4 Context of the Organization

No. Question Hasil Asesment

4.1 Understanding the Organization and its context

1 Has the organization determined external and internal issues that are
relevant to its purpose, strategic direction and that affect its ability
to achieve the intended result(s) of its quality management system?

2 Is the organization monitoring and reviewing information about

these external and internal issues?

4.2 Understanding the needs and expectations of

interested parties
3 Has the organization:

a) Determined the interested parties that are relevant to the quality

management system?

b) Determined the requirements of these interested parties that are

relevant to the quality management system?

4 Is the organization reviewing and monitoring information about

these interested parties and their relevant requirements?

4.3 Determining the scope of the quality management

system
5 Has the organization determined the boundaries and the
applicability of the quality management system in order to establish
its scope?
6 When establishing the scope has the organization taken into
consideration:
a) The external and internal issues referred to in 4.1?

b) The requirements of relevant interested parties referred to in 4.2?

c) The products and services of the organization?

7 Has the organization applied all of the requirements of the ISO

9001:2015 International Standard (if applicable) within the
determined scope of its quality management system?

8 Is the scope of the organization’s quality management system

available and maintained as documented information?

9 Does the organization’s scope state the types of products and

services covered?
10 Does the scope provide any justification for any requirement of the
ISO 9001:2015 International Standard that the organization
determines is not applicable to the scope of its quality management
system?

11 Can the organization claim conformity to the ISO 9001:2015

International Standard by:
a) Ensuring that requirements determined as not applicable do not
affect the organization’s ability or responsibility to ensure the
conformity of its products, services and enhancement of customer
satisfaction?

4.4 Quality Management System and its Processes

441

12 Has the organization established, implemented, maintained and

continually improved the quality management system including the
processes needed and their interactions?

13 Has the organization determined the processes needed for the

quality management system and their application throughout the
organization by:
a) Determining the inputs required and the outputs expected from
these processes?
b) Determining the sequence and interaction of these processes?

c) Determining and applying the criteria and methods (including

monitoring, measurements and related performance indicators)
needed to ensure the effective operation and control of these
processes?

d) Determining the resources needed for these processes and

ensuring their availability?

e) Assigning responsibility and authority for these processes?

f) Addressing the risks and opportunities as determined in

accordance with the requirements of 6.1?

g) Evaluating these processes and implementing any changes

needed to ensure that these processes achieve their intended results?

h) Improving the processes and the quality management system?

442

14 Has the organization to the extent necessary:

a) Maintained documented information to support the operation of

its processes?
b) Retained documented information to have confidence that the
processes are being carried out as planned?
5 Leadership
No. Question
5.1 Leadership and commitment
5.1.1 General

1 Has top management demonstrated leadership and commitment

with respect to the quality management system by:

a) Taking accountability for the effectiveness of the quality

management system?
b) Ensuring that the quality policy and quality objectives are
established for the quality management system and are compatible
with the context and strategic direction of the organization?

c) Ensuring the integration of the quality management system

requirements
into the organization’s business processes?
d) Promoting the use of the process approach and risk-based
thinking?
e) Ensuring that the resources needed for the quality system are
available?
f) Communicating the importance of effective quality management
and of conforming to the quality management system requirements?

g) Ensuring that the quality management system achieves its

intended results?
h) Engaging, directing and supporting persons to contribute to the
effectiveness of the quality management system?

i) Promoting improvement?

j) Supporting other relevant management roles to demonstrate their

leadership as it applies to their areas of responsibility?

5.1.2 Customer Focus

2 Has top management demonstrated leadership and commitment

with respect to customer focus by:

a) Ensuring that customer and applicable statutory and regulatory

requirements are

determined, understood and consistently met?

b) Ensuring that the risks and opportunities that can affect

conformity of products and services along with the ability to
enhance customer satisfaction are determined and addressed?

c) Ensuring that the focus on enhancing customer satisfaction is

maintained?
5.2 Policy
 5.2.1 Establishing the quality policy

3 Has top management established, implemented and maintained a

quality policy that:
a) Is appropriate to the purpose and context of the organization and
supports its strategic direction?

b) Can provide a framework for setting quality objectives?

c) Includes a commitment to continual improvement to satisfy

applicable requirements?

d) Includes a commitment to continual improvement of the quality

management system?

5.2.2 Communicating the Quality Policy

4 Is the quality policy:

a) Available and maintained as documented information?

b) Communicated, understood and applied within the organization?

c) Available to relevant interested parties, as appropriate?

5.3 Organizational roles, responsibilities and authorities

5 Has top management ensured that the responsibilities and

authorities for relevant roles are assigned, communicated and
understood within the organization?

6 Has top management assigned the responsibility and authority by:

a) Ensuring that the quality management system conforms to the

requirements of the ISO 9001:2015 International Standard?

b) Ensuring that the processes are delivering their intended outputs?

c) Reporting on the performance of the quality management system

and on

opportunities for improvement (see 10.1) in particular to top

management?
d) Ensuring the promotion of customer focus throughout the
organization?
e) Ensuring that the integrity of the quality management system is
maintained when changes to the quality management system are
planned and implemented?

6 Planning
No. Question Proc. Ref.
6.1 Actions to address risks and opportunities

611
1 Has the organization considered the issues referred to in 4.1 and the
requirements referred to in 4.2 and determined the risks and
opportunities that need to be addressed?

2 Has the organization:

a) Given assurance that the quality management system can

achieve its intended results?

b) Enhanced desirable effects?

c) Prevented or reduced undesired effects?

d) Achieved improvement?

612

3 Has the organization planned:

a) Actions to address these risks and opportunities?

b) How to integrate and implement the actions into its quality

management system processes (see 4.4) and evaluate the
effectiveness of these actions?

4 Has the organization taken actions to address risks and opportunities

that are proportionate to the potential impact on the conformity of
products and services?

6.2 Quality objectives and planning to achieve them

621

5 Has the organization established quality objectives at relevant

functions, levels and

processes needed for the quality management system?

