quality objectives at relevant functions, levels a
3 Does the organization have quality objectives which are relevant to the conform
satisfaction?
4 Are quality objective measureable and do they take account of applicable requir
6.2.2
1 For achieving quality objectives does the organization determines what will be d
when will it be completed and how are the result to be evaluated?
2 While planning for change, does the organization consider the purpose of the ch
QMS; the availability of resources; and allocation and reallocation of responsibilit
7 Support
7.1 Resources
7.1.1 General
1 Has the organization determined and provided the resources needed for the esta
improvement of the QMS?
2 Has the organization considered the capabilities and constraints of existing inter
3 Has the organization considered what needs to be obtained from external provid
7.1.2 People
1 Has the organization determined and provided the persons required for effective
processes?
7.1.3 Infrastructure
1 Has the organization determined and maintained the infrastructure needed for o
and services?
1 Has the organization determined, provided and maintain the environment neces
conformity of products and services?
7.1.5.1 General
1 Has the organization determined and provided the necessary resources needed
product and service requirement?
2 Are resources suitable for the type of monitoring and measurement activities un
4 Where no such standard is existing, are documented information retained for the
2 Does the organization maintain this knowledge and make it available to the exte
3 While addressing changing needs and trends, does the organization considers it
any necessary additional knowledge and required updates?
7.2 Competence
1 Does the organization determine the necessary competence of its employees wh
QMS?
2 Does the organization ensure that its employees are competent on basis of appr
3 Does the organization take applicable actions to acquire the necessary compete
7.3 Awareness
1 Does the organization ensure that the persons doing work under the organizatio
objectives, their contribution to the effectiveness of QMS including the benefits o
QMS requirements?
7.4 Communication
Does the organization determine the internal and external communication releva
communicate, with whom to communicate, how to communicate, and who comm
1
7.5 Documented Information
7.5.1 General
1 Does the organization’s QMS include documents required by ISO 9001:2015 and
effectiveness of the QMS?
2 While creating and updating documented information does the organization ens
3 While creating and updating documented information, does the organization ens
suitability and adequacy?
7.5.3.1
1 Does the organization control its documented information to ensure that it is ava
7.5.3.2
1 Is the distribution, access, retrieval and use of documented information adequat
2 Has the organization established criteria for the processes and acceptance of pro
4 Does the organization implement controls of the processes in according with the
5 Does the organization determine, maintain and retain necessary documented in
carried out as planned and to demonstrate the conformity of products and servic
6 Does the organization control its planned changes and review the consequences
7 Does the organization take action to mitigate any adverse effects of its unintend
2 Does the organization obtain customer feedback relating to products and service
3 Does the organization communicate with the customers relating handling or con
4 Has the organization established requirements for contingency action, where req
1 Has the organization determined the requirements for product and services to b
2 Are the requirements defined and does it includes applicable statutory & regulat
organization?
3 Can the organization meet the claims for the product and services it offers?
1 Has the organization ensured that it has the ability to meet the requirements for
4 Has the organization reviewed the requirements not stated by the customers bu
5 Has the organization reviewed the statutory & regulatory requirements applicab
the organization?
6 Have the organization reviewed and resolved contract or order requirements diff
7 When the customer does not provide a documented statement of their requirem
requirements before acceptance?
8 Does the organization retain documented information on the results of the revie
1 Does the organization ensure that the relevant documented information is amen
requirements, when the requirements for the products and services are changed
8.3 Design and development of products and services
8.3.1 General
1 In determining the stages and controls for D&D, has the organization taken into
activities?
2 In determining the stages and controls for D&D, has the organization taken into
reviews?
3 In determining the stages and controls for D&D, has the organization taken into
4 In determining the stages and controls for D&D, has the organization taken into
the D&D process?
5 In determining the stages and controls for D&D, has the organization taken into
6 In determining the stages and controls for D&D, has the organization taken into
involved in D&D?
7 In determining the stages and controls for D&D, has the organization taken into
8 In determining the stages and controls for D&D, has the organization taken into
product and services?
9 In determining the stages and controls for D&D, has the organization taken into
customers and other relevant interested parties?
