Reference Code IQT-ACL-00
Effectivity Date
AUDIT CHECKLIST
Revision No.
Process: Process Owner:
CORE PROCESSES OF EEMPSD
EEMPSD
Auditee/s: Time Start:
EEMPSD PERSONNEL
Time End:
Criteria to be Checked
(what must be happening) Observed Evidence
Possible Questions to ask Documented Information/ (what is actually happening)
Evidence to Look For
Define the planned results and planned activities
to be fulfilled, including actions to address risks Describe your observations on the extent of
and opportunities, and the relevant requirements achievement of the planned results and realization
that must be satisfied. (i.e. customer, regulatory, of planned activities, including actions to address
product, service, process, international standard) risks and opportunities, and conformance with the
relevant requirements
4.4 Quality management system and its
processes
4.4.1
The organization shall establish, implement, How has the QMS been established? Show
maintain and continually improve a quality me how this is implemented. How is it
management system, including the processes maintained and continually improved?
needed and their interactions, in accordance with
the requirements of this International Standard
How have the processes been determined
and how do they interact?
The organization shall determine the processes How have the processes been determined
needed for the quality management system and for the QMS?
their application throughout the organization and
shall: What are the inputs and outputs for those
processes?
a) determine the inputs required and the outputs
expected from these processes;
b) determine the sequence and interaction of What is the sequence and interaction of the
these processes; Flowcharts processes?
c) determine and apply the criteria and methods
(including monitoring, measurements and related
performance indicators) needed to ensure the What are the criteria, methods,
effective operation and control of these processes; measurement and related performance
KPI’s. indicators needed to operate and control
those processes?
d) determine the resources needed for these
processes and ensure their availability; Resources
e) assign the responsibilities and authorities for What resources are needed and how are
these processes;Resources these made available?
f) address the risks and opportunities as
determined in accordance with the requirements of
6.1; Risk Register How are responsibilities and authorities
assigned for those processes?
g) evaluate these processes and implement any
changes needed to ensure that these processes
achieve their intended results;
How are risks and opportunities considered
h) improve the processes and the quality and what plans are made to implement
management system. actions to address them?
What methods are used to monitor, measure
and evaluate processes and, if needed,
what changes are made to achieve intended
results?
How are opportunities to improve the
processes and the QMS determined?
4.4.2
To the extent necessary, the organization shall:
a) maintain documented information to support the
operation of its processes; Operations Manual
b) retain documented information to have
confidence that the processes are being carried
out as planned
5.1.2 Customer focus
Top management shall demonstrate leadership
and commitment with respect to customer focus
by ensuring that:
a) customer and applicable statutory and
regulatory requirements are determined,
understood and consistently met;
b) the risks and opportunities that can affect
conformity of products and services and the ability
to enhance customer satisfaction are determined
and addressed;
c) the focus on enhancing customer satisfaction is
maintained.
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management How are risks and opportunities determined
system, the organization shall consider the issues and addressed so that the QMS can:
referred to in 4.1 and the requirements referred to
in 4.2 and determine the risks and opportunities a) achieve its intended results;
that
need to be addressed to:
b) prevent or reduce undesired effects;
a) give assurance that the quality management c) achieve continual improvement?
system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 The organization shall plan:
a) actions to address these risks and
opportunities; How are actions planned to address risks
and opportunities?
b) how to:
How are actions integrated and
implemented into the QMS processes?
1) integrate and implement the actions into its
quality management system processes (see 4.4); How do you evaluate the effectiveness of
the actions?
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities
shall be proportionate to the potential impact on
the
conformity of products and services. How do you determine the actions taken to
address risks and opportunities as being
appropriate to the potential impact on the
conformity of products and services?
6.2 Quality objectives and planning to achieve them
6.2.1 The organization shall establish quality
objectives at relevant functions, levels and
Where are the quality objectives
processes needed for the quality management
documented and are these at all relevant
system. The quality objectives shall:
functions, levels and processes?
(OPCR/DPCR)
a) be consistent with the quality policy;
Are they consistent with the quality policy?
b) be measurable; Are they measureable?
Do they consider applicable requirements?
c) take into account applicable requirements;
Are they relevant to the conformity of
d) be relevant to conformity of products and products and services and do they enhance
services and to enhancement of customer customer satisfaction?
satisfaction;
Are they monitored? How? How often?
e) be monitored; How are they communicated?
How are they updated?
f) be communicated;
Where is the documented information on the
g) be updated as appropriate. quality objectives?