6 Has the organization developed quality objectives that:

a) Are consistent with the quality policy?

b) Are Measurable?

c) Take into account applicable requirements?

d) Are relevant to conformity of products and services and to

enhancement of customer satisfaction?

e) Are monitored?

f) Are communicated?

g) Are updated as appropriate?

7 Has the organization maintained documented information on the

quality objectives?
622
 8 When planning how to achieve quality objectives has the
organization determined:
a) What will be done?

b) What resources will be required?

c) Who will be responsible?

d) When it will be completed?

e) How the results will be evaluated?

6.3 Planning of changes

9 Has the organization determined the need for changes to the quality
management system and carried those changes out in a planned
manner (see 4.4)?

10 When planning for changes has the organization considered:

a) The purpose of the changes and their potential consequences?

b) The integrity of the quality management system?

c) The availability of resources?

d) The allocation or reallocation of responsibilities and authorities?

7 Support
No. Question Proc. Ref.
7.1 Resources
7.1.1 General

1 Has the organization determined and provided the resources

necessary for the establishment, implementation, maintenance and
continual improvement of the quality management system?

2 When providing resources has the organization considered:

a) The capabilities of, and constraints on, existing internal

resources?
b) What needs to be obtained from external providers?

7.1.2 People

3 Has the organization determined and provided the persons necessary

for the effective implementation of its quality management system
and for the operation and control of its processes?

7.1.3 Infrastructure

4 Has the organization determined, provided and maintained the

infrastructure necessary for the operation of its processes and to
achieve conformity of products and services?

7.1.4 Environment for the operation of processes

 5 Has the organization determined, provided, and maintained the
environment necessary for the operation of its processes and to
achieve conformity of products and services?

7.1.5 Monitoring and measuring resources

7.1.5.1 General

6 Has the organization determined and provided the resources needed

to ensure valid and reliable results when monitoring and measuring
is used to verify the conformity of products and services to
requirements?

7 Has the organization ensured that the resources provided:

a) Are suitable for the specific type of monitoring and measurement

activities being undertaken?

b) Are maintained to ensure their continuing fitness for their

purpose?

8 Has the organization retained documented information as evidence

of fitness for purpose of the monitoring and measurement
resources?
7.1.5.2 Measurement Traceability

9 Has the organization ensured that when measurement traceability is

a requirement, or is considered by the organization to be an
essential part of providing confidence in the validity of
measurement results, that measuring equipment is:

a) Calibrated or verified, or both, at specified intervals, or prior to

use, against measurement standards traceable to international or
national measurement standards and when no such standards exist,
the basis used for calibration or verification is retained as
documented information?

b) Identified in order to determine their status?

c) Safeguarded from adjustments, damage or deterioration that

would invalidate the calibration status and subsequent measurement
results?

10 Has the organization determined if the validity of previous

measurement results have been adversely affected when measuring
equipment is found to be unfit for its intended purpose, and takes
appropriate action as necessary?

7.1.6 Organizational knowledge

11 Has the organization determined the knowledge necessary for the

operation of its processes and to achieve conformity of products and
services?
12 Has this knowledge been maintained and made available to the
extent necessary?
13 Has the organization when addressing its changing needs and
trends, considered its current knowledge and determined how to
acquire or access any necessary additional knowledge and required
updates?

7.2 Competence

14 Has the organization:

a) Determined the necessary competence of a person(s) doing work

under its control that affects the performance and effectiveness of
the quality management system?

b) Ensured that these persons are competent on the basis of

appropriate education,

training, or experience?

c) Ensured where applicable taken actions to acquire the necessary

competence, and evaluate the effectiveness of the actions taken?

d) Retained appropriate documented information as evidence of

competence?
7.3 Awareness

15 Has the organization ensured that the persons doing work under the
organization’s control are aware of:

a) The quality policy?

b) Relevant quality objectives?

c) Their contribution to the effectiveness of the quality management

system, including benefits of improved performance?

d) The implications of not conforming with the quality management

system requirements?

7.4 Communication

16 Has the organization determined the internal and external

communications relevant to the quality management system
including:
a) What it will communicate?

b) When to communicate?

c) With whom to communicate?

d) How to communicate?

e) Who communicates?

7.5 Documented Information

7.5.1 General
17 Has the organization’s quality management system included
documented information that:
a) Is required by the ISO 9001:2015 International Standard?

b) Is documented information determined by the organization as

being necessary for the effectiveness of the quality management
system?

7.5.2 Creating and updating

18 When creating and updating documented information has the

organization ensured:

a) The documented information has an appropriate identification

and description?
b) The documented information has an appropriate format?

c) The documented information has been reviewed and approved

for suitability and adequacy?

7.5.3 Control of documented information

7,531

19 Has the organization ensured that documented information required

by the quality management system and by the ISO 9001:2015
standard is controlled to ensure:

a) That is available and suitable for use, where and when it is

needed?
b) That it is adequately protected (from loss of confidentiality,
improper use, or loss of integrity)?

7,532

20 Has the organization, in order to control documented information,

addressed:
a) Its distribution, access, retrieval and use?

b) Its storage and preservation, including preservation of legibility?

c) Its control of changes (e.g. version control)?

d) Its retention and disposition?

21 Has the organization determined documented information of

external origin necessary for the planning and operation of the
quality management system be identified as appropriate, and be
controlled?

22 Has the organization retained documented information as evidence

of conformity and protected it from unintended alterations?

8 Operation
No. Question Proc. Ref.
 8.1 Operational planning and control
1 Has the organization planned, implemented and controlled the
processes (see 4.4) needed to meet the requirements for the
provision of

products and services and implemented the actions determined in

Clause 6, by:
a) Determining the requirements for the products and services?

b) Establishing criteria for the processes and the acceptance of

products and services?
c) Determining the resources needed to achieve conformity to the
product and service requirements?

d) Implementing control of the processes in accordance with the

criteria?
e) Determining, maintaining and retaining documented information
to the extent necessary to ensure:

1. Processes have been carried out as planned?

2. That conformity of products and services have been

demonstrated to their requirements?

2 Has the organization ensured that the output of this planning is

suitable for the organization’s operations?

