1. The New Management Standards
ISO 9001 and :2015

2. The New Management Standards
This is a personal view on some of the issues that I have encountered on the recent assessments / transition work.
Time table
August 2018 drop dead date for earler versions.

3. Annex SL- overview
Annex SL is the structure for all new and revised ISO Standards
•Annex SL (previously ISO Guide 83) defines the framework for a generic management system
•All new ISO management systems standards (MSS) will adhere to this framework and all current MSS will migrate at their next revision
•Whilst the structure and terminology has changed, there is no requirement to use these terms or to follow the numbering or structure within your management system.

4. Layout of Standards - ISO Directive: Annex SL, Appendix 3 The ten clauses
1)Scope
2)Normative references
3)Terms and definitions Auditable area
4)Context of the organization
5)Leadership
6)Planning
7)Support
8)Operation
9)Performance evaluation
10)Improvement
One Day, all standards will be built this way!

7. Integration possibilities
The standard clauses of Annex SL mean that there is much greater commonality across the Management System Standards that use the HLS
•For example: in your current systems, the existing procedures for Document Control and Internal Audit are probably common … with the advent of Annex SL there will be many more common elements
•The first major difference with the advent of Annex SL is the greater focus on Risk and Risk Management
•This is a bigger change for the implementers of the ISO 9001 standard than it is for those that implement the ISO standard

8. One Possible model – Stonehenge.
Context, Leadership, Audits, Documented Information, Management review, Complaints, Training, Policy, Planning , Monitoring and measurement (general)
Appendix 1
ISO 9001
Design
Changes to product/service
Knowledge
Property, preservation
Changes contrl:
Post delivery etc
MM specific
Appendix 2
ISO 14001
Legal register
Emergency response
Incidents
Aspects and impacts
MM specific
Appendix 3
OHSAS 18001
Legal register
Emergency Response
Accidents
Risk assessments (all types)
MM specific

9. RISK
Risk-based thinking is something we all do automatically and often sub-consciously
•The concept of risk has always been implicit in ISO 9001 – this revision makes it more explicit and builds it into the whole management system
•Risk-based thinking is already part of the process approach
•Risk-based thinking makes preventive action part of the routine hence no more PA.
•Risk is often thought of only in the negative sense. However, risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk.- Important and it gets missed

10. Risk
Definition:-
The concept of ‘risk’ in the context of ISO 9001 relates to the uncertainty in achieving the management system objectives.

11. 4.1 Understanding the organization and its context
Clause 4
New requirements
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the management system
4.4 Quality management system and its processes (ISO 9001) Environmental management system (ISO 14001)

12. Clause 4.1 Understanding the organization and its context
What are your external and internal issues?
Examples of common tools to identify issues ;-
•PEST analysis - Political, Economic, Social and Technological
•PESTLE analysis – PEST + Legal and Environment
•SWOT analysis - Strengths, Weaknesses, Opportunities and Threats
•Stakeholder analysis

13. PESTLE Analysis
A fancy term for issues that affect a business but are outside of its control is ‘’macro drivers’’ sometimes grouped together under the acronym P.E.S.T.L.E.
–Political
–Economic
–Socio-cultural
–Technological
–Legal
–Environmental
Some versions add Ethical too.

14. Clause 4.2 Interested Parties- needs and expectations
New requirement
Question 1 Who are the interested parties that are relevant to your Quality and Environmental Management System?
Question 2 How do you determine their requirements?
Question 3 Do you think that this will require any changes to your current system?
Question 4 What are the opportunities generated here

15. Clause 4.2 Interested parties – examples
•Neighbours
•Commercial Partners , Landlords
•Local Officials
•Regulatory Bodies
•Employees
•Shareholders
•Emergency Responders
•Other Industries, suppliers
•Customers, Clients
•Suppliers of Raw Materials
•Designers
•Non Government organizations (Industrial)
•Non Government organizations (Non-Industrial)

16. Evaluation of results Clauses 4.1 & 4.2
“The organisation shall consider the issues in 4.1 and 4.2…” some sort of Logical process
Finger in the air!!
RAG indicators
Risks 5 by 5 matrix
Opportunities reverse 5 by 5 matrix

17. Evaluation of results Clauses 4.1 & 4.2
Whatever methodology you use needs to have some logical justification to it .
Help advice-resources
PD ISO/TS :2016 including corrigendum November 2016
BS EN ISO 14004:2016- Both have good advice and help
4.1 – CONTEXT
Evaluation 4.1 & 4.2
Risks & Opportunities
OUTPUT to 6.1
Planning
4.2 Int: Parties

18. Clause 5 Leadership
No substantive changes to the role of top management
Worth noting that they are required to…
•demonstrate leadership and commitment
•Link policy and objectives to organisational strategy and context
•Promote awareness of the process approach
•Ensure risks are managed
•Be accountable for the effectiveness of the QMS /EMS
Role of top management
Note :-
A management representative is no longer explicitly mentioned

19. Clause 6 Planning Quality
6.1 Actions to address risk associated and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
Environmental
6.1.1 General
6.1.2 Environmental aspects
6.1.3 Compliance obligations
6.1.4 Planning action
6.2 Environmental objectives and planning to achieve them
6.2.1 Environmental objectives
6.2.2 Planning actions to achieve environmental objectives

20. Clause 6.1 actions to address risks and opportunities
Clause 6 Planning Quality
Clause 4.2 Needs and expectations
Clause 10.2 Corrective action
Clause 4.1 Context
PLANNING
Clause 6.1 actions to address risks and opportunities
PLAN
Clause 9.13 Analysis
Clause Management review
Clause 4.4.1
QMS Processes
Clause 5.1 Leadership
Clause 5.1 Customer focus
Clause 7.1.6
Knowledge

21. Clause 6. actions to address risks and opportunities
Clause 6 Planning ENVIRONMENTAL
Clause 4.2 Needs and expectations
Clause 10.2 Corrective action
Clause 4.1 Context
PLANNING
Clause 6. actions to address risks and opportunities
PLAN
Clause 8.2 Emergency Response
Clause Management review
Clause 4.4.1
EMS Processes
Clause 5.1 Leadership
Clause 6.13 Compliance obligations
Clause 6.12
E Aspects

22. RISK 1 discussion

23. 2) To enhance customer satisfaction
RISK 2 - aims
1) To provide confidence in the organisation’s ability to consistently provide customers with conforming goods and services
2) To enhance customer satisfaction
Remember
The concept of ‘risk’ in the context of ISO 9001 relates to the uncertainty in achieving these objectives

24. Clause 7
No significant changes except Knowledge and Communication in ISO 9001
What is knowledge ?
Clause 8
ISO – Life cycle issues
It is not a full life cycle analysis – though if you have them that is good.
Meeting the environmental compliance obligations- typically WEEE, ROHS, ELV, etc.

25. Clause 9
Audit 9001 Clause 5.11d- Process approach (leadership ) also applies to ISO 14001:
Audit types
Process approach (new)
Clause approach (Traditional)
Operational control (can be process audit)
Compliance audit (14001)

26. PROCESS Approach

27. Process approach for waste

28. Clause 9.3 9.3 Management review 9.3.1 Inputs
a)the status of actions from previous management reviews;
b)changes in external and internal issues that are relevant to the Quality or Environment management;
c)information on the performance and effectiveness of the Quality/environmental management system including trends in:
1)customer satisfaction and feedback from relevant interested parties;
2)the extent to which quality or environmental objectives have been met; evidence !
3)process performance and conformity of products and services;
4)nonconformities and corrective actions;
5)monitoring and measurement results;
6)audit results;
7)the performance of external providers;
d)the adequacy of resources;
e)the effectiveness of actions taken to address risks and opportunities (see clause 6.1);
f) opportunities for improvement.

29. Clause 9.3 Environmental Additional
Significant changes in Aspects and impacts
Compliance obligations
Fulfilment of compliance obligations
Issues with demonstrating compliance obligations
Opportunities for Environmental improvement
General Issues in management review
If no complaints say so
Link any failures in MR to your plans and possibly your audit findings log.
Consider a management dash board for each standard ( optional)

30. The future
ISO –Health and safety
Revisions to AS/EN 9100
Revisions to ISO/TS 16949

31. Last Thoughts Transition to the 2015 standards:-
If it is in the standard it should be within your Management system
If the clause says “document” or “documented” it needs to be written down – there are at least 13 references to documented in ISO 9001:2015 alone.
EVIDENCE, EVIDENCE, EVIDENCE –
Records, signed and dated, Photographs, s, reports, minutes , attendance list signed and dated, etc etc.