bob deysher qms & process improvement...
TRANSCRIPT
![Page 1: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/1.jpg)
Bob DeysherQMS & Process Improvement Consultant
![Page 2: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/2.jpg)
• Chronology• Must Haves• Key Themes• Annex SL• New Terms, Concepts, & Major Changes • Items Dropped• Exclusions• What You Should Do• Internal Audit Challenges
• Back Up Slideso ISO 9001 2008 – 2015 Map
October 16, 2014 2
![Page 3: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/3.jpg)
History• 1987 - Introduction • 1994 - Update• 2000 - Significant
Change• 2008 - Update• 2015 Significant
Change
ISO 9001:2015 ScheduleEvent Schedule ActualDesignSpec
May 2012
Start Nov 2012CD April 2013 June 2013DIS Mar 2014 May 2014FDIS Mar 2015 Mar 2015?Publication Sept 2015 Sept 2015?
October 16, 2014 3
![Page 4: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/4.jpg)
•Remain RELEVANT•INTEGRATE with other management systems•Provide ORGANIZATIONAL management•FOUNDATION for next 10 years•Reflect increasingly COMPLEX ORGANIZATIONAL ENVIRONMENTS•Reflect needs of ALL POTENTIAL USERS•Enhance an organization’s ability to SATISFY CUSTOMERS
October 16, 2014 4
![Page 5: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/5.jpg)
• Increased emphasis on intended outcomes and customer focus
• De-emphasis on prescriptive requirements and documented procedures
• Improved applicability for service organizations• Increased leadership requirement• Increased organizational alignment • Risk Based Thinking• Process Approach• PDCA Cycle
October 16, 2014 5
![Page 6: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/6.jpg)
• High-level structure developed by the Joint Technical Coordination Group (JTCG),
• All ISO technical committees who develop management system standards in future will use this as their blueprint.
• Designed to align format, text, terms and definitions
• It still gives standards developers flexibility to integrate their technical topics and requirements.
Clause 1 ScopeClause 2 Normative
ReferencesClause 3 Terms and
DefinitionsClause 4 Context of the
OrganizationClause 5 LeadershipClause 6 PlanningClause 7 Support Clause 8 OperationClause 9 Performance
EvaluationClause 10 Improvement
October 16, 2014 6
Common Core
![Page 7: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/7.jpg)
4 Context of the organization
5 Leadership 10 Improvement6 Planning for the quality management system
7 Support 8 Operations 9 Performanceand evaluation
Understandingof the organization and its context
Understanding the needs and expectations Of interested parties
Scope of management systems
QMS
Leadership and commitment
Quality policy
Organizational roles,responsibilitiesand authorities
Action to address risk and opportunity
Quality objectives
Planning of changes
Resources
Competence
Awareness
Communication
DocumentedInformation
Release of products and services
Operationsplanning and control
Determinationof requirements for products and services
Design and development of products and services
Control of externally provided products and services
Production and service provisions
Control of non-conforming process outputs, products and services
Monitoring,measurement.analysis andevaluation
Internal audit
Management review
Nonconformity and correctiveaction
Continual Improvement
Plan
Do
Check Act
General
October 16, 2014 7
![Page 8: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/8.jpg)
Context of the Organization–business environment; combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services…and interested partieso “4 Context of the organization”o “4.1 Understanding the organization and its context”o “The organization shall determine external and internal
issues that are relevant to its purpose and its strategic direction that affect its ability to achieve the intended results of its QMS.”
October 16, 2014 8
![Page 9: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/9.jpg)
Documented Information –information required to be controlled and maintained by an organization and the medium on which it is contained. [replaces ‘documented procedure’ and ‘records’]o “The organization shall maintain documented
information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned”
October 16, 2014 9
![Page 10: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/10.jpg)
October 16, 2014 10
![Page 11: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/11.jpg)
October 16, 2014 11
![Page 12: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/12.jpg)
Products and Services–replaces “product”; [self-explanatory]o “The organization shall plan, implement and control
processes needed to meet requirements… for the provision of products and services…
Externally Provided–replaces ‘Purchasing’ and ‘Outsourced’; also to include associated organizations (e.g. divisions)o “The organization shall ensure that externally provided
processes, products, and services conform to specified requirements”
o “Type and extent of control of external provision”o “Information for external providers”
October 16, 2014 12
![Page 13: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/13.jpg)
Risks and Opportunities–effect of uncertainty on an expected resulto “When planning for the QMS, the organization shall
consider the issues referred to in 4.1 [Org & Context] and the requirements referred to in 4.2 [Interested parties] and determine the risks and opportunities that need to be addressed…”
o “The organization shall plan actions to address these risks and opportunities…”
o i.e. avoiding, taking, eliminating, changing likelihood
October 16, 2014 13
![Page 14: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/14.jpg)
There is no clause giving specific requirements for preventive action. The reason is the assumption that key purposes of a formal management system is to act as a preventive tool.• in Clause 4 the organization is required to determine the risks
which can affect its ability to meet these objectives• in Clause 5 top management are required to commit to
ensuring Clause 4 is followed• in Clause 6 the organization is required to take action to
address risks and opportunities • in Clause 8 the organization is required to have processes
which identify and address risk in its operations• in Clause 9 the organization is required to monitor, measure,
analyse and evaluate the risks and opportunities• in Clause 10 the organization is required to improve by
responding to changes in riskOctober 16, 2014 14
![Page 15: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/15.jpg)
These requirements are considered to:• Cover the concept of preventive action, • Take a wider view that looks at risks and opportunities.
This approach requires risk based thinking and a risk driven approach to preventive action throughout the development and implementation of the quality management system.