3 Has the organization controlled planned changes and reviewed the

consequences of unintended changes while taking action to mitigate
any adverse effects?

4 Has the organization ensured that outsourced processes are

controlled?
8.2 Requirements for products and services

8.2.1 Customer communication

5 Has the organization ensured that communication with customers

includes:
a) Providing information relating to products and services?

b) Handling enquiries, contracts or orders, including changes?

c) Obtaining customer feedback relating to products and services,

including customer complaints?

d) Handling or controlling customer property?

e) Establishing specific requirements for contingency actions, when

relevant?
8.2.2 Determining the requirements for products and services

6 Has the organization when determining the requirements for

products and services offered to
 customers ensured that:
a) The requirements for the products and services are defined
including: applicable statutory and regulatory requirements along
with those considered necessary by the organization?

b) The organization can meet the claims for the products and
services it offers?
8.2.3 Review of the requirements for products and services

8,231

7 Has the organization ensured that it has the ability to meet the
requirements for products and services to be offered to customers?

8 Has the organization conducted a review before committing to

supply products and services to a customer that includes:

a) Requirements specified by the customer, including requirements

for delivery and post-delivery activities?

b) Requirements not stated by the customer, but necessary for the

specified or intended use, when known?

c) Requirements specified by the organization?

d) Statutory and regulatory requirements applicable to the products

and services?
e) Contract or order requirements differing from those previously
expressed?
9 Has the organization ensured that contract or order requirements
differing from those previously defined are resolved?

10 Has the organization ensured that customer requirements are

confirmed by the organization before acceptance, when the
customer does not provide a documented statement of their
requirements?

8,232

11 Has the organization retained documented information as

applicable:
a) On the results of the review?

b) On any new requirements for the products and services?

8.2.4 Changes to requirements for products and services

12 Has the organization ensured that relevant documented information

is amended, and that relevant persons are made aware of the
changed

requirements, when the requirements for products and services are

changed?
 8.3 Design and development of products and services

8.3.1 General

13 Has the organization established, implemented and maintained a

design and development process that is appropriate to ensure the
subsequent provision of products and services?

8.3.2 Design and development planning

14 Has the organization in determining the stages and controls for

design and development, considered:

a) The nature, duration and complexity of the design and

development activities?
b) The required process stages, including applicable design and
development reviews?

c) The required design and development verification and validation

activities?
d) The responsibilities and authorities involved in design and
development process?

e) The internal and external resource needs for the design and
development of products and services?

f) The need to control interfaces between persons involved in the

design and development process?

g) The need for involvement of customers and users in the design

and development process?

h) The requirements for subsequent provision of products and

services?
i) The level of control expected for the design and development
process by customers and other relevant interested parties?

j) The documented information needed to demonstrate that the

design and development requirements have been met?

8.3.3 Design and development inputs

15 Has the organization determined the requirements essential for the

specific types of products and services to be designed and
developed by considering:

a) Functional and Performance requirements?

b) Information derived from previous similar design and

development activities?
c) Statutory and regulatory requirements?

d) Standards or codes of practice that the organization has

committed to implement?
 e) The potential consequences of failure due to the nature of the
products and services?
16 Has the organization ensured that inputs are adequate for design and
development purposes, complete and unambiguous?

17 Has the organization resolved conflicting design and development

inputs?
18 Has the organization retained documented information on design
and development inputs?
8.3.4 Design and development controls

19 Has the organization applied controls to the design and development

process to ensure that:
a) The results to be achieved are defined?

b) The reviews are conducted to evaluate the ability of the results

of design and development to meet requirements?

c) Verification activities are conducted to ensure that the design

and development outputs meet the input requirements?

d) Validation activities are conducted to ensure that the resulting

products and services meet the requirements for the specified
application or intended use?

e) Any necessary actions are taken on problems determined during

the reviews, or verification and validation activities?

f) Documented information of these activities is retained?

8.3.5 Design and development outputs

20 Has the organization ensured that design and development outputs:

a) Meet the input requirements?

b) Are adequate for the subsequent processes for the provision of

products and services?

c) Include or reference monitoring and measuring requirements, as

appropriate, and acceptance criteria?

d) Specify the characteristics of the products and services that are

essential for their intended purpose and their safe and proper
provision?

21 Has the organization retained documented information on design

and development outputs?
8.3.6 Design and development changes

22 Has the organization identified, reviewed, and controlled changes

made during, or subsequently to the design and development of
products and services, to ensure that there is no adverse impact on
conformity to requirements?
23 Has the organization retained documented information on:

a) The design and development changes?

b) The results of reviews?

c) The authorization of the changes?

d) The actions taken to prevent adverse impacts?

8.4 Control of externally provided processes, products

and services
8.4.1 General

24 Has the organization ensured that the externally provided processes,

products and services conform to requirements?

25 Has the organization determined the controls to be applied to

externally provided processes, products and services when:

a) The products and services from external providers are intended

for incorporation into the organization’s own products and services?

b) The products and services are provided directly to the

customer(s) by external providers on behalf of the organization?

c) A process, or part of a process, is provided by an external

provider as a result of a decision by the organization?

26 Has the organization determined and applied the criteria for the
evaluation, selection, monitoring of performance and re-evaluation
of external providers, based on their ability to provide processes or
products and services in accordance with requirements?

27 Has the organization retained documented information of these

activities and any necessary actions arising from the evaluations?

8.4.2 Type and extent of control

28 Has the organization ensured that externally provided processes,

products and services do not adversely affect the organization’s
ability to

consistently deliver conforming products and services to its

customers?
29 Has the organization:

a) Ensured that externally provided processes remain within the

control of its quality management system?

b) Ensured that it has defined both the controls it intends to apply

to an external provider and those it intends to apply to the resulting
output?
 c) Taken into consideration the potential impact of the externally
provided processes, products and services on the organization’s
ability to consistently meet customer requirements along with
applicable statutory and regulatory requirements?

d) Taken into consideration the effectiveness of the controls applied

by the external provider?

e) Determined the verification, or other activities, necessary to

ensure that externally provided processes, products and services
meet requirements?

