ISO 9001 & ISO 14001

1. Asian Pharmaceuticals Pvt. Ltd.
Omsatiya-1, Rupandehi , Nepal
ISO: International Organization
for Standardization

2. Introduction of ISO
The International Organization for Standardization (ISO) is
ISO is an independent, non-governmental organization and
facilitates world trade by providing common standards
between nations.
Aim for setting body composed of representatives from
various national standards organizations.
Founded on 23 February 1947, the organization promotes
worldwide proprietary, industrial and commercial standards.
 It is headquartered in Geneva, Switzerland, and as of March
2017 works in 162 countries.

3. History
 Began in 1926 as the International Federation of the National
Standardizing Associations (ISA).
 After the war ISA, formed United Nations Standards Coordinating
Committee (UNSCC) with a proposal to form a new global standards
body.
 In October 1946, ISA and UNSCC delegates from 25 countries met in
London and created International Organization for Standardization;
the new organization officially began operations in February 1947
Most Common Standards In Industry are:-
1. Quality Management System – QMS – ISO 9001
2. Environmental Mgmt System – EMS – ISO 14001
3. Occupation Health & Safety Mgmt - OHSAS 45001

4. Top 10 countries for ISO 9001 certificates (2014)
Rank Country No. of certificates
1 China 342,800
2 Italy 168,960
3 Germany 55,363
4 Japan 45,785
5 India 41,016
6 United Kingdom 40,200
7 Spain 36,005
8 United States 33,008
9 France 29,122
10 Australia 19,731

5. ISO 9000 satisfy its customers, meet regulatory requirements, and achieve
continual improvement.
ISO 9000 is a series of standards. ISO 9001 is a standard within the family.
Individuals and organizations cannot be certified to ISO 9000.
 ISO 9001 is the only standard within the ISO 9000 to certify.
The ISO 9000:2000 revision had five goals:
Meet stakeholder needs
Be usable by all sizes of organizations
Be usable by all sectors
Be simple and clearly understood
Connect quality management system to business processes
The ISO 9000 family contains these standards:
1. ISO 9000:2015: Quality management systems - Fundamentals
2. ISO 9001:2015: Quality management systems - Requirements
3. ISO 9004:2009: Quality management systems – Managing for the
sustained success of an organization (continuous improvement)
4. ISO 9011:2011: Guidelines for auditing management systems
History & revisions: ISO 9000:2000, 2008, and 2015
Originally published in 1987

6. 7 quality management principles of ISO 9000 :
QMP 1 – Customer focus
◦ Understand the needs of existing and future customers
◦ support organizational objectives with customer needs and
expectations
◦ Meet customer requirements
◦ Measure customer satisfaction
◦ Manage customer relationships
◦ Aim to exceed customer expectations
QMP 2 – Leadership
◦ Establish a vision and direction for the organization
◦ Set challenging goals
◦ Model organizational values
◦ Establish trust
◦ Equip and empower employees
◦ Recognize employee contributions

7. Seven quality management principles of ISO 9000 series are:
QMP 3 – Engagement of people
◦ Ensure that people’s abilities are used and valued
◦ Make people accountable
◦ Enable participation in continual improvement
◦ Evaluate individual performance
◦ Enable learning and knowledge sharing
◦ Enable open discussion of problems and constraints
QMP 4 – Process approach
◦ Manage activities as processes
◦ Measure the capability of activities
◦ Identify linkages between activities
◦ Prioritize improvement opportunities
◦ Arrange resources effectively

8. Seven quality management principles of ISO 9000 series are:
QMP 5 – Improvement
◦ Improve organizational performance and capabilities
◦ Align improvement activities
◦ Empower people to make improvements
◦ Measure improvement consistently
◦ Celebrate improvements
QMP 6 – Evidence-based decision making
◦ Ensure the accessibility of accurate and reliable data
◦ Use appropriate methods to analyze data
◦ Make decisions based on analysis
◦ Balance data analysis with practical experience
QMP 7 – Relationship management
◦ Identify and select suppliers to manage costs, optimize resources,
and create value
◦ Establish relationships considering both the short and long term
◦ Share expertise, resources, information, and plans with partners
◦ Collaborate on improvement and development activities
◦ Recognize supplier successes