The organization shall maintain documented
information on the quality objectives.
6.2.2 When planning how to achieve its quality
objectives, the organization shall determine:
a) what will be done;
b) what resources will be required; How does the organization determine the
actions, required resources, person
responsible, completion time, and evaluation
c) who will be responsible; process to achieve the quality objectives?
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes
When the organization determines the need for
changes to the quality management system, the
changes
shall be carried out in a planned manner (see 4.4).
The organization shall consider:
How are changes to the QMS
planned/documented?
a) the purpose of the changes and their potential
Demonstrate the purpose and potential
consequences;
consequences of changes;
Demonstrate the integrity of the QMS;
b) the integrity of the quality management system;
Demonstrate how resources are made
available?
c) the availability of resources;
Demonstrate how responsibility and
authority is allocated or reallocated.
d) the allocation or reallocation of responsibilities
and authorities.
7.1 Resources
7.1.1 General
How does the organization determine and
The organization shall determine and provide the provide the resources needed for
establishment, implementation, maintenance
resources needed for the establishment,
and continual improvement of the QMS.
implementation, maintenance and continual
improvement of the quality management system.
The organization shall consider:
How does the organization determine the
a) the capabilities of, and constraints on, existing capabilities and constraints of existing
internal resources;
internal resources and what needs to be
obtained from providers for the improvement
b) what needs to be obtained from external of the QMS?
providers.
7.1.2 People
How do you determine and provide
competent personnel to consistently meet
The organization shall determine and provide the
customer needs and applicable statutory
persons necessary for the effective
and regulatory requirements for the QMS
implementation of its quality management system
processes?
and for the operation and control of its processes.
7.1.3 Infrastructure
The organization shall determine, provide and
maintain the infrastructure necessary for the
operation
of its processes and to achieve conformity of
products and services.
NOTE Infrastructure can include: How do you determine, provide, and
a) buildings and associated utilities; maintain
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.
7.1.4 Environment for the operation of processes
The organization shall determine, provide and
maintain the environment necessary for the
operation of its processes and to achieve
conformity of products and services.
NOTE A suitable environment can be a
combination of human and physical factors, such
as:
a) social (e.g. non-discriminatory, calm, non-
confrontational); (HR)
b) psychological (e.g. stress-reducing, burnout
prevention, emotionally protective) ;(HR)
c) physical (e.g. temperature, heat, humidity, light,
airflow, hygiene, noise).
These factors can differ substantially depending
on the products and services provided.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The organization shall determine and provide the Usage of measuring devices such as:
resources needed to ensure valid and reliable
results when monitoring or measuring is used to
verify the conformity of products and services to
requirements.
The organization shall ensure 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.
The organization shall retain appropriate
documented information as evidence of fitness for
purpose of
the monitoring and measurement resources.
7.1.5.2 Measurement traceability
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, measuring
equipment shall be:
a) calibrated or verified, or both, at specified
intervals, or prior to use, against measurement
standards
traceable to international or national measurement
standards; when no such standards exist, the
basis used for calibration or verification shall be
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.
The organization shall determine if the validity of
previous measurement results has been adversely
affected when measuring equipment is found to be
unfit for its intended purpose, and shall take
appropriate action as necessary.
How do you determine necessary
7.1.6 Organizational knowledge knowledge for the operation of processes?
The organization shall determine the knowledge How do you determine necessary
necessary for the operation of its processes and to knowledge to achieve conformity of products
achieve conformity of products and services. and services?
How do you maintain this knowledge and
This knowledge shall be maintained and be made
how do you make it available to the extent
available to the extent necessary.
necessary?
When addressing changing needs and trends, the
organization shall consider its current knowledge
and determine how to acquire or access any
necessary additional knowledge and required
updates.
NOTE 1 Organizational knowledge is knowledge
specific to the organization; it is generally gained
by
experience. It is information that is used and
shared to achieve the organization’s objectives.
How do you consider current knowledge and
NOTE 2 Organizational knowledge can be based how do you acquire additional knowledge
on: when addressing changing needs and
trends?
a) internal sources (e.g. intellectual property;
knowledge gained from experience; lessons
learned from failures and successful projects;
capturing and sharing undocumented knowledge
and experience; the results of improvements in
processes, products and services);
b) external sources (e.g. standards; academia;
conferences; gathering knowledge from customers
or external providers).
8.1 Operational planning and control
The organization shall plan, implement and control
the processes (see 4.4) needed to meet the
requirements for the provision of products and
services, and to implement the actions determined
in Clause 6, by:
a) determining the requirements for the products
and services; How are processes needed to meet
requirements for provision of products and
services planned, implemented and
b) establishing criteria for:
controlled?
