Delta Audits

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 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


TÜV SÜD America locations


The Evolution of ISO 9001

TÜV SÜD America Slide 6 �

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


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


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

TÜV SÜD America Slide 9 �

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


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


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


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


TÜV SÜD’s Delta Audit Program


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.



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.


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


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


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.


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 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


http://www.tuv-sud-america.com/iso-9001-2015



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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.

Questions?


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