ISO 9001:2015 Quality Management System Audit Checklist

Clause 4: CONTEXT OF OUR ORGANIZATION

4.1 Understanding our organization and its context

1 Has our organization determined the external and internal Yes. Name, number and Location of Needs improvement
issues that are relevant to its purpose and its strategic documented information:
direction and a) Hard copy
that affect our ability to achieve the intended result(s) of our b) Electron (link to the folder to be
quality management system? inserted here)
(Are documents available like Business Plans, SWOT Analysis,
Stakeholder Analysis, etc…)
2 Is our organization monitoring and reviewing information Yes
about these external and internal issues? How is it done?

4.2 Understanding the needs and expectations of interested parties

1 Due to their effect or potential effect on our organization’s ability to Yes

consistently provide products and services that meet our customer and
applicable statutory and regulatory requirements, has our organization
determined in documented format ...
a) the interested parties that are relevant to our quality management
system?
b) the requirements of these interested parties that are relevant to our
quality management system? (Any documentation available as
evidence for that?)
2 Whether and how our organization monitors and reviews information Yes
about these interested parties and their relevant requirements?
4.3 Determining the scope of our quality management systems

1 Has our organization determined the boundaries and applicability of Yes. AZO-QMS-MAN-001
our quality management system to establish its scope? (Scope Quality Manual Rev1.
Statement available?) Soft and hard copy available
in Server and Folder
2 When determining this scope, did our organization consider: Yes. AZO-QMS-MAN-001
Quality Manual Rev1.
a) the external and internal issues referred to in 4.1? Soft and hard copy available
b) the requirements of relevant interested parties referred to in 4.2? in Server and Folder
c) the products and services of our organization.
3 Did our organization apply all the requirements of the ISO 9001:2015 Yes
standard if they were applicable within the determined scope of our
QMS?
4 Is the scope of our organization’s quality management system visually Yes. AZO-QMS-MAN-001
available and maintained as documented information somewhere? Quality Manual Rev1.
Soft and hard copy available
in Server and Folder
5 Does the scope state the types of our products and services covered, Yes
and provide justification for any requirement of the ISO 9001:2015
standard that our organization determines as not applicable to the
scope of our quality management system?
6 Are we aware that conformity to the ISO 9001:2015 standard may only Yes
be claimed if the requirements determined as not applicable do not
affect our organization’s ability or responsibility to ensure the
conformity of our products and services and the enhancement of
customer satisfaction?
4.4 Determining the scope of our quality management systems

1 (4.4.1) Has our organization determined the main QMS related Yes. AZO-QMS-MAN-001 Quality
processes needed for our quality management system and their Manual Rev1.
application throughout our organization? Soft and hard copy available in Server
and Folder
2 (4.4.1) Yes. a) Need to determine
Has our organization ... 1. AZO-LMP-QMS-PRO-001 Inputs
a) determined the inputs required and the outputs expected rev1 Manufacturing of b)Need to draw flow charts
from these processes? driling fluids for each processes
b) determined the sequence and interaction of these processes? 2. AZO-LMP-QMS-PRO-003 f) need to determine risks
(Flow charts?) rev1 Shipping Procedure and opportunities for each
c) determined and applied the criteria and methods (including 3. AZO-LMP-QMS-PRO-002 proce+6sses
monitoring, measurements and related performance Material Receiving, Storage, g) all processes need to be
indicators) needed to ensure the effective operation and Handling and Preservation evaluated. Achievement of
control of these processes? Procedure the intended results need
d) determined the resources needed for these processes and to be ensured
ensured their availability?
e) assigned the responsibilities and authorities for these
processes?
f) addressed the risks and opportunities as determined in
accordance with the requirements of 6.1 (planning)?
g) evaluated these processes and implemented any changes
needed to ensure that these processes achieve their intended
results?
h) tried to improve these processes and also our entire quality
management system?
3 (4.4.2) Yes. Process map needs to be
To the extent necessary, does our organization ... AZO-QMS-MAN-001 Quality Manual developed
a) maintain documented information to support the operation Rev1.
of our QMS related processes? Please cite some examples like Soft and hard copy available in Server
Core Process Map, Quality Manual, etc... and Folder
b) retain documented information to have confidence that all
QMS related processes are being carried out as planned?
Records keeping? Please cite some examples.
Clause 5: LEADERSHIP
5.1 Leadership and commitment

