1. ISO 14001: 2015 Preparing for transition to the revised standard
Thursday 27 November 2014, Keele Conference Centre

2. Welcome Nikki Sammé Marketing & Portfolio Development Director

3. ISO 14001 breakfast briefing agenda
Welcome
Nikki Sammé
Key changes and likely impacts of the new standard
Steve Blackwell
ISO 14001: the transition path
Questions
All

4. Key changes and likely impacts of the new standard Steve Blackwell Alcumus ISOQAR Lead Auditor ISO 9001, ISO 14001, OHSAS 18001

5. The standard has a new clause numbering based on Annex SL
Clause numbers now 4.0 to 10.0
4 Context
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement

6. Summary of changes Very little has been removed from the old standard
Reference to procedures is minimal
‘Documented information’ replaces ‘documentation and records’
The phrase ‘compliance obligations’ replaces ‘legal requirements and other requirements to which the organisation subscribes’
Let’s look at the main changes clause by clause………

7. Clause 4: Context of the organisation
How might this impact your business?
What you need to consider
4.1 Understanding the context of the organisation
The intent of 4.1 is to provide a high-level, conceptual understanding of the important issues that can affect, either positively or negatively, the way the organisation manages its environmental responsibilities
Top level management involvement will need to be demonstrated
The areas to be considered will vary depending on the type, size and nature of your business activities

8. Clause 4: Context of the organisation
How might this impact your business?
What you need to consider
Areas to consider:
External cultural, social, political, legal, regulatory, financial, technological, economic issues
Internal characteristics or conditions of the organisation, such as its activities, products and services, strategic direction, culture and capabilities (people, knowledge, processes, systems) and resource availability
Documented information is not required
Evidence will be required of a review of external and internal issues as opposite
Generally, anything that
can either affect the organisation’s purpose,
or be affected by its
environmental aspects

9. Clause 4: Context of the organisation
How might this impact your business?
What you need to consider
You will need to:
Identify the interested parties
What are their needs and expectations?
Regulatory – Legal – Permits Contractual – Voluntary
The above represent compliance obligations and they should be considered when planning
the EMS (Clause 4.4)
4.2 Understanding the needs and expectations of interested parties
An organisation is expected to gain a general (ie. high-level, not detailed) understanding of the expressed needs and expectations of those internal and external interested parties that have been determined to be relevant, so that the knowledge gained can be considered when determining its compliance obligations

10. How might this impact your business?
Clause 5: Leadership
How might this impact your business?
What you need to consider
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with respect to the environmental management system
Accountability for:
Policy/objectives
EMS integration
Ensuring resources
Communication
Supporting employees in their roles
Documented information is not required
Top management involvement regarding the support of the processes and personnel will need to be demonstrated
This may require verification by the external auditor, interviewing members of top management

11. How might this impact your business?
Clause 6: Planning
How might this impact your business?
What you need to consider
6.1 Actions to address risk associated with threats and opportunities
The context of the organisation (see 4.1 and 4.2) provides an overarching framework for evaluating the risk associated with threats and opportunities in 6.1
6.1.2 Significant environmental aspects
6.1.3 Compliance obligations
6.1.4 Risk associated with threats and opportunities
6.1.5 Planning to take action
Documented information is required
Methods may have to be introduced to carry out
the following:
Assessment of risk associated with threats and opportunities
Plans to take action to address the risks will be required

12. How might this impact your business?
Clause 6: Planning
How might this impact your business?
What you need to consider
6.2: Environmental objectives and planning to achieve them
To include consideration of the risks associated with threats and opportunities
How the results will be evaluated, including indicators for monitoring progress toward achievement of measurable environmental objectives
You may be required to set objectives to reduce risks
to the EMS
Measures will need to be determined

13. How might this impact your business?
Clause 7: Support
How might this impact your business?
Evidence of communications both internal and external will need to be retained
What you need to consider
Includes:
Resources
Competence – records required
Awareness
Communication – internal & external
Document control – no procedure required

14. How might this impact your business?
Clause 8: Planning
How might this impact your business?
Documented information to the extent necessary, to have confidence that the processes have been carried
out as planned
This information will need to be retained
What you need to consider
8.1 Operational planning and control
Can include documented procedures
Control of risk
Meeting objectives

15. Making the transition

16. Revision timeline Draft international standard July 2014
Feb 2015
Final draft international standard
End 2015
ISO international standard released

17. Next steps
There is no need to make any changes to your system/documentation just yet
Study the significant changes and consider actions or methods to meet compliance
Identify minor changes (improvements???) Options – introduce now – wait until next year
Consider training requirements for EMS transition – refer to your training leaflet for courses offered by Alcumus ISOQAR