This has also facilitated some reduction in prescriptive requirements and their replacement by performance based requirements. Although risks have to identified and acted upon there is no requirement for formal risk management.
October 16, 2014 15
![Page 16: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/16.jpg)
Expanded Process Approach – (Clause 4.4 -Quality management system and its processes) specifies requirements considered essential to the adoption of a process approach. •ISO 9001:2008 promoted the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system. •This proposed revision to the standard makes this more explicit by including Clause 4.4
October 16, 2014 16
![Page 17: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/17.jpg)
4.4 Quality Management system and its processes The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine:a) the inputs required and the outputs expected from these processes;b) the sequence and interaction of these processes;c) the criteria, methods, including measurements and related performance indicators needed to
ensure the effective operation, and control of these processes;d) the resources needed and ensure their availability;e) the assignment of the responsibilities and authorities for these processes;f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement
the appropriate actions to address them;g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if
needed, the changes to processes to ensure that they achieve intended results;h) opportunities for improvement of the processes and the quality management system.
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.October 16, 2014 17
![Page 18: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/18.jpg)
o Quality Manual – not specifically required, nor mandated as to its content.
o Documented Procedures – none specifically called out, but left to the organization’s determination and needs (4.4, 7.5.1).
o Management Representative – not specifically called out as an individual having the sole responsibility and authority for the QMS; now considered part and parcel of the organization’s leadership and top management (5.1.1, 5.3).
o Preventive Action – not a specific clause/record moving forward, but risk is assumed to supplement
October 16, 2014 18
![Page 19: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/19.jpg)
• No reference made to exclusions ( Scope 1.0)
• Annex A.5 – Applicability- The standard clarifies that the organization can not decide a requirement to be not applicable if it falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer satisfaction
October 16, 2014 19
![Page 20: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/20.jpg)
8.3 Design and development of products and services8.3.1 General•Where the detailed requirements of the organization’s products and services are not already established or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the organization shall establish, implement and maintain a design and development process.
October 16, 2014 20
![Page 21: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/21.jpg)
DON’T RUSH TO CHANGE YOUR CURRENT QMS !!!
•Changes can occur to any sections of the DIS•Details of the process for certification will not happen by the accreditation boards until the final draft (FDIS) is published •Consultants do not have all the answers at this time•Maintain your current ISO 9001:2008 QMS
October 16, 2014 21
![Page 22: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/22.jpg)
DO THE FOLLOWING !!!!•Stay current with the progress of 9001:2015 from DIS to FDIS to publication•Get familiar with “Risk Based Thinking” o ISO 31000 is a resourceo Experiment with Risk Management tools and
techniques•Understand the meanings of “Context of the Organization” & “Interested Parties”o ISO 9004 is a resource
October 16, 2014 22
![Page 23: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/23.jpg)
DO THE FOLLOWING !!!!• Learn how to apply the Process Approach to all
your key processes in your Quality Management System (4.4)
• Develop an implementation plan including resources
• Use your current Quality Management System to get prepared????
October 16, 2014 23
![Page 24: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/24.jpg)
Management Review5.6.1 GeneralTop management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
5.6.2 Review inputThe input to management review shall include information on
f) changes that could affect the quality management system
October 16, 2014 24
![Page 25: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/25.jpg)
• Evaluating a Quality Management System in terms of Process Focused and Metrics Driveno Have all the requirements of Clause 4.4 been met?o How do you determine if a process is “Ineffective”?
• Determining if Risk Based Thinking has been adequately applied to the Quality Management Systemo Have all key processes been assessed for ‘Risk”?o Does Management Review take action when “risks” are
too high? (*) These are the opinions of the author; opinions may change when the FDIS & IS are
released or better understanding of ISO 9001:2015 is realizedOctober 16, 2014 25
![Page 26: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/26.jpg)
• Determining if Needs and Expectations of Interested Parties plus external and internal issues have been applied to the Quality Management System and continually monitored.o Has the Scope of the Quality Management System
taken into account these factors? o Does Leadership understand how strategic issues
impact the organizations Quality Management System?
• Determining appropriate “Exclusions”.o Ex: When is “Technical Support” actually “Design”?
(*) These are the opinions of the author; opinions may change when the FDIS & IS are released or better understanding of ISO 9001:2015 is realized
October 16, 2014
26
![Page 28: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/28.jpg)
October 16, 2014 28
![Page 29: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/29.jpg)
October 16, 2014 29
![Page 30: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/30.jpg)
October 16, 2014 30
![Page 31: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/31.jpg)
October 16, 2014 31
![Page 32: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/32.jpg)
October 16, 2014 32
![Page 33: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/33.jpg)
October 16, 2014 33
![Page 34: Bob Deysher QMS & Process Improvement Consultantrube.asq.org/audit/2014/10/iso-9001-2015-update.pdf · Expanded Process Approach (Clause 4.4 - Quality management system and its processes)](https://reader030.vdocuments.mx/reader030/viewer/2022040409/5ec373b257513462a8064442/html5/thumbnails/34.jpg)
• ISO TC/176/SC2 Home Page• Document: ISO/TC 176/SC 2/N 1147 (ISO9001:2015 , June 3,
2013) Committee Draft• Draft International Standard - ISO/DIS 9001 (ISO/TC 176/SC
2)• “A First Look At ISO 9001:2015”, TUV Rheinland, January
2014• “ISO 9001:2015 Revision”, NQA Client Conference, April 16,
2014• RIASQ Meeting - Denise Robitaille Presentation,
January,2014• NQA Conference – Boston – September 2014• ISO/TC 176/SC 2 Document N1224, July 2014
October 16, 2014 34