Study Set Content:
ISO is an independent, non-governmental
international organization with a membership of
(blank) national standards bodies, with a Central
Secretariat in
164
Geneva, Switzerland, that
coordinates the system
The current version of the standard is known as
the ISO 9000 series
call for integration for
all activities which have a direct or indirect effect
on the quality of a product or services
ISO 9000 series standards
It defines the basic concepts and specifies the
procedures and criteria to ensure that the
outgoing product meets
the customer’s
requirements
The quality standards are designed to be
user
friendly
ISO 9000 series standards tells the suppliers
and manufactures what is required of
quality-oriented working system
Areas Covered by ISO Standards
● Management
● Responsibility
● Quality system
● Contract Review
● Design Control
● Document Control
● Purchasing
● Purchaser’s Supplied Products
● Product Identification and Traceability
● Process Control
● Inspection and testing
● Inspection
● Measuring and Testing Department
● Inspection and Test Status
● Non-Conformity Control
● Corrective Actions
● Handling
● Storage
● Packing and Delivery
● Quality Records
● Internal Quality Audits
● Training
● Services and Statistical techniques
Benefits of ISO:9000
● It is an internationally accepted series of (blank)
● It helps in achieving (blank)
● It increases customers'(blank)
● It reduces the need for inspection by the (blank)
● The ISO certification by a company is a source of (blank)
quality standards.
consistency economy and cost effectiveness.
confidence.
buyers.
motivation.
Concept of Quality Control
● Refers to the process of striving to produce a
perfect product.
Requires a series of measures requiring an
organized effort
Prevent or eliminate errors at every stage in the
production.
The scientific groups formulated proposals and
guidelines for research in the field of drug
development.
WHO GUIDELINES
These reports also provided the basis for the
ICH GCP.
WHO GUIDELINES
To prevent defects with a focus on process
QA Focus
To improve development and test processes so that defects do not arise
Goal
To identify defects in the finished product
QC Focus
Establish a good QMS and assessment of its adequacy with continuous monitoring
QA How
Prevention of quality problems through planned and systematic activities
QA What
To identify defects after a product is developed and before it is released
QC goal
Finding sources of quality problems to continually meet customer's requirements
QC How
