ISO STANDARDS UPDATES SEMINAR “CHANGES …€¦ · ISO 9001:2008. ISO 9001:2015. Products...

ISO STANDARDS UPDATES SEMINAR “CHANGES AHEAD”

SEMINAR AGENDA

Annex SL 18:30 ISO 9001 18:45 ISO 14001 19.30 ISO 45001 20:15 Finish 20:30

WHAT IS ANNEX SL?

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

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

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

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

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

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.

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

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

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

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

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

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

9001:2015 KEY CHANGES

TOOLS TO HELP YOU

KEY CONCEPTS DOCUMENT GAP ANALYSIS

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

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

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

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

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

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

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

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

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

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

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

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

Q&A

14001:2015 KEY CHANGES

A BRIEF HISTORY OF ISO 14001

• BS 7750 pilot launched – March 1992

• BS 7750 : 1994 launched – January 1994

• ISO 14001 : 1996 issued – September 1996

• BS 7750 withdrawn – September 1997

• ISO 14001 : 2004 issued – November 2004

• ISO 14001 : 2015 – Currently in progress

ISO 14001:2015 DEVELOPMENT TIMELINE

November 2011 – ISO votes to revise ISO 14001 February 2012 – ISO confirms use

of a new High Level Structure (Annex SL) May 2013 – Committee Draft 1

published October 2013 – Committee Draft 2 published

January 2014 – ISO votes to begin work on DIS July 2014 – Public Draft (DIS)

published (available for public comment until 31 October 2014) March 2015 – Final Draft (FDIS)

expected to be published

Q3 2015 – ISO 14001 : 2015 expected to be published. Three year transition period to commence.

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 6.1.1 – General 6.1.2 – Significant environmental aspects 6.1.3 – Compliance obligations 6.1.4 – Risk associated with threats and opportunity 6.1.5 – Planning to take action 6.2 – Environmental objectives and planning to achieve them 6.2.1 – Environmental objectives 6.2.2 – Planning actions to achieve environmental objectives

7 – Support 7.1 – Resources

7.2 – Competence 7.3 – Awareness 7.4 – Communication 7.4.1 – General 7.4.2 – Internal Communication 7.4.3 – External communication 7.5 – Documented Information 7.5.1 – General 7.5.2 – Creating and updating 7.5.3 – 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 9.1.1 – General 9.1.2 – Evaluation of compliance 9.2 – Internal audit 9.3 – Management review

10 – Improvement 10.1 – Nonconformity and corrective action 10.2 – Continual improvement

Elements of ISO 14001 : 2015 (DIS)

ISO 14001:2015 – PDCA CYCLE

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

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.

LEADERSHIP

• Top management need to demonstrate leadership and commitment with

respect to the environmental management system.

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.

RISK ASSOCIATED WITH THREATS AND OPPORTUNITIES

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.

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

ISO 14001:2015 – KEY CHANGES

Environmental management system: part of the management system used to […] address risk associated with threats and opportunities

ISO/DIS 14001 : 2014

International Organization for Standardization

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-of-life treatment”

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

Q&A

ISO 45001 THE FUTURE OF OHSAS 18001

THE FUTURE OF OHSAS 18001

WWW.NQA.COM/45001

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