AUDIT CHECKLIST

OPERATION
ISO Mandatory &

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

4. CONTEXT OF THE ORGANIZATION

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
Established at relevant functions, levels & processes Approved Process KRA
Measurable & Monitored? C & Objectives relevant to Quality Objectives
Communicated & updated? functions
Documented Information (KRA)

6.3 Planning of changes - Any Changes? C

7.3 Awareness

7.4 Communication

7.5 Documented Information

7.5.1 General Documented
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)
b. Format (PDF,…) Media (Paper, E-doc)
C DCRF
c. Reviewed & Approved?
 7.5.3 - Control of documented information a. Protection
1a) it is available and suitable for use, where and when it is b. distribution, Access,
needed; Retrieval
1b) it is adequately protected (e.g. from loss of confidentiality, c. Version,
d. Retention &
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, approve), C External Doc edition IT SECTION HAS ITS
retrieval and use; 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 &
8.1 Operational planning and control Procedures), Documented
Plan, Implement & Control processes (see 4.4) and implement PM Plan, Calibration information that
Plan, processes are carried
actions (see Clause 6): requirements, criteria, resources,
implementing control, determine, maintain, retain documented
P CS Survey Plan, out as planned and
Hiring & Trainng Plan demonstrate
information. PPMP & APP, conformity of the
Outsourced processes are controlled. AIP, Budget & CO product/service
Control of Ext Processes
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 C ...)
SERVICES OFFERED
c. Customer feedbacks & complaints * Customer Feedbacks &
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
 Results of
* Controls (Service evaluation, 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 external
Determine & apply criteria for the evaluation, selection, P * Criteria for Selection providers; HRDM HAS
monitoring of performance & re-evaluation Retain documented (BAC) AN OUTSOURCED
information * Evaluation of SERVICE PROVIDER
Suppliers/Service THAT KEEPS THE
Providers 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 controls P Verification of Outputs
applied by the external providers
Determine the verification to ensure meeting the requirements
* TOR & Service
8.4.3 Information for external providers Contracts Requirements
Ensure adequacy of requirements and communicate the: * Competence &
goods & services (PR Worksheet) to be provided, approval,
P Qualification of persons TAKE NOTE THAT
competence, interactions with osmak, verfication activites * Interaction with process HR WILL ONLY
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
a. availability of documented information (activities & results * Result of Measurement Records of the
needed) (devices) & Monitoring product/services
* Use of Equipment & provided or the
b. measuring resources & activities P Facilities activities to be
c. infrastructure & environment * Delegation of performed; and the
d. competent personnel competent persons results to be achieved
e. validation & revalidation (panic values) * 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
unique identification of status of outputs
P & batches) & Unique
ACCESS HIMS
Identification of Outputs
RECORD
(Traceability)

8.5.3 Property belonging to customers and external Record on the

Reports on what has
providers Identification, protection
occurred; ALSO
Identify, verify, protect & safeguard customers or external of customer properties
KEEPS YELLOW
providers property (equipment, specimen, personal data) CARD & OTHER IDS
 Identification, handling,
8.5.4 Preservation contamination,
identification, handling, packaging, storage, transportation & P expiration, packaging,
protection of outputs (goods & results) storage & transmission DYE-CONTRAST
of outputs USED
Post delivery activities:
8.5.5 Post-Delivery activities Customer feedback &
Requirements for post-delivery activities (claiming of results) legal requirements,
including customer feedbacks, validity & expiration
P Warranty & Maintenance MEDICAL
contractual obligations (maintenance, disposal) services, Final disposal CERTIFICATE WITH
(safety & environment) DRY SEAL
8.5.6 Control of changes in service provision Control of changes
Review & Control of changes in services C Changes if any -results of reviews,
Retain documented information re-evaluation
8.6 Release of products and services Evidence of
Implement release of products and services to the customer conformity and
Release of outputs
shall not proceed until the planned arrangements have been traceability to
(product & services) by
persons authorizing
satisfactorily completed, unless otherwise approved by a P relevant authority,
the release; MSS FOR
relevant authority and as applicable, by the customer. conformity and
REFERRALS AND
Retain documented information (conformity with criteria & traceability
CASH FOR OFFICIAL
traceablity to the person authorizing the release) RECEIPT
8.7 - Control of nonconforming outputs
outputs that do not conform to their requirements are identified
and controlled to prevent their unintended use or delivery Segregation, return of Records of
Correction, segregation, informing customer, authorization for P product, labelling & nonconformity, action
concession actions taken taken concessions
Verfication needed upon correction & retain documented
information (nonconformity, actions, concession, authority id)
9. PERFORMANCE EVALUATION
9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General Evidence of

Results of the KRA
Retain documented information on the results of monitoring P periodic monitoring
monitoring and
(monthly KRA, temp, calibration/ maintenance,…) measurement 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 and external providers
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 results
CPARS & Effectiveness
Corrective Action & effectiveness (CPAR) P of actions
of corrective action
Update risks & opportunities and nature of 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 are needs or
P
opportunities