ISO 9001:2015 DIS 16 th October 2014 Mark Braham MSc, MCQI CQP The AA, Quality Assurance Manager The CQI, ISO9001:2015 Team Leader

Join the discussion at Call us on +44 (0) Why now, reason for change? Annex SL. What has changed in the DIS? Next steps, be prepared. Agenda

Why now? Reason for change….

Join the discussion at Call us on +44 (0) Business evolution Quality/business management systems maturity Quality development - Service sectors, NHS etc. ISO process every 5 years Reason for change

Join the discussion at Call us on +44 (0) Schedule Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2014 (DIS Ballot) 2015 (FDIS Ballot)

Annex SL Future ISO standards

Join the discussion at Call us on +44 (0) Annex SL What is annex SL? High Level Structure Identical Core Text Common Terms and Core Definitions We have no choice…….. Main headings are mostly annex SL text

ISO9001:2015 What has changed.

Join the discussion at Call us on +44 (0) What has changed 1 of 5 Quote Goes here Break time ISO 9001:2008ISO DIS 9001: Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system4 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 quality management system 4.1 General requirements4.4 Quality management system and its processes 4.2 Documentation requirements7.5 Documented information

Join the discussion at Call us on +44 (0) Quote Goes here Break time ISO 9001:2008ISO DIS 9001: Management responsibility5 Leadership 5.1 Management commitment5.1 Leadership and commitment 5.2 Customer focus5.1.2 Customer focus 5.3 Quality policy5.2 Quality policy 5.4 Planning 6 Planning for the quality management system 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 5.5 Responsibility, authority and communication 5.3 Organizational roles, responsibilities and authorities 7.4 Communication 5.6 Management review9.3 Management review What has changed 2 of 5

Join the discussion at Call us on +44 (0) Quote Goes here Break time ISO 9001:2008ISO DIS 9001: Resource management7 Support 6.1 Provision of resources7.1 Resources 6.2 Human resources 7.2 Competence 7.3 Awareness 7.4 Communication 6.3 Infrastructure7.1.3 Infrastructure 6.4 Work environment Environment for the operation of processes What has changed 3 of 5

Join the discussion at Call us on +44 (0) Quote Goes here Break time ISO 9001:2008ISO DIS 9001: Product realization8 Operation 7.1 Planning of product realization8.1 Operational planning and control 7.2 Customer-related processes 8.2 Determination of requirements for products and services 7.3 Design and development 8.3 Design and Development of products and services 7.4 Purchasing 8.4 Control of externally provided products and services 7.5 Production and service provision8.5 Production and service provision 7.6 Control of monitoring and measuring equipment Monitoring and measuring resources 8.6 Release of products and services What has changed 4 of 5

Join the discussion at Call us on +44 (0) Quote Goes here Break time ISO 9001:2008ISO DIS 9001: Measurement, analysis and improvement 9 Performance evaluation 8.1 General 9.1 Monitoring, measurement, analysis and evaluation 8.2 Monitoring and measurement 9.2 Internal audit 9.3 Management review 8.3 Control of nonconforming product 8.7 Control of nonconforming process outputs, products and services 9.1 Monitoring, measurement, analysis and evaluation 8.4 Analysis of data 9.1 Monitoring, measurement, analysis and evaluation 8.5 Improvement 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual Improvement What has changed 5 of 5

Fail to prepare, prepare to fail Next steps

Join the discussion at Call us on +44 (0) Next steps Need to prepare –Awareness and understanding of the changes –Regularly check sources for data –IAF – 3 years from publication –Need to make changes, systems and people –Triaster – number of process or processes = ?

Join the discussion at Call us on +44 (0) Break time

Coffee break! until 15:00 Then at 11:05am: Business Track: A roundup demonstration of the most beneficial Triaster Solution functionality with Carma Cooper and Victoria Glancy Technical Track: A glimpse of the future with Andrew Ridgeley and Chris Mawdsley #triaster Triaster Conference 2014