10 In determining the stages and controls for D&D, has the organization taken into
demonstrate that design and development requirement have been met?
8.3.3 Design and Development inputs
1 Has the organization determined the essential requirements for the specific type
2 Does the organization consider the following functional and performance require
code of practices that the organization has committed to implement; information
potential consequences of failure due to the nature of the product and services?
3 Does the organization ensure that the inputs are adequate for D&D purpose, com
1 Has the organization applied the necessary controls to D & D processes to ensur
2 Has the organization conducted review to evaluate the ability of the results of D
3 Has the organization conducted the verification to ensure that D&D meet input r
4 Has the organization conducted the validation to ensure that the resulting produ
application or intended use?
5 Has the organization taken necessary action on the problems determined during
1 Does the organization ensure that D&D outputs meet the input requirements?
2 Does the organization ensure that D&D outputs are adequate for the subsequen
3 Does the organization ensure that D&D outputs include (or has reference) monit
4 Does the organization ensure that D&D outputs specify the characteristics of the
use?
8.3.6 Design and Development changes
1 Has the organization identified, reviewed and controlled changes made during, o
ensure that there is no averse to the impact on conformity to requirement?
2 Has the organization retained the documented information on D&D changes, the
taken to prevent adverse impact?
8.4 Control of externally provided processes, products and services
8.4.1 General
1 Does the organization ensure that the externally provided processes, products a
2 Does the organization determine the controls needed when the product and serv
own product and services?
3 Does the organization determine the controls needed when the product and serv
customer by external providers?
4 Does the organization determine the controls needed when process or part of pr
5 Has the organization determined and applied the criteria for selection, evaluatio
providers?
6 Has the organization retained the documented information of these activities an
1 Does the organization ensure that the externally provided processes, product an
deliver conforming products and services to the customers?
2 Does the organization ensure that the externally provided process remain within
3 Has the organization defined the controls to be applied to external provider and
4 Has the organization taken into consideration the potential impact of the organiz
statutory and regulatory requirement?
5 Has the organization taken into consideration the effectiveness of the controls a
1 Has the organization implemented production and service provision under contro
2 Are there any documented information available that defines the characteristics
results to be achieved?
3 Are any suitable monitoring and measuring resources available? Are they being
6 Is the infrastructure and environment being used suitable for operation of proces
8 Has the organization implemented any release, delivery and post-delivery activi
1 Has the organization used any suitable means to identify output when it is neces
2 Has the status of outputs with respect to monitoring and measuring requiremen
identified by the organization?
3 Has the organization controlled the unique identification of the outputs when tra
4 Has the organization retain the documented information necessary to enable tra
3 When the property or the customer or external provider is lost, damaged or othe
report this to the customer or external provider? Does the organization retain do
8.5.4 Preservation
1 Does the organization preserve the outputs during production and service provis
requirements?
8.5.5 Post-delivery activities
1 Does the organization conduct review and control changes for production or serv
requirements?
2 Does the organization retain documented information describing the results of th
and any necessary actions arising from the review?
8.6 Release of products and services
8.7.1
1 Does the organization ensure that the outputs which do not conform to their req
unintended use or delivery?
2 Is the action appropriate to the nature of the nonconformity and its effect on the
9.1.1 General
1 Did the organization plan how to monitor, measure, analyze, and evaluate its Q
2 Did the organization plan how to monitor QMS performance and effectiveness?
3 Did the organization figure out what needs to be monitored and select methods?
4 Did the organization determine its QMS monitoring requirements?
5 Do the organization select monitoring methods that can produce valid results?
6 Did the organization establish when monitoring should be done and who should
7 Did the organization plan how to measure QMS performance and effectiveness?
8 Did the organization figure out what needs to be measured and did the organiza
10 Do the organization select measurement methods that can produce valid results
11 Did the organization establish when measuring should be done and who should
12 Did the organization plan how to analyze QMS performance and effectiveness?
13 Did the organization select analytical methods that are capable of producing val
14 Did the organization decide when monitoring and measurement results are anal
15 Did the organization plan how to evaluate QMS performance and effectiveness?
16 Did the organization select evaluation methods that are capable of producing va
17 Did the organization decide when monitoring and measurement results are evalu
20 Do the organization record monitoring results and do the organization retain and
24 Do the organization record analytical results and do the organization retain and
25 Do the organization evaluate the performance and effectiveness of the its QMS?
26 Do the organization record evaluation results and do the organization retain and
1 Do the organization establish methods that the organization can use to monitor
2 Do the organization figure out how the organization is going to obtain informatio
their needs and expectations?
