1 ISO 14001: 2015 Preparing for transition to the revised standard Thursday 27 November 2014, Keele...

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ISO 14001: 2015 Preparing for transition to the revised standard

Thursday 27 November 2014, Keele Conference Centre

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WelcomeNikki SamméMarketing & Portfolio Development Director

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ISO 14001 breakfast briefing agenda

0800-0805 Welcome Nikki Sammé

0805-0845 Key changes and likely impacts of the new standard

Steve Blackwell

0845-0850 ISO 14001: the transition path Steve Blackwell

0850-0900 Questions All

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Key changes and likely impactsof the new standard

Steve BlackwellAlcumus ISOQAR Lead AuditorISO 9001, ISO 14001, OHSAS 18001

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The standard has a new clause numbering based on Annex SLClause numbers now 4.0 to 10.0 4 Context 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement

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Summary of changes Very little has been removed from the old standard Reference to procedures is minimal ‘Documented information’ replaces ‘documentation

and records’ The phrase ‘compliance obligations’ replaces ‘legal

requirements and other requirements to which the organisation subscribes’

Let’s look at the main changes clause by clause………

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Clause 4: Context of the organisation

4.1 Understanding the context of the organisation

The intent of 4.1 is to provide a high-level, conceptual understanding of the important issues that can affect, either positively or negatively, the way the organisation manages its environmental responsibilities

What you need to consider How might this impact your business?

Top level management involvement will need to be

demonstrated

The areas to be considered will vary depending on the type,

size and nature of your business activities

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Areas to consider: External cultural, social, political, legal,

regulatory, financial, technological, economic issues

Internal characteristics or conditions of the organisation, such as its activities, products and services, strategic direction, culture and capabilities (people, knowledge, processes, systems) and resource availability

Documented information is not required


Evidence will be required of a review of external and internal

issues as opposite

Generally, anything that can either affect the

organisation’s purpose, or be affected by its

environmental aspects

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4.2 Understanding the needs and expectations of interested parties

An organisation is expected to gain a general (ie. high-level, not detailed) understanding of the expressed needs and expectations of those internal and external interested parties that have been determined to be relevant, so that the knowledge gained can be considered when determining its compliance obligations

What you need to consider How might this impact your business?You will need to:

• Identify the interested parties• What are their needs and

expectations?• Regulatory – Legal – Permits

Contractual – Voluntary

The above represent compliance obligations and they should be

considered when planning the EMS (Clause 4.4)

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Clause 5: Leadership

5.1 Leadership and commitment Top management shall demonstrate

leadership and commitment with respect to the environmental management system

Accountability for: Policy/objectives EMS integration Ensuring resources Communication Supporting employees in their roles

Documented information is not required


Top management involvement regarding the support of the

processes and personnel will need to be demonstrated

This may require verification by the external auditor, interviewing

members of top management

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Clause 6: Planning

6.1 Actions to address risk associated with threats and opportunities

The context of the organisation (see 4.1 and 4.2) provides an overarching framework for evaluating the risk associated with threats and opportunities in 6.1

6.1.2 Significant environmental aspects 6.1.3 Compliance obligations 6.1.4 Risk associated with threats and

opportunities 6.1.5 Planning to take action Documented information is required


Methods may have to be introduced to carry out

the following:

• Assessment of risk associated with threats and opportunities

• Plans to take action to address the risks will be required

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6.2: Environmental objectives and planning to achieve them

To include consideration of the risks associated with threats and opportunities

How the results will be evaluated, including indicators for monitoring progress toward achievement of measurable environmental objectives

Clause 6: Planning


You may be required to set objectives to reduce risks

to the EMS

Measures will need to be determined

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Includes:

Resources Competence – records required Awareness Communication – internal &

external Document control – no

procedure required

Clause 7: Support


Evidence of communications both internal and external will

need to be retained

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8.1 Operational planning and control

Can include documented procedures Control of risk Meeting objectives

Clause 8: Planning


Documented information to the extent necessary, to have

confidence that the processes have been carried

out as planned

This information will need to be retained

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Making the transition

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July 2014

Draft international

standard

Revision timeline

Feb 2015

Final draft international

standard End 2015

ISO international

standard released

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There is no need to make any changes to your system/documentation just yet

Study the significant changes and consider actions or methods to meet compliance

Identify minor changes (improvements???)Options – introduce now – wait until next year

Consider training requirements for EMS transition – refer to your training leaflet for courses offered by Alcumus ISOQAR