9. There is 3-year transition period after publication after that audit
will as per 2015 version

10. 10
Process based Quality Management System
Continual Improvement of the quality management system
Product
Product
Realization
Management
Responsibility
Resource
Management
Measurement,
Analysis &
Improvement
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Input Output
Value-adding activities
Information flow
Leadership

11. Annex SL
• Created by ISO to provide a universal high-level structure,
identical core text, and common terms and definitions for all
management system standards
1. Scope: The scope defines the intended outcomes of the
management system. The outcomes are industry-specific and
aligned with the context of the organization (clause 4).
2. Normative references: Provides details of the reference
standards or publications relevant to the particular standard.
3. Terms and definitions (subdivided into three parts): high-level
structure, identical core text, and common terms and core
definitions

12. Annex SL
4. Context of the organization: Consists of four subclauses:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested
parties
4.3 Determining the scope of the managements system
4.4 The management system
5. Leadership: Comprises three subclauses:
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6. Planning: Includes two subclauses:
6.1 Actions to address risks and opportunities
6.2 Management system objectives and planning to achieve
them

13. Annex SL
7. Support: Consists of five subclauses:
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8. Operation: Has one subclause:
8.1 Operational planning and control
9. Performance evaluation: Formed of three subclauses:
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement: Clause 10 deals how nonconformities and corrective
actions managed. It includes two subclauses:
10.1 Nonconformity and corrective action
10.2 Continual improvement

14. ISO 9001:2008 ISO 9001:2015
1. Scope
2. Normative References
3. Terms and Definitions
4. Quality Management
System
5. Management
Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis
and Improvement
Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the
Organization
5. Leadership
6. Planning
7. Support
8. Operations
9. Performance Evaluation
10.Improvement

15. Key terms & definitions
Context of the organization
 All internal and external factors and conditions
affecting its products and services, have an influence
on its QMS, and are relevant to its purpose and
strategic direction.
 External context includes all of the needs and
expectations of interested parties, as well as its
social, cultural, legal, technological, regulatory, and
competitive environment.
 Internal context includes its values, culture,
knowledge, and performance.

16. Key terms & definitions
Documented information
Information that are controlled and maintained
and its supporting medium.
That may any format and on any medium and
can come from any source.
Information on management system and related
processes.
Information needed to operate and used to
document the results.

17. Key Terms & Definitions
Process-based quality management system
 Use of Process approach is to manage and control to
implement quality policy and achieve the quality
objectives.
 Network of interrelated and interconnected processes
where each process uses resources to transform inputs
into outputs.
 The output of one process is the input of another
process, processes interact and are interrelated by
means of such input-output relationships and
interactions make a single integrated process-based
QMS.

18. Key terms & definitions
 Risk
 Risk is the “effect of uncertainty on an expected
result” and an effect may be positive or negative
deviation from what is expected
 Risk-based thinking
 Risk-based thinking is coordinated set of activities
and methods used to manage and control risks that
affect its ability to achieve objectives.
 Risk-based thinking replaces preventive action.

19. Key terms & definitions
Top management
 Refers to people at the top of an organization who
provide resources and delegate authority and
coordinate, direct, and control organizations.
 Establishes quality policy and assign QMS roles,
responsibilities, and authorities.
 If the scope of QMS covers only part of an
organization, then the top management refers to the
people who direct and control that part of the
organization.

20. Objectives for ISO 9001:2015
A. Maintain current focus on effective process
management to produce desired outcomes
B. Apply the new High Level Structure of ISO
Directives to enhance compatibility and
alignment with other management system
standards
C. Simplified language and writing styles to aid
understanding and consistent interpretations of
requirements

21. Risk Based Thinking
ISO 9001:2015 will require a risk based approach in
organizational processes
Identify what the risks and opportunities are in the
organization – it depends on context
An effect is a deviation from the expected — positive or
negative.
Uncertainty is the state, even partial, of efficiency of
information related to, understanding or knowledge of, an
event, its consequence, or likelihood.
Risk is often characterized by reference to potential events
and consequences or combination of these
Risk is often expressed in terms of a combination of the
consequences of an event and the associated likelihood of
occurrence.

