ISO 9001 2015 DIS 7.0 Support Slides 01-25-15
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Highlights of the ISO 9001 2015 Draft International Standard (DIS) Section 7.0 Support
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ISO 9001 2015 DIS 7.0 Support Slides 01-25-15
- 1. ISO/DIS 9001:2015 7.0 Support © 2014 Cavendish Scott, Inc. www.CavendishScott.com 1
- 2. Overall Purpose • Address support processes in an organization – resources – people, infrastructure, environment, monitoring and measuring resources - and documented information – other supports such as management review, internal audits, corrective action are addressed Section 9 Performance Evaluation – Very few new requirements • Clarify intent of what ISO 9001:2008 implied © 2014 Cavendish Scott, Inc. www.CavendishScott.com 2
- 3. 2015 DIS v. 2008 Comparison ISO/DIS 9001:2015 ISO 9001:2008 7.1 Resources 7.1.1 General 7.1.2 People Title removed 7.2 Competence 7.3 Awareness 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, training and awareness Significant Differences • Resources must consider capabilities of, and constraints on, existing internal resources and what needs to be obtained from external providers. • Changed to appropriate education, training or experience, and removed skills Added: • 7.1.5 Monitoring and measuring of resources (includes calibration) • 7.1.6 Organizational knowledge (lessons learned, undocumented knowledge)
- 4. 2015 DIS v. 2008 Comparison ISO/DIS 9001:2015 ISO 9001:2008 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 6.3 Infrastructure 6.4 Work environment Significant Differences • Changed ‘work environment’ from what is necessary to achieve product requirements to ‘environment’ - what is necessary for the operation of the processes
- 5. ISO/DIS 9001:2015 vs. ISO 9001:2008 ISO/DIS 9001:2015 ISO 9001:2008 7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment Significant Differences • ‘Equipment’ has been changed to ‘Resources’ to allow for other types of monitoring and measuring that do not involve equipment (i.e., visual monitoring). • Measuring instruments must be calibrated when measurement traceability is required by a statutory or regulatory requirement, customers, relevant interested party expectation, or considered by the organization to be essential to providing valid measuring results
- 6. 2015 DIS v. 2008 Comparison ISO/DIS 9001:2015 ISO 9001:2008 7.4 Communication 5.5.3 Internal communication Significant Differences • Added determining requirements for internal as well as external communications: what, when, how and with whom
- 7. 2015 DIS v. 2008 Comparison ISO/DIS 9001:2015 ISO 9001:2008 7.5 Documented Information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information 4.2 Documentation requirements 4.2.1 General 4.2.3 Control of Documents 4.2.4 Control of Records Significant Differences • Combined documents and records as one term “documented information” • Not as prescriptive as to identifying “how” records are stored but retention length still must be determined
- 8. What do you need to do? • Determine what monitoring and measurement resources are needed – including those that are not instruments • Define what organizational knowledge is necessary • Determine competence necessary for person(s) doing work under the organization’s control – Including contracted personnel and outsourced processes to external providers • Determine internal and external communications relevant to the QMS (what, when, to whom, how) • Ensure Documented Information is controlled © 2014 Cavendish Scott, Inc. www.CavendishScott.com 8
- 9. We are here to help! For more information please contact us! • Colin Gray – colin@cavendishscott.com 303 668 2500 • Emily Myers – emily@cavendishscott.com 720 226 5968 • Dave Moskal – dave@cavendishscott.com 303 386 6788 • Diana Lough – diana@cavendishscott.com 720 212 7300 Or visit our Website for current status: www.cavendishscott.com © 2014 Cavendish Scott, Inc. www.CavendishScott.com 9
Editor's Notes
- section 7.4 Support actually has very few new requirements, but a more clearly defined intent of what was always intended with ISO 9001:2008
- 7.3 Awareness has been made its own clause for extra focus. It combines specific requirements that personnel have to be aware of from the following ISO 9001:2008 clauses: 5.3d – Quality Policy (communicated and understood) - now ISO/DIS 2015 section 7.3a 6.2.2d – aware of relevance and importance of their activities and how they contribute to achievement of quality objectives - now ISO/DIS 2015 section 7.3b 5.5.3 – communication regarding the effectiveness of the quality management system – now ISO/DIS 2015 section 7.3c (but this now focuses more on contribution and benefits of improved performance) ISO/DIS 2015 section 7.3d adds in the implications of NOT conforming to quality management system requirements, which is somewhat comparable to ISO 9001:2008 section 8.2.3 “where planned results are not achieved, correction and corrective action shall be taken as appropriate”. ISO/DIS 9001:2015 7.1.6 Organizational knowledge This is a new requirement for ensuring that organizations have or obtain necessary knowledge to operate their processes to achieve conformity of products and services. It also requires organizations to obtain necessary knowledge to address changing needs and trends. Note 2 provides considerations on where to obtain knowledge required (i.e. internal resources – lessons learned from project successes and failures, as well as capturing knowledge and experience from experts in the organization; external resources – standards, academia, conferences, customers or providers). This knowledge should be communicated as necessary within the organization and maintained.
- ISO/DIS 9001:2015 7.1.3 Infrastructure has the same intent and meaning as ISO 9001:2008 section 6.3 Infrastructure. ISO/DIS 9001:2015 7.1.4 Environment This section updates ISO 9001:2008 section 6.4. The most significant change is the title “work environment” was changed to “environment” and now can include physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics and cleanliness). This is an expansion applicable to the organizations processes, not just product requirements as was in the 2008 version.
- Documented Information is a new term introduced in the ISO/DIS. The specific references to a documented quality manual, documented procedures and records have been removed and replaced with ‘documented information’. This is information the organization is required to keep, control and maintain, but formats and storage methods are not prescribed in the DIS, as it is left up to the organization to do what best fits their operation of their business. Documented information can refer to the quality management system, information created in order for the organization to operate (documentation), or evidence of results (records).