8.4.3 Information for external providers

30 Has the organization ensured the adequacy of requirements prior to

their communication to the external provider?

31 Has the organization communicated to external providers its

requirements for:
a) The processes, products and services to be provided?

b) The approval of products and services, methods, processes,

equipment and the release of products and services?

c) Competence, including any required qualification of persons?

d) The external provider’s interactions with the organization?

e) The controlling and monitoring of external providers’

performance applied by the organization?

f) Verification or validation activities that the organization, or its

customer, intends to perform at the external providers’ premises?

8.5 Production and service provision

8.5.1 Control of production and service provision

32 Has the organization implemented production and service provision

under controlled conditions that includes:

a) The availability of documented information that defines the

characteristics of the products to be produced, services to be
provided, or
the activities to be performed and the results to be achieved?

b) The availability and use of suitable monitoring and measuring

resources?
 c) The implementation of monitoring and measurement activities at
appropriate stages to verify the criteria for control of processes or
outputs and that acceptance criteria for products and services have
been met?

d) The use of suitable infrastructure and environment for the

operation of processes?

e) The appointment of competent persons, including any required

qualification?
f) The validation, and periodic revalidation, of the ability to achieve
planned results of the processes for production and service
provision when the resulting output cannot be verified by
subsequent monitoring or measurement?

g) The implementation of actions to prevent human error?

h) The implementation of release, delivery and post-delivery

activities?
8.5.2 Identification and traceability

33 Has the organization used suitable means to identify outputs when it

is necessary to ensure the conformity of products and services?

34 Has the organization identified the status of outputs with respect to

monitoring and measuring requirements throughout production and
service provision?

35 Has the organization controlled the unique identification of the

outputs when traceability is a requirement and retained the
documented information necessary to enable traceability?

8.5.3 Property belonging to customers or external providers

36 Has the organization exercised care with property belonging to

customers or external providers while it is under the organization’s
control or being used by the organization?

37 Has the organization identified, verified, protected and safeguarded

customer or external providers’ property provided for use or
incorporation into the products and services?

38 When property of a customer of external provider is lost, damaged

or found to be unsuitable for use, has the organization reported this
to the customer or external provider and retained documented
information on what has occurred?

8.5.4 Preservation

39 Has the organization preserved the outputs during production and

service provision, to the extent necessary to ensure conformity to
requirements?

8.5.5 Post-delivery activities

40 Has the organization met the requirements for post-delivery
activities associated with the products and services?

41 In determining the extent of the post-delivery activities that are

required has the organization considered:

a) Statutory and Regulatory requirements?

b) The potential undesired consequences associated with its

products and services?
c) The nature, use and intended lifetime of its products and
services?
d) Customer requirements?

e) Customer feedback?

8.5.6 Control of changes

42 Has the organization reviewed and controlled changes for

production or service provision, to the extent necessary to ensure
continuing conformity with requirements?

43 Has the organization retained documented information describing

the results of the review of changes, the person(s) authorizing the
change, and any necessary actions arising from the review?

8.6 Release of products and services

44 Has the organization implemented planned arrangements, at
appropriate stages, to verify that the product and service
requirements have been met?

45 Has the organization ensured that the release of products and

services to the customer not proceed until the planned arrangements
have been satisfactorily completed, unless otherwise

approved by a relevant authority and as applicable, by the

customer?
46 Has the organization retained documented information on the
release of products and services which includes:

a) Evidence of conformity with the acceptance criteria?

b) Traceability to the person(s) authorizing the release?

8.7 Control of nonconforming outputs

871

47 Has the organization ensured that outputs that do not conform to

their requirements are identified and controlled to prevent their
unintended use or delivery?

48 Has the organization taken appropriate action on outputs based on

the nature of the nonconformity and its effect on the conformity of
products and services?
49 Has the organization also applied action on nonconforming products
and services detected after the delivery of products and during or
after the provision of services?

50 Has the organization dealt with nonconforming outputs in one or

more of the following ways by:
a) Correction?

b) Segregation, containment, return or suspension or provision of

products and services?

c) Informing the customer?

d) Obtaining authorization for acceptance under concession?

51 Has the organization verified conformity to the requirements when

nonconforming outputs are corrected?

872

52 Has the organization retained documented information that:

a) Describes the nonconformity?

b) Describes the actions taken?

c) Describes any concessions obtained?

d) Identifies the authority deciding the action in respect of the

nonconformity?

9 Performance Evaluation
No. Question Proc. Ref.
9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

1 Has the organization determined:

a) What needs to be monitored and measured?

b) The methods for monitoring, measurement, analysis and

evaluation needed to ensure valid results?

c) When the monitoring and measuring shall be performed?

d) When the results from monitoring and measurement are

analyzed and evaluated?
2 Is the organization evaluating the performance and the effectiveness
of the quality management system?

3 Has the organization retained appropriate documented information

as evidence of the results?

9.1.2 Customer satisfaction

4 Is the organization monitoring customers’ perceptions of the degree
to which their needs and expectations are being fulfilled and
determining the methods for obtaining, monitoring and reviewing
this information?

9.1.3 Analysis and evaluation

5 Is the organization analyzing and evaluating appropriate data and

information arising from monitoring and measurement?

6 Has the organization used the results of the analysis to evaluate:

a) The conformity of products and services?

b) The degree of customer satisfaction?

c) The performance and effectiveness of the quality management

system?
d) If planning has been implemented effectively?

e) The effectiveness of actions taken to address risks and

opportunities?

f) The performance of external providers?

g) The need for improvements to the quality management system?

9.2 Internal audit

921

7 Is the organization conducting internal audits at planned intervals to

provide information on whether the quality management system:

a) Conforms to the organization’s own requirements for its quality

management system and the requirements of the ISO 9001:2015
International Standard?

b) Is effectively implemented and maintained?

