Transitioning to 9001 and 14001 :2015 What our auditors will be looking for

ISO 9001 : 2015
ISO 14001: 2015
Revision Changes
Sustainable Certification Pty Ltd
ISO 9001 & 14001 : 2015 Changes Presentation
1

Welcome
Recent Changes to the Standards
ü  Summary review of the changes to 9001 & 14001
ü  Auditors requirements for transition
ü  Client transition process and requirements
2

Part 1: Changes to the Standards

Quality:
ISO 9001:2008 to ISO 9001:2015
(released September 2015)
Environment :
ISO 14001:2004 to ISO 14001:2015
(released September 2015
Coming soon (Late 2016)
Safety:
OHSAS 18001:2007 to ISO 45001:2016

3

High Level Structure
Annex SL.9 High level structure, identical core text and common terms and core definitions for use in
Management Systems Standards from now on:
1.  Scope
2.  Normative references
3.  Terms and definitions
4.  Context of the organization
5.  Leadership
6.  Planning
7.  Support
8.  Operation
9.  Performance evaluation
10.  Improvement

4

Context of the Organisation
ü  The MS has to be relevant to the organizations purpose and strategic
direction (4.1)
ü  Need to determine issues that affect its ability to achieve intended
results (4.1)
o  External context can include legal, technological, competitive,
market, cultural, social, and economic, and can be, international,
national , regional or local (4.1 note 1)
o  Internal context can included values, culture, knowledge and
performance (4.1 note 2)
5

Risk Based Thinking
ü  Risk-based thinking was implicit in previous standards it is now more explicit in 2015
ü  ISO 31000 provides guidelines on formal risk management which may be appropriate –
but it is not a requirement of these new standards.
o  Risk for some customers is a minor inconvenience
o  Risk for others can be far reaching and fatal
ü  Risk is not always negative – it also includes opportunities
ü  Options to address risks and opportunities can include:
o  Avoiding risk
o  Taking risk in order to pursue an opportunity
o  Eliminating the risk source
o  Changing the likelihood or consequences
o  Sharing the risk
o  Retaining the risk by informed decision

6

No more documented procedures…..sort of
ü  No need for a Quality Manual
ü  Documented procedures not mandated – remember the 6 from ISO 9001:2008
ü  Records not as clearly specified – no more as in ISO 9001:2008
However you now need…
ü  “Documented information” determined by the organization as being
necessary for the effectiveness of the management system (and this includes
any records) Now needs to ensure appropriate….
o  identification and description – (e.g. a title, date, author, reference
number)
o  format (e.g. language, software version, graphics) and media (e.g. paper,
electronic)
7

4.Context of the Organisation
ü  The system has to be relevant to the organization’s purpose and strategic
direction
ü  Need to determine issues that affect its ability to achieve intended results
o  External context can include legal, technological, competitive, market,
cultural, social, and economic; it can also be international, national,
regional, or local
o  Internal context can include values, culture, knowledge, and performance
ü  This is standard business planning
o  Tools such as SWOT analysis and Porter’s five forces can help with this

8

4. Context of the Organisation - what to look for
ü  How has the internal and external context been determined?
ü  Does the context consider legal and non-regulatory requirements,
including community expectations?
ü  What are the needs and expectations of interested parties?
ü  What is the scope of the system? Have any requirements been
excluded?
ü  What is the interaction of the organisation’s business practices/
processes?

9

5. Leadership
ü  How does your organization demonstrate its leadership?
o  Integration of discipline-specific requirements into
organizational structure
ü  Policy
o  Documented information, available to interested parties
o  Framework for setting objectives
ü  Roles, responsibilities, and authorities
o  Assigned and communicated
10

5. Leadership:
What your auditor will be looking for
ü  How have top management demonstrated their commitment to the
system?
ü  Is the policy reflective of the organization’s operations and direction?
ü  Does the policy contain the necessary discipline-specific requirements?
ü  When was the policy last reviewed?
ü  Do staff understand their own roles and responsibilities?
11

6. Planning
ü  Actions to address risks and opportunities
o  Actions taken to be proportionate to the potential impact
o  Integrated into the organization’s business processes
ü  Objectives and planning to achieve them
o  At relevant functions and levels; to achieve continual improvement
ü  Risk – the effect of uncertainty on objectives
ü  Requirements for the establishment, implementation, maintenance, and continual
improvement of the system
ü  Framework can be taken from ISO 31000 Risk management principles and guidelines
ü  Not all processes will present the same level of risk within a system; the system should
prioritise high risk processes above low risk processes

