AUDIT CHECKLIST

SUPPORT ISO Mandatory &

ISO 9001:2015 CLAUSE & Organizational Approved
C / NC / O
REQUIREMENTS Requirements Documented

IT
NOTES
Information
6. PLANNING
6.1 - Actions to address risk and opportunities
1. Risks & Opportunities determined? 1. Process FMEA &
Issues & interested
Dept-FMEA-Process-
Issues & Requirements of Interested Parties
C parties risks;
2. Actions to address risk
Assurance of QMS effectiveness & improvement & effectiveness
2. Actions to address these risk?
6.2 - Quality objectives and planning to achieve
them
Approved Process KRA &
Established at relevant functions, levels & processes
Measurable & Monitored?
C Objectives relevant to Quality Objectives
functions
Communicated & updated?
Documented Information (KRA)
6.3 Planning of changes - Any Changes? C
7. SUPPORT
7.1.3 Infrastructure INCLUDED IT
Determine/Provide infrastructure? Maintained? ML-05 Facilities, PM/CM BECAUSE OF THE
P Plan, LETTER "D" LISTED
IN THE STANDARD
7.1.4 Environment for the operation of processes Environment
Requirement
P Temp Range controlled
room? Radioactive
room? Hygiene room?
7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented Information

Documented
7.5.1 General
information
a. Documented information required by ISO C ML-01, ML-02, ML-03,
determined by the
b. Documented Information required by Osmak QMS organization
7.5.2 General Creating and updating
a. Identification & Description (Number, Title, Date)
C DCRF
b. Format (PDF,…) Media (Paper, E-doc)
c. Reviewed & Approved?
7.5.3 - Control of documented information a. Protection
1a) it is available and suitable for use, where and b. distribution, Access,
when it is needed; Retrieval
1b) it is adequately protected (e.g. from loss of c. Version,
d. Retention &
confidentiality, improper use, or loss of integrity). Disposition
address the following activities, as applicable: Storage (Records Room) ACCESS OF HIMS
a) distribution, access (e docs - view, review, External Doc edition
approve), retrieval and use;
C -- IT SECTION HAS
ITS RECORD
b) storage and prevention, including preservation of
legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
External Documented Information identified &
controlled (edition)
8. OPERATION
(Quality Plan & Documented
8.1 Operational planning and control Procedures), information that
Plan, Implement & Control processes (see 4.4) and PM Plan, Calibration Plan, processes are
implement actions (see Clause 6): requirements, CS Survey Plan, carried out as
criteria, resources, implementing control, determine,
P Hiring & Trainng Plan planned and
maintain, retain documented information. PPMP & APP, demonstrate
Outsourced processes are controlled. AIP, Budget & CO conformity of the
Control of Ext Processes product/service
8.2 Requirements for products and services
8.2.1 Customer Communication shall include: * Services Information
a. information relating to services (Citizens' Charter, Portal, ARTA; LIST OF
b. handling enquiries P ...) SERVICES
c. Customer feedbacks & complaints * Customer Feedbacks & OFFERED
d. handling & controlling customer property Complaints

Determine (checklist)
8.2.2 Determining requirements for products and
services
P Requirements prior to
accepting
 8.2.3 - Review of the requirements and for products
and services
Ensure ability to meet the requirements by conducting a
review :
a) requirements specified by the customer,
Checklist records
b) requirements not stated by the customer, Records of review
c) requirements specified by the organization;
P confirmation before
of requirements
acceptance
d) statutory and regulatory requirements applicable to
the product and services;
e) contract and order requirements differing from those
previously expressed.
Retain Documented Information (checklist Records)
Amended or new
8.2.4 Changes to requirements for services P requirements
8.3 Design and Development of products and
services
P
8.4 Control of externally provided processes,
products (goods) and services
Results of
evaluation,
* Controls (Service selection,
Data Service Reports/ monitoring of
8.4.1 General Outputs of Service performance and re-
Determine controls to be applied Providers /Suppliers) evaluation of
Determine & apply criteria for the evaluation, P * Criteria for Selection external providers;
selection, monitoring of performance & re-evaluation (BAC) HRDM HAS AN
Retain documented information * Evaluation of OUTSOURCED
Suppliers/Service SERVICE PROVIDER
Providers THAT KEEPS THE
OLD CHARTS OF
THE HOSPITAL
8.4.2 Type and extent of control
Define controls to external provider & to the resulting
output
Control Types &
Take into consideration the effectiveness of the P Verification of Outputs
controls applied by the external providers
Determine the verification to ensure meeting the
requirements
8.4.3 Information for external providers
* TOR & Service
Ensure adequacy of requirements and communicate Contracts Requirements
the: * Competence &
goods & services (PR Worksheet) to be provided,
P
Qualification of persons TAKE NOTE THAT
approval, competence, interactions with osmak, * Interaction with process HR WILL ONLY
verfication activites owners COVER "F" ONLY
8.5 Production and service provision
 Conformity to
Controlled conditions
(evidenced by records):
8.5.1 Control of production and service provision * Implementaion of
Implement services under controlled conditions: procedural steps
Records of the
a. availability of documented information (activities & * Result of Measurement
product/services
results needed) (devices) & Monitoring
provided or the
* Use of Equipment &
b. measuring resources & activities P Facilities
activities to be
c. infrastructure & environment performed; and the
* Delegation of
d. competent personnel results to be
competent persons
e. validation & revalidation (panic values) achieved
* Validation &
f. releasing of results revalidation of panic
values
* Releasing of outputs,
delivery & post delivery
Means of Identifying of
Records of
Status of outputs (labels
8.5.2 Identification and traceability traceability; ALSO
& batches) & Unique
unique identification of status of outputs ACCESS HIMS
Identification of Outputs
RECORD
(Traceability)
8.5.3 Property belonging to customers and external Record on the
providers Reports on what has
Identification, protection
Identify, verify, protect & safeguard customers or P of customer properties
occurred; ALSO
external providers property (equipment, specimen, KEEPS YELLOW
personal data) CARD & OTHER IDS
8.5.4 Preservation Identification, handling,
identification, handling, packaging, storage, contamination, expiration,
transportation & protection of outputs (goods & packaging, storage & DYE-CONTRAST
results) transmission of outputs USED
Control of
8.5.6 Control of changes in service provision
changes -results of
Review & Control of changes in services C Changes if any
reviews, re-
Retain documented information evaluation
9. PERFORMANCE EVALUATION
9.1 Monitoring, measurement, analysis and
evaluation

9.1.1 General Evidence of

Retain documented information on the results of Results of the KRA monitoring and
monitoring (monthly KRA, temp, calibration/
P periodic monitoring measurement
maintenance,…) results
 9.1.3 Analysis and evaluation
analyse and evaluate appropriate data and information
arising from monitoring and measurement.
a) Conformity of products and services;
b) The degree of customer satisfaction; Data Analyses:
c) The performance and effectiveness of the quality KRA, CSS results, NCs,
management system; P Effectiveness of Risk
d) If planning has been implemented effectively; actions, performance of
e) The effectiveness of actions taken to address risks external providers
and opportunities;
f) The performance or external providers;
g) The need for improvement to the quality management
system

10 IMPROVEMENT
10.1 General
determine and select opportunities for improvement and P
implement any necessary
10.2 - Nonconformity and corrective action
Correction of NC Evidence of
CPARS & Effectiveness of results of corrective
Corrective Action & effectiveness (CPAR) P actions action and nature of
Update risks & opportunities NC
Retain documented information
10.3 Continual improvement
consider the results of analysis and evaluation, and the
outputs from management review, to determine if there
P
are needs or opportunities