922

8 Has the organization:

a) Planned, established, implemented and maintained an audit

programme(s) including the frequency, methods, responsibilities,
planning requirements and reporting which takes into consideration
the importance of processes concerned, changes affecting the
organization, and the results of previous audits?

b) Defined the audit criteria and scope for each audit?

c) Selected auditors and conducted audits to ensure objectivity and

impartiality of the audit process?
 d) Ensured that the results of audits are reported to relevant
management?
e) Taken appropriate correction and corrective actions without
undue delay?
f) Retained documented information as evidence of the
implementation of the audit programme and the audit results?

9.3 Management Review

9.3.1 General

9 Has top management reviewed the organization’s quality

management system, at planned intervals, to ensure its continuing
stability, adequacy, effectiveness and alignment with the strategic
direction of the organization?

9.3.2 Management review inputs

10 Has the organization planned and carried out taking into

consideration:
a) The status of actions from previous management reviews?

b) Changes in external and internal issues that are relevant to the

quality management system?

c) Information on the performance and effectiveness of the quality

management system which includes trends in:

1. Customer satisfaction and feedback from relevant interested

parties?

2. The extent to which quality objectives have been met?

3. Process performance and conformity of products and services?

4. Nonconformities and corrective actions?

5. Monitoring and measuring results?

6. Audit results?

7. The performance of external providers?

d) The adequacy of resources?

e) The effectiveness of actions taken to address risks and

opportunities (see 6.1)?
f) Opportunities for improvement?

9.3.3 Management review outputs

11 Has the organization ensured that the outputs of the management

review includes decisions and actions related to:

a) Opportunities for improvement?

 b) Any need for changes to the quality management system?

c) Resource needs?

12 Is the organization retaining documented information as evidence of

the results of the management reviews?

10 Improvement
No. Question Proc. Ref.
10.1 General
1 Has the organization determined and selected opportunities for
improvement and implemented any necessary actions to meet
customer requirements and enhance customer satisfaction?

2 Do these opportunities for improvement and necessary actions

include:
a) Improving products and services to meet requirements as well as
to address future needs and expectations?

b) Correcting, preventing or reducing undesired effects?

c) Improving the performance and effectiveness of the quality

management system?

10.2 Nonconformity and corrective action

10.2.1

3 When a nonconformity occurs, including any arising from

complaints has the organization:
a) Reacted to the nonconformity as applicable and taken action to
control and correct it and also deal with the consequences?

b) Evaluated the need for action to eliminated the cause(s) of the

nonconformity, to ensure that it does not recur or occur elsewhere
by:

1. Reviewing and analyzing the nonconformity?

2. Determining the causes of the nonconformity?

3. Determining if similar nonconformities exist, or could potentially

occur?

c) Implemented any action needed?

d) Reviewed the effectiveness of any corrective action taken?

e) Updated risks and opportunities determined during planning, if

necessary?

f) Made changes to the quality management system, if necessary?

4 Has the organization ensured that corrective actions are appropriate
to the effects of the nonconformities encountered?

10.2.2
5 Has the organization retained documented information as evidence
of:
a) The nature of the nonconformities and any subsequent actions
taken?
b) The results of any corrective action?

10.3 Continual improvement

6 Is the organization continually improving the suitability, adequacy

and effectiveness of the quality management system?

7 Has the organization considered the results of analysis and

evaluation, and the outputs from management review to determine
if there are needs and opportunities to address as a part of continual
improvement?
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4. Konteks Organisasi

Perhitungan tentang bagaimana masalah

internal dan eksternal, yang mengarah ke
A.
pemahaman tentang konteks di mana
organisasi beroperasi sudah jelas.

Pertimbangan kebutuhan pihak yang

berkepentingan harus fungsional untuk
kepuasan pelanggan, seperti :
- Pengguna akhir produk, yang mungkin
memiliki harapan yang berbeda
dibandingkan dengan persyaratan tertentu
dari pelanggan langsung;

- Pemegang saham, yang melalui kebijakan

mereka mempengaruhi sistem manajemen
B. dengan dampak pada kualitas produk;

- Karyawan dan serikat pekerja, manajemen

kerja jam, klaim mengenai keselamatan
dengan permintaan untuk berinvestasi di
bidang infrastruktur;

- Penyedia eksternal, harus memenuhi syarat

pembayaran untuk keberlanjutan timbal
balik, perlu merencanakan perintah untuk
mematuhi tenggat waktu pengiriman.

Sebuah analisis mendalam tentang

keakuratan ruang lingkup Sistem Manajemen
Mutu merupakan hal yang sejalan dengan
permintaan pelanggan dan dengan
C.
persyaratan wajib. Konsistensi dengan
konteks internal dan eksternal di mana
organisasi beroperasi dan dengan persyaratan
pihak yang berkepentingan juga telah jelas.

Manual mutu / perusahaan, grafik atau tabel,

matriks tanggung jawab, prosedur atau
dokumentasi lain yang setara dapat dibuat,
D telah tersedia. Indikator yang ditentukan oleh
organisasi cocok untuk mengukur efektivitas
proses dalam kaitannya dengan output yang
diharapkan dari setiap proses.

5. Kepemimpinan
Kepatuhan dengan persyaratan standar bisa
diperiksa melalui :

- Pembicaraan dengan Top Management

untuk menilai komitmen yang sebenarnya;

- Verifikasi tinjauan manajemen;

- Verifikasi tujuan dan arah strategis;
A.
- Wawancara dengan personil;

- Verifikasi komunikasi manajemen puncak;

- Ketersediaan aktual sumber daya yang

sesuai;
- Verifikasi keterlibatan personel yang
sebenarnya.
Kebijakan Mutu dan penyusunannya yang
sesuai dengan konteks, arah dan strategi
B. organisasi, keinginan dan harapan pelanggan
serta pihak-pihak yang berkepentingan,
persyaratan wajib.
Kebijakan Mutu tersebut telah tersedia
sebagai informasi didokumentasikan, telah
C.
dikomunikasikan dalam organisasi dan
dipahami serta diterapkan.

Struktur organisasi, dokumen organisasi dan

D.
Uraian tugas (job description) telah tersedia.

6. Perencanaan
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Sehubungan dengan analisa risiko,

organisasi mengidentifikasi metode yang
cocok untuk membuat hirarki risiko,
misalnya, indeks berdasarkan keseriusan
(konsekuensi) dan probabilitas peristiwa
yang terjadi.