1) the processes; 1. How do you determine the
requirements for your
services?
2) the acceptance of products and services;
2. How is criteria for processes
and acceptance for services
c) determining the resources needed to achieve determined?
conformity to the product and service
requirements; 3. How are resources determined
to achieve service reqt’s?
d) implementing control of the processes in
accordance with the criteria; 4. Do you have a documentation
of your Service process/es?
How are they maintained?
e) determining, maintaining and retaining 5. How do you ensure that
documented information to the extent necessary: processes have been carried
out as planned and can
demonstrate conformity of
services?
1) to have confidence that the processes have
been carried out as planned;
2) to demonstrate the conformity of products and
services to their requirements.
How have you determined that the output
The output of this planning shall be suitable for the
from the planning process is suitable for
organization’s operations.
your operations?
Do you have a method for controlling
changes?
The organization shall control planned changes How do you control planned changes?
and review the consequences of unintended
changes, How do you review the consequences of
taking action to mitigate any adverse effects, as unintended changes?
necessary.
What action is taken to mitigate any adverse
effects?
The organization shall ensure that outsourced
How do you control outsourced processes?
processes are controlled (see 8.4).
8.5 Production and service provision
8.5.4 Preservation
How do you ensure preservation of process
The organization shall preserve the outputs during outputs during production and service
production and service provision, to the extent provision to maintain conformity to product
necessary to ensure conformity to requirements. requirements?
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs
that do not conform to their requirements are
identified and controlled to prevent their
How do you identify and control process
outputs, products and services that do not
unintended use or delivery. conform to requirements and prevent their
unintended use or delivery?
What appropriate corrective actions are
The organization shall take appropriate action taken based on the nature of the
based on the nature of the nonconformity and its nonconformity and its impact on the
effect on the conformity of products and services. conformity of products and services? How
This shall also apply to nonconforming products
and services detected after delivery of products, do you apply this to nonconformity detected
during or after the provision of services. after delivery?
How you deal with nonconforming process
The organization shall deal with nonconforming outputs, products and services in terms of:
outputs in one or more of the following ways:
Correction;
a) correction; Segregation, containment, return or
suspension of provision of products and
services?
b) segregation, containment, return or suspension
of provision of products and services;
Informing the customer?
c) informing the customer; Obtaining authorization for use as-is?
Release, continuation or re-provision of the
d) obtaining authorization for acceptance under products and service?
concession.
Acceptance under concession?
Conformity to the requirements shall be verified
when nonconforming outputs are corrected.
How do you verify conformance where
process outputs, products and services are
corrected following nonconformance?
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
Show me how you determine:
The organization shall determine:
What needs to be monitored and measured?
a) what needs to be monitored and measured; Methods for monitoring, measurement,
analysis and evaluation to ensure valid
results?
b) the methods for monitoring, measurement,
analysis and evaluation needed to ensure valid When to perform monitoring and
results; measuring?
When results shall be analysed and
c) when the monitoring and measuring shall be
evaluated?
performed;
d) when the results from monitoring and
measurement shall be analysed and evaluated.
The organization shall evaluate the performance Show me how you evaluate the quality
performance and the effectiveness of the
and the effectiveness of the quality management
QMS.
system.
The organization shall retain appropriate
documented information as evidence of the What documented information can you
results. show me that monitoring and measurement
activities have been implemented in
accordance with determined requirements?
How do you monitor customer perception of
the degree to which requirements have been
9.1.2 Customer satisfaction met?
The organization shall monitor customers’ How do you obtain information relating to
perceptions of the degree to which their needs customer views and opinions of your
and expectations have been fulfilled. The products and services?
organization shall determine the methods for
obtaining,
monitoring and reviewing this information.
What methods for obtaining and using this
information do you have?
10.1 General
10.2
10.3 Continual improvement
The organization shall continually improve the Demonstrate that you continually improve
suitability, adequacy, and effectiveness of the
quality management system. the suitability, adequacy and effectiveness
of the QMS.
The organization shall consider the results of Demonstrate that outputs of analysis and
analysis and evaluation and the outputs from
management review, to determine if there are evaluation and the outputs from
needs or opportunities that shall be addressed as management review are considered to
part of continual improvement. confirm if there are areas of
underperformance or opportunities that shall
be addressed as part of continual
improvement.
Nero M. Austero
IQA Lead Auditor
Date:
