FOR B.PHARM SEMESTER 7

1. ISO : International organization
for standardization
By: Kirankumar Solanki

2. Introduction
 ISO-‘International Organization for Standardization’.
 ISO is an independent, non-governmental international
organization with a membership of 164 national
standards bodies.
 It is worlds largest developer & publisher of
International standards.
 Through its members, it brings together experts to
share knowledge and develop voluntary, consensus-
based, market relevant International Standards that
support innovation and provide solutions to global
challenges.

3. History of ISO
 In 1946, delegates from 25 countries met at the
Institute of Civil Engineers in London and
decided to create a new international
organization ‘to facilitate the international
coordination and unification of industrial
standards’.
 On 23 February 1947 the new organization, ISO
officially began operations in Geneva,
Switzerland.

4. Benefits of ISO:
 ISO International Standards ensure that products
and services are safe, reliable and of good
quality.
 For business, they are strategic tools that reduce
costs by minimizing waste and errors and
increasing productivity.
 They help companies to access new markets,
level the playing field for developing countries
and facilitate free and fair global trade.

5. ISO series
 ISO 9000 : It is a guide, it includes Quality
management systems Fundamentals and
vocabulary.
 ISO 9001 : Set of Requirements for Quality Management
Systems.
 ISO 9002 : Set of standards for products.
 ISO 9003 : Final inspection & testing.
 ISO 9004 : Guidelines for developing & implementing
quality system principles, auditing and review. Or
Management for the sustained success of an organization
- A quality management approach.
 ISO 14000 : It is a family of standards related to
environment management.

6. ISO 9000 Series
 Definition : It is a series(family) of standards, developed
and published by ISO that define, establish & maintain an
effective QA system for manufacturing & service
industries.
 There are various revisions happened in the ISO 9001
series.
 ISO 9001 : 1987. -1st edition.
 ISO 9001 : 1994. - Focus more on QA less on quality
inspection.
 ISO 9001 : 2000.- Revision on importance of process
management & stakeholder needs.
 ISO 9001 : 2008.- Added ISO 9004:2009 ”Managing for
sustained success”
 ISO 9001 : 2015.- Focus on PDCA at all levels of organization
system management.

7. Benefits of ISO 9000 series
 Improved controls, discipline (eg. Prevents
duplication of activities & shortcuts), procedures,
documentations, communication, dissemination &
customer satisfaction, quick identification and
solution of problems, greater consistency(i.e job is
done the same way everytime).
 Reduction in errors, customer complaints & non-
conforming products, cost, and retention of
customers.
 Liberalization of trade through common rules &
language.
 Responsibility of quality issues is placed where it
belongs, with the supplier & not the customer.

8. Benefits of ISO 9000 series
 Reduction in the number of customer audits, also
reduction in time taken for the audit which saves
resources needed for such activities.
 Identification of ineffective and surplus procedures &
documents and other unwanted things.
 It creates a better working environment.

9. ISO registration
 ISO itself doesn’t conduct audit and provide
certificate.
 ISO only prepares the standards.
 ISO registration is not mandatory.
 The organization can implement them for the
internal benefits without spending money on a
certification program.
 Most trusted accreditation agency in India for ISO
registration is NABCB (National accreditation
board for certification bodies).
 Most trusted agency for training in ISO standards
is NBQP (National board for quality promotion).

10. Steps for ISO registration
1. Top management considers ISO registration.
2. Training of personnel.
3. Prepare quality manual & policy.
4. Prepare operating procedures.
5. Hold internal audit.
6. Selection of registrar.
7. Go through registration process.
8. Obtain ISO 9000 certificate.

11. Steps for ISO registration
1. Top management considers ISO
registration.
 Quality steering committee meets to evaluate
process.
 Committee informs top management about ISO 9000
costs, schedules etc.
 Top management commits to get ISO registration.
2. Training of personnel.
 Hold basic quality and ISO 9000 training for
employees.
 Select and train personnel to be internal auditor.

12. Steps for ISO registration
3. Prepare quality manual & policy.
 Study and understand ISO 9000 requirements as
they apply to your company.
 Write (or re-write) company Vision and Mission
statements.
 Write basic Quality Policy Manual outline.
 Complete first draft of Quality Policy Manual.
 Send copy of manual to customer desiring ISO
9000 compliance (if necessary).

13. Steps for ISO registration
4. Prepare Operating Procedures.
 Define responsibilities, using Quality Manual as a
guide.
 Have those responsible for functions, outline
their procedures.
 Interview managers and fine-tune procedures.
 Compare Operating Procedures with Quality
Manual for consistency.

14. Steps for ISO registration
5. Hold internal audit
 Hold internal audit of ISO 9000 manual &
compare if it comply with ISO 9000
requirements.
 Implement corrective action items from audit.
6. Selection of registrar
 Research registrars and their cost.
 Qualify possible registrars.
 Select third party registrar.

15. Steps for ISO registration
7. Go through registration process.
 Apply for registration and audits.
 Create an agreement/contract of audit process etc. with
registrar.
 Hold the (stage 1) pre-assessment audit.
 Take corrective action suggested by auditor.
 Have ISO 9000 registration audit (stage 2).
 Take corrective action suggested by auditor (if any).
 Auditor will assess whether all the corrective actions are
taken or not, if satisfied will make an ISO audit report of
compliance.
8. ISO 9000 certificate is obtained from the
registrar.