A. Selain itu, harus diperiksa apakah organisasi

telah mengidentifikasi / merencanakan
kebutuhan untuk meninjau tindakannya.

Para personil organisasi menyadari bahwa

pendekatan Sistem Manajemen Mutu dan
proses didasarkan pada pemikiran berbasis
risiko.

Sebuah sistem pengendalian perubahan

diadakan untuk mengelola perubahan
manufaktur dan kualitas produk yang
B. signifikan. Ini mencakup ketentuan untuk
memberitahu lembaga terkait, sebagai
otoritas pendaftaran, variasi dalam detail
produk.

Bukti yang terdokumentasi dari penyusunan

Sasaran Mutu termasuk didalamnya
spesifikasi tujuan yang jelas, metode
C. pencapaian tujuan, penugasan tanggung
jawab dan sumber daya secara obyektif
untuk mencapai tujuan dan pengendalian
organisasi untuk menjaga pencapaian tujuan.

Apakah ada perubahan yang berdampak

pada Sistem Manajemen Mutu dan
bagaimana mereka telah direncanakan dan
dikelola, termasuk di dalamnya pengenalan
D.
terhadap produk baru, pasar baru, perubahan
persyaratan dalam kontrak dan peraturan
serta struktur organisasi, perubahan atau
pengenalan sistem IT baru.

7. Penunjang
Verifikasi untuk setiap proses yang :
- Menilai kecukupan sumber daya manusia
dan infrastuktur (internal dan eksternal) telah
dialokasikan, sejalan dengan tujuan yang
A. ditetapkan;
- Indikator kinerja, laba atas investasi dan
kebutuhan untuk memperoleh sumber daya
penghasil produk atau layanan, telah
ditetapkan.
Verifikasi mengenai jumlah orang yang
dibutuhkan untuk setiap kegiatan sehingga
B.
implementasi Sistem Manajemen Mutu
berjalan efektif.

Pemastian kecukupan dan efektivitas

infrastruktur, organisasi harus menyediakan
Instruksi Kerja yang sesuai, dengan
C.
mempertimbangkan sesuai kompetensi
pengguna dan program rutin pekerjaan
pemeliharaan.

Kepatuhan dengan persyaratan lingkungan

proses operasi bisa diperiksa melalui:

- Analisa kondisi lingkungan disesuaikan

dengan kebutuhan organisasi;
- Pemeriksaan rencana pengendalian kondisi
D. lingkungan kerja dan catatan pemeriksaan
dan pemantauan dilakukan (dalam kaitannya
dengan kualitas produk / layanan yang
disediakan) serta kualifikasi penyedia
eksternal digunakan;
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- Pemeriksaan kontrak dengan penyedia

eksternal jasa pemeliharaan.
Kepatuhan dengan persyaratan sumber daya
pemantauan dan pengukuran bisa diperiksa
melalui:

- Pemeriksaan prosedur atau instruksi kerja

yang memberikan bukti perencanaan sumber
daya yang dibutuhkan untuk melakukan
kegiatan pemantauan dan pengukuran yang
valid dan dapat diandalkan;
E.
- Pemeriksaan catatan pemantauan dan
pengukuran;
- Catatan kalibrasi, manajemen dan
pengendalian sumber daya pemantauan dan
pengukuran;
- Pemeriksaan pendapat kecukupan
penyedia eksternal, jika kegiatan ini
disediakan secara eksternal.

Kepatuhan dengan persyaratan pengetahuan

organisasi bisa diperiksa melalui:

- Analisis dokumen yang mengidentifikasi

sumber dan jenis pengetahuan yang
F. diperlukan (mis .: tinjauan manajemen);
- Bukti bahwa penilaian pengetahuan telah
dibuat sebelum perubahan pada sistem
manajemen atau mengikuti kebutuhan untuk
perubahan tertentu..
Kepatuhan dengan persyaratan kompetensi
bisa diperiksa melalui:

- Identifikasi dan analisis kompetensi yang

diperlukan, juga dalam hal perubahan;

- Ulasan Manajemen dengan penilaian risiko

(Identifikasi, konfirmasi, memperbarui

kompetensi, permintaan kompetensi baru
untuk bisnis baru);
- Verifikasi rencana pengembangan personil
dan
G.
tujuan terkait;
- Verifikasi rencana pengembangan
kompetensi;
- Verifikasi kompetensi setiap rencana
pemantauan;
- tindakan korektif;
- Pemeriksaan hasil audit internal untuk
mengevaluasi kompetensi atau kompetensi
baru yang akan diperbarui;

- Pemeriksaan catatan kegiatan pelatihan

dilakukan dan verifikasi efektivitas mereka.

Pemeriksaan catatan bisa memberikan

dukungan juga untuk memverifikasi
pelaksanaan persyaratan, terutama dalam hal
proses yang disediakan secara eksternal.

Metode untuk membawa kesadaran

karyawan dapat bervariasi dan dapat
mencakup:

H. - Komunikasi langsung;
- Pertemuan;
- Sistem manajemen audit;
- Pelatihan khusus;
- Berbagi tujuan / hasil;
- Berbagi NC ditemukan;
- Berbagi isi kebijakan mutu;
- Kesadaran kuesioner;
- Instruksi / prosedur.
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Organisasi harus menentukan komunikasi

internal dan eksternal yang akan dibuat, oleh
siapa dan kepada siapa, bagaimana mereka
harus dibuat dan kapan, tanggung jawab dan
wewenang.

I.
Manajemen puncak harus menjamin
komunikasi yang dikirim keluar di semua
tingkatan, jelas, dimengerti dan sejalan
dengan tujuan; komunikasi eksternal
memungkinkan kebutuhan dan harapan dari
pihak yang berkepentingan yang relevan
untuk dipahami dan bertemu.

Informasi yang didokumentasikan secara

khusus diperlukan oleh standar adalah
sebagai berikut.

- Cakupan (lihat 4.3) (termasuk pembenaran

untuk penerapan non dari kebutuhan).

