SMIS-AGS 23-P, Commercial Zone, Gate 9, Defence

Road, Valancia Town, Lahore-Pakistan.

E-Mail: info@smis-ags.com | ags.pakistan@gmail.com
www.smis-ags.com Tel: 0300-8425587 | 0321-8425587

A SS E SS M E N T P R O G R A M M E
COMPANY

CONTACT PERSON
CLIENT NUMBER
Mr. Sohail (Manager
AGS-P-120064-Q
QC)
AUDITOR
KHALID MAHMOD (L.A),
DOCTOR ASMA
VIQAR (L.A),
MUHAMMAD FARHAN (A),
MUHAMMAD ALI (OBS)

Medisave Pharmaceuticals
ASSESSMENT CRITERIA
ISO 9001:2008 QMS

SCOPE: Manufacturing of Pharmaceutical Products (By Way of Formulation)

Assessment Date: Friday (27 June 2014)
Time * 1

Area /
Department

10:00 AM

Opening Meeting

10:30 AM

MR

11.00 AM

MR

MR, Dept. Heads

Confirmation of scope, System Changes

since last visit, Issues from last report
including outstanding Nonconformances
Documentation, Quality manual, SOPs,
Records, Master Folder
Management Commitment, Customer
Focus , QMS Planning, Responsibility ,
Authority, Communication & Accountability,
Management Representative Quality Policy /
Objectives & Targets, Management Review
(Input & Output), Resource Management,
Competence, Awareness & Training,
Infrastructure & Work Environment (Noise,
Humidity, Lux & Temperature, Weather)

13:00
PM

MR

MR, HR, Technical

Manager,

Prayer & Lunch Break

MR, QCL, Purchase

15:00 PM

MR, Maintenance,
Sales & Marketing

16:00 PM

MR/QC

16:30 PM

Recommended
Auditee * 3

Auditor on Site

10:15 AM

14:00 PM

Some Key Considerations * 2

Closing Meeting

17:00 PM

Title: Audit Plan

Purchase & Inventory, Control Of Measuring

& Monitoring Devices , Testing , Calibration,
Equipment Management, Work Environment
Identification & Traceability, Maintenance
System, Work Control, Customers
Satisfaction (Customer complaints &
Feedback), Planning, control, determination
& review of customer requirements
communication,
Monitoring and Measurement of processes
Analysis of data, Improvement, Internal
Audit, Control of Nonconforming product,
Corrective and Preventive action
Lead Auditor will present Assessment
findings to the management,

Chief Chemist (Lab

Incharge)
MR, Store /
Inventory Incharge,
Production

MR, DMR
Audit /Head of Dept.,
MR

Auditor Leave On Site

Revised Date: 27/8/13

Form No: QMS-AP-14

Page 2

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SMIS-AGS 23-P, Commercial Zone, Gate 9, Defence

Road, Valancia Town, Lahore-Pakistan.
E-Mail: info@smis-ags.com | ags.pakistan@gmail.com
www.smis-ags.com Tel: 0300-8425587 | 0321-8425587

NOTE:

*1 Time may vary according to audit trail, however all concerned auditee are required to be present on specified
time as its important aspect of the audit.
*2 These are minimum considerations and the auditor is not bound to restrict to these only

`
*3 They must be present in addition to other required staff
Important Instructions:
Please circulate this Audit Plan to all department heads and get their receiving
Please ensure timely availability of all concerned as mentioned
During the audit ensure availability of maximum staff at place of work
Opening & Closing meetings to be held on time (as mentioned above), where all dept. heads
are to be present.
5. During the Opening Meeting all dept. heads are to bring one copy of this Assessment / Audit
Plan with them

1.
2.
3.
4.

Title: Audit Plan

Revised Date: 27/8/13

Form No: QMS-AP-14

Page 2

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