3 Do the organization figure out how the organization is going to review informatio
their needs and expectations?
4 Do the organization monitor how well customer needs and expectations are bein
5 Do the organization monitor how the organization’s customers feel about how w
(do the organization monitor the organization’s customers’ perceptions)?
9.1.3 Analysis and evaluation
2 Do the organization analyze and evaluate appropriate data and information?
9.2.1
2 Did the organization plan a program that can find out if QMS meets Organization
3 Did the organization plan a program that can find out if QMS is effectively implem
9.2.2
1 Did the organization plan, establish, implement and maintain and audit program
2 Did the audit program include the frequency, methods, responsibilities, planning
3 Does the audit program take into consideration the importance of the process co
previous audits?
4 Did the organization define the audit criteria and scope of each audit?
5 Does the organization ensure that the audit is conducted by the auditors to ensu
6 Does the organization ensure that the results of the audits are reported to releva
7 Does the organization take appropriate correction and corrective action without
9.3.1 General
1 Does the Top Management review the organization QMS at planned intervals?
1 Does the review take into consideration the status of actions from previous man
3 Does the review take into consideration information on the performance and effe
4 Does the review take into consideration customer satisfaction and feedback from
5 Does the review take into consideration the extent to which the quality objective
6 Does the review take into consideration process performance and conformity of
7 Does the review take into consideration nonconformities and corrective actions?
8 Does the review take into consideration monitoring and measuring results?
10 Does the review take into consideration the performance of external providers?
12 Does the review take into consideration the effectiveness of actions taken to add
13 Does the review take into consideration the opportunities for improvement?
1 Does the outputs of the Management review include decision and actions related
to the QMS; and resource needed?
2 Does the organization retain documented information as evidence of the result o
10 Improvement
10.1 General
2 Has the organization implemented any necessary action to meet customer requi
3 Has the organization taken action for improving products & services to meet req
expectations?
4 Has the organization taken action for correcting, preventing or reducing undesire
5 Has the organization taken action for improving the performance and effectivene
7 Has the organization reviewed the effectiveness of the corrective action taken?
8 Has the organization updated risk and opportunities determined during planning
10 Are the corrective actions appropriate to the effects of the nonconformities enco
10.2.2
1 Does the organization retain documented information on the nature of the nonco
any corrective action?
10.3 Continual improvement
1 Does the organization continually improve the suitability, adequacy and effectiv
2 Does the organization consider the results of analysis and evaluation, and outpu
opportunities to be addressed as part of continual improvement?
ISO 9001:2015 Checklist
Clause 4 Context of the organization
determined the external and internal issues relevant to the Purpose & strategic direction of its QMS and that
ntended results?
monitor and review information about these external and internal issues?
monitor and review the information about these interested parties and their relevant requirement?
e scope, has the organization determined the external and internal issues, requirements of relevant intere
of the organization?
plicability, does the organization determine if it affects its ability or responsibility to ensure the conformity o
enhancement of customer satisfaction?
ustification for any requirements that the organization determines and is not applicable to the scope of its QM
determined and applied the criteria and methods needed to ensure the effective operation and cont
evaluated these processes and implemented any changes needed to ensure that these process achieve
tain documented information as an evidence that the processes have been carried out as planned?
ment
ment demonstrate leadership and commitment by taking accountability for effectiveness of its QMS?
ent ensured that the quality policy and quality objective are established?
quality objective compatible with the context and strategic direction of the organization?
moting the use of process approach and risk based thinking throughout the organization?
nt ensuring that the resources needed for the QMS are available?
t engage, directs and supports the persons required to contribute to the effectiveness of the QMS requiremen
omoting improvements?
pporting other relevant management roles to demonstrate their leadership as it applies to their area of respo
ement demonstrate leadership and commitment by ensuring that customer and applicable statutory an
rmined, understood and are consistently meeting the requirements?
portunities that can affect conformity of products and services and the ability to enhance customer sat
ssed?
ty policy
ent established, implemented and maintained a quality policy?
priate to the purpose and context of the organization and does it supports its strategic directions?
uality policy
ent ensured that the responsibilities and authorities for relevant roles are assigned, communicated and unde
n?
sponsibilities and authorities, do the top management ensure that its QMS meets the requirement of ISO 900
sponsibilities and authorities, do the top management ensure that the processes are meeting its intended re
sponsibilities and authorities, do the top management ensure that there is promotion of customer focus thro
sponsibilities and authorities, do the top management ensure that performance of its QMS and opportunities
rted to them?
sponsibilities and authorities, do the top management ensure that integrity of QMS is maintained when chan
maintained?
and opportunities
S, does the organization considers the issues referred in clause 4.1 and requirement referred in clause 4.2?
determined the risks and opportunities that has to be addressed so that QMS can achieve its intended results
ent, or reduce undesired effects and achieve improvement?
stablished quality objectives at relevant functions, levels and process needed for the QMS?
have quality objectives which are relevant to the conformity of product and services and enhancement of cu
objectives does the organization determines what will be done, what resources are required, who will be resp
ted and how are the result to be evaluated?
anges for the QMS, are changes carried out in planned manner?
nge, does the organization consider the purpose of the change and their potential consequence; the integrit
f resources; and allocation and reallocation of responsibilities and authorities?
determined and provided the resources needed for the establishment, implementing, maintaining and contin
MS?
determined and provided the persons required for effective maintenance of QMS and for operation and contro
determined and maintained the infrastructure needed for operation of its processes and to achieve conformit
peration of processes
determined, provided and maintain the environment necessary for the operation of its processes and to achie
s and services?
ring resources
determined and provided the necessary resources needed when monitoring and measuring is used to verify c
quirement?
retain appropriate documented information as evidence of fitness for the purpose of the monitoring and me
ability
for measurement traceability?
raceability is a requirement, are measurement equipment calibrated or verified at specified interval or prior
rd is existing, are documented information retained for the basis used for calibration or verification?
ment safeguarded from adjustments, damage or deteriorated that would invalidate the calibration and subseq
determine and take appropriate action if validity of pervious measurement results have been adversely affe
is found to be unfit for its intended purpose?
dge
determine the knowledge necessary for the operation of its processes and to achieve conformity of product
nging needs and trends, does the organization considers its current knowledge and determine how to acquire
nal knowledge and required updates?
determine the necessary competence of its employees whose work affects the performance and effectivene
ensure that its employees are competent on basis of appropriate education, training or experience?
take applicable actions to acquire the necessary competence and evaluate the effectiveness of action taken
ensure that the persons doing work under the organization’s control are aware of its quality policy, relevant
bution to the effectiveness of QMS including the benefits of improved performance and the implications of n
determine the internal and external communication relevant to the QMS including on what it will communica
hom to communicate, how to communicate, and who communicates?
’s QMS include documents required by ISO 9001:2015 and documents determined by the organization neces
MS?
dating documented information, does the organization ensure it is appropriate in terms of identification & de
dating documented information does the organization ensure that it is in proper format and in correct media?
dating documented information, does the organization ensure that there is appropriate review and approval
cy?
d information
control its documented information to ensure that it is available and suitable for use, whenever it is needed?
mented information necessary for planning and operation of QMS appropriately identified and controlled?
plan, implement and control the processes needed to meet the requirement for the provision of product and
action determined in clause 6?
control
determine the requirements for the products and services?
stablished criteria for the processes and acceptance of products and services?
determine the resources needed to achieve conformity to the product and service requirements?
control its planned changes and review the consequences of unintended changes?
ion
communicate with customers to provide information relating to products and services, handling enquiries, c
changes)?