Next steps

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Date and venueThursday 27 November 2014, Keele Conference Centre

ISO 9001: 2015 Preparing for transition to the revised standard

Morning session

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Welcome

Nikki SamméMarketing & Portfolio Development Director

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Aims and objectives of today To provide an understanding of the likely significant changes

to the standard To begin to evaluate the potential impacts of these changes To explore how the changes might alter how we carry out 3rd

party certification audits

We are all on a learning journey and in it togetherWe encourage you to ask questions and offer your thoughts

and interpretations

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Agenda0915-0935 Welcome and introduction Nikki Sammé

0935-0945 Why are standards revised? Andrew Patefield

0945-1025 Key differences between ISO 9001:2015 and ISO 9001:2008

Andrew Patefield

1025-1030 Understanding the ISO 9001 transition path

Andrew Patefield

1030-1050 Coffee Break

1050-1150 Potential impacts as a result of the changes with panel Q&A

Steve Blackwell

1150-1200 Closing summary and next steps

Steve Blackwell

1200-1300 Lunch

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Alcumus Overview

To create a market-leading compliance and certification service company

We combine simple yet innovative technology with expert advice to support our clients to manage their exposure to risk, comply with the latest legislation, improve business performance and encourage workforce engagement

SaaS Compliance Managment

2010

HS/HR Advice

& Support2011

CMS (COSHH)

2009

MonitoringServices

2009

UKAS Accredited

Certification 2010

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Why are standards revised?

Andrew PatefieldAlcumus Academy IRCA Approved Trainer

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To keep standards current and relevant to industry

To respond to the latest market trends

To ensure compatibility with other management system standards

Why are standards revised?

1987 1994 2000 2008 2015

Previous revisions

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Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC2, Quality systems is responsible for the forthcoming changes to ISO 9001

The change to the 2008 quality standard represents a technical change

How is ISO 9001 changing (1)?

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1New standard is

proposed to relevant technical

committee2

Working group of experts start

discussion to prepare working

draft

31st working draft

shared with technical

committee and with ISO CS

If consensus is reached within the

TC4Draft shared with all ISO national

members, who are asked to comment

5 Final draft sent to all ISO members

If standard is approved by member

vote 6 ISO International Standard

Transition path

If consensus is reached

If proposal accepted

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April 2014

Draft international

standard

Revision timeline

Feb 2015

Final draft international

standard Sept 2015

ISO international

standard released

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1. New concepts and methodologies to manage Quality

1a. New concept ‘Risk Based Quality Management System’

2. To revise the ‘Quality Management Principles’

3. To revise the clause sequence so that common elements between the ISO standards are identically numbered to create ease in integration

4. To adopt the new format for standards introduced in Annex SL

How is ISO 9001 changing (2)?

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A guidance document that explains the new high level structure/format that all new standards will follow

The structure of the standards will change by creating standards that have: identical number for common

elements between standards common core definitions

Annex SL – what is it?

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The aim of the changes: To create ISO management system standards with enhanced

consistency where the alignment of the standards are the same This means that the common elements between standards will

be numbered the same

The objective: This common approach to new management system standards

will make it easier for organisations to create a single management system known as an Integrated Management System (IMS)

Aims and objectives

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Two new clauses and changes clause 4 to:4. Context of the organisation

The new clauses are:4.1 Understanding the organisation and its context4.2 Understanding the needs and expectations of interested parties

Annex SL introduces…

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Key differences between ISO 9001:2015 and ISO 9001:2008

Andrew PatefieldAlcumus Academy IRCA Approved Trainer

ISO 9001:2008 Clause 4 The Quality Management System ISO 9001:2015 Changes Clause 4 to ‘Context of the Organisation’

New Clauses:

Changes to Clause 4

4.1 Understanding the organisation and its context

4.2 Understanding the needs and expectation of interested parties

4.3 Determine the scope of the quality management system

4.4 Quality management system and its processes. Was 4.1 General Requirements

Documentation required was covered under 4.2 of ISO 9001:2008. In the new standard this is covered under 7.5 ‘Documented Information’


ISO 9001:2008 ISO 9001:20155.1 Management Commitment 5.1 Leadership and Commitment

Under this heading far greater involvement in the Quality Management System is expected by management

5.2 Customer Focus 5.1.2 Customer Focus

5.3 Quality Policy 5.2 Quality Policy

5.4 Planning Clause 6: Planning for the Quality Management System

5.5 Responsibilities, Authorities and Communication

5.3 Organisational Roles, Responsibilities and Authorities

Communication 7.4 Communication

Also clause 5.5.2 requiring a management representative to be appointed for Quality has been removed

