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DATE OF AUDIT:
REFERENCE NUMBER:
COMPANY AUDIT AREA QUESTION POSED COMPLIANCE OBSERVATION EVIDENCE
REFERENCE YES/NO PROVIDED
SECTION 1. DOCUMENTS AND RECORDS
1.1 MANUALS AND Are various types of
PROCESSES documents and records
maintained by the
organization?
Are documents and
records classified or
categorized according to
specific criteria?
Is there a designated
individual or team
responsible for managing
documents and records?
Are there legal or
regulatory requirements
in place for retaining
documents and records?
Is there a defined
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process for creating new
documents or records?
Are standardized
templates or formats
used for documents and
records?
Are documents and
records reviewed and
approved before
finalization?
Is there a system for
tracking revisions and
updates to documents?
Are access controls
implemented for
documents and records,
with designated
individuals granted
access?
Are procedures in place
to safeguard sensitive or
confidential information?
Are electronic documents
and records protected
against unauthorized
access or manipulation?
Are backup and disaster
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recovery procedures
established for critical
documents and records?
Is there a documented
policy for retaining
documents and records?
Are retention periods
determined based on
specific criteria?
Are procedures in place
for securely disposing of
obsolete or expired
documents and records?
Has the organization
encountered any
challenges related to
document retention or
disposal?
Are documents and
records maintained in
accordance with relevant
laws, regulations, and
standards?
Are errors or
discrepancies in
documents and records
promptly identified and
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corrected?
Are procedures in place
to validate the accuracy
and completeness of
documents and records?
Has the organization
undergone audits or
inspections related to
document and record-
keeping practices?
Are employees trained on
policies and procedures
for document and record
management?
Is awareness of
document and record-
keeping requirements
promoted within the
organization?
Are there ongoing
training initiatives related
to document and record
management?
Are employees
encouraged to participate
in professional
development activities
related to document and
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record management?
Does the organization
monitor compliance with
document and record-
keeping requirements?
Are internal audits or
reviews conducted to
assess the effectiveness
of document and record
management processes?
Are measures in place to
continuously improve
document and record-
keeping practices?
Are lessons learned from
past experiences or best
practices used to
enhance document and
record management?
What software or
systems are utilized for
document and record
management?
Are electronic signatures
or digital certificates used
for authenticating
documents and records?
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Are there any challenges
or limitations associated
with the technology
infrastructure for
document and record
management?
1.2 EFFECTIVENESS Are documents
processed with controls
in place to ensure
accuracy and
completeness?
Are procedures in place
to verify the authenticity
of documents?
Is there a system for
tracking changes or
revisions to documents,
along with approval
processes?
Is there a designated
person responsible for
assigning control
numbers to documents?
Are control numbers
assigned systematically
following predetermined
conventions?
Is there a centralized
registry or database for
managing control
numbers?
Is there a process for
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monitoring the use and
allocation of control
numbers?
Are control numbers
periodically audited to
identify gaps, duplicates,
or irregularities?
Are control numbers
linked to specific
documents, and is there
a tracing mechanism?
Are employees trained on
procedures for assigning
and managing control
numbers?
Are deviations from
control procedures
identified and addressed?
Are regular reviews or
audits conducted to
assess compliance with
control procedures?
Are measures in place for
continuous improvement
of control processes?
Are feedback
mechanisms used to
gather input on potential
enhancements to control
procedures?
Are lessons learned from
past experiences or
audits used to refine
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control mechanisms?
General Understanding:
Documentation Processes:
Access and Security:
Retention and Disposal:
Compliance and Accuracy:
Training and Awareness:
Monitoring and Improvement:
Technology and Tools:
Control of Document Processing:
Assignment of Control Numbers:
Monitoring of Control Numbers:
Compliance with Control Procedures:
Continuous Improvement:
