ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers. Get an in-depth overview of the upcoming changes to ISO 9001:2015, including: - Revision timing and roll out - Details on structure change - In-depth review of changes including risk assessment - Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements - and more.

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October 29, 2014
Cindy Soltis
UL DQS Inc.
ISO 9001:2015 Overview
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Revision Process Overview
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Why are revisions needed?
•Web-based ISO 9001 user survey in 2011 - 122 countries input
•International ballot decision to revise in 2012
All ISO standards are considered for revision periodically to assure relevance and adequacy.
•Increasing diversity of ISO 9001 users
•Developments in knowledge and technologies
•Broader user interests
•Changes in industry
Revision Considerations

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Development of ISO 9001
1987: Quality assurance  20 elements
1994: Small revision
2000: Quality management
 process approach 
2008: Minor revision
2015: Planned publication of the revised standard
 New structure, including risk based thinking
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ISO 9001:2015 Timeline
June 2013: CD
(Committee Draft)
May 2014: DIS (Draft International Standard)
July 2015: FDIS (Final Draft International Standard)
September 2015: IS
International Standard
2015
2014
2013
Transition period for certification

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ISO 9001:2015 Certification Transition
September 2015: Start of 3 years transition period to September 2018
2018
2017
2016
2015
September 2015: Published International Standard
Transition Timeline for ISO 14001 not yet determined but likely three years

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Main objectives for ISO 9001:2015
Maintain current focus on effective process management to produce desired outcomes
Apply the new High Level Structure of ISO Directives to enhance compatibility and alignment with other management system standards
Simplified language and writing styles to aid understanding and consistent interpretations of requirements
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Source: Design specification for the revised ISO 9001

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Summary of Changes
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General Changes to ISO 9001
High level structure and core text from „annex SL“
Increased requirements for top management commitment and involvement.
Emphasis on risk-based thinking
Increased emphasis on achieving value for the organization and its customers (“output matters”)
Need to understand the context of the organization and the needs and expectations of interested parties
Increased flexibility on the use of documentation
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Consistent structure for MS
ISO/IEC Directives, Part 1, Consolidated ISO supplement, 2013, Annex SL, Appendix 2 sets out the high level structure, identical core text and common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001 and ISO 14001.
High level structure and common text is public information and can be found in Annex SL of the www.iso.org/directives
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Organizations implementing multiple management systems (e.g. quality, environmental, information security) can achieve better integration and easier implementation

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High Level Structure
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of stds
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ISO/TC 176/SC 2/WG23 N063
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
6 Planning
•Actions to address risks and opportunities
•Quality objectives and planning to achieve them
•Planning of changes
New structure - Details (9001)

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ISO/TC 176/SC 2/WG23 N063
New structure - Details (9001)
7 Support
•Resources
•Competence
•Awareness
•Communication
•Documented information
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

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ISO/TC 176/SC 2/WG23 N063
New structure - Details (9001)
9 Performance evaluation
•Monitoring, measurement, analysis and evaluation
•Internal audit
•Management review
10 Improvement
•General
•Nonconformity and corrective action
•Continual Improvement

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High Level Structure Question
Will certified organizations be required to revise their management system manuals to align with the high level structure and terms?
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Other ISO 9001 Changes
Explicit requirement for process approach
Preventive action disappears as explicit requirement – included in risk-based approach
More readily applicable by “service” type organizations
Enhance requirements for competence of personnel
Revised Quality Management Principles
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Customers remain the primary focus

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Details of Selected Changes
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Context of the Organization (New)
•The organization shall
•determine external & internal issues that are relevant to its purpose & its strategic direction and that affect its ability to achieve the intended results of its QMS
•shall monitor and review the information about these external and internal issues
4.1 Understanding the organization and its context
ISO/ DIS 9001:2014
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Interested Parties (New)
•Due to their impact or potential impact on the organization’s ability to consistently provide products & services that meet customer & applicable statutory & regulatory requirements, the organization shall determine
•The interested parties that are relevant to the QMS
•The requirements of these interested parties that are relevant to the QMS
•The organization shall monitor & review the information about these interested parties and their relevant requirements
4.2 Understanding the needs and expectations of interested parties
ISO/ DIS 9001:2014
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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
•ISO 9001:2015 will not require a full, formal risk assessment nor a “risk register”
•Risk based approach addressed in all Sections 4 to 10 with primary requirement in 6.1
•ISO 31000 (“Risk management — Principles and guidelines”) will be useful but not mandated.
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Risk based approach
Risk: Effect of uncertainty on an expected result
Note 1: An effect is a deviation from the expected — positive or negative.
Note 2: Uncertainty is the state, even partial, of efficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood.
Note 3: Risk is often characterized by reference to potential events and consequences or combination of these
Note 4: Risk is often expressed in terms of a combination of the consequences of an event and the associated likelihood of occurence.
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Source: ISO/DIS 9001, 3.09