obtain customer feedback relating to products and services including customer complaint?
determined the requirements for product and services to be offered the customer?
defined and does it includes applicable statutory & regulatory requirements and those considered necessary
nsured that it has the ability to meet the requirements for products and services?
eviewed the requirements specified by customer, including the requirements for delivery and post-delivery a
eviewed the requirements not stated by the customers but necessary for the specified or intended use when
eviewed the statutory & regulatory requirements applicable to the product and services and requirements sp
reviewed and resolved contract or order requirements differing for those previously defined?
oes not provide a documented statement of their requirement, does the organization confirm to the custome
cceptance?
retain documented information on the results of the review and on any new requirements for the products a
ensure that the relevant documented information is amended and the relevant persons are made aware of t
he requirements for the products and services are changed?
t of products and services
stablished, implemented and maintain a D&D processes that is appropriate to the subsequent provision of p
ent planning
ges and controls for D&D, has the organization taken into consideration the nature, duration and complexity
ges and controls for D&D, has the organization taken into consideration the required process stages includin
ges and controls for D&D, has the organization taken into consideration the D& D verification and validation
ges and controls for D&D, has the organization taken into consideration the responsibilities and authorities in
ges and controls for D&D, has the organization taken into consideration the external and internal resources n
ges and controls for D&D, has the organization taken into consideration the need to control interfaces betwe
ges and controls for D&D, has the organization taken into consideration the need for involvement of custome
ges and controls for D&D, has the organization taken into consideration the requirements of subsequent prov
ges and controls for D&D, has the organization taken into consideration the level of the control expected for
elevant interested parties?
ges and controls for D&D, has the organization taken into consideration the documented information needed
gn and development requirement have been met?
ent inputs
determined the essential requirements for the specific types of products and services to be designed and dev
consider the following functional and performance requirements; statutory and regulatory requirements; sta
the organization has committed to implement; information derived from previous design and development a
es of failure due to the nature of the product and services?
ensure that the inputs are adequate for D&D purpose, complete and unambiguous?
ent controls
pplied the necessary controls to D & D processes to ensure that the result to be achieved are defined?
onducted review to evaluate the ability of the results of D& D to meet the requirements?
onducted the validation to ensure that the resulting product and service meet the requirements of the speci
d use?
aken necessary action on the problems determined during reviews, verification or validation activities?
ent outputs
ensure that D&D outputs are adequate for the subsequent processes for provision of product and services?
ensure that D&D outputs include (or has reference) monitoring and measuring requirements and acceptance
ensure that D&D outputs specify the characteristics of the products and services that are essential for their
ent changes
dentified, reviewed and controlled changes made during, or subsequent to the D & D of the product and serv
o averse to the impact on conformity to requirement?
etained the documented information on D&D changes, the result of reviews, authorization of the changes an
rse impact?
ovided processes, products and services
ensure that the externally provided processes, products and services conform to the requirements?
determine the controls needed when the product and services from the external providers are incorporated
ces?
determine the controls needed when the product and services from the external providers are provided dire
providers?
determine the controls needed when process or part of process is provided by the external providers?
determined and applied the criteria for selection, evaluation, monitoring of performance and re – evaluation o
etained the documented information of these activities and any action arising out or evaluation/re-evaluation
ntrol
ensure that the externally provided processes, product and services do not adversely affect the its ability to
oducts and services to the customers?
ensure that the externally provided process remain within the control of its QMS?
defined the controls to be applied to external provider and its resulting outputs?
aken into consideration the potential impact of the organization’s ability to consistently meet customer and a
ry requirement?
aken into consideration the effectiveness of the controls applied by the external providers?
determined the verification or other activities, necessary to ensure that the externally provided processes, pr
ments?
al providers
communicate to the external providers its requirements for the processes, products and services required?
communicate to the external providers its requirements for the approval of the product and services; metho
ent; the release of product and services?
communicate to the external providers its requirements for competence including any qualification of perso
communicate to the external providers its requirements for external provider’s interactions with the organiz
communicate to the external providers its requirements for control and monitoring of the external providers
plied by the organization?
