ISO 9001:2015 Quality Management System As an Organizational Process Asset

Chad J. Dehmler, MBA, PMP Presenter Background IT Project Management consulting to the Manufacturing Technology department of Globalfoundries Project management consulting for NYS ITS Chief Portfolio Office, Governance eCommerce industry experience in Madrid, Spain Quality Management and Project Management Experience in Rochester NY for a Fortune 500 medical devices company. chad@dehmler.com

ISO 9001:2015 Quality Management System As an Organizational Process Asset

Introduction Provide a presentation whose theme reviews the salient points of an ISO 9001:2015 QMS, their interrelation with the PMBOK® knowledge areas, and how they can be used in developing an organizational methodology that improves project results and enhances quality products and services.

Process Groups & Knowledge Areas

PMBOK® Concepts Knowledge Areas Process Groups Project Integration Management Project Scope Management Project Time Management Project Cost Management Project Quality Management Project Human Resource Management Project Communications Management Project Risk Management Project Procurement Management Project Stakeholder Management Process Groups Initiating Planning Executing Controlling Closing The Process Groups consist of Processes (47 in total) Each Process consists of Inputs Tools & Techniques Outputs

Quality Management System Definition Quality Management System as recommend by ISO is a “collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management” (as defined at Wikipedia.org).

PMBOK® Organizational Process Asset Definition Plans, processes, policies, procedures and knowledge bases that are specific to and used by the performing organization. PMBOK®5th edition page 548. In most input/outputs Opa, my wise old grandfather

Organizational Process Asset as an Input One thing that we as PMP’s recognize is that Organizational Process Assets (OPA) are an important part of project management. The PMBOK® says, “these should be taken into account for every process, even if they are not explicitly listed as inputs in the process specifications. Organizational Process Assets provide guidelines and criteria for tailoring the organization’s processes to the specific needs of the project.” (5th edition, page 47).

“An integrative approach through process management” “Project Management in Quality has become the topic of various publications as the methodology was found to be an effective and efficient way to implement a quality management system per ISO 9001 or other quality related standards.” “On the other hand, the issue of Quality and Project Management has received very little attention as judged by the quasi absence of reference material on the subject. In other words, how can proper project management methodology (per the PMBOK® Guide guidelines) be implemented at the enterprise level, that complies with the ISO 9001 (revision 2000) requirements in order to obtain third party registration?” https://www.pmi.org/learning/library/integrative-approach-process-management-iso-7836

Quality Management System ISO 9001:2015 Sections Scope Normative References Terms and Definitions Context of the Organization Leadership Planning Support Operation Performance Evaluation Improvement Quality Management System

Methodologies Compared ISO 9001: 2015 Section PMBOK® Concept 1. Scope Scope Management 4. Context of the Organization Enterprise Environmental Factors 5. Leadership Human Resource Management 6. Planning Planning Process Group Risk Management Communications Management 7. Support Execution Process Group 8. Operation Disintegration Management 9. Performance Evaluation Monitoring & Controlling Process Group 10. Improvement

Context Environment Context of the Organization1 Enterprise Environmental Factors2 External Analysis Marketplace conditions Interested Parties Political Climate Legal environment Government or Industry Standards Geographic Source Geographic distribution of facilities Internal Analysis Organizational Culture Personnel Administration 1 Cochran, Craig, ISO 9001:2015 in Plain English, 2015, page 12 2 PMBOK, Project Management Institute, 5th Edition, 2013, page 29

ISO 9001:2015 Section 5 Leadership [Plan]

ISO 9001:2015 Section 6 Planning [Process Group] “The planning process group consists of those processes performed to establish the total scope of the effort, define and refine the objectives, and develop the course of action required to attain those objectives” PMBOK® 5th edition page 55.

ISO 9001:2015 6.1 Actions to Address Risks & Opportunities Risk Management “Effective risk management is critical to mission success. The implementation of a thorough, disciplined risk management approach is now required of all NASA programs and projects. Although formal risk management is essential, the Agency encourages program managers to tailor the risk management approach so that it fits the unique needs of the program.” (https://www.hq.nasa.gov/office/codeq/risk/index.htm).

11.1 Plan Risk Management Tools & Techniques Analytical Techniques Expert Judgment Meetings

11.2 Identify Risks Brainstorming Delphi Technique Ishikawa Documentation Reviews Information gathering techniques Checklist analysis Assumptions analysis Diagramming techniques SWOT analysis Expert Judgment Brainstorming Delphi Technique Ishikawa Influence diagrams

11.3 Perform Qualitative Risk Analysis Tools & Techniques Probability and Impact Matrix Risk Data Quality Assessment Risk Categorization

11.4 Perform Quantitative Risk Analysis Tools & Techniques Data gathering and representation techniques Quantitative risk analysis and modeling techniques

11.5 Plan Risks Responses Tools & Techniques Negative: Avoid/Transfer/Mitigate/Accept Positive: Exploit/Enhance/Share/Accept

ISO 9001:2015 7.4 Communication [Management Plan] Who are you communicating with? What are you trying to communicate? When are you going to communicate? Where is the communication coming from? [Why are you communicating?] How are you going to communicate? 1 Cochran, Craig, ISO 9001:2015 in Plain English, 2015, page

ISO 9001:2015 Section 10 Improvement “Project Quality Management […] supports continuous process improvement activities as undertaken on behalf of the performing organization.” PMBOK®5th edition page 227.

PMBOK® Quality Management Knowledge Area “…uses policies and procedures to implement […] the organization’s quality management system” PMBOK®5th edition page 227. PMBOK recognizes orgs have QMSs Defined ones or not

PMBOK® Quality Management Knowledge Area

Chad J. Dehmler, MBA, PMP Presenter Background IT Project Management consulting to the Manufacturing Technology department of Globalfoundries Project management consulting for NYS ITS Chief Portfolio Office, Governance eCommerce industry experience in Madrid, Spain Quality Management and Project Management Experience in Rochester NY for a Fortune 500 medical devices company. chad@dehmler.com