22. Risk Inventory / Register
From Risk Sources –
 External Context
 Internal Context
 Needs of Interested Parties
 Expectations of Interested Parties
 Process Steps
 S – I – P – O – C Interfaces
 Process Supports – Resources Etc.
 Compliance Obligation

23. Structure - Details (9001: 2015)
 1 Scope
 2 Normative references
 3 Terms and definitions
 4 Context of the organization
 Understanding the organization and its context
 Understanding the needs and expectations of
interested parties
 Determining the scope of QMS
 Quality management system and its processes
 5 Leadership
Leadership and commitment
Quality policy
Organizational roles, responsibilities and authorities

24. Structure - Details (9001: 2015)
6 Planning
Actions to address risks and opportunities
Quality objectives and planning to achieve them
Planning of changes
7 Support
 Resources
 Competence
 Awareness
 Communication
 Documented information

25. Structure - Details (9001: 2015)
8 Operation
◦ Operational planning and control
◦ Determination of requirements for products and services
◦ Design and development of products and services
◦ Control of externally provided products and services
◦ Production and service provision
◦ Release of products and services
◦ Control of nonconforming process outputs, products & services
9 Performance evaluation
◦ Monitoring, measurement, analysis and evaluation
◦ Internal audit
◦ Management review
10 Improvement
◦ General
◦ Nonconformity and corrective action
◦ Continual Improvement

27. Changes (9001: 2015)
 Risk based thinking through PDCA
 Identify of sources of risk in context of org– internal / external
 Interested party – needs & expectations
S – I – P – O – C
 Top mgmt accountable for the system
 No single MR, every process owner is MR for his / her area.
 Ten clause structure
 Preventive action clause dropped
 Quality manual is not mandatory, but can be continued.
 Documented information used in place of document or documented
procedures, quality manual or records.
 Retention of documented information, the period of time and the
media is to determine .
 Monitor and review the information about these external and internal
issues.

28. ISO 14001:2015

29. ISO 14001:2015
Standard that setsrequirementsfor an environmental
management system.
It helpsorganizationsimprovetheir environmental
performancethrough more efficient useof resourcesand
reduction of waste, reduced energy and water consumption,
a more systematic approach to legal compliance gaininga
competitive advantage and the trust of stakeholders.
Identify, manage, monitor and control their environmental
issues like air pollution, water and sewage issues, waste
management, soil contamination, climate change
mitigation and adaptation, and resource use and efficiency.

30. ISO 14001:2015
Clause Title
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement

31. ISO 14001:2015
Clause 4 – Context of the organization
4.1 – Understanding the organization and its context
4.2 – Understanding the needs and expectations of interested parties
4.3 – Determining scope of the environmental management
system
4.4 - Environmental management system
 Clause 5 – Leadership
◦ 5.1 – Leadership and commitment
◦ 5.2 – Environmental policy
◦ 5.3 – Organizational roles, responsibilities and authorities
Significant Changes
1. Management representative no longer required
2. Places responsibility for the effectiveness of the management
system with top management
3. Requires integration of the environmental management system
requirements into the organization’s business processes

32. ISO 14001:2015
Clause 6 – Planning
◦ 6.1 – Actions to address risks and opportunities
 6.1.1 –Plan considering Issues & Requirements related to
Environmental aspects
 6.1.2 – Environmental aspects considering of life cycle perspective
with Change and Abnormal conditions
 6.1.3 – Taking Compliance obligations when establishing,
implementing, maintaining and continually improving its EMS
 6.1.4 – Take Planning action to address significant environmental
aspects and compliance obligations Integrate and implement actions
into EMS processes

33. ISO 14001:2015
◦ 6.2 – Environmental objectives and planning to achieve them
 6.2.1 – Environmental objectives Consistent with policy that is
Measurable, Monitored, Communicated
 6.2.2 – Planning actions to achieve environmental objectives
considering to be done, resources, responsibility, time ,
evaluation method.
 Significant Changes
◦ Introduces several new terms(Life cycle perspective, Compliance
obligations and Risks and opportunities)
◦ Planning process restructured to consider life cycle perspective
◦ Specific requirements for establishing objective