12

6. Planning:
ü  Have high risk activities and processes
been considered in the planning of the system?
ü  Has the full life cycle of activities, processes, and products been
considered?
ü  How have significant environmental aspects been determined? Does
the method used deliver consistent results?
ü  How do compliance obligations apply to business processes?
ü  What are the responsibilities, means, and timeframes for achieving
objectives?
ü  Are there processes in place to plan and manage change at various
functions and levels?
13

7. Support
ü  Resources
o  Including people, infrastructure, work environment, knowledge;
o  Consider the capabilities and constraints of internal resources and what’s needed from
external providers
ü  Competence
o  What level of competence is required?
ü  Awareness
o  Policy; objectives; their contribution; implication of not conforming with
requirements; benefits of improved performance
ü  Communication
o  Internal and external
ü  Documented Information
o  In a suitable medium; creation, updating, and control
o  Can differ from one organization to another due to:
§  Size and type of the organization
§  Complexity of operations
§  Competence of personnel

14

7. Support:
ü  Are the resources adequate?
ü  What are the necessary competence requirements for personnel?
ü  Are employees aware of their own responsibilities?
ü  Have effective communication strategies been implemented to
ensure the exchange of relevant information in a timely manner?
ü  Has control been lost due to a lack of documentation?
ü  What has been decided to communicate about externally? How
will it be communicated?

15

8. Operation
ü  Discipline specific:
o  Quality – Are you customers happy?
o  Environmental – Are you controlling your significant environmental
aspects?
o  Occupational health and safety – Are you keeping people safe,
now and into the future?
ü  Control of outsourced processes, including procurement
16

8. Operation:
ü  What are the requirements for products and services? What
happens when these requirements change?
ü  Is the hierarchy of control considered when controlling significant
environmental aspects?
ü  Are controls of high risk aspects, activities, and processes prioritised?
ü  Are external providers controlled according to their level of risk?
ü  What processes are in place to control production and provision?
ü  Who is authorized to release products and services? Is the authority
traceable?
ü  What is a nonconforming product? How about a nonconforming
service?

17

9. Performance Evaluation
ü  Monitoring, measurement, analysis, and evaluation
o  What do you need to monitor; how are you performing; how will
you monitor your performance; are you improving; how do you
know?
ü  Internal audit
o  Do you conform to your system’s requirements?
o  Does you system conform to your business processes?
ü  Management review
o  Top management to review the system and its performance at
planned intervals

18

9. Performance Evaluation:
ü  What documented information is necessary to demonstrate
monitoring and measurement?
ü  What do various interested parties (including customers) think about the
organization’s performance?
ü  What is done with the information that is collected?
ü  Has the organization developed a risk-based audit programme? How
often does it review the effectiveness of the programme?
ü  Have management reviews resulted in improvements to the system,
including opportunities for enhanced customer satisfaction?

19

10. Improvement
ü  Non Conformity
o  What is a non conformity ?
o  What will you do to stop the issue from happening again?
ü  Continual improvement
o  Including identification of under performance and opportunities
20

10. Improvement:
ü  What is a non conformity?
ü  What are the details of previous non conformity ?
ü  Has the organization undertaken effective corrective actions that
have prevented the recurrence of the non conformity?
ü  Has the organization transferred knowledge gained from corrective
actions across departments and projects?

21

Requirements to transition
ü  Identify organizational gaps which need to be
addressed
ü  Develop an implementation plan
ü  Provide appropriate training to applicable personnel
ü  Update the MS to meet revised requirements
22

SC Audit Approach
ü  Next audit ensure a transition plan is developed & in place
ü  Summary will be included in audit report on the progress towards the transition.
ü  When your organisation confirms readiness to transition to 2015 standard a Triennial/Re-
Certification must be conducted.
ü  ISO 9001: 2008 and ISO 14001: 2004 Certification & Triennial audits conducted from this
point will have a certificate expiry of 31st of August 2018
ü  All clients expected to be transitioned by this date 31st of August 2018
ü  Between now and 31st August 2017 observations only will be made against the gaps to the
revised standards.
ü  From 31st of August 2017 any identified gaps will be raised as minor NC’s to ensure
adequate time to address and comply with 2015 requirements.
ü  SC will be ready to take applications to the 2015 standards from 1st of December 2015
23

ISO 9001:2015 & ISO 9001: 2008 Comparison Table
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ISO 9001:2015 & ISO 9001: 2008 Comparison Table Cont..

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ISO 9001:2015 & ISO 9001: 2008 Comparison Table Cont….

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ISO 14001:2015 & ISO 14001:2004 Comparison Table


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ISO 14001: 2015 & ISO 14001: 2004 Comparison Table Cont…..

Documentation Requirements
29

Transitioning to 9001 and 14001 :2015 What our auditors will be looking for

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