ISO 9001:2015 Transition Guide

ISO 9001:2015 Transition Guide ISO 9001:2015 TIMESCALES

ISO 9001:2015 was published on the 15th September 2015 and is the replacement for ISO 9001:2008. For organisations currently using ISO 9001:2008 there will be a three year transition period to switch over to the new standard ISO 9001:2015. Certificates to ISO 9001:2008 will not be valid after the 14 th September 2018.

STRUCTURE OF ISO 9001:2015

ISO 9001:2015 is based on the high level structure (Annex SL Framework) being applied to all new and revised ISO management system standards: 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of the Organisation 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement

KEY CONCEPTS

4.0 Context of the organisation

The standard introduces a new requirement to identify the internal and external factors which are relevant to purpose and strategic direction and that will affect the ability to achieve the required outcomes in terms of quality.

5.0 Leadership

There is more of a requirement in this new standard for top management to demonstrate leadership and management direction with the system. Top management will have to be able to demonstrate leadership and commitment and detail the areas where this occurs. Applicable legal and regulatory requirements have to be determined, understood and the organisation clearly meeting these requirements.

6.0 Planning

This is a new term added to the high level structure with a requirement to address risks and opportunities and to carefully plan changes within the management system. The company will have to demonstrate that they have assessed the risks and opportunities for the organisation. Objectives have been enhanced with the company having to establish objectives at ‘Relevant’ functions, levels and processes including what will be done, what resources are required, who is responsible for each of the objectives, when they are expected to be completed by and how evaluation of the objectives will occur.

7.0 Support

This new term builds upon the ISO 9001:2008 requirements for competence and awareness and is now extended to include persons under the organisation’s control and not just employees.

Document control and records is now referred to as Documented Information. There is no longer a requirement for a quality manual and the six procedures.

All employees will need to demonstrate that they are aware of the current Quality Policy, Relevant Quality Objectives, their own contribution to the effectiveness of the quality management system, and the implications of not conforming to the QMS requirements.

8.0 Operation

This includes many of the old requirements from clause 7 and the basic principles of controlling operations have not changed.

World Certification Services Ltd. Station Court, Ormskirk Road, Aintree, Liverpool, L9 5AA Tel. 0151 924 7474 [email protected] www.world-cert.co.uk ISO 9001:2015 Transition Guide

9.0 Performance Evaluation

This has similar themes to the existing standard, but with a new emphasis on evaluation in addition to the current requirement to measure and analyse. The requirement to monitor customer perception still exists.

10.0 Improvement

This section includes non-conformity, corrective action and continual improvement. The requirement for preventive action has been removed and replaced by the risk based thing earlier in the standard.

PRACTICAL STEPS TO TRANSITION

The new standard was published on the 15th September 2015 and is the replacement for the ISO 9001:2008 standard. For organisations currently operating to the ISO 9001:2008 standards there is a three year transition period to switch over to the new ISO 9001:2015 standard.

Organisations currently operating to the ISO 9001:2008 standard should at this stage be considering how they are going to transition to the new standard.

A staged approach might include:

 Buy and read the ISO 9001:2015 Standard  Look at the freely available and practical information on the internet to help understand the changes and the impact on your existing environmental management system  Highlight the key changes  Develop an implementation plan  Consider having a gap assessment by WCS Ltd. to confirm the areas already compliant and to highlight gaps in the system  Provide appropriate training and awareness to all parties  Make changes to your existing documentation to reflect the new structure of the standard  Implement the new requirements including leadership, risk and context of your organisation  Check the impact and compliance with the new requirements by auditing against the standard  Review the impact and need for further changes

WCS APPROACH TO TRANSITION

 WCS is able to undertake a gap analysis if the organisation requires it. A Gap Analysis Audit identifies omissions and areas of weakness against the new ISO 9001:2015. A Gap Analysis audit is chargeable at a day rate of £600 plus VAT. A report is provided at the end of the audit showing actions required. If you are interested in this service please email [email protected].  If a gap analysis is not required, WCS encourages organisations to request that they be audited to the new Standard at one of their scheduled surveillance or recertification visits. To comply with accreditation requirements some additional time has to be allocated to such audits .

* Please note: WCS Auditors will not be able to undertake analysis at normal surveillance audits or re-certification audits without additional time being allocated by WCS HQ.

If non-conformances are raised against the new requirements in ISO 9001:2015 this will not impact on existing certification. However, the non- conformances will have to be satisfactorily addressed before consideration can be given to certificating the organisation to the new Standard. This will not take place until UKAS advises WCS that it is accredited to the new Standard. Once organisations have satisfactorily demonstrated conformance to the new Standard and WCS has been advised of UKAS accreditation, old certificates will be withdrawn and new certificates will be issued. Please Advise World Certification Services when you wish your organisation to be audited to the new standards