communicate to the external providers its requirements for verification or validation activities that the organ
o perform at the external providers’ premises?
provision
t cannot be verified by subsequent monitoring or measurement, has the organization conducted validation a
cess for production and service provision?
eability
used any suitable means to identify output when it is necessary to ensure the conformity of products and ser
uts with respect to monitoring and measuring requirements throughout the production and service provision
nization?
ontrolled the unique identification of the outputs when traceability is a requirement?
etain the documented information necessary to enable traceability, when traceability is a requirement?
ing to customers or external providers is under the organization’s control or being used being used by the or
exercise adequate care?
identify, verify, protect and safeguard customers’ or external providers’ property?
the customer or external provider is lost, damaged or otherwise fount to be unsuitable for use, does the orga
omer or external provider? Does the organization retain documented information on what has occurred?
preserve the outputs during production and service provision, to the extent necessary to ensure conformity
meet requirements for post-delivery activities associated with the product and services?
ent of post-delivery activities does the organization considers the statutory & regulatory requirements; the p
es associated with its product and services; customer requirement & feedback; the nature, use and intended
es?
conduct review and control changes for production or service provision to ensure continuing conformity with
retain documented information describing the results of the review of changes, the person(s) authorizing the
ions arising from the review?
services
mplemented planned arrangements, at appropriate stages, to verify that the product and service requiremen
ensure that the release of product and service proceed only after the planned arrangement is satisfactorily c
authority and as applicable by the customer?
retain the documented information on the release of products and services and it includes information relati
y with the acceptance criteria; traceability of the person authorizing the release?
g outputs
ensure that the outputs which do not conform to their requirements are identified and controlled to prevent
very?
te to the nature of the nonconformity and its effect on the conformity of product and services?
so consider nonconforming product and services detected after delivery of products, during and after provisi
product and services is detected does the organization take correction action and/or segregation, containme
n of product & services and/or informing the customer and/or obtaining authorization for acceptance under c
retain documented information that describes the nonconformity; describes the actions taken; describes any
e authority deciding the action in respect of the nonconformity?
gure out what needs to be measured and did the organization select methods?
cord monitoring results and do the organization retain and control these records?
cord measurement results and do the organization retain and control these records?
cord analytical results and do the organization retain and control these records?
stablish methods that the organization can use to monitor customer perceptions?
gure out how the organization is going to obtain information about how customers feel about how well the it
tations?
gure out how the organization is going to review information about how customers feel about how well the it
ctations?
onitor how well customer needs and expectations are being fulfilled?
onitor how the organization’s customers feel about how well the organization is meeting their needs and exp
monitor the organization’s customers’ perceptions)?
n
lan a program that can find out if QMS meets Organization’s own requirement and ISO 9001:2015 requireme
lan a program that can find out if QMS is effectively implemented and maintained?
m take into consideration the importance of the process concerned, changes affecting the organization and t
ensure that the audit is conducted by the auditors to ensure objectivity and impartiality of the audit process
ensure that the results of the audits are reported to relevant management?
mented information as evidence of the implementation of the audit program and the audit results?
e QMS’s continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the org
nputs
nto consideration customer satisfaction and feedback from relevant interested parties?
nto consideration the extent to which the quality objectives have been met?
nto consideration the effectiveness of actions taken to address risks and opportunities?
utputs
e Management review include decision and actions related to the opportunities for improvement; any need f
rce needed?
retain documented information as evidence of the result of management review?
mplemented any necessary action to meet customer requirement and enhance satisfaction?
aken action for improving products & services to meet requirements as well as to address future needs and
aken action for correcting, preventing or reducing undesired effects?
aken action for improving the performance and effectiveness of the QMS?
rrective action
mity (including complaints) occurs, does the organization take action to control and correct it and deal with th
mity (including complaints) occurs, does the organization evaluate the need for action to eliminate the causes
retain documented information on the nature of the nonconformities and any subsequent actions taken; and
consider the results of analysis and evaluation, and output from management review to determine if there a
dressed as part of continual improvement?
Evidence