5.6 Management Review 9.3 Management Review

Clause 6 ‘Resource Management’ of the old standard is now covered under:

Clause 6: Planning for the Quality Management System

Clause 7: Support

Clause 6 of the new standard now covers ‘Planning’

Clause 6.1 of the new standard discusses ‘Actions to address risk and opportunities’

Clause 6.2 covers ‘Quality objectives and planning to achieve them’

Clause 6.3 talks about the ‘Planning of changes’

Clause 7: Support

ISO 9001:2008 ISO 9001:2015

Clause 6 ‘Resources Management of the old standard’

Clause 7 ‘Support of the new standard’

6.1 covered the ‘Provision of Resources’

7.1 Resources

6.3 Infrastructure 7.1.3 Infrastructure

6.4 Environment 7.1.4 Environment for the operation of processes

6.2 Human Resources 7.2 Competence

The new standard then goes on to identify clauses7.3 Awareness, 7.4 Communication and 7.5 Documented Information

Clause 8: Operation

ISO 9001:2008 ISO 9001:2015

Clause 7 ‘Product realisation’ Clause 8 ‘Operation’

7.1 Planning and production realisation of the old standard

8.1 Operational planning and control

7.2 Customer related processes 8.2 Determination of requirements for product & services

7.3 Design & development 8.3 Design & development of products & services

7.4 Purchasing 8.4 Control of externally provided products & services

Clause 8: Operation

ISO 9001:2008 ISO 9001:2015

7.5 Product and service provision

8.5 Product and service provision

7.6 Control of monitoring and measuring equipment

7.1.5 Monitoring and measuring resources

8.2.4 Monitoring and measurement of product

8.6 Release of products and services

Clause 9: Performance Evaluation

ISO 9001:2008 ISO 9001:2015

8.1 General 9.1 Monitoring, measurement, analysis and evaluation

8.2 Monitoring and measurement

9.2 Internal audits

8.3 Control of nonconforming product

8.7 Control of nonconforming process outputs, product and services

8.4 Analysis of data 9.1 Monitoring, measurement, analysis & evaluation

8.5 Improvement 10 Improvement

‘Management Review’ in the new standard is now under clause 9.3 ‘Management Review’

Clause 10: Improvement

ISO 9001:2008 ISO 9001:2015

Clause 8.5 ‘Improvement of the old standard’

Clause 10 ‘Improvement’

10.1 General10.2 Nonconforming and corrective action 10.2.1 When nonconformity occurs10.2.2 The organisation shall retain documented information as evidence10.3 Continual improvement

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Understanding the ISO 9001 transition path Andrew PatefieldAlcumus Academy IRCA Approved Trainer

How to prepare for ISO 9001:2015

1• Understand the requirements of the revised standard

2• Identify any gaps which need to be addressed to meet the new risk–based

requirements

3• Prepare a transition plan & share this internally

4• Provide appropriate training & awareness for relevant parties

5• Revise QMS documentation (eg. quality manual & procedures) where

appropriate

6• Update your internal audit programme & identify areas for continual

improvement

7• Talk to your certification body for further transition

arrangements

ISO 9001 transition 1 day course

We will keep you continually updated on your company’s specific transition arrangements

ISO 9001 IRCA transition 2 day lead auditor course

Need the helpof a consultant?

Need the helpof a consultant?

How can we help?

Provide you with further guidance and arrangements for the transition process

Share updates

Train our auditors

Ensure our auditors and technical support are fully competent and knowledgeable about the revision

Arrange transition audit schedules for existing customers

Continue to update our network of consultants

Provide ISO 9001 1 day transition courses and 2 day IRCA Lead auditor conversion

Update our IAN

members

Transition audit

schedules

Run training courses

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Potential impacts as a result of the changes with panel Q&A

Steve BlackwellAlcumus ISOQAR Lead AuditorISO 9001, ISO 14001, OHSAS 18001

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Let’s look at potential impacts of the key changes as outlined by Andrew: Clause 4: Context of the Organisation

4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.4 Quality management system and its processes

Clause 5: Leadership 5.1 Leadership and commitment - 5.1.2 Customer focus

Clause 6: Planning of the QMS, including 6.1 - 6.1.1 - 6.1.2

Clause 7.1.6 Organisational knowledge Clause 8.1 Operational planning and control

Significant changes

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The existing ISO 9001:2008 Manual and Procedures can still be retained as these will meet most of the requirements of the new standard