34. ISO 14001:2015
 Clause 7 – Support
 7.1 –Determine and provide necessary resources
 7.2 – determine necessary competency of persons doing work
under the company’s control that affects its environmental
performance and “its ability to fulfill its compliance obligation
and action taken
 7.3 – Ensure awareness of Environmental policy and its aspects
and impacts
 7.4 – Communication
◦ 7.4.1 – determine What, When ,whom and How to communicate
◦ Retain documented evidence of communications
◦ 7.4.2 – Internal communication relevant to EMS
◦ 7.4.3 – External communication Dependent on Defined
communication process

35. ISO 14001:2015
 7.5 – documented information
 7.5.1 – determine documented information required by ISO 14001
 7.5.2 – creating, updating, identify and description format and media
with review and approval
 7.5.3 – Control of documented information as documents & records
 Significant changes
1. Determination of competence for persons who can affect
environmental performance and ability to fulfill compliance
obligations
2. Requires awareness of the benefits of improved environmental
performance
3. More emphasis on communication with documented information
requirements take into account wider scope of records media

36. ISO 14001:2015
 Clause 8 – Operation
 8.1 – Operational planning and control
 Control of Processes in accordance with operating criteria with
planned changes and Outsourced processes
 The organization shall maintain documented information to the
extent necessary to have confidence that the process(es) is (are)
carried out as planned
 8.2 – Emergency preparedness and response
 Plan actions to prevent or mitigate adverse impacts from
emergency situations
 Respond to actual emergency situations
 Periodically test planned response actions
 Maintain documented information to have confidence that the
process(es) is (are) carried out as planned

37. ISO 14001:2015
 Clause 9 – Performance evaluation
 9.1 – Monitoring, measurement, analysis and evaluation
 9.1.1 – Determine what, when to monitor, methods for monitoring,
measurement and criteria against which the environmental performance is
evaluated.
 Ensure calibrated/verified monitoring & measurement equipment is used
and maintained and communicate information internally and externally
retain documented information carried out as planned
 9.1.2 – Evaluation of compliance with frequency, Take action and retain
documented information as evidence of compliance results
◦ 9.2 – Internal audit
 9.2.1 – Conduct internal audits to provide information on whether EMS
Conforms to internal requirements and ISO 14001 requirements is
effectively implemented and maintained
 9.2.2 – Internal audit program includes audit criteria frequency, methods,
scope responsibilities, planning requirements and reporting
◦ Select auditors and conduct audits to ensure objectivity and Report results

38. ISO 14001:2015
 9.3 – Management review
 Input Considering Status of actions from previous management
reviews
◦ Extent to which environmental objectives have been achieved
◦ Information on environmental performance, including trends in
 Nonconformities and corrective actions
 Monitoring and measurement results
 Fulfillment of compliance obligations
 Opportunities for continual improvement
◦ Outputs include Conclusions on suitability, adequacy and
effectiveness of EMS
 Decisions related on continual improvement opportunities
◦ Retain documented information as evidence of review results
Significant Change
 Strengthens requirements for environmental performance evaluation
 Provides more specific requirements for monitoring activities

39. ISO 14001:2015
 Clause 10 – Improvement
◦ 10.1 – Determine opportunities for improvement and implement
necessary actions to achieve the intended
◦ 10.2 – React to nonconformity take action to control and correct
them and evaluate by reviewing , Determining causes
nonconformities exist
 Implement and review effectiveness of corrective action taken
and retain documented information as evidence of nature of
nonconformities and subsequent actions taken with Results of
corrective actions
◦ 10.3 - Continual improvement
 Continually improve the suitability, adequacy and effectiveness of
the EMS to enhance environmental performance
 Significant Changes
◦ Removed requirement for preventive action
◦ Corrective action and continual improvement focused on
enhancement of environmental performance

40.  The ISO 14000 family comprises Environmental
management – The ISO 14000 family of International
Standards, a basic introduction to the ISO 14000 series of
standards.
 ISO 14004 provides guidance on the establishment,
implementation, maintenance and improvement of an
environmental management system and its coordination
with other management systems.
 ISO 14006 is intended to be used by those organizations that
have implemented an environmental management system in
accordance with ISO 14001, but can help integrate eco-
design into other management systems.
 ISO 14064-1 specifies principles and requirements at the
organizational level for the quantification and reporting of
greenhouse gas (GHG) emissions and removal.
Other standards in the ISO 14000 family

