1. Quick Guide to help your transition
ISO 9001:2015
Quick Guide to help your transition

2. ISO 9001 revision ISO REVISION PROCESS
ISO regularly review standards approximately every 5-7 years.
How much the standard is revised is determined by user input.
There seems to be quite significant changes in structure and some additional concepts/requirements in the revision
ISO REVISION PROCESS
CD – Committee Draft
ISO 9001 reached this phase in June 2013
DIS –Draft International Standard
ISO 9001 reached this phase in May 2014
FDIS – Final Draft International Standard
ISO 9001 reached this phase July 2015
ISO – Official Standard published
ISO 9001 is projected to reach this phase in September 2015; thus the ‘ISO 9001:2015’ reference
This guide is based upon the ISO 9001:2015 Final Draft International Standard (FDIS), the final publication is due later this year, therefore you should take into consideration that further changes could take place.

3. Transition Period of transition Audit Time Requirements
Organisations have up to 3 years from release of the new standards in which to transition their existing certification. Transition can be done at any time, the most efficient way will be to transition during recertification Organisations will need to meet the revised requirements and show effectiveness of their processes. TÜV UK will be communicating and facilitating these transitions to their clients.
Usually additional audit time will be required.
TÜV UK are encouraging clients to do early gap analysis and be able to interpret standard requirements.
TÜV UK can do Pre-audits  to help clients.
Early reviews of gap analysis are possible, followed by final review after the publication of the standard.
TÜV UK will offer transition audits after the publication and certificates after successful accreditation (expected towards the end of 2015). 

4. Overview of Proposed New Structure
4 Context of the organisation
Understanding & organisation
Expectations of interested parties/stakeholders
Scope
Quality Management System
5 Leadership
Management & commitment
Quality policy
Responsibilities, authorities
6 Planning
Risks & opportunities
Quality objectives
Planning of changes
7 Support
Resources
Competence
Awareness
Communication
Documented information
8 Operation
Operational planning
Market requirements, customer interaction
Planning process of organisation
Control of externally provided products & services
Design & development of products & services
Production of products & services
Releases of products & services
Nonconforming products & services
9 Performance evaluation
Measurement, analysis, evaluation
Internal audits
Management review
10 Improvement
Non conformity & corrective action
Improvement

5. Concept of Risk Based Thinking
ISO 9001:2015 assumes that a basic understanding of risk assessment is increasingly important for organisations of all kinds.
No risk assessments are required, use the term risk thinking instead.
Different methods can be used, including risk assessments.
However, no formal risk management system is required

6. Interpretation of the Additional Requirements4
Context of the organisation clauses - include determination of external and internal issues relevant to the organisation’s purpose and strategic direction; more akin to a “business management system” rather than an isolated “quality management system”. 5
Leadership clauses – In effect replace “top management” clauses with some enhancements on commitments including accountabilities, compatibility, actions and effectiveness.
7.16
Organisational knowledge – New concept of determining necessary knowledge for operation of processes and conformity of products and services
7.5
Documented information – Essentially combines requirements for documented procured and records into one section with similar treatment.
8.4
Externally provided products and services – Incorporates requirements of Purchasing and Outsourcing into one; recognising that today’s organisations get services and materials from more than ‘traditional’ purchasing arrangements, but in essence the concerns and controls are the similar regardless of the path these external products and service comes from

7. Management Representative Documented Procedures
What has been dropped? Some specific requirements have been dropped from the standards. Examples are:
Quality Manual
not specifically required, nor mandated as to its contents
Management Representative
now considered part and parcel of the organisation’s leadership and top management (5.1.1; 5.3)
Documented Procedures
left to organisation’s determination and needs (4.4; 7.5.1)
Preventative Action
Not a specific clause/record moving forward, but effectively usurped by the “Risk Based Thinking” to be applied throughout the QMS.
It should be noted that these changes do not require organisations to eliminate existing documents, roles etc if they are found to be effective or necessary for operation of the QMS, but do provide additional flexibility.

8. Competence and Awareness needs Organisations using ISO 9001:2008 are recommended to take the following actions: 1
Identify organisational gaps which need to be addressed to meet new requirements. 2
Develop an implementation plan. 3
Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organisation. 4
Update the existing quality management system (QMS) to meet the revised requirements and provide verification of effectiveness. 5
Where applicable, liaise with their Certification Body for transition arrangements.

9. Dual Compliance
Organisations should plan to remain compliant to the current standards while preparing for and implementing changes for the 2015 standards. Early disassociation from the existing requirements may leave organisations without certification should their 2015 transition not go as planned.
Organisations should consider themselves certified/compliant to the existing standard until such time as they have their 2015 certificate in hand; only then can they consider disassembling any previously required framework no longer mandated by the new standards.

10. Further information
TÜV UK has already communicated information on the coming ISO 9001 & ISO transitions to its clients. This information can be found at: Factsheet 9001; Factsheet 14001
Additional resources include:
ISO/DIS/FDIS standard

11. Contact us TÜV UK Limited AMP House Suites 27-29, Fifth Floor
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Croydon, CR0 2LX
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