18. ISO 9001: 2015 Preparing for transition to the revised standard
Morning session
Thursday 27 November 2014, Keele Conference Centre

19. Welcome Nikki Sammé Marketing & Portfolio Development Director

20. Aims and objectives of today
To provide an understanding of the likely significant changes to the standard
To begin to evaluate the potential impacts of these changes
To explore how the changes might alter how we carry out 3rd party certification audits
We are all on a learning journey and in it together
We encourage you to ask questions and offer your thoughts and interpretations
Q&A Panel

21. Agenda 0915-0935 Welcome and introduction Nikki Sammé 0935-0945
Why are standards revised?
Andrew Patefield
Key differences between ISO 9001:2015 and ISO 9001:2008
Understanding the ISO 9001 transition path
Coffee Break
Potential impacts as a result of the changes with panel Q&A
Steve Blackwell
Closing summary and next steps
Lunch

22. UKAS Accredited Certification 2010
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We combine simple yet innovative technology with expert advice to support our clients to manage their exposure to risk, comply with the latest legislation, improve business performance and encourage workforce engagement
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23. Why are standards revised
Why are standards revised? Andrew Patefield Alcumus Academy IRCA Approved Trainer

24. Why are standards revised?
1987
1994
2000
2008
2015
To keep standards current and relevant to industry
To respond to the latest market trends
To ensure compatibility with other management system standards
Previous revisions

25. How is ISO 9001 changing (1)?
Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC2, Quality systems is responsible for the forthcoming changes to ISO 9001 The change to the 2008 quality standard represents a technical change

26. ISO International Standard
Transition path 1
New standard is proposed to relevant technical committee 2
Working group of experts start discussion to prepare working draft 3
1st working draft shared with technical committee and with ISO CS
If consensus is reached within the TC
If proposal accepted
If consensus is reached
Draft shared with all ISO national members, who are asked to comment 4 5
Final draft sent to all ISO members 6
If standard is approved by member vote
ISO International Standard

27. Revision timeline Draft international standard April 2014
Feb 2015
Final draft international standard
Sept 2015
ISO international standard released

28. How is ISO 9001 changing (2)?
1. New concepts and methodologies to manage Quality
1a. New concept ‘Risk Based Quality Management System’
2. To revise the ‘Quality Management Principles’
3. To revise the clause sequence so that common elements between the ISO standards are identically numbered to create ease in integration
4. To adopt the new format for standards introduced in Annex SL

29. Annex SL – what is it?
A guidance document that explains the new high level structure/format that all new standards will follow
The structure of the standards will change by creating standards that have:
identical number for common elements between standards
common core definitions

30. Aims and objectives The aim of the changes: The objective:
To create ISO management system standards with enhanced consistency where the alignment of the standards are the same
This means that the common elements between standards will be numbered the same
The objective:
This common approach to new management system standards will make it easier for organisations to create a single management system known as an Integrated Management System (IMS)

31. Annex SL introduces… Two new clauses and changes clause 4 to:
4. Context of the organisation
The new clauses are:
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties

32. Key differences between ISO 9001:2015 and ISO 9001:2008 Andrew Patefield Alcumus Academy IRCA Approved Trainer

33. Changes to Clause 4 New Clauses:
ISO 9001:2008 Clause 4 The Quality Management System
ISO 9001:2015 Changes Clause 4 to ‘Context of the Organisation’
New Clauses:
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectation of interested parties
4.3 Determine the scope of the quality management system
4.4 Quality management system and its processes. Was 4.1 General Requirements
Documentation required was covered under 4.2 of ISO 9001:2008. In the new standard this is covered under 7.5 ‘Documented Information’

34. Clause 5: Leadership ISO 9001:2008 ISO 9001:2015
5.1 Management Commitment
5.1 Leadership and Commitment
Under this heading far greater involvement in the Quality Management System is expected by management
5.2 Customer Focus
5.1.2 Customer Focus
5.3 Quality Policy
5.2 Quality Policy
5.4 Planning
Clause 6: Planning for the Quality Management System
5.5 Responsibilities, Authorities and Communication
5.3 Organisational Roles, Responsibilities and Authorities
Communication
7.4 Communication
Also clause requiring a management representative to be appointed for Quality has been removed
5.6 Management Review
9.3 Management Review

35. Clause 6: Planning for the Quality Management System
Clause 6 ‘Resource Management’ of the old standard is now covered under:
Clause 7: Support
Clause 6 of the new standard now covers ‘Planning’
Clause 6.1 of the new standard discusses ‘Actions to address risk and opportunities’
Clause 6.2 covers ‘Quality objectives and planning to achieve them’
Clause 6.3 talks about the ‘Planning of changes’