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What does 6.1 require an organization do?
Learn from experience – continual improvement
Check the effectiveness of the actions – does it work?
Implement the plan – take action
Plan actions to address the risks
Analyse and prioritize your risks and opportunities
Identify what YOUR risks and opportunities are – it depends on context
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7 Quality Management Principles
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence- based decision making
Relationship management
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Annex B

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No Management Representative?
While no explicit requirement for a “Management Representative”, 5.3 requires that:
•Top management shall assign the responsibility and authority for:
•Ensuring that the QMS conforms to the requirements of the standard
•Reporting on the performance of the QMS, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management
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ISO/TC 176/SC 2/WG23 N063
Scope / Exclusions
ISO/DIS 9001:2014 continues to allow for exclusions (2008 version: 1.2 Application)
•Not restricted to specific section (2008 “Clause 7”)
•Only allowed if requirement cannot be applied
•Documented Justification required

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ISO/TC 176/SC 2/WG23 N063
Documented Information
From Annex SL Appendix 2 core text replaces the terms ‘document’ and ‘record’ throughout the standard by ‘documented information’.
Documented information can be in any format and media and from any source.
Documented information can refer to the management system/ processes, information created in order for the organization to operate (documentation) or evidence of results achieved (records).

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ISO 14001 Changes
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6.1.2 Environmental Aspects: Now includes consideration of a life cycle perspective when evaluating environmental aspects
6.1.3 Legal Requirements & other requirements: now ‘Compliance obligations’
6.2 Environmental objectives: Performance indicators are to be defined for each environmental objective
8.1 Supply chain planning & control: New requirement to ensure outsourced processes, design process/ life cycle related environmental requirements are controlled or influenced
9.1.2 Evaluation of compliance: New requirement for the evaluation process with including a requirement for the organization to maintain knowledge and understanding of its compliance status.

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Transition Process
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Transition Planning Guidance
IAF issued Draft Transition Planning Guidance for ISO 9001:2015 available here:
http://isotc.iso.org/livelink/livelink/open/tc176SC2public
Guidance intended for:
Organizations certified to ISO 9001:2008
Accreditation Bodies
Certification Bodies
Training Bodies & Consultants
Draft will not be finalized until ISO 9001:2015 is published, but it gives all parties the opportunity to prepare
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Transition Planning
Transition period from September 2015 to September 2018
18 months after publication (March 2017), initial certifications shall be to ISO 9001:2015
Existing certificates must upgrade by September 2018 through a transition audit
Transition audits during a scheduled surveillance or recertification audits will more audit time
A staged approach to transition is allowed. Audit records must show progress.
We will encourage customers to transition during their recertification audit to minimize the additional costs
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Certification Body Activities
Auditors
•Comprehensive training of auditors at DIS Stage
•Additional training on differences at FDIS and ISO stages
•Verify Auditor Competence
Accreditation Body
•Apply for Accreditation after Auditor training
•Complete CB Transition Audit focused on changes and the CB’s transition plan (May include Witness audit)
Certified Customers
•Start briefing customers at DIS stage
•Preliminary Evaluations allowed
•Perform Transition audit (Surveillance, Recertification or Special)
•Verify closure of any nonconformities
•Issue certificate to ISO 9001:2015
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Sector Standard Impact
Revision of Sector standards will follow after the ISO standards are published.
Sector Representatives are actively engaged and have influenced the ISO 9001 revisions
•Aerospace – AS9100 (likely release early 2016)
•Telecom – TL9000
•Automotive – ISO/TS16949
•Exception – Medical Device – ISO 13485:2015 revision aligns with ISO 9001:2008 structure
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Questions?
Contact me:
Cindy Soltis
Business Manager
Cindy.Soltis@us.dqs-ul.com
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