Introduction for ISO 9001 2015 Implementation. This is a very basic presentation with description of important points for consideration during implementation.

1. INTRODUCTION TO
ISO 9001:2015
FOR IMPLEMENTATION
Varinder Kumar
CISA, ISO27001 LA, ISO 9001 LA, ITIL, CEH, MEPGP IT, Certificate
course in PII & Privacy Management,
Twitter: ISOGeek
varinder@auditgaps.com

2. Disclaimer
The information in this presentation represents my
personal opinions and interpretation and has not
been formally endorsed by ISO or any of its
subcommittee or any of the ISO representatives or
my current employer.

3. Agenda
• What prompted revision to ISO 9001:2008
• Objectives of Revision
• What’s new ?
• Structure of ISO 9001:2015
• ISO 9001:2015 Clauses – brief
• Points to ponder during implementation
• Need help?

4. What prompted revision of ISO 9001:2008 ?
• Business and industry has evolved drastically in last ten
years due to technology adoption and innovations.
• Greater diversity of ISO 9001 implementation not just in
manufacturing but in service industry too.
• To bring in ease of alignment with other ISO standards
adopted by industries such as 27001, 20000, 22000 etc.
• To lower to documentation burden and minimizing it to
absolutely necessary with more focus on records and
production efficiency.
• Addition of Risk Management (identification, assessment,
mitigation, acceptance) to achieve objectives
• Achieve value for stakeholders by including external and
internal issues.

5. Objectives of Revision
• Enhance an organization’s ability to satisfy customers and
stakeholders.
• Provide integrated approach to organizational management
to achieve its objectives and integrate with other
management systems.
• Greater emphasis on leadership engagement
• Reflect needs of all external and internal stakeholders
• Enhance organization’s ability to address risks as well as
pursue opportunities.
• Lay a consistent foundation for next 10 years.

6. New Structure Of ISO 9001:2015
• 0. Introduction
• 1. Scope
• 2. Normative reference
• 3. Terms and definitions
• 4. Context of the organisation
• 5. Leadership
• 6. Planning
• 7. Support
• 8. Operation
• 9. Performance evaluation
• 10. Improvement

7. ISO 9001:2015 - Clauses at a Glance
Below are the clauses in the revised ISO 9001 standards:
4.0 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 the scope of the quality management
system
4.4 Quality management system and its processes

8. ISO 9001:2015 - Clauses at a Glance
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and
authorities
6. Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

9. ISO 9001:2015 - Clauses at a Glance
8. Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and
services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

10. ISO 9001:2015 - Clauses at a Glance
10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

11. Points to consider during Implementation
• Determine the context of the organization – business
operations and processes and how these are influenced by
external and internal issues such as strategic decisions ,
regulations, political changes etc. A good way is to conduct
PEST Analysis
• Determine Interested parties - for example employees ,
customers, regulatory bodies, local authorities etc. and
understand their needs and expectations. Also understand
how these can be affected by the organization activities and
can thus impact organization objectives.
• Engage Leadership – Leadership or the top management
must get involved and support the QMS. They must align the
QMS policy to organizations strategy, mission and vision.
Leadership should also ensure that not only roles and
responsibilities but authorities are also delegated to
respective to roles.
• Consider Risks and Opportunities – The new standard
demands that organizations consider risks which can impact
the achievement of objectives as well as should consider
opportunities while pursuing a risk.

12. Points to consider during Implementation
• External Communication – Communicating the
stakeholders and interested parties is another requirement in
the new standard. Organization must authorize a role to
communicate its key decisions or any adverse incidents , risk
materializations which can impact the interested parties.
• Knowledge Management – The standard considers
knowledge as a resource and expects that organization
should managed this resource. This will help the organization
to control the quality and consistency of goods and services.
Organization may need to develop an appropriate system for
learning from experience and an approach for knowledge
retention including mentoring, documenting experiences,
learning etc. Such measures can help the organization in
becoming independent of person and sustaining quality and
service delivery even in absence of the person managing that
operation. Organizations are expected to manage their
Intellectual property, formulas and patents etc under this
requirement.

13. Points to consider during Implementation
• Documented Information – All documentation and records
are now covered under documented information.
Organization must ensure all documented information is
easily accessible, retrievable and should implement
measures for protection against loss of confidentiality,
integrity and availability. Loss of confidentiality is very
important in outsourced manufacturing for example a pharma
company manufacturing a drug as outsourced partner for
another company owning the patent. Similarly loss of
document or damage to document containing some specific
instructions during manufacturing can lead to chaos if the
person managing day to day operations is not available.
• Outsourcing Control – Organizations must have controls on
outsourced processes by way of contractual requirements,
audits, SLA monitoring, quality testing etc. The term supplier
has been used for goods and service suppliers.

14. Need Help ?
Contact me for :
1. Implementation Projects: ISO 9001, ISO 27001, ISO 27018,
ISO 29100, ISO 20000, ISO 22301, ISO 31000, ISO 13485
and ISO 55001
2. Documentation Review & Improvements
3. Internal Audit
4. Internal Auditor Training Course
5. Second Party / Supplier Audits for above standards
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