1 (5.1.1 - General) Yes. Org chart needs to be

In order to demonstrate its leadership and commitment with respect to our updated
quality management system, is our top management “Hands on” ... Would be a good idea to
AZO-QMS-POL-001 train each department a
a) taking accountability for the effectiveness of our quality management Quality policy-Azorel relative standard
system? Please cite some examples. LLC
b) ensuring that our quality policy and quality objectives are established for top management should
our quality management system and are compatible with the context and AZO-LMP-QMS-F-017 communicate the
strategic direction of our organization? Please cite some examples (Quality Azorel OrgChart importance of the QMS to
Policy signed, etc…?). all staff
c) ensuring the integration of our quality management system requirements AZO-LMP-QMS-F-001
into our organization’s business processes? Please cite some examples. MASTER LIST
d) promoting the use of the process approach and risk-based thinking? Please
cite some examples. (Quality training, E-newsletter, any other documented
evidence, etc)
e) ensuring that the resources needed for our quality management system are
available? Please cite some examples. Is there are Employee Handbook
available?
f) communicating the importance of effective quality management and of
conforming to our quality management system requirements? Please cite
some examples.
g) ensuring that our quality management system achieves its intended
results? Please cite some examples. Is there a List of
authorities/Responsibilities, Org-Chart available?
h) engaging, directing and supporting persons to contribute to the
effectiveness of our quality management system? Please cite some examples.

2 (5.1.2 - Customer focus) Yes

In order to demonstrate its leadership and commitment with respect to AZO-LMP-QMS-F-027
customer focus, is our top management ensuring that ... Customer Satisfaction
 a) customer and applicable statutory and regulatory requirements are Questionnaire
determined, understood, monitored and consistently met?
b) the risks and opportunities that can affect conformity of products and AZO-LMP-QMS-F-030
services and the ability to enhance customer satisfaction are determined and Continual
addressed? (Risk plan?) Improvement Register
c) the focus on enhancing customer satisfaction is maintained?

5.2 Policy

1 Has our top management established, implemented and maintaining a quality Yes
policy that ... AZO-QMS-POL-001
Quality policy-Azorel
a) is appropriate to the purpose and context of our organization and supports LLC
its strategic direction?
b) provides a framework for setting our quality objectives?
c) includes a commitment to satisfy applicable requirements?
d) includes a commitment to continual improvement of the quality
management system?
2 (5.2.2 - Communicating the quality policy) Yes,
Whether the quality policy ... All places where the
a) is available and is maintained as documented information? staff attends it was
b) is communicated, understood and applied within our organization? posted on the wall
Posters, e-newsletter?
c) is available to relevant interested parties, as appropriate?
5.3 Organizational roles, responsibilities and authorities

1 Does our top management ensure that the responsibilities and authorities for Yes
relevant QMS related process roles are assigned, communicated and
understood within our organization? (Responsibility Charts, Org-Chart, etc…) AZO-LMP-QMS-F-017
Azorel OrgChart

2 Has our top management assigned the responsibility and authority for ... Yes
a) ensuring that our quality management system conforms to the
requirements of the ISO 9001:2015 standard?
b) ensuring that all QMS related processes are delivering their intended
outputs?
c) reporting on the performance of our quality management system and on
opportunities for improvement, in particular to our top management?
d) ensuring the promotion of customer focus throughout our organization?
e) ensuring that the integrity of our quality management system is maintained
when changes to our quality management system are planned and
implemented?

Clause 6: PLANNING
6.1 Actions to address risks and opportunities

1 (6.1.1) Yes. Risk Management

When planning for our quality management system, did our AZO-LMP-HSE-PRO-004-Risk procedure should be
organization consider the issues referred to in 4.1 and the Management reviewed.
requirements referred to in 4.2 and determine all risks and relevant
new opportunities that need to be addressed to: COTO log should be
AZO-LMP-QMS-F-024 Risk developed for risk and
a) give assurance that our quality management system can achieve its Register opportunities register
intended result(s)? Global Risk plan if needed? Inclusive Supplier risk
evaluation? AZO-LMP-QMS-F-030
 b) enhance desirable effects? Continual Improvement
c) prevent, or reduce, undesired effects? (FMEA, or any other Risk Register
planning tool?)
d) achieve improvement?
2 (6.1.2) Yes. 1.Planning and
Has our organization planned ... implementing risk
a) actions to address these risks and opportunities? Job Safety Analysis management activities
(Continuity/Contingency plan?) were not identified and
b) how to: Continual Improvement appointed from
1) integrate and implement the actions into its quality management AZO-LMP-QMS-F-030 appropriate team of
system processes (see 4.4)? Do we have a Risk and/or Safety parties
Committee? AZO-LMP-QMS-F-024 Risk
2) evaluate the effectiveness of these actions? Regular Risk status Register 2.Not determined
meetings? sequence of processes,
process diagram or
process map

3. Leadership and
commitment in planning of
the processes (risk based
thinking)

4.Risk assessment and

control needed for
purchased products,
ordered processes,
products, or services,
delivery or provision (201)
5.Purchasing of material
6. Consequences of a
change in QMS aspects
must be assessed(97)
7.Assessment of reaction of
external providers to
nonconformities in order
to prevent reoccurrence of
 them has not included in
risk assessment (274)
8.Risks are not assessed
for Post-delivery of
products activities(327)
3 (6.1.2)
Whether the actions taken to address risks and opportunities shall be
proportionate to the potential impact on the conformity of products
and services? Global and local?
4 (6.1.2) Yes.
Do the options to address all to our organization relevant risks include Risk Management Procedure
avoiding risk, taking risk in order to pursue an opportunity, eliminating AZO-LMP-HSE-PRO-014
the risk source, changing the likelihood or consequences, sharing the
risk, or retaining risk by informed decision?