- Keterangan dari sistem manajemen mutu

dan proses (lihat 4.4).
- Kebijakan mutu (lihat 5.2.2).
- Sasaran mutu (lihat 6.2.1).
- Kecukupan pemantauan dan pengukuran
sumber
(Lihat 7.1.5).
- Ketika pengukuran ditelusuri adalah
persyaratan, kalibrasi atau verifikasi metode;
jika tidak ada standar seperti, dasar yang
dipakai untuk kalibrasi atau verifikasi harus
ditunjukkan (lihat 7.1.5.2).
- Kompetensi (lihat 7.2).
- Demonstrasi kesesuaian proses seperti yang
direncanakan dan produk dengan persyaratan
(lihat 8.1).
- Ulasan persyaratan untuk produk (lihat
8.2.3).
- Desain dan pengembangan input (lihat
8.3.3)
- Desain dan pengembangan kontrol (lihat
8.3.4).
- Desain dan pengembangan output (lihat
8.3.5).
- Desain dan pengembangan perubahan (lihat
8.3.6).
J. - Dokumentasi pada evaluasi dan
pemantauan
kinerja penyedia eksternal (lihat 8.4.1).
- Definisi karakteristik produk / jasa dan
hasil yang akan dicapai (lihat 8.5.1).
- Kegiatan yang akan dilakukan dan hasil
yang akan dicapai
(Lihat 8.5.1).
- Identifikasi dan mampu telusur (lihat
8.5.2).
- Properti dari pelanggan atau eksternal
penyedia hilang,
rusak atau ditemukan tidak cocok untuk
digunakan (lihat 8.5.3).
- Pengendalian perubahan (lihat 8.5.6).

- Bukti kesesuaian dengan kriteria

penerimaan produk / jasa dirilis (lihat 8.6).

- Lacak kepada orang (s) otorisasi pelepasan

produk / layanan kepada pelanggan (lihat

8.6).
- Pengendalian output yang tidak sesuai
proses,
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produk atau jasa (lihat 8.7).

- Bukti hasil pemantauan dan pengukuran,

analisis dan evaluasi (lihat 9.1.1).

- Bukti pelaksanaan program audit internal
dan hasil relatif (lihat 9.2.2).
- Manajemen output (lihat 9.3.3).
- Sifat ketidaksesuaian, tindakan selanjutnya
diambil
dan tindakan korektif (lihat 10.2.2).

Ketika membuat dan memperbarui informasi

didokumentasikan, organisasi harus
K. memastikan identifikasi yang tepat dan
deskripsi, format dan kecukupan melalui
ulasan yang cocok dan persetujuan.

Kepatuhan dengan persyaratan pengendalian

informasi terdokumentasi dapat dinilai
melalui:

- Pemeriksaan pelaksanaan metode

manajemen, kontrol dan perlindungan
informasi didokumentasikan;

L. - Pemeriksaan identifikasi dan memperbarui

metode informasi didokumentasikan asal
eksternal;

- Pemeriksaan setiap daftar informasi

didokumentasikan dengan status diperbarui;

- Akses ke dan penggunaan setiap sistem

elektronik yang digunakan untuk
kontrol didokumentasikan informasi.
8. Operasional
Untuk perencanaan operasional, organisasi
harus menyediakan bukti bagaimana ia telah
merencanakan "kontrol" dari kegiatan
operasional.

Dalam kasus manajemen operasional,

berikut ini harus, misalnya, diperiksa:

A. - Rencana mutu;
- Rencana kontrol kualitas;
- Rencana desain;
- Rencana penyediaan pembuatan produk /
layanan;
- Siklus kerja;
- Perencanaan sumber daya;
- Daftar bahan..
Metode yang diterapkan untuk mencapai
komunikasi pelanggan yang efektif,
termasuk tanggung jawab dan wewenang,
harus diperiksa.
Bagaimana informasi, secara umum, untuk
pasar disimpan di bawah kontrol harus
diverifikasi, misalnya melalui:

- brosur
B.
- situs web
- katalog
- iklan
- Label dan kemasan
- Instruksi produk untuk digunakan
- Charter layanan
- Menawarkan pelatihan rencana
- Penawaran / konfirmasi pesanan
Organisasi harus memastikan bahwa:
- Persyaratan untuk produk / jasa
didefinisikan secara penuh;

C.
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- Ia mampu memenuhi persyaratan yang

C. ditetapkan untuk produk / layanan yang
ditawarkan;
- Dapat memenuhi klaim untuk produk dan
jasa
ia menawarkan.
Ketersediaan informasi didokumentasikan
terkait untuk meninjau kegiatan (tawaran,
pesanan / kontrak, ulasan order) harus
D. diverifikasi dan apakah itu cukup untuk
memberikan bukti eksekusi yang benar, juga
memeriksa bahwa telah dilakukan sebelum
konfirmasi penyediaan.

Ketika persyaratan untuk produk dan jasa

yang berubah, organisasi harus memastikan
E. bahwa informasi didokumentasikan relevan
diubah dan bahwa orang relevan disadarkan
tentang persyaratan yang diubah.

Ini harus diperiksa bahwa, untuk

menentukan tahap dan menjaga proses
desain dan pengembangan di bawah kontrol,
F. informasi didokumentasikan, diperlukan
untuk mengkonfirmasi bahwa persyaratan
desain telah dipenuhi, telah
dipertimbangkan.

Ketersediaan catatan desain dan

G.
pengembangan input data harus diperiksa.

Itu harus mungkin untuk memeriksa

informasi mempertahankan
didokumentasikan pada ulasan, verifikasi
H.
desain dan validasi dan pada setiap tindakan
yang diambil untuk menyelesaikan masalah
ditentukan selama tahap ini.

Ini harus diverifikasi bahwa informasi

didokumentasikan terkait dengan desain dan
pengembangan proses output memadai untuk
I.
penggunaan produk / layanan dan
memberikan bukti bahwa persyaratan relatif
telah terpenuhi.

