1 ISO STANDARDS UPDATES SEMINAR CHANGES AHEAD
2 SEMINAR AGENDA Annex SL 18:30 ISO :45 ISO ISO :15 Finish 20:30
3 WHAT IS ANNEX SL?
4 ANNEX SL PURPOSE Annex SL prescribes a high level structure with identical text headings Its purpose is ensure standards can be easily integrated across an organisations business There are now many standards that organisations may wish to use or be certified to Annex SL allows easy integration for organisations that wish to apply more than one standard within its business activities
5 ANNEX SL HIGH LEVEL STRUCTURE 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
6 1. SCOPE Covers the intended outcome and the boundaries between which the management system applies The scope is specific to each standard Auditors should expect alignment between what the organisation has determined in Clause 4 and what is stated here
7 2. NORMATIVE REFERENCES This is where other standards relevant and useful to the standard under consideration should be referenced Note: Many of the revisions and draft revisions that have taken place have not always utilised this facility in an effective manner
8 3. TERMS AND DEFINITIONS This is where other definitions applicable to that particular standard can be introduced. It can even be used to override the definition used in a Normative reference by changing it to suit the needs of that particular standard In this way there is no need to put every definition into each new standard
9 4. CONTEXT OF AN ORGANISATION Organisations have already considered the content of their business The organisation needs to determine its own scope defining where the boundaries are set for the organisations management system? What is in and what is outside the defined boundaries? At first glance clause 4 is radical but on further consideration it makes sense. This is because the organisation can include what it believes is necessary to meet the Clause 1 scope of the applicable standard.
10 5. LEADERSHIP Emphasis is on leadership not just management Top management must have a greater involvement in the management system The policy has to be made available to all parties and communicated to interested parties First glance this seems the same as what has gone before namely policy, organisational roles, responsibilities and authorities, communication etc. The main difference is that top management has to have a greater hands on involvement and be able to demonstrate their commitment to the management system
11 6. PLANNING After much deliberation this now includes risks and opportunities Having highlighted the issues and requirements in Clause 4 now is the time to address the risks and opportunities the organisation faces through the planning stage How will the organisation prevent or reduce undesired effects. How can they ensure they meet the intended output and continually improve This clause puts more emphasis on that planning that is integral to the business
12 7. SUPPORT Covers the support needed to achieve the intended output. The organisation must supply competent resources The need to consider internal and external communication The terms documents, documentation and records have been removed The new approach is to refer to documented information It removes the previously perceived need for everyone to have work instructions Everyone should understand the term documented information and its broader meaning
13 8. OPERATION Covers what the organisation is there to achieve It addresses both in-house and outsourced processes It covers process management including having process criteria, controlling the processes within the criteria, controlling planned change and addressing unintended change as necessary Whatever is at the heart of the business it goes into Clause 8
14 9. PERFORMANCE EVALUATION Having carried out the activities within Clause 8 it is time to check the performance It covers what, how and when things are monitored, measured, analysed and evaluated It includes audits, management reviews which should include deciding on what action should be taken to prevent problems reoccurring or stop them happening in the first place. (Risk!) If a discipline needs procedures or other documents they can be added as required by the organisation
15 10. IMPROVEMENT This is where you address non conformity and corrective action Risk and Opportunity is intended to not only address the above but prevent things happening There is no mention of procedures and work instructions etc. but where disciplines consider they are necessary they may be used wherever the organisations decides they are beneficial The need to continually improve is a basic premise for all standards using Annex SL
16 9001:2015 KEY CHANGES
17 TOOLS TO HELP YOU KEY CONCEPTS DOCUMENT GAP ANALYSIS
18 ISO 9001:2015 KEY CHANGES Structured according to Annex SL, with its own specific requirements and terminology uses where relevant The most significant changes are in sections: 4 Context of the organisation 5 Leadership 6 Planning
19 4. CONTEXT OF THE ORGANISATION This will influence the type and complexity of management system required Needs and expectations of interested parties Quality management system and its processes
20 5. LEADERSHIP Top management is expected to demonstrate leadership and commitment, and to engage, direct and support persons to contribute to the effectiveness of the QMS The quality policy must be compatible with the strategic direction and context of the organisation, and be available to relevant interested parties. The need for a management representative has been removed
21 6. PLANNING FOR THE QUALITY MANAGEMENT SYSTEM Actions to address risks and opportunities Quality objectives and planning to achieve them much more emphasis now on how to achieve objectives Planning of changes
22 7. SUPPORT Recognises modern business practices such as electronic systems and increasing use of outsourcing Monitoring and measuring resources, as opposed to just equipment Organisational knowledge a new requirement Documented information the requirements for a quality manual, procedures and record have been removed
23 8. OPERATION A reworking and reorganising of the former Clause 7 Product realisation Emphasis on products and services, external provision of products and services, and external providers After much deliberation, a separate sub-clause, 8.3 Design and development of products and services, has been incorporated Otherwise, no significant changes
24 9. PERFORMANCE EVALUATION Evaluation is a new requirement in 9001:2015: this term is already used in ISO14001:2004 Internal audit not much change, but extended requirement to consider customer feedback organisational changes quality objectives Management review no significant change
