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The ISO 9000 movie 13/04/2017 ISO 9000 for Managers

Agenda ISO 9001 for managers. Overview about the standards in Question: SA8000/ISO 26000, PMBOK (and for information ISO 27000, ISO 14000) Planning of next session, time and location: Suggestion: 20/01/2011. 13/04/2017 ISO 9000 for Managers

ISO standards Technical specifications Guidelines Requirements for certification (120) and Accreditation (21) There are more than 20 organizations that issue international recognized standards. ISO is the largest 163 countries are members. 18000 standards: 120 Certification; Certification and Accreditation Organizations that issue credentials or certify third parties against official standards are themselves formally accredited by accreditation bodies (such as UKAS); hence they are sometimes known as "accredited certification bodies". The accreditation process ensures that their certification practices are acceptable, typically meaning that they are competent to test and certify third parties, behave ethically and employ suitable quality assurance. Management standards 13/04/2017 ISO 9000 for Managers

Overview: ISO 9000 ISO 9000:2005 Quality management systems -- Fundamentals and vocabulary ISO 9001:2008 Quality management systems – Requirements ISO 9004:2009 Managing