ISO 9001:2008

General:

The ISO 9001 is a quality management standard, it is built on

theory that Quality is achieved through implementing and
improving organizational activities and behaviors.
Aim:

1. The international standard is to enhance customer satisfaction

by meeting customer requirements.
2. It is used to assess the organizational ability to meet customer,
statutory and regulatory requirements applicable to the
product, and the organizations own requirements.
Principles:

1. Customer Focus, 2. Leadership, 3. Involvement of people, 4.

Process Approach,
5. System approach to management, 6. Continual Improvement,
7. Factual Approach to decision making, 8. Mutual beneficial
supplier relationship
Process Approach:
Departme
nt

Process
Responsibility

Accounts

Pricing, Customer
accounts, Cash
dispensation.
Order Taking, Order
Processing,
Customer Service,
Sales Recovery &
Refunds.
Market Analysis,
Business Analysis,
Promotional

Sales

Marketing

ISO
Standards
Requireme
nts

Legal
Requireme
nts
Drug Law
2012,

The drugs
Labeling &
Packing

Goals

Form
s

Retail Sales

activities, Product
development.
Retail Shops
business
development,
Hiring-Training &
Retail Operations.

Production

Product realization
from RM to Packing

Stores

Goods stores
inventory receipt
to Dispatch.
Recycle and
discard materials.
Induction, training,
performance
evaluation,
compensation
QA, R&D,
Standards and
their assurance.
Tests and reports.
Listing, evaluation,
contracts,
purchase, quality &
price comparison.
Documentation &
on-ground
comparison.

HR

QA

Purchase

Audit &
Records

Rules. Drug
Law 2012,
Shop &
Hakim
registration,
Drug Law
2012, Shop
Act
Drug Law
2012, Health
& Sanitation
Dept. Labor
Dept. Weight
& Measures,
Market
Committee.
GMP
Fire Safety
rules,
Stacking &
storage
rules.
Labour Laws,
PESSI, EOBI.

Drug Law
2012, GMP

System approach to Management:

1. Management Processes. The processes of planning and providing resources
for basic and supporting processes, and monitoring and measuring overall
performance of the quality management system and customer satisfaction.

Management responsibility. The process of defining responsibilities,

policies, and strategies for the organization.
Resource Management. The process where top-level management
provides financial and other resources in order to ensure the execution of
these processes.
Measurement, analysis and improvement. The process where
management demonstrates
conformance with requirements for product (e.g., Procedure for Control of
Non-Conforming Product and Procedure for Measuring Customer
Satisfaction), process (e.g., Matrix of Key Performance Indicators),
conformance with the quality management system (e.g., Procedure for
Internal Audit), and continual improvement (Procedure for Corrective and
Preventive Action).
2. Basic and Support Processes. The processes providing the added value; they
meet customer
requirements and provide customer satisfaction.
Marketing and business analysis. The process of finding a way to
discover unfulfilled customer needs and bring to market products and
services that satisfy those needs.
Sales and customer service process. It includes series of activities,
from recording the customers request to delivery of product and service.
Design and development process. The process of designing and
developing a new product or service according to customers
requirements or market surveys.
Purchase process. The process of acquiring necessary resources for the
execution of the
Production and Service Provision process.
Production and service provision. One of the main processes that
create value for
your organization.
Stores and dispatch/ receiving process. The process of storing
finished products prior to transport and receipt of raw materials necessary
for production.
Accounts and Costing. Customer billing and their recoveries. Costing
and in turn put price to the products.
Quality assurance process.
3. Outsourced Processes. The processes that the organization needs for its
Product realization and maintenance of equipment; which the organization
chooses to have performed by an external party.
Printing and containers.
Overproduction.
Transportation. A process of delivery of products to customers.

Equipment calibration and maintenance. The process of maintaining

equipment through preventive maintenance and repairs in order to
prevent production halt due to malfunctioning.

Factual approach to decision making

1. Mandatory Documents ISO 9001 Clause
Quality Manual 4.2.2
Quality Policy Statement 5.3
Quality Objectives Statements 5.4.1
Control of Documents 4.2.3
Control of Records 4.2.4
Internal Audit 8.2.2
Control of Non-Conforming Product 8.3
Corrective Action 8.5.2
Preventive Action 8.5.3
2. Mandatory Records ISO 9001- Clause
Management Review 5.6
Education, Training Skills & Experience 6.2.2
Evidence that Processes and Product Meet Requirements 7.1
Review of Requirements Related to the Product 7.2.2
Inputs Related to Product Requirements 7.3.2
Design and Development Reviews 7.3.4
Design and Development Verification and Action 7.3.5
Design and Development Validation and Actions 7.3.6
Review of Design and Development Changes 7.3.7
Evaluation of Supplier Selection 7.4.1
Identification and Traceability 7.5.3
Results and Standards for Equipment Calibration and Verification 7.6
Internal Audit Records and Results 8.2.2
Release of Product to Customer 8.2.4
Nonconformities and Actions Taken 8.3
Results of Corrective Actions 8.5.2
Results of Preventive Actions 8.5.3
3. Documented Procedures ISO 9001- Clause
Purchasing 7.4
Design 7.3
Production/Service Operations 7.5
Monitoring & Measurement 8.2
Sales (Customer-Related Processes) 7.2
Customer Satisfaction 8.2.1
Management Review 5.6

Suggested List of ISO Training Attendees

Sales: Kashif Mahyudin, Abdul Ahad, Badar.

Marketing: Yousaib.
Production: Hanif, Jahangir.
Store: Umer, Abid.
HR: Adeel.
QA: Fatima.
Accounts: Muaz, Ejaz.
Audit: Shahbaz, Mohsin.

Vision:

Mission:

Quality Policy:

Quality Objectives: