TÜV SÜD Slide 1
Delta Audits Transitioning to the new requirements of ISO 9001:2015 and ISO 14001:2015
TÜV SÜD in numbers: Growing from strength to strength
1 One-stop technical solution provider
800 locations worldwide
employees worldwide 22,000
million Euro in sales revenue 2014
2,060
150 years of experience
Note: Figures have been rounded off.
TÜV SÜD America Slide 2
Global expertise. Local experience.
INTERNATIONAL
Euro 820 mio 10,600 staff
GERMANY
Euro 1,240 mio 11,400 staff
Legend: Countries with TÜV SÜD offices
Regional headquarters
Note: Figures have been rounded off, 2014
Global Headquarters Munich, Germany
TÜV SÜD America Slide 3
TÜV SÜD America Inc.
• TÜV SÜD America Inc., founded in 1987, is the North American subsidiary of TÜV SÜD AG.
• TÜV SÜD America Inc. provides complete services through its divisions: – Management Service – Product Service – Industry Service – Chemical, Oil & Gas – Global Risk Consultants (GRC) – RCI Consultants
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The Evolution of ISO 9001
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1987 ISO 9001:1987 offers three QMS models
covering different types of businesses
1994
2000
2008
2015
ISO 9001:2000 replaces quality control with quality and process management
ISO 9001:2008 moves toward alignment with ISO 14001:2004
ISO 9001:2015 adopts Annex SL structure
ISO 9001:1994 focuses on documented procedures and prevention
ISO 9001:2015: Comparison with Structure of ISO 9001:2008
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ISO 9001:2015 ISO 9001:2008
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Context of the organization 4. Quality management system
5. Leadership 5. Management responsibility
6. Planning 6. Resource management
7. Support 7. Product realisation
8. Operation 8. Measurement, analysis and improvement
9. Performance Evaluation
10. Improvement
ISO 9001:2015: Changes and Impact
TÜV SÜD America Slide 8
The changes The impact New structure ISO 9001:2015 adopts the Annex SL structure, aligning it with other management systems standards
Facilitates adoption, maintenance and auditing of multiple management systems.
Extended Scope The scope of the standard has been clarified to include businesses in service industries
Eases the implementation of quality management systems in all types of businesses
Role of stakeholders Requires the consideration of the interests of all stakeholders, including customers, suppliers, etc.
Requires a broader assessment of the impact of quality issues in QMS planning and implementation.
Focus on risk The revised standard emphasizes the adoption of a risk-based approach and steps to prevent risk
Anticipated risks must be identified and acted upon. However, there is no requirement for standardized risk management.
More flexible documentation The term “documented information” replaces “documents” and “records”
Organizations will have greater flexibility in how processes are described and documented, as well as meeting record retention requirements.
Process approach further defined and promoted
Organizations need to define required inputs and expected outputs of QMS processes. The performance indicators and the assignment of responsibilities of these processes are also required.
The Evolution of ISO 14001
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1992 BS 7750 published, the first standard for
environmental management systems
1996
2004
2015
ISO 14001:2004 strengthens document and evaluation requirements
ISO 14001:2015 adopts Annex SL structure; facilitates multiple MS audits
ISO 14001:1996 specifies general requirements for EMSs
ISO 14001:2015: Comparison with Structure of ISO 14001:2004
TÜV SÜD America Slide 10
ISO 14001:2015 ISO 14001:2004
1. Scope 1. Scope 2. Normative references 2. Normative references 3. Terms and definitions 3. Terms and definitions 4. Context of the organization 4. Environmental management system requirements 5. Leadership Annex A: Guidance on the use of this international
standard 6. Planning Annex B: Correspondence of ISO 14001:2004 and
ISO 9001:2000 7. Support 8. Operation 9. Performance Evaluation 10. Improvement
ISO 14001:2015: Changes and Impact
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The changes The impact New structure ISO 14001:2015 adopts the Annex SL structure, aligning it with other management systems standards
Facilitates adoption, maintenance and auditing of multiple management systems
A strategic approach Organizations must now address all internal and external environmental aspects and impacts
Requires a broader, more comprehensive assessment of an organization’s environmental impact
A greater role for leadership The standard now assigns specific responsibilities to those in senior leadership roles in organizations
Will require integration of EMS with an organization’s strategy, and greater executive involvement and oversight
Focus on environmental performance Shifts the focus from continued improvement to actual environmental performance
Requires an organization to establish environmental objectives that are consistent with its capabilities and commitments
More flexible documentation The term “documented information” replaces “documents” and “records”
Organizations will have greater flexibility in how processes are described and documented, as well as meeting record retention requirements
Transitioning to the revised standards
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Potential transition challenges Transition to the new requirements must be
completed by September 14, 2018 Getting accurate information and
interpretation of contents of new standards Training and awareness of applicable ISO
9001/14001:2015 standards to achieve required competency
Leadership engagement Internal communications to get internal key
stakeholders involved and engaged New Concepts: Organization Context,
Interested Parties Involvement, Risk Based Thinking, Knowledge Management etc.
The key to a smooth transition is preparing early and taking action now.
