ISO 9001 certification and Quality Management System

1. ISO 9001
V R A J K H A N D H A R A [ M . P H A R M ] | I P N U

2. POINTS TO BE COVERED
• Quality Management System
• ISO 9001
• ISO 9001 timeline
• Research Framework
• Benefits
• Revised ISO 9001
• New version
• Certification

3. ISO 9000 STANDARD
• The ISO 9000 family of quality management
systems standards is designed to help organizations ensure
that they meet the needs of customers and other stakeholders
while meeting statutory and regulatory requirements related
to a product or service.

4. ISO 9000 SERIES QUALITY
MANAGEMENT PRINCIPLES
Customer focus Leadership
Engagement of
people
Process
approach
Improvement
Evidence-based
decision making
Relationship
management

5. ISO 9001 STANDARD
• ISO 9001 deals with the requirements that organizations wishing to
meet the standard must fulfil.
• ISO 9001 is the international standard that specifies requirements for a
quality management system (QMS). Organizations use the standard to
demonstrate the ability to consistently provide products and services
that meet customer and regulatory requirements.

6. WHO IS ISO 9001 FOR ?
• ISO 9001 is suitable for organizations of all types, sizes and sectors.
• In fact, one of the key improvements of the newly revised ISO 9001:2015 was to make it
more applicable and accessible to all types of enterprises.
• Smaller companies that do not have staff dedicated to quality can still enjoy the benefits of
implementing the standard – ISO has many resources to assist them.

7. ISO 9001
TIMELINE
•Technical
committee 176
formed
1980
•First edition1987
•First minor
revision1994
•First major
revision2000
•Second minor
revision2008
•Second major
revision2015
From the start of the project to the initial
certification audit typically takes 6 months.
The time taken depends on the resources
committed to the project and the size and
complexity of the organisation, and it can be
as fast as 4 months.
“Instant Certification” is not possible due the
requirement for records that demonstrate use
of the quality system.
After the initial certification, the external
auditor will usually revisit after 6 months for a
surveillance audit. Thereafter, external audits
are conducted at least every 12 months, and
sometimes every 6 months – depending on
the business. After 3 years, a major re-
certification audit takes place to renew
the ISO 9001 certificate.
An internal audit is often scheduled 2-3
months prior to each external audit. This gives
you a chance to correct any problems prior to

8. RESEARCH FRAMEWORK
Product Innovation
Motivation for implementation
Region
Sector
Size
Standard version
ISO 9001
Adoption of ISO 9001
standard
ISO 9001 certification
Radical Product
Innovation
Incremental product
innovation

9. ISO 9001 BENEFITS
Benefits to
your
Organizatio
n
Reduces your
costs
Provides
continuous
assessment
and
improvement
Marketing
opportunities
Provides
senior
management
with an
efficient
management
process
Communicate
s a positive
message to
staff and
customers
Identifies and
encourages
more efficient
and time
saving
processes
Benefits to
your
Customer
Improved
quality and
service
Delivery on
time
Right first
time attitude
Fewer
returned
products
Independent
audit
demonstrate
s
commitment
to quality
Less
Complaints

10. WHY WAS ISO 9001 REVISED?
• All ISO standards are reviewed and revised regularly to make sure they remain relevant
to the marketplace.
• ISO 9001 has been updated to take into account the different challenges that businesses
now face.
• For example, increased globalization has changed the way we do business and
organizations often operate more complex supply chains, and there are increased
expectations from customers.
• ISO 9001 needs to reflect these changes in order to remain relevant.

11. NEW VERSION
ISO 9001:2015

12. BENEFITS FROM NEW VERSION
The new version of the standard brings the user a number of benefits.
ISO 9001:2015:
• Puts greater emphasis on leadership engagement
• Helps address organizational risks and opportunities in a structured manner
• Uses simplified language and a common structure and terms, particularly helpful to
organizations using multiple management systems
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organizations

13. KEY IMPROVEMENTS
Structure
• ISO 9001:2015 now follows the same overall structure as other ISO management
system standards (High-Level Structure), making it easier for anyone using multiple
management systems.
Focus on risk-based thinking
• This has always been part of the standard, but the new version gives it increased
prominence.

14. ISO 9001:2015 -- REQUIREMENTS
• ISO 9001:2015 specifies requirements for a quality management system
when an organization:
a) needs to demonstrate its ability to consistently provide products and
services that meet customer and applicable statutory and regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective application
of the system, including processes for improvement of the system and the
assurance of conformity to customer and applicable statutory and
regulatory requirements.
• All the requirements of ISO 9001:2015 are generic and are intended to be
applicable to any organization, regardless of its type or size, or the products
and services it provides.

15. CERTIFICATION OF ISO 9001
• With the right preparation and a good understanding of what is required for ISO
9001certification, most organisations can expect to achieve certification within 3 to 6
months depending on their size and complexity.
• At this stage it is vital to have someone (internal or external) who has experience of
implementing Quality Management Systems and who knows what is needed to achieve ISO
9001 certification.
• Once the groundwork has been done and the ISO 9001 Quality Manual has been
completed, you will be ready for your Stage 1 Audit.
• The assessor/auditor will check that your written Quality Management Systems meet the
requirements of the ISO 9001 Standard and match what you are actually doing and
highlight any areas of deficiency and potential improvement of the system.
• Once any required changes have been made, your organisation will then be ready for your
Stage 2 Certification Assessment. The assessor/auditor will check that you are working to
the requirements of Quality Management Systems and the ISO 9001 Standard. This may be
conducted by an independent 3rd party, UKAS Accredited Certification Body.
• ACS Registrars Ltd are a UKAS Accredited Certification Body.

16. The documentation will define:
• Organisation structure
• Who should record information and what information is recorded
• Responsibilities of employees
• Lines of communication throughout the company
• What actions are required
• How continuity will be maintained as staff change

17. MAINTAINING
Corrective and
preventive
measures
On-going
support and
training
Management of
Documentation
Regular Internal
Quality Auditing

18. N U M B E R O F
C E R T I F I C A T E S
0 20 40 60
Africa
North America
East Asia & Pacific
Africa
Central &
South
America
North
America
Europe
East Asia
& Pacific
Central &
South Asia
2017 4.3 3.6 36.8 48.5 3.6 1.9
2016 4.7 4 40.8 43.4 3.7 2.1
2015 4.8 4.5 42.5 40.9 3.9 2.2
2014 4.8 4 43.8 40 4.3 2.1
Regional Share – in %
201
7
201
6
Note for data in 2017: Decrease
of overall number of certificates
compared to 2016 due to a
reduction in the number of
certificates reported by some
data providers that changed
their way of reporting their data.
The decrease can be seen for
several countries and is
significant for Italy and
Germany.

19. WORKS CITED
• www.iso9001.com
• www.iso.org