1 Date and venueThursday 27 November 2014, Keele Conference Centre ISO 9001: 2015 Preparing for transition to the revised standard Morning session

2 Welcome Nikki Sammé Marketing & Portfolio Development Director

3 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 3 rd party certification audits We are all on a learning journey and in it together We encourage you to ask questions and offer your thoughts and interpretations

4 Agenda Welcome and introductionNikki Sammé Why are standards revised?Andrew Patefield Key differences between ISO 9001:2015 and ISO 9001:2008 Andrew Patefield Understanding the ISO 9001 transition path Andrew Patefield Coffee Break Potential impacts as a result of the changes with panel Q&A Steve Blackwell Closing summary and next steps Steve Blackwell Lunch

5 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 & Support 2011 CMS (COSHH) 2009 Monitoring Services 2009 UKAS Accredited Certification 2010

6 Why are standards revised? Andrew Patefield Alcumus Academy IRCA Approved Trainer

7  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? Previous revisions

8 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)?

9 1 New standard is proposed to relevant technical committee 2 Working group of experts start discussion to prepare working draft 3 1 st working draft shared with technical committee and with ISO CS If consensus is reached within the TC 4 Draft 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

10 Revision timeline

11 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)?

12  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?

13 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

14 Two new clauses and changes clause 4 to: 4. Context of the organisation The new clauses are: 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties Annex SL introduces…

15 Key differences between ISO 9001:2015 and ISO 9001:2008 Andrew Patefield Alcumus 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 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’

Clause 5: Leadership ISO 9001:2008ISO 9001: Management Commitment5.1 Leadership and Commitment Under this heading far greater involvement in the Quality Management System is expected by management 5.2 Customer Focus5.1.2 Customer Focus 5.3 Quality Policy5.2 Quality Policy 5.4 PlanningClause 6: Planning for the Quality Management System 5.5 Responsibilities, Authorities and Communication 5.3 Organisational Roles, Responsibilities and Authorities Communication7.4 Communication Also clause requiring a management representative to be appointed for Quality has been removed 5.6 Management Review9.3 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 9001:2008ISO 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 Infrastructure7.1.3 Infrastructure 6.4 Environment7.1.4 Environment for the operation of processes 6.2 Human Resources7.2 Competence The new standard then goes on to identify clauses 7.3 Awareness, 7.4 Communication and 7.5 Documented Information

Clause 8: Operation ISO 9001:2008ISO 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 processes8.2 Determination of requirements for product & services 7.3 Design & development8.3 Design & development of products & services 7.4 Purchasing8.4 Control of externally provided products & services

Clause 8: Operation ISO 9001:2008ISO 9001: Product and service provision 8.5 Product and service provision 7.6 Control of monitoring and measuring equipment Monitoring and measuring resources Monitoring and measurement of product 8.6 Release of products and services

Clause 9: Performance Evaluation ISO 9001:2008ISO 9001: General9.1 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 data9.1 Monitoring, measurement, analysis & evaluation 8.5 Improvement10 Improvement ‘Management Review’ in the new standard is now under clause 9.3 ‘Management Review’

Clause 10: Improvement ISO 9001:2008ISO 9001:2015 Clause 8.5 ‘Improvement of the old standard’ Clause 10 ‘Improvement’ 10.1 General 10.2 Nonconforming and corrective action When nonconformity occurs The organisation shall retain documented information as evidence 10.3 Continual improvement

24 Understanding the ISO 9001 transition path Andrew Patefield Alcumus Academy IRCA Approved Trainer

How to prepare for ISO 9001: 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 help of 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 day transition courses and 2 day IRCA Lead auditor conversion Update our IAN members Transition audit schedules Run training courses

27 Potential impacts as a result of the changes with panel Q&A Steve Blackwell Alcumus ISOQAR Lead Auditor ISO 9001, ISO 14001, OHSAS 18001

28 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 Customer focus  Clause 6: Planning of the QMS, including  Clause Organisational knowledge  Clause 8.1 Operational planning and control Significant changes

29  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

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

31 The organisation shall monitor and review the information about external and internal issues Clause 4.1: Context of the organisation What you need to consider How might this impact your business? 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

32 Internal  Awareness of company culture/environment  Performance analysis  Job knowledge/information  Management structure Clause 4.1: Context of the organisation What you need to consider How might this impact your business? 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

33 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 Shareholders Good return on investment 4.2: Understanding the needs and expectations of interested parties What you need to consider How 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

34  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

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 Clause 5: Leadership What you need to consider How might this impact your business? 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

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 Clause 5: Leadership What you need to consider How might this impact your business? 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)

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

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 What you need to consider How might this impact your business? When addressing changing needs and trends, the organisation shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge

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

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

41  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

42 Get up to speed with the ISO revisions... Book one of our courses by end 2014 and save £100 CourseWho is it for?DurationPrice ISO 9001:2015 Transition course If you are responsible for any aspect of your ISO 9001 or ISO management system including internal auditing these courses are for you 1 day £395 ISO 14001: 2015 Transition course 1 day £395 IRCA QMS (ISO 9001:2015 ) Lead auditor transition course If you are currently a lead auditor and need to get up to speed with the new ISO 9001 or ISO revisions then these courses are for you 2 day £645 IRCA EMS (ISO 14001:2015 ) Lead auditor transition course 2 day £645