TÜV SÜD Services
Transition (Certification) Planning from current QMS / EMS Standards
Delta Audits
How TÜV SÜD can help in achieving new ISO 9001:2015 and/or ISO
14001:2015 certifications or transition from existing management systems
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TÜV SÜD’s Delta Audit Program
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What is a Delta audit? A Delta audit is an efficient approach to analyzing the differences between your existing Quality Management or Environmental Management System according to the requirements of ISO 9001:2015 and/or ISO 14001:2015. Delta audit is a pre-audit for 2015 version standards. What are the particulars? Delta Audits are conducted by TÜV SÜD Lead Auditors, who have been specifically trained
regarding the requirements of the new versions of the standards. Delta Audits are not certification/recertification audits, and are generally completed in less time.
A Delta Audit is between 4 – 16 hours, depending on the size of the organization, but not more then 50% of the on-site time for a certification audit. Exact time is mutually agreed.
Delta Audits are planned and executed in a collaborative manner between an organization and
TÜV SÜD. For example, audit plan and Delta Audit focus priorities. Upon completion of the Delta Audit, your organization will receive a detailed report that identifies the areas of concerns to be addressed prior to formal audits to ISO 9001 or ISO 14001 2015 versions of standards.
TÜV SÜD’s Delta Audit Program
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What are the advantages of a Delta audit? A systemic approach to the transition process: Based on the TÜV SÜD Delta Audit feedback
and identified Areas of Concerns (AC), an organization can plan its priorities and resources for transition to 2015 versions of standards, in a cost-effective and efficient manner. A Delta Audit, is not a requirement for transition to 2015 versions of standards and only gives feedback to organizations regarding their Areas of Concern, so that they do not show during the formal transition audits.
Avoid misinterpretations due to lack of inaccurate information from unreliable sources: As
TÜV SÜD Delta Audits are conducted by certified lead auditors and technical experts, you will receive accurate feedback about state of your Quality / Environment Systems. TÜV SÜD does not do any consultancy for ISO 9001 and/or ISO 14001 management systems. Hence the feedback provided by TÜV SÜD is objective.
Faster Readiness for transition: Enables your organization to focus on those areas of concern
that require action, resulting in faster readiness for transition to new versions of standards.
TÜV SÜD’s Delta Audit Program
What are the focus areas of a Delta audit?
Understanding the organization and its context: Business Issues & Impact
Understanding the needs and expectations of interested parties
Changed methodology to define scope of QMS or EMS
Leadership & Commitment: Top management engagement
Planning: Risk Based Thinking (RBT) approach & Actions Management
Quality objectives & planning: resources, responsibility, timeline and results
Focus on stakeholder relationship management & communications
Support, Monitoring and Measurements: People, Knowledge
Information management: Maintenance (documents) and retention (records)
Operation and Performance Evaluation
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Following are typical key project management seven (7) steps for transition to ISO 9001 / 14001:2015 standards. Delta Audits can be done anytime during Steps 1 to 4:
Timing for Delta Audits
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7. QMS Sustainment & Continual Improvement Activities
6. Certification Achieved
5. External (3rd Party) Audit Execution
4. Internal Audits & Management Reviews
3. Competency / Training
2. Quality Management System Planning
1. Kick-Off: Top Management Commitment and Engagement
Your business benefits
Costs & inefficiencies
Via a one-stop service provider that avoids the need for multiple supplier and third-party assessments.
Save time
By combining audits with ISO 9001 / ISO 14001 to achieve a faster turnaround.
Brand reputation
With an ISO certificate from TÜV SÜD that is widely recognized and highly respected in the global community industry.
Minimize risk
By ensuring conformity to the international management standard requirements.
TÜV SÜD America Slide 18
Transition Planning: Strategy & Steps
Q: What is the quickest, most direct way for transition to 2015 versions of ISO 9001 and/or ISO 14001? What approach should be taken to keep the transition process simple?
A: The best approach for any company (small or big), is to design, develop and implement a Quality
or Environment Management System that fits the size of the organization, the kind of activities in which it is involved and their complexity.
Prior to formal transition audit, you must have implemented the QMS and/or EMS effectively,
completed at least one internal audit cycle and one management review. The total transition time from start to finish could vary from 3 months to 12 months, based on the maturity of existing QMS and/or EMS.
TÜV SÜD America has extensive experience in certification / managing its customers base with
the scope that varies from two-person companies to global single multi-site certifications across the world. We can provide additional details, as necessary. Delta Audit feedback from TÜV SÜD could be used to determine adequacy, suitability and effectiveness of your transition strategy.
TÜV SÜD America Slide 19
• TÜV SÜD has a resource web page that has info on ISO 9001:2015 and ISO 14001:2015 , as well as an “Ask the Expert” button, where you can submit additional questions.
http://www.tuv-sud-america.com/iso-9001-2015 http://www.tuv-sud-america.com/iso-14001-2015
• For further information about TÜV SÜD’s Delta Audit program, visit
www.tuv-sud-america.com/ISO-9001-Delta-Audits , www.tuv-sud-america.com/ISO-14001-Delta-Audits, or contact Tiffany Long at [email protected].
Resources
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TÜV SÜD’s Delta Audit Program
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Why choose TÜV SÜD?
Highly qualified auditors—Our auditors have extensive knowledge and experience and receive continual training.
Worldwide network—Our global business network allows us to serve your local business operations.
Deep domain knowledge—We have in-depth knowledge of all major industrial sectors.
Wide product portfolio—We fully support integrated management systems.