6.2 Quality objectives and planning to achieve themSl. #

1 (6.2.1) Yes,
Has our organization established and connected our quality objectives with AZO-LMP-QMS-F-009
relevant functions, levels and processes needed to achieve our quality Quality Objectives
management system objectives?
2 (6.2.1) Yes. Need to develop SOP for
Whether the chosen quality objectives ... AZO-LMP-QMS-F-009 QMS planning
a) are consistent with our quality policy? Any SOP for QMS planning? Quality Objectives
b) are measurable and broken down visible in our QMS processes?
c) take into account applicable requirements? Key Performance Indicator (KPI) AZO-QMS-PLC-001
Plan? Quality Policy
d) are relevant to conformity of our products and services and focus on
 enhancement of customer satisfaction?
e) are monitored? Do we have a Records keeping plan?
f) are communicated throughout our organization?
g) are updated, as appropriate?
3 (6.2.1) Yes Established Quality
Does our organization maintain documented information on the QMS quality objectives needs to be
objectives? improved. They shall
established at relevant
functions and levels and
also updated as
appropriate.
4 (6.2.2) Yes
When planning how to achieve our quality objectives, does our organization
determine ... Management Review
a) what will be done? Do we collect and track monthly KPI Records for status Protocol
update? AZO-LMP-QMS-F-032
b) what resources will be required?
c) who will be responsible? Process owners responsible for tracking process
interruptions?
d) when it will be completed? Quarterly, Monthly, weekly?
e) how the results will be evaluated? Is the Quality team tracking/analyzing KPI
trends?

6.3 Planning of changes #

1 When our organization determines the need for changes to our quality No There is no evidence for
management system, are the changes carried out in a planned manner? consideration of
Any SOP for that available? AZO-LMP-QMS-F-025 estimation of Potential
Does our organization consider ... Change request form Consequences
a) the purpose of the changes and their potential consequences?
b) the integrity of our quality management system? AZO-LMP-QMS-PRO- Quality Objectives are not
c) the availability of resources to cover the changes? 007 considered while changes
 d) the allocation or reallocation of responsibilities and authorities? Management of Change are done
procedure
Process outputs are not
Allocation of considered
employees and
equipment(forklift) Customer requirements
which affected and satisfaction were not
Process environment considered
in LMP due to the
change Risks are not considered

Gap analysis between

conditions, situations and
results before and after
changes must be done

Changes did not submitted

to PDCA cycle (98)

Clause 7: SUPPORT

7.1 Resources

(7.1.1 – General) Yes, Storage, handling,

Has our organization determined and is providing the resources needed for Raw material and transportation regualatory
the establishment, implementation, maintenance and continual improvement equipment are requirements for raw
of our quality management system? Is that a constant item line of our QMS determined and materials are not
Management Reviews? provided by partner controlled by competent
company employee
Has our organization considered ...
a) the capabilities of, and constraints on, existing internal resources? Truck and forklist by Raw materials must be
b) what needs to be obtained from external providers? the org. comformed of adequate
quality and quantity with
Correct volume and COA and QR
quality are provided by
the organization Diezel as a fuel for
equipment does not have a
Regulatory method to ensure adequate
requirements are also criteria for safe use in
by the organization. equipment.
Such as transport,
storage, handling and Better to arrange
dispose awareness presentation
for each department
relevant QMS aspects

No proper training on
storage, handling for
warehouseman

No awareness of msds

(7.1.2 - People) Yes, Quality policy should have

Does our organization determine and provide the persons necessary for the Competency sheet statement about human
effective implementation of our quality management system and for the operation Organization chart resources. And reference to
and control of its relevant processes? Job Skill Matrix? Annual Training plan in organization diagram
place? etc...
(7.1.3 - Infrastructure) Yes,
Does our organization determine, provide and maintain the infrastructure necessary
for the operation of its processes and to achieve conformity of products &
services?

What is the status of the following infrastructure (if applicable) ...

a) buildings and associated utilities?
b) equipment, including hardware and software?
c) transportation resources?
d) information and communication technology?