36. Clause 7: Support ISO 9001:2008 ISO 9001:2015
Clause 6 ‘Resources Management of the old standard’
Clause 7 ‘Support of the new standard’
6.1 covered the ‘Provision of Resources’
7.1 Resources
6.3 Infrastructure
7.1.3 Infrastructure
6.4 Environment
7.1.4 Environment for the operation of processes
6.2 Human Resources
7.2 Competence
The new standard then goes on to identify clauses
7.3 Awareness, 7.4 Communication and 7.5 Documented Information

37. Clause 8: Operation ISO 9001:2008 ISO 9001:2015
Clause 7 ‘Product realisation’
Clause 8 ‘Operation’
7.1 Planning and production realisation of the old standard
8.1 Operational planning and control
7.2 Customer related processes
8.2 Determination of requirements for product & services
7.3 Design & development
8.3 Design & development of products & services
7.4 Purchasing
8.4 Control of externally provided products & services

38. Clause 8: Operation ISO 9001:2008 ISO 9001:2015
7.5 Product and service provision
8.5 Product and service provision
7.6 Control of monitoring and measuring equipment
7.1.5 Monitoring and measuring resources
8.2.4 Monitoring and measurement of product
8.6 Release of products and services

39. Clause 9: Performance Evaluation
ISO 9001:2008
ISO 9001:2015
8.1 General
9.1 Monitoring, measurement, analysis and evaluation
8.2 Monitoring and measurement
9.2 Internal audits
8.3 Control of nonconforming product
8.7 Control of nonconforming process outputs, product and services
8.4 Analysis of data
9.1 Monitoring, measurement, analysis & evaluation
8.5 Improvement
10 Improvement
‘Management Review’ in the new standard is now under clause 9.3 ‘Management Review’

40. Clause 10: Improvement ISO 9001:2008 ISO 9001:2015
Clause 8.5 ‘Improvement of the old standard’
Clause 10 ‘Improvement’
10.1 General
10.2 Nonconforming and corrective action
When nonconformity occurs
The organisation shall retain documented information as evidence
10.3 Continual improvement

41. Understanding the ISO 9001 transition path Andrew Patefield Alcumus Academy IRCA Approved Trainer

42. How to prepare for ISO 9001:2015 1
Understand the requirements of the revised standard 2
Identify any gaps which need to be addressed to meet the new risk–based requirements 3
Prepare a transition plan & share this internally 4
Provide appropriate training & awareness for relevant parties 5
Revise QMS documentation (eg. quality manual & procedures) where appropriate 6
Update your internal audit programme & identify areas for continual improvement 7
Talk to your certification body for further transition arrangements
ISO 9001 transition 1 day course
Need the help of a consultant?
ISO 9001 IRCA transition 2 day lead auditor course
Need the help of a consultant?
We will keep you continually updated on your company’s specific transition arrangements

43. Transition audit schedules
How can we help?
Share updates
Provide you with further guidance and arrangements for the transition process
Train our auditors
Ensure our auditors and technical support are fully competent and knowledgeable about the revision
Update our IAN members
Continue to update our network of consultants
Transition audit schedules
Arrange transition audit schedules for existing customers
Provide ISO day transition courses and
2 day IRCA Lead auditor conversion
Run training courses

44. Potential impacts as a result of the changes with panel Q&A Steve Blackwell Alcumus ISOQAR Lead Auditor ISO 9001, ISO 14001, OHSAS 18001

45. Significant changes
Let’s look at potential impacts of the key changes as outlined by Andrew:
Clause 4: Context of the Organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.4 Quality management system and its processes
Clause 5: Leadership
5.1 Leadership and commitment Customer focus
Clause 6: Planning of the QMS, including
Clause Organisational knowledge
Clause 8.1 Operational planning and control

46. General
The existing ISO 9001:2008 Manual and Procedures can still be retained as these will meet most of the requirements of the new standard
Records, documents and procedures have been replaced by ‘Documented Information’
The clause and need for a Preventive Action Procedure has been removed, however as part of ‘Planning’, risks to the processes should be identified and preventive measures adopted

47. Clause 4.1: Context of the organisation
How might this impact your business?
A review of the business situation and any foreseeable problems or opportunities needs to be carried out
The depth of this review will vary depending on the type, size and complexity of your business activities
What you need to consider
4.1 Understanding the organisation and its context
The organisation shall determine external and internal issues that are relevant to its purpose and its strategic direction
No mandatory requirement for documentation but it needs to be auditable

48. Clause 4.1: Context of the organisation
How might this impact your business?
Companies may need to demonstrate that they are aware of:
Current sales trends
Market share
New equipment - software
Forthcoming changes to legislation
Effects to job costs – materials/services
Customer requirements/feedback
Supplier performance/availability
Neighbours/community issues
What you need to consider
The organisation shall monitor and review the information about external and internal issues
External
The business market
Existing/new technology
Legal requirements
The economy
Cultural/social issues

49. Clause 4.1: Context of the organisation
How might this impact your business?
Companies may need to demonstrate that they are aware of:
Current sales trends
Employee morale
Staff turnover
Absenteeism
Employee training needs
Any additional staff required
Past problems
Poor equipment
Inadequate methods
Production/service delivery data
What you need to consider
The organisation shall monitor and review the information about external and internal issues
Internal
Awareness of company culture/environment
Performance analysis
Job knowledge/information
Management structure

50. 4.2: Understanding the needs and expectations of interested parties
What you need to consider
How might this impact your business?
The company will have to demonstrate that they have identified all interested parties and they are aware of their requirements
These requirements may change, so a periodic review of them may be needed
Customers Goods/services on time to correct specification Suppliers Correct information, ample lead times Employees Adequate job information/environment/ equipment Regulators Evidence/records of conformity Neighbours Consideration of noise/emissions Shareholders Good return on investment

51. What you need to consider
4.4: Quality Management system and its processes
What you need to consider
How might this impact your business?
A method will need to be used to assess the risks and opportunities regarding the context of the organisation and the needs of interested parties
Actions will need to be planned to address these risks and opportunities
To determine the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them

52. How might this impact your business?
Clause 5: Leadership
How might this impact your business?
Top management involvement regarding the support of the processes and personnel will need to be demonstrated
This may require verification by the external auditor interviewing members of
top management
What you need to consider
5.1 Leadership and commitment
No requirement for any mandatory documentation in this section but top management need to demonstrate their methods and commitment regarding communication of QMS requirements and their methods for providing resources, and support for relevant roles and responsibilities

53. How might this impact your business?
Clause 5: Leadership
What you need to consider
How might this impact your business?
Methods for assessing these risks need to be established
Where, within the business processes, the assessments
are to be carried out is up
to the company
(See clause 6 - Planning
of the QMS)
5.1.2 Customer focus
No requirement for any mandatory documentation but top management need to demonstrate how risks to meeting customer requirements have been assessed, legal requirements have been established/met and customer satisfaction enhanced

54. Clause 6: Planning of the QMS
How might this impact your business?
Risks/opportunities to the business and meeting customer requirements need to be assessed (4.1 & 4.2)
No documented, formal risk assessment process is required.
However, this a fundamental requirement of the standard and it needs to be auditable
What you need to consider
6.1 – – Actions to address risks and opportunities
Consideration of the following is required:
Risk regarding 4.1 & 4.2
Prevention measures
Planning of implementation
Evaluation of effectiveness

55. How might this impact your business?
Clause 7: Support
How might this impact your business?
When addressing changing needs and trends, the organisation shall consider its current knowledge and determine how to acquire or access any necessary
additional knowledge
What you need to consider
7.1.6 Organisational knowledge
The organisation shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services
‘Information needed to achieve requirements’

56. 7.1.6: Organisational knowledge
How might this impact your business?
Good and in-depth record keeping is essential to meet the requirements of this clause
Employee knowledge may have to be enhanced
External sources may be required
What you need to consider
Previous/existing job information, including:
Job files
Contract information
Past problems
Employee experience
Successes – past jobs/projects
Design history
Information from customers/providers
Experts/advisors

57. How might this impact your business?
Clause 8: Operation
How might this impact your business?
Current company planning operations will have to include actions to address risk and opportunities regarding the context of the organisation and the needs of interested parties
What you need to consider
8.1 Operational planning and control
The organisation shall plan, implement and control the processes, as outlined in 4.4 and implement the actions determined in 6.1
4.4 The risks and opportunities in accordance with the requirements of 6.1
6.1 When planning for the quality management system, the organisation shall consider the issues referred to in 4.1 (Context) and the requirements referred to in 4.2 (Interested parties)

58. Next steps
There is no need to make any changes to your system/documentation just yet
Study the significant changes and consider actions or methods to meet compliance
Identify minor changes (improvements???) Options – introduce now – wait until next year
Consider training requirements for QMS transition – refer to your training leaflet for courses offered by Alcumus ISOQAR

59. Get up to speed with the ISO revisions...
Book one of our courses by end 2014 and save £100
Course
Who is it for?
Duration
Price
ISO 9001:2015
Transition course
If you are responsible for any aspect of your ISO 9001 or ISO management system including internal auditing these courses are for you
1 day
£395
ISO 14001: 2015
IRCA QMS (ISO 9001:2015 )
Lead auditor transition course
If you are currently a lead auditor and need to get up to speed with the new ISO 9001 or ISO revisions then these courses are for you
2 day
£645
IRCA EMS (ISO 14001:2015 )