ISO 9001:2008 ISO 9001:2015

Clause title Clause Clause Clause title

Quality Management Systems general requirements 4.1 4.1 Quality Management Systems and its processes Documentation requirements 4.2 7.5 Documented information Management Responsibility 5 5.1 Leadership and commitment Customer Focus 5.2 5.1.2 Customer Focus Quality Policy 5.3 5.2 Quality Policy Planning 5.4 6 Planning for the Quality Management System Quality Objectives 5.4.1 6.2 Quality Objectives and planning to achieve them Quality Management System Planning 5.4.2 6 Planning for the Quality Management System Responsibility and authority 5.5.1 5.3 Organisational roles, responsibilities and authorities Management Representative 5.5.2 5.3 Organisational roles, responsibilities and authorities Internal Communication 5.5.3 7.4 Communication Management Review 5.6 9.3 Management Review Resource Management 6 7.1 Resources

Human Resources 6.2 7.2 Competence

Infrastructure 6.3 7.1 Infrastructure

Work Environment 6.4 7.1.4 Environment for the operation of processes

Product Realisation 7 8 Operation

Planning of product realisation 7.1 8.1 Operational planning and control

Customer related processes 7.2 8.2 Determination of requirements for products and services

Design and development 7.3 8.5 Design and development of products and services

Purchasing 7.4 8.4 Control of externally provided products and services

Verification of purchased product 7.4.3 8.6 Release of products and services

8.5.1 Control of production and service provision Control of production and service provision 7.5.1 8.5.5 Post-Delivery activities

Validation of processes for production and service provision 7.5.2 8.5.1 Control of production and service provision

Identification and traceability 7.5.38.5.2 Identification and traceability

Customer Property 7.5.4 8.5.3 Property belonging to customers or external providers Preservation of product 7.5.5 8.5.4 Preservation 7.6 Control of monitoring and measuring equipment 8.1.5 Monitoring and measuring resource

Measurement, analysis and improvement 8 9.1 Monitoring, measurement, analysis and evaluation

Customer Satisfaction 8.2.1 9.1.2 Customer Satisfaction

Internal Audits 8.2.2 9.2 Internal Audits

Monitoring and measurement of processes 8.2.3 9.1.1 General Release of products and services Monitoring and measurement of product 8.2.4 8.6

Control of nonconforming product 8.3 8.7 Control of nonconforming process outputs

Analysis of data 8.4 9.1.3 Analysis and evaluation

Continual Improvement 8.5.1 10.3 Continual Improvement

Corrective Action 8.5.2 10.2 Nonconformity and corrective action

Preventative Action 8.5.3 6.1 Actions to address risks and opportunities WCS Support

ISO 9001:2015 Transition training

World Certification Services Ltd. Station Court, Ormskirk Road, Aintree, Liverpool, L9 5AA Tel. 0151 924 7474 [email protected] www.world-cert.co.uk ISO 9001:2015 Transition Guide The 1st one day event is due to be held on the 1st March 2016 in Liverpool for £170 (Exclusive of VAT) per person, [Refreshments and Lunch provided] with the course starting at 8:30am and finishing at 6pm.

The course aims to provide attendees who have an existing, basic knowledge of, or experience in, quality management with an understanding of the management systems approach and the requirements of ISO 9001:2015.

Delegates will, at the end of the course be able to:

 Understand the purpose of a quality management system, of quality management systems standards, and the business benefits of improved performance of the quality management system  Understand the structure and content of ISO 9001:2015 and its relationship with ISO 9000  Understand the specific quality management related requirements of ISO 9001:2015  An understanding of Risk-based thinking  Relationship with other management system standards

Certificates of attendance will be provided following the course. An optional technical questionnaire will be provided following the course to test attendee understanding of the new standard.

 Further courses including ISO 14001:2015 Transition Training will be run during 2016 with dates to be confirmed.  Should you wish to attend, please complete the Booking Form which is available on our website and return to [email protected]  If you have any queries, please do not hesitate to contact WCS on 0151 924 7474 or [email protected]

For reference other UK Certification Body fee’s for running similar ISO 9001 transition courses:

Alcumus ISOQAR £ 415 excluding vat (1 day) BM Trada £ 195 excluding vat (1/2 day) Lloyds Register £ 495 excluding vat ( 1 day) NQA £ 199 excluding vat (1/2 day)

ISO 9001:2015 Foundation Training

£230.00 - 1 Day Training event

Delegates will, at the end of the course be able to:

 Understand the purpose of a quality management system, of quality management systems standards, and the business benefits of improved performance of the quality management system  Understand the structure and content of ISO 9001 and its relationship with ISO 9000  Understand the specific quality management related requirements of ISO 9001

Booking arrangement can be found at http://www.world-cert.co.uk/training-2/training-2iso-90012015-foundation/

ISO 9001:2015 Internal Auditor Training

£415.00 - 2 Day Training event

Delegates will, at the end of the course be able to:

 With reference to the PDCA cycle, explain the process-based quality management system model for ISO 9001 and the role of an internal audit in the maintenance and improvement of quality management systems (see 3.1).  Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal quality management system audit, in accordance with ISO 19011  Plan, conduct, report and follow-up an internal audit of part of a quality management system based on ISO 9001, and in accordance with ISO 19011 : Booking arrangement can be found at http://www.world-cert.co.uk/training-2/iso-90012015-internal-auditor-training/

World Certification Services Ltd. Station Court, Ormskirk Road, Aintree, Liverpool, L9 5AA Tel. 0151 924 7474 [email protected] www.world-cert.co.uk