ISO 9001 Requirement Checklist

This checklist was developed base on ISO 9001:2018 version standard. This is the requirement in the standard which have been simplified here.

You can use this to check through your organization whether you are ready for ISO 9001 Certification Audit.

For more information, kindly please visit our website at www.pearl-certification.com or you can email us at info@pearl-certification.com.

Compliant If No, % of
Context of Organization Remark
(Yes/No) completed
Have your organization determine the external and internal issues that related to the purpose,
1
achievement of customer satisfaction and organization's strategic direction?
2 Have you reviewed and monitored the external and internal issue frequently?
Have the interested parties's needs and expectations (relevant to the QMS) being determine,
3
monitor and review?
4 Have your organization define and documented the policy, objectives and scope?
Was the scope taking into account all the external and internal issues, the needs of interested
5
parties and the scope your products and services?
6 Is your objectives consistent with the policy for the QMS?
7 Have the criteria/procedure to monitor and measure the objective being establish?
Leadership

Has the Top management defined and communicate the responsibilities and authorities within
8
the organization, including the appointment of its representative and Management Team?

9 Have the policy and objectives for the QMS been communicated to the interested parties?
Have the objectives been established at relevant departmental and individual levels with the
10
business?
Have the requirements for the QMS been integrated into the business processes and have
11
management promoted awareness of the process approach?
Have staff shown enough awareness of the quality system and with Complaints handling system
12
in place?

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 ISO 9001 Requirement Checklist

Have you determine, met and communicate customer requirements, applicable legislation or
13
statutory requirements in the organization?

14 Have the risks and opportunities that are relevant to the QMS been established, and addressed?

Planning
Have the risks and opportunities that need to be addressed to give assurance that the QMS can
15
achieve its intended result(s) been established?
Has organization establish the action plan to address the risk and opportunities and integrated,
16
implement and evaluate them?
Have organization establish the quality objectives, documented, monitor and communicated
17
them
Is there a defined process for the determining the need for changes to the QMS and managing
18
their implementation?
Support
Has the organization determined and provided the resources needed for the establishment,
19 implementation, maintenance and continual improvement of the QMS (including people,
environmental and infrastructure requirements)?
Is monitoring or measuring is used for evidence of conformity of products and services to
20
specified requirements?
Has the organization determined the resources needed to ensure valid and reliable monitoring
21
and measuring of results?
Has the organization determined the knowledge necessary for the operation of its processes and
the achievement of conformity of products and services and implemented a lessons learned
22
process?

Has the organization ensured that those persons who can affect the performance of the QMS are
23 competent on the basis of appropriate education, training, or experience or taken action to
ensure that those persons can acquire the necessary competence?

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 ISO 9001 Requirement Checklist

Has the documented information required by the standard and necessary for the effective
24
implementation and operation of the QMS been established?
Has the organization calibrate/verify and documented the measuring equipment at a specific
25
interval or prior to use to ensure to provide confidence in the validity of measurement results.

Has the organization determine the organization knowledge (information regarding a process,
product or service; previous specifications and work instructions; experience of skilled people
26 operating their processes; mentoring and coaching by more experienced employees; knowledge
of technologies and infrastructure relevant to our organization, etc) and maintain and make
available?

Has the organization ensure that everyone in the organization are aware on the Quality Policy,
27
objectives.
Has organization ensure when creating and updating documented information with description
28
(name, rev, etc), format, approval and review and protected the document
Operation
Is there a defined process for the provision of products and services that meet the requirements
29
defined by the customer? Are there any changes planned?
30 Are they carried out in a controlled way and actions taken to mitigate any adverse effects?
31 Are any outsourced processes managed and controlled?
Is there a defined process for reviewing and communicating with customers in relation to
32
information relating to products and services, enquiries, contracts or order handling?

33 Is this review conducted prior to the organisation’s commitment to supply products and services?

34 Do you design and develop (R&D) products or services?

Has the organization apply control (evaluate, review, validation, verification, and documented) to
35
the R&D Process?
Do you ensure that externally provided processes, products, and services conform to specified
36
requirements?

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Do you have criteria for the evaluation, selection, monitoring of performance and re-evaluation
37
of external providers? Have the organization documented the above activities?

Is the provision of products and services carried out in controlled conditions which include:
• the availability of documented information that defines the characteristics of the products and
services?
• the availability of documented information that defines the activities to be performed and the
38 results to be achieved?
• monitoring and measurement activities at appropriate stages to verify that criteria for control
of processes and process outputs, and acceptance criteria for products and services, have been
met?
• the people carrying out the tasks are competent?

39 Do you have effective methods of ensuring traceability during the operation process?
Is property belonging to customers or external providers used in the provision of the product or
40
service?
41 Is this controlled effectively?
Is there a requirement for post-delivery activities associated with the products and services such
42
as warranty, maintenance services, recycling or final disposal?

43
Are any nonconforming process outputs managed so as to prevent their unintended use?
Performance Evaluation
Has the organisation determined what needs to be monitored and measured, How and when to
44
monitor and measurement?
Has it established when the results from monitoring and measurement shall be analyzed and
45
evaluated?
46 Has the evaluation record being documented?
Has the organization monitoring customer perceptions of the provision of products and services
47
been established?
Has it determined the need or opportunities for improvements within the QMS and how these
48
will be fed into management reviews?

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Does your organization plan, establish, implement and maintain the internal audit process?
49
(Notes : Internal audit must be conducted before external certification body come to audit)
50 How Frequent your organization conduct the internal audit?
Has the non conformance found in internal audit have take appropriate correction and
51
corrective actions?
52 Has an approach to perform management reviews been established and implemented?
Improvement

Has the organisation determined and selected opportunities for improvement and implemented
53
the necessary actions to meet customer requirements and enhance customer satisfaction?

Does the organisation operate appropriate processes (review, analyze, determine root cause) for
54
managing nonconformities and the related corrective actions?
Has the organisation decided on how it will address the requirement to continually improve the
55
suitability, adequacy, and effectiveness of the QMS?

Checked By : Reviewed By:

Name and Signature: Name and Signature:

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