2. What is ISO?
ISO is an independent, non-governmental international organization with a membership of 163
national standards bodies with a Central Secretariat in Geneva, Switzerland, that coordinate the
system
The ISO 9000 family of international quality management standards and guidelines has earned a
global reputation as a basis for establishing effective and efficient quality management systems.
3. Development of ISO 9000 Standards
• ISO 9000 standards were issued in 1987
• The revised and improved version were published in the year 2000
• ISO 9001:2008 was released in the year 2008, does not introduce new requirements, it clarifies
the existing requirements of ISO 9001:2000
• ISO 9001:2015 is released in the year 2015
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4. Quality System Standards
Standard Title Scope
ISO
9001-2015
Quality Management Systems-
Fundamentals and
vocabulary
Provides fundamentals of quality management system and
specifies quality management terms and definitions.
ISO
9001-2015
Quality Management Systems-
Requirements
Specifies requirements for a quality management system where
an organization needs to demonstrate its capability to
meet customer requirements for product and / or
services and assessment of that capability by internal
and external parties
ISO
9004:2009
Managing for the sustained
success of an
organization – A quality
management approach
Provides guidance for the continual improvement of an
organisation’s overall performance, efficiency and
effectiveness based on a process based approach. It
focuses on meeting the needs and expectations of
customers and other relevant parties, over the long term,
and in a balanced way. It focuses on how to make a
quality management system more efficient and
effective.
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5. Quality Management Principles
• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationship
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6. ISO 9001:2015 Quality Management System
The ISO 9001:2015 Quality Management System replaces the previous version ISO 9001:2008. ISO
9001:2015 consists of 10 clauses. Clauses 1 to 3 are basic clauses and Clauses 4 to 10 are main
clauses as shown below:
• Basic Clauses (1 to 3)
• Main Clauses (4 to 10)
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7. ISO 9001:2015
• 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 organisations using multiple management systems.
9. EMS- ISO 14000 series
• ISO 14000 is a series of environmental management standards developed and by ISO.
• The ISO 14000 standards provide a guideline or framework for organisations that need to
systemize and improve their environmental management efforts.
• ISO 14001:2015 Is intended for use by an organisation seeking to Manage its environmental
responsibilities in a systematic manner that contributes to the environmental pillar of
sustainability
11. ISO 14001:2015 Requirements
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
12. OHSMS (ISO 45001:2016)
An Occupational Health and Safety Management System (OHSMS) is a coordinated and systematic
approach to managing health and safety risks. OHSMAs help organisations to continually improve
their safety performance and compliance to health and safety legislation and standards.
13. Integrated Management System (IMS)
• IMS combines all related components of a business into one system for easier management and
operations. QMS, EMS and OHSMS are often combined and managed as an IMS.
• These systems are not separate systems that are later joined together, rather they are integrated
with linkages so that similar processes are seamlessly managed and executed without duplication
15. Certification Bodies
• ABS Group Inc.
• Banner Pharmacaps India Pvt. Ltd
• Bureau Veritas Quality International (BVQI)
• International Certifications Services (Asia) Pvt. Ltd (ICS)
• KPMG Quality Registrar India
• Lloyd’s Register Quality Assurance
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16. Benefits of ISO Certification
External Benefits:
• The logos will increase the stature of the company in the marketplace and help to enlarge the customer base
• It will satisfy the larger businesses that the company operates and will result in fewer customer audits needing to be
carried out to confirm the on-going commitment to getting it right the first time
• It will reduce one of the hurdles to entering an approved supplier list run by a potential customer
• ISO 9001 is an international standard and it will open international doors and not just those locally
• The quality manuals can be used as a sales and marketing tool. It will both describe the company’s commitment to
standards and customer requirements as well as promote the company to new customers
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17. Benefits of ISO Certification
Internal Benefits:
• A properly implemented system reduces production errors and leads to a reduction in the necessary rectification work in the long term
• The reduced rectification work coupled with a maintained list of suppliers and sub-contractors leads to reduced warranty work as the
product becomes more reliable
• The implementation will give the company a one-off opportunity to fully assess its management systems to ensure they are efficient and
effective. It will give the staff the opportunity to assist with the production of the system.
• The regular internal views required will make the company look hard at itself to ensure there are fewer areas where errors could occur
• Staff will be better aware of their responsibilities and the need to satisfy customers
• In certain areas the introduction of a suitable system could suggest to an insurance company that there is a reduced problem with regards
to negligence and lead to reduced insurance premiums
• It will provide an improvement in communications both internally and to customers
• It provides an opportunity for the management to introduce procedures and other requirements it has been trying to introduce for a long
time.
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