Find out about the main differences between ISO 9001:2008 and ISO 9001:2015 and how it will affect your organisation. Learn how you can implement the changes and get your team up to speed on the new 2015 standard with BywaterExcel.
2. Are you and your organisation
ready to meet the new
requirements of ISO 9001:2015?
BywaterExcel’s IRCA Certified ISO 9001:2015 Auditor
Transition training will help to secure a smooth
transition, review existing approaches to auditing and
determine additional auditing activities
4. ISO 9001:2015 Transition Auditor Course
The new requirements of ISO 9001:2015 are likely to require
internal and external auditors to widen their focus.
BywaterExcel’s ISO 9001:2015 transition training
course explores the standard in terms of structure, terminology
and interpretation in order for delegates to:
Understand the way the emphasis of ISO 9001 has changed.
Identify any change in approach necessary to competently
conduct an audit against ISO 9001:2015
Implement the changes required and communicate the
implications these changes will have for organisations.
Meet the IRCA upgrade requirements for registered auditors.
5. The Key Differences – an overview of how
the standard has changed
1. ISO 9001:2015 adopts the Annex SL structure
This new common ISO format developed for use
across all Management System Standards presents
common text, terms and definitions
2. New concepts have been included in ISO
9001:2015
Although not a new concept in itself, risk-based
thinking is new to ISO 9001 and is a predominant
foundation to the revised standard
3. The standard has become more generic and
more easily applicable to service industries
6. The Key Differences – an overview of how
the standard has changed
4. Criteria for exclusion claims has been changed
Although exclusions are no longer mentioned in the
Scope, where requirements may not be applicable to
an organisation, this can be defined and justified by
the organisation within 4.3 Determining the Scope of
the Quality Management System
5. The requirements for improvement have been
revised – though there is no longer reference to
preventive action!
Examples of improvement are given and opportunities
for improvement extend to include improving products
and services
7. The Key Differences – an overview of how
the standard has changed
6. ISO 9001:2015 uses the term ‘products and
services’ instead of ‘product’
Other new and revised terms include risk, outsource
and context of the organisation
7. The revised standard uses clearer wording to
clarify existing requirements and make implied
requirements explicit
8. Prescriptive clause requirements originally
hardware derived, have been removed
In particular for ‘Monitoring & measuring resources’
(7.1.5) and ‘Design and development of products and
services’ (8.3)
8. The Underlying Philosophy Remains the Same
The premise of the
ISO 9000 Series
remains fundamental
for effective quality
management and the
following philosophy
still provides the
foundation for ISO
9001:2015:
10. The Quality Management Principles
Revised 7
Quality
Management
Principles
Customer
Focus
Leadership
Engagement
of People
Process
Approach
Improvement
Evidence
Based
Decision
Making
Relationship
Management
The previous 8
quality
management
principles have
been revised
and republished
as 7 within ISO
9000.
11. Changes within the Quality Management
Principles
• An emphasis on customer needs,
expectations and satisfaction.
• Requirements are placed on the role of top
management to provide leadership and
demonstrate their commitment.
• The importance of customer satisfaction is
to be understood by all staff and internal
communication must be managed.
• The structure of the standard is based on a
business process approach.
12. Changes within the Quality Management
Principles
• Improving performance should be an
objective.
• Decisions based on facts, planning
changes and verifying effectiveness
(plan-do-check-act) is a guiding
principle.
• Managing relationships with product
and service providers effectively to
achieve objectives.
14. Structural Changes Between 2008 and 2015
ISO 9001:2008 Structure
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realisation
8. Measurement, analysis and
improvement
ISO 9001:2015 Structure
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
15. Highlights of Some of the General Changes
1. Greater emphasis on the definition of scope, which has
always been the most important and critical aspect of any
management system.
2. The term “product” replaced by “products & services” and
the word “continual” dropped from “continual
improvement.”
3. “Purchasing” and “outsourcing” replaced by “external
provision of goods and services”
4. References are made to risk, identification of risks and
opportunities and planning actions to address risks and
opportunities identified, to replace preventive action in the
2008 edition of the standard
16. Highlights of Some of the General Changes
5. Use of a risk-based approach to determine the type and
extent of controls appropriate to each external provider and
all external provision of goods and services.
6. Top management is required to take a more active
involvement in the management system.
7. There are general requirements for documentation as
“Documented Information” with no reference to a
documented quality manual, documented procedures or to
records.
8. The need for exclusions may not be considered to be
necessary in the new 2015 version as it is intended to be
fully applicable to all organisations.
18. Want to Learn More?
• Differences between ISO 9001:2008 and ISO 9001:2015 – structure,
terminology and interpretation.
• Annex SL, the new structure for management system standards, in terms
of:
• Context of the organisation, scope and objectives.
• Leadership; Planning; Managing Risk; and Support.
• The audit life cycle – an Auditor’s approach to assessing the changes.
• Involvement of top management.
• Implications for organisations.
• Timeline for the transition from ISO 9001:2008 to ISO 9001:2015
ISO 9001:2015 Transition Auditor training course
19. Enhancing your skills through our training and
consultancy support:
• IRCA Certified ISO 9001:2015 Transition Auditor training
28-29 June – London 27-28 July - Bristol
10-11 Aug – Leeds 31 Aug-1 Sept - Coventry
13-14 Sept – London 11-12 Oct - Bristol
1-2 Nov – Coventry 22-23 Nov - Leeds
• IRCA Certified ISO 9001 Lead Auditor training
27 June-1 July – Leeds 11-15 July - Bristol
25-29 July – London 8-12 Aug - Coventry
22-26 Aug – Leeds 5-9 Sept - Bristol
• Gap analysis / System audits
• Interpretation and guidance for implementation
• In-house training is also available to get your team up to speed at your site