QUALITY MANAGEMENT SYSTEMS What Is a QMS

QUALITY MANAGEMENT SYSTEMS What is a QMS

 A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements.

 It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management.

 “Quality management” ensures superior quality products and services.

 Quality management is essential for customer satisfaction which eventually leads to customer loyalty.

Deming’s 14 Points on Quality Management, a core concept on implementing total quality management, is a set of management practices to help companies increase their quality and productivity. 1. Create constancy of purpose for improving 8. Drive out fear. products and services. 9. Break down barriers between staff areas. 2. Adopt the new philosophy. 10. Eliminate slogans, exhortations and targets 3. Cease dependence on inspection to for the workforce. achieve quality. 11. Eliminate numerical quotas for the workforce 4. End the practice of awarding business on and numerical goals for management. price alone; instead, minimize total cost by 12. Remove barriers that rob people of pride of working with a single supplier. workmanship, and eliminate the annual rating or 5. Improve constantly and forever every merit system. process for planning, production and service. 13. Institute a vigorous program of education 6. Institute training on the job. and self-improvement for everyone. 7. Adopt and institute leadership. 14. Put everybody in the company to work accomplishing the transformation. Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Quality Management Systems Standards

 There are many QMS Standards:

 International Standards Organization (ISO)

 Capability Maturity Model Integration (CMMI)

 ITIL - IT Service Management

 Control Objectives for Information and Related Technology (COBIT)

 and others

 8 Principles of Quality Management 1. Customer Focus 2. Leadership 3. Involvement of people 4. Process Approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relations

ISO / CMMI Similarities and Differences Maturity Level 4 Subprocesses are CMMI Maturity level 5 focuses on selected that significantly contribute to continually improving process overall process performance. These performance through both selected subprocesses are controlled using incremental and innovative statistical and other quantitative technological improvements. techniques. Level 5 Maturity Level 3, processes are well characterized and Level 4 • Quality management understood, and are system described in standards, Level 3 • Management responsibility procedures, tools, and ISO 9001 methods. • Resource management Level 2 • Product realization Maturity Level 2, • Measurement, analysis requirements, Level 1 and improvement processes, work products, and services are managed. Maturity Level 1, processes are usually ad hoc and chaotic Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015

ISO 9001:2008 QMS

ISO 9001:2008 Quality management systems — Requirements 4. Quality management system 7. Product realization The organization shall establish, The organization shall plan and document, implement and maintain a quality management system and develop the processes needed for continually improve its effectiveness in product realization. Planning of accordance with the requirements of this product realization shall be consistent International Standard. with the requirements of the other 5. Management responsibility processes of the quality management Top management shall provide evidence system of its commitment to the development 8. Measurement, analysis and and implementation of the improvement quality management system and continually improving its effectiveness The organization shall plan and 6. Resource management implement the monitoring, The organization shall determine and measurement, analysis and provide the resources needed improvement processes needed

REF: ISO 2008

 There are several versions of the CMMI. This guide will focus on the models for service delivery (CMMI-SVC) and product development (CMMI-DEV).

 The two models are tightly linked and complementary to each other. Each model consists of a number of Process Areas containing Specific and Generic Goals and Practices focused on improving performance in a defined area such as project planning or requirements management.

Development Maturity Level 3 - Defined Services Maturity Level 3 - Defined DAR - Decision Analysis and Resolution CAM - Capacity and Availability Management

IPM - Integrated Project Management DAR - Decision Analysis and Resolution 12 Process Areas OPD - Organizational Process Definition IRP - Incident Resolution and Prevention OPF - Organizational Process Focus IWM - Integrated Work Managements OT - Organizational Training OPD - Organizational Process Definition PI - Product Integration OPF - Organizational Process Focus RD - Requirements Development OT - Organizational Training RSKM - Risk Management RSKM - Risk Management TS - Technical Solution SCON - Service Continuity

VAL - Validation SSD - Service System Development 11 Process Areas Process 11 VER – Verification SST - Service System Transition STSM - Strategic Service Management

Development Maturity Level 2 - Managed Services Maturity Level 2 - Managed 8 Process 8 Areas CM - Configuration Management CM - Configuration Management MA - Measurement and Analysis MA - Measurement and Analysis PMC - Project Monitoring and Control PPQA - Process and Product Quality Assurance PP - Project Planning REQM - Requirements Management PPQA - Process and Product Quality Assurance SAM - Supplier Agreement Management REQM - Requirements Management SD - Service Delivery

SAM - Supplier Agreement Management WMC - Work Monitoring and Control

Both CMMI Development and Services have the

same process areas for Maturity Level 4 and 5 2 Process 2 Areas

Services Maturity Level 5 - Optimizing CAR - Causal Analysis and Resolution

OPM - Organizational Performance Management

Services Maturity Level 4 - Quantitatively Managed OPP - Organizational Process Performance

QWM - Quantitative Work Management 2 Process Areas Process 2

 The three factors that impact implementing a QMS are: √ Leadership Commitment √ Effort √ Funding

 For a small to medium-sized firm, it will probably come in the range of 6 - 12 months. If you are a large organization, have a complex system, or are starting from a very low base line, you may require longer.

 An ISO Audit and CMMI Appraisal both observe the implementation of the QMS across your customers.

 ISO Certification  CMMI Certification

 Internal Cost - the time your  Internal Cost - the time your employees will need to employees will need to spend building and spend building and implementing the system implementing the system  Initial assessment (optional)  Formal Process and  Certification audit (Year 1) Appraiser Training  Surveillance audits (Year 2  Initial assessment and 3)  Certification Appraisal (Year 1 and Year 4)  Internal Surveillance audits

Why you need to get started

 Starting small is thinking big.  Implementing a QMS that encompasses the organizational structure, policies, procedures, and processes becomes more complex the larger you become.  Your employees will appreciate the structure. Especially during on ramp and turnover.  Your customer will know you have establish quality processes.  It’s often a requirement.

 It takes time – what is your competitor doing

Questions

Presenter: Phillip Selleh Phone: 703-652-0949 Email: [email protected]

 Over 20 years of Business Process experience

 ISO 9001:2008 Quality Management Systems Auditor

 ISO 27001 Information Security Management Auditor

 CMMI SEI Partner