Records, documents and procedures have been replaced by ‘Documented Information’

The clause and need for a Preventive Action Procedure has been removed, however as part of ‘Planning’, risks to the processes should be identified and preventive measures adopted

General

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4.1 Understanding the organisation and its context The organisation shall

determine external and internal issues that are relevant to its purpose and its strategic direction

No mandatory requirement for documentation but it needs to be auditable

Clause 4.1: Context of the organisation


A review of the business situation and any foreseeable

problems or opportunities needs to be carried out

The depth of this review will vary depending on the type, size and complexity of your

business activities

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The organisation shall monitor and review the information about external and internal issues



Companies may need to demonstrate that they are aware of:

Current sales trends Market share New equipment - software Forthcoming changes to legislation Effects to job costs –

materials/services Customer requirements/feedback Supplier performance/availability Neighbours/community issues

External The business market Existing/new technology Legal requirements The economy Cultural/social issues

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Internal Awareness of company

culture/environment Performance analysis Job knowledge/information Management structure



Companies may need to demonstrate that they are aware of:

Current sales trends Employee morale Staff turnover Absenteeism Employee training needs Any additional staff required Past problems Poor equipment Inadequate methods Production/service delivery data

The organisation shall monitor and review the information about external and internal issues

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Customers Goods/services on time to correct specification

Suppliers Correct information, ample lead times

Employees Adequate job information/environment/equipment

Regulators Evidence/records of conformity

Neighbours Consideration of noise/emissions

ShareholdersGood return on investment

4.2: Understanding the needs and expectations of interested parties

What you need to considerHow might this impact

your business?

The company will have to demonstrate that they have identified all interested parties and they are aware of their requirements

These requirements may change, so a periodic review of them may be needed

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To determine the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them

What you need to consider

4.4: Quality Management system and its processes

How might this impact your business?

A method will need to be used to assess the risks and opportunities regarding the context of the organisation and the needs of interested parties

Actions will need to be planned to address these risks and opportunities

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5.1 Leadership and commitment

No requirement for any mandatory documentation in this section but top management need to demonstrate their methods and commitment regarding communication of QMS requirements and their methods for providing resources, and support for relevant roles and responsibilities



Top management involvement regarding the support of the processes and personnel will need to be demonstrated

This may require verification by the external auditor

interviewing members of top management

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5.1.2 Customer focus

No requirement for any mandatory documentation but top management need to demonstrate how risks to meeting customer requirements have been assessed, legal requirements have been established/met and customer satisfaction enhanced



Methods for assessing these risks need to be established

Where, within the business processes, the assessments are to be carried out is up

to the company(See clause 6 - Planning

of the QMS)

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6.1 – 6.1.1 – 6.1.2 Actions to address risks and opportunities

Consideration of the following is required: Risk regarding 4.1 & 4.2 Prevention measures Planning of implementation Evaluation of effectiveness

Clause 6: Planning of the QMS


Risks/opportunities to the business and meeting customer

requirements need to be assessed (4.1 & 4.2)

No documented, formal risk assessment process is required.

However, this a fundamental requirement of the standard and it needs to be auditable

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7.1.6 Organisational knowledge

The organisation shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services

‘Information needed to achieve requirements’

Clause 7: Support


When addressing changing needs and trends, the

organisation shall consider its current knowledge and

determine how to acquire or access any necessary additional knowledge

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Previous/existing job information, including:

Job files Contract information Past problems Employee experience Successes – past jobs/projects Design history Information from

customers/providers Experts/advisors

7.1.6: Organisational knowledge


Good and in-depth record keeping is essential to meet the requirements of this clause

Employee knowledge may have to be enhanced

External sources may be required

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8.1 Operational planning and control The organisation shall plan, implement and

control the processes, as outlined in 4.4 and implement the actions determined in 6.1

4.4 The risks and opportunities in accordance with the requirements of 6.1

6.1 When planning for the quality management system, the organisation shall consider the issues referred to in 4.1 (Context) and the requirements referred to in 4.2 (Interested parties)

Clause 8: Operation


Current company planning operations will have to include

actions to address risk and opportunities regarding the

context of the organisation and the needs of interested parties

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There is no need to make any changes to your system/documentation just yet

Study the significant changes and consider actions or methods to meet compliance

Identify minor changes (improvements???)Options – introduce now – wait until next year

Consider training requirements for QMS transition – refer to your training leaflet for courses offered by Alcumus ISOQAR

Next steps

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