Ini harus diverifikasi bahwa informasi

didokumentasikan pada desain dan
pengembangan perubahan, termasuk
otorisasi perubahan dan justifikasi mereka,
J.
serta tindakan yang diambil untuk mencegah
dampak yang merugikan memadai dan
memberikan bukti bahwa persyaratan relatif
telah terpenuhi.

Kepatuhan dengan persyaratan dapat dinilai

melalui:

- Verifikasi kriteria yang ditentukan untuk

pilihan penyedia eksternal, sejalan dengan
penilaian risiko / peluang;
- Verifikasi kriteria yang ditentukan untuk
memantau dan
penelaahan secara periodik terhadap kinerja
K. penyedia eksternal sesuai dengan jenis
penyediaan eksternal (misalnya, perbedaan
antara penyedia eksternal dari layanan dan
produk);
- Verifikasi informasi didokumentasikan di
awal
evaluasi penyedia eksternal dan re-evaluasi
mereka;
- Verifikasi penanganan ketidaksesuaian,
keluhan dan komentar mengenai penyedia
eksternal..
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Kepatuhan dengan persyaratan dapat dinilai

melalui:

- Pemeriksaan instruksi kerja, juga dalam

"disederhanakan"

bentuk, seperti tabel, gambar, diagram alir;

- Pemeriksaan rencana kontrol, termasuk

penerimaan
batas;
L. - Pemeriksaan catatan kontrol dilakukan;

- Pemeriksaan informasi didokumentasikan

pada setiap proses yang harus divalidasi dan
bukti validasi relatif;

- Identifikasi situasi di mana kesalahan

manusia mungkin memiliki

berdampak pada produk layanan kesesuaian /

dan dari definisi tindakan pencegahan dan /
atau penahanan dilaksanakan.

Kepatuhan dengan persyaratan dapat dinilai

melalui:

- Verifikasi metode berurusan dengan

ketidaksesuaian dan catatan terkait
(misalnya, praktek, instruksi, bentuk);
- Bukti ketidaksesuaian yang ditemukan
yang telah ditangani dan koreksi yang dibuat
terkait dengan masing-masing;
- Catatan yang berhubungan dengan
informasi kepada pelanggan;
- Dokumentasi yang berkaitan dengan
verifikasi ulang dari dikoreksi
produk;
- Konsesi yang diperoleh dari orang yang
M. berwenang untuk menempatkan di pasar /
release / menyediakan layanan;

- Verifikasi kewenangan tersedia untuk

personil menyediakan layanan untuk
memutuskan waktu yang terlibat dan alat
(misalnya, jika dan ketika untuk
mengganggu penyediaan output yang tidak
sesuai, bagaimana memperbaiki / mengganti
layanan);
- Verifikasi tindakan dilaksanakan dalam
kaitannya dengan
penanganan ketidaksesuaian (misalnya,
pengembalian dana, penawaran baru,
kredit ...);
- Identifikasi, segregasi dan penggantian
sarana / peralatan.
9. Evaluasi Performa
Kepatuhan dengan persyaratan bisa diperiksa
melalui:

- Verifikasi kriteria yang ditentukan untuk

melakukan pemantauan dan pengukuran,
sejalan dengan hasil penilaian risiko /
A. peluang;
- Verifikasi bagaimana hasil pemantauan
dikelola;

- Pemeriksaan informasi didokumentasikan

sebagai bukti pemantauan, pengendalian dan
pengukuran dilakukan.

Kepatuhan dengan persyaratan bisa diperiksa

melalui:

- Verifikasi bagaimana kepuasan pelanggan

B.
dimonitor, termasuk frekuensi;
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B.

- Adanya sistem untuk mengumpulkan,

menganalisis dan menggunakan
Data kepuasan pelanggan.
Kepatuhan dengan persyaratan bisa
diperiksa melalui:

- Verifikasi perencanaan data yang akan

C. dikumpulkan;
- Verifikasi metode pengumpulan data;
- Verifikasi metode analisis data;
- Pemeriksaan hasil analisis data;
- Analisis dari tinjauan manajemen output.
Kepatuhan dengan persyaratan bisa diperiksa
melalui:

- Verifikasi program audit;

- Pemeriksaan laporan audit;
D.
- Verifikasi kompetensi auditor dan
independensi;
- Verifikasi tindakan yang diambil menyusul
hasil audit;
- Analisis dari tinjauan manajemen.

Serta input yang ditetapkan oleh standar,

input lain dapat dianggap, seperti misalnya:

- Analisis data per titik 8,4;

- Kebutuhan pelatihan;
- Masalah yang berkaitan dengan penyedia
eksternal;
- Kebutuhan untuk peralatan baru dan
pemeliharaan;
- Keadaan lingkungan kerja dan
E. infrastruktur.
Tinjauan output harus mencakup:

- Kesempatan peningkatan;
- Keputusan yang berkaitan dengan tindakan
yang akan diambil;
- Tugas tanggung jawab dan memadai
sumber daya untuk
setiap kegiatan;
- Perlu memodifikasi sistem manajemen;
- Kebutuhan sumber daya..
10. Perbaikan
Bukti tindakan yang akan diambil dapat
ditemukan sebagai:

- Output dari tinjauan manajemen;

A. - Konsekuensi dari pelaksanaan tindakan
korektif;

- Konsekuensi dari reorganisasi perusahaan;

- Pengembangan proyek / lini bisnis baru

tindakan korektif mungkin diperlukan
berikut:

- Ketidaksesuaian;
B.
- Masalah dengan penyedia eksternal;
- keluhan pelanggan;
- Permintaan bantuan selama garansi;
- Audit internal (lihat 9.2)..

perbaikan berkesinambungan dari sistem

manajemen merupakan bagian integral dari
tujuan yang ditetapkan oleh Manajemen Top.

Kepatuhan dengan persyaratan bisa diperiksa

melalui:

C.
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C. - Pemeriksaan output dari tinjauan sistem

manajemen;
- Pemeriksaan setiap strategi peningkatan
dan kebijakan;
- Pemeriksaan setiap program perbaikan
(dibagi menjadi proyek, tindakan,
inisiatif ...) dan memperbarui terus-menerus
mereka dengan organisasi.
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