41. Cls.No. ISO 9001:2015 ISO 14001:2015
4 Context of the organization Context of the organization
4.1 Understanding the organisation and its
context
Understanding the organisation and
its context
4.2 Understanding the needs and
expectations of interested parties
Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality
management system
Determining the scope of the
Environment management system
4.4 Quality management system and its
processes
Environment management system
5 Leadership Leadership
5.1 Leadership and commitment Leadership and commitment
5.1.1 General -
5.1.2 Customer focus -
5.2 Policy Environmental Policy
5.2.1 Establishing the quality policy -
5.2.2 Communication quality policy -
5.3 Organizational roles, responsibilities
and authorities
Organisational roles, responsibilities
and authorities

42. Cls.No. ISO 9001:2015 ISO 14001:2015
6 Planning Planning
6.1 Actions to address risks and
opportunities
Actions to address risks and
opportunities
- 6.1.1 General
- 6.1.2 Environmental aspects
- 6.1.3 Compliance obligations
- 6.1.4 Planning action
6.2 Quality objectives and planning to
achieve them
Environmental objectives and
planning to achieve them
6.3 Planning of changes -
7 Support Support
7.1 Resources Resources
7.1.1 General -
7.1.2 People -
7.1.3 Infrastructure -
7.1.4 Environment for the operation of
processes
-
7.1.5 Monitoring and measuring
resources
-
7.1.6 Organisational knowledge -

43. Cls.No. ISO 9001:2015 ISO 14001:2015
7.2 Competence Competence
7.3 Awareness Awareness
7.4 Communication Communication
- 7.4.1 General
- 7.4.2 Internal communication
- 7.4.3 External communication
7.5 Documented information Documented information
7.5.1 General 7.5.1 General
7.5.2 Creating and updating 7.5.2 Creating and updating
7.5.3 Control of documented
information
7.5.3 Control of documented
information
8 Operation Operation
8.1 Operational planning and control Operational planning and control
8.2 Requirements for products and
services
Emergency preparedness and
response
8.2.1 Customer communication -
8.2.2 Determining of requirements for
products and services
-
8.2.3 Review of requirements for
products and services
-
8.2.4 Changes to the requirements for -

44. Cls.No. ISO 9001:2015 ISO 14001:2015
8 Operation Operation
8.3 design and development of products and services -
8.3.1 General -
8.3.2 Design and development planning -
8.3.3 Design and development inputs -
8.3.4 Design and development controls -
8.3.5 Design and development outputs -
8.3.6 Design and development changes
8.4 Control of externally provided processes,
products and services
-
8.4.1 General -
8.4.2 Type and extent of control -
8.4.3 Information for external providers -
8.5 Production and service provision -
8.5.1 Control of production and service provision -
8.5.2 Identification and traceability -
8.5.3 Property belonging to customers or external
providers
-
8.5.4 Preservation -
8.5.5 Post-delivery activities -
8.5.6 Control of changes -

45. Cls.No. ISO 9001:2015 ISO 14001:2015
9 Performance evaluation Performance evaluation
9.1 Monitoring, measurement, analysis
and evaluation
Monitoring, measurement, analysis
and evaluation
9.1.1 General 9.1.1 General
9.1.2 Customer satisfaction 9.1.2 Evaluation of compliance
9.1.3 Analysis and evaluation -
9.2 Internal audit Internal audit
9.2.1 General
9.2.2 Internal audit program
9.3 Management review Management review
9.3.1 General -
9.3.2 Management review inputs -
9.3.3 Management review outputs -
10 Improvement Improvement
10.1 General General
10.2 Nonconformity and corrective action Nonconformity and corrective action
10.3 Continual improvement Continual improvement

46. Benefit of ISO
Requirement of suppliers to hold ISO certification.
Create safe, reliable and of good quality
products/services
 Maximize benefit to Stakeholders.
Superior operational performance
Increase productivity by reducing cycle time, errors
and waste
Increasing international trade and domestic market
share
 Increase customer satisfaction, interdepartmental
communications, work processes, and
customer/supplier relationship
Serve to safeguard consumers and the end-users of
products and services

47. ISO 14001:2015