25 10. IMPROVEMENT Proactive improvement may be as a result of corrective action, innovation or reorganisation Analysis and evaluation, and outputs from management review to be used to identify areas of underperformance and opportunities for improvement The requirement for a documented preventive action procedure has gone
26 CHANGES IN EMPHASIS AND TERMINOLOGY 1. Context 2. Process approach 3. Risk based thinking 4. Leadership and planning 5. Strategic direction and context 6. Documented information 7. Organisational knowledge 8. Externally provided products and services
27 KEY CHANGES IN TERMINOLOGY ISO 9001:2008 ISO 9001:2015 Products >>> Products and services Supplier >>> External provider Documentation and Records >>> Documented information Work environment >>> Environment for the operation of processes Purchased product >>> Externally provided products and services Exclusions >>> Term not used Management Representative >>> Term not used Documented procedure >>> Term not used Quality Manual >>> Term not used Preventive action >>> Term not used Term not used >>> Leadership Term not used >>> Risk
28 WHAT DO THE CHANGES MEAN FOR ME? The emphasis is on the needs of the modern organisation not on the needs of auditors Less prescription, particularly in relation to documentation This may be more of a challenge to your assessors than to you Business leaders need to be actively involved in the management system and assessors will need to interview them as part of an audit
29 WHAT DO THE CHANGES MEAN? CONT Be prepared to spend time with your assessor(s), in dialogue on issues such as strategy, risks and opportunities and interested parties Think process, if you do not already do so: however, your assessor should be able to guide you through this Start talking to your assessor(s) now about how your future audits will look and feel
31 14001:2015 KEY CHANGES
32 A BRIEF HISTORY OF ISO BS 7750 pilot launched March 1992 BS 7750 : 1994 launched January 1994 ISO : 1996 issued September 1996 BS 7750 withdrawn September 1997 ISO : 2004 issued November 2004 ISO : 2015 Currently in progress
33 ISO 14001:2015 DEVELOPMENT TIMELINE November 2011 ISO votes to revise ISO May 2013 Committee Draft 1 published January 2014 ISO votes to begin work on DIS March 2015 Final Draft (FDIS) expected to be published February 2012 ISO confirms use of a new High Level Structure (Annex SL) October 2013 Committee Draft 2 published July 2014 Public Draft (DIS) published (available for public comment until 31 October 2014) Q ISO : 2015 expected to be published. Three year transition period to commence.
34 Elements of ISO : 2015 (DIS) 4 Context of the organization 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 environmental management system 4.4 Environmental management system 5 Leadership 5.1 Leadership and commitment 5.2 Environmental policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risk associated with threats and opportunities General Significant environmental aspects Compliance obligations Risk associated with threats and opportunity Planning to take action 6.2 Environmental objectives and planning to achieve them Environmental objectives Planning actions to achieve environmental objectives 7.2 Competence 7.3 Awareness 7.4 Communication General Internal Communication External communication 7.5 Documented Information General Creating and updating Control of documented information 8 Operation 8.1 Operational planning and control 8.2 Emergency preparedness and response 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation General Evaluation of compliance 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 7 Support 7.1 Resources
35 ISO 14001:2015 PDCA CYCLE
36 CONTEXT OF THE ORGANISATION Internal and external issues need to be determined The needs and expectations of interested parties need to be determined The scope shall not exclude activities, products and services that can have significant environmental aspects The scope shall be available as documented information and be available to the public
37 PROTECTION OF THE ENVIRONMENT Policy commitment to the protection of the environment Protection of the environment includes prevention of pollution and others (specific to context). This can include: sustainable resource use, climate change mitigation and adaptation, and protection of biodiversity and ecosystems.
38 LEADERSHIP Top management need to demonstrate leadership and commitment with respect to the environmental management system.
39 STRATEGIC ENVIRONMENTAL MANAGEMENT Policy and objectives need to be compatible with the strategic direction of the organization. Management review outputs should include any implications for the strategic direction of the organization.
40 RISK ASSOCIATED WITH THREATS AND OPPORTUNITIES
41 RISK. CONTINUED Significant environmental aspects and compliance obligations can result in risk associated with either adverse impacts (threats) or beneficial impacts (opportunities). The organisation shall determine the risk associated with threats and opportunities that needs to be addressed to: give assurance that the environmental management system can achieve its intended outcome(s); prevent, or reduce, undesired effects, including the potential for external environmental conditions to affect the organization; achieve continual improvement.
42 RISK. CONTINUED The organization shall plan to take actions to address the risk associated with threats and opportunities Considered when determining the environmental objectives Taken into consideration during internal audit planning and management review
43 ISO 14001:2015 KEY CHANGES Environmental management system: part of the management system used to [ ] address risk associated with threats and opportunities ISO/DIS : 2014 International Organization for Standardization
44 LIFE CYCLE PERSPECTIVE Aspects and impacts should be identified whilst considering a life cycle perspective Procurement and design activities should be undertaken taking into account a life cycle perspective Life cycle definition: consecutive and interlinked stages of a product system, from raw material acquisition or generation from natural resources to end-oflife treatment
45 COMMUNICATION Organisation must ensure communicated environmental information is reliable The organisation must respond to communications on the EMS Specific sub-clauses for internal and external communication Organisation must enable internal personnel contribute to continual improvement
47 ISO THE FUTURE OF OHSAS 18001
48 THE FUTURE OF OHSAS 18001
49 WE ARE HERE TO HELP
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