The New Management Standards

ISO 9001 and 14001 :2015

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

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

 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

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)
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
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 9002 :2016 including corrigendum November
2016
• BS EN ISO 14004:2016- Both have good advice and help
4.1 –
Evaluation 4.1
CONTEXT
& 4.2 OUTPUT to 6.1
Risks & Planning
4.2 Int: Opportunities
Parties
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
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
6.3 Planning of changes
Clause 6 Planning Quality
Clause 4.2 Needs
and expectations Clause 10.2
Clause 4.1
Context Corrective action

PLANNING
Clause 9.13 Clause 6.1 actions to Clause 9.3.2
Analysis address risks and Management
review
opportunities
PLAN
Clause 4.4.1
Clause 5.1 QMS Processes
Leadership Clause 5.1
Customer focus

Clause 7.1.6
Knowledge
Clause 6 Planning ENVIRONMENTAL
Clause 4.2 Needs
and expectations Clause 10.2
Clause 4.1
Context Corrective action

PLANNING
Clause 8.2 Clause 6. actions to Clause 9.3.2
Emergency address risks and Management
Response review
opportunities
PLAN
Clause 4.4.1
Clause 5.1 EMS Processes
Leadership Clause 6.13
Compliance
obligations

Clause 6.12
E Aspects
RISK 1 discussion
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
Clause 7
No significant changes except Knowledge and
Communication in ISO 9001
What is knowledge ?
Clause 8
ISO 14001 – 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.
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)
PROCESS Approach
Process approach for waste
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.
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)
The future

ISO 45001 –Health and safety

Revisions to AS/EN 9100
Revisions to ISO/TS 16949
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, emails,
reports, minutes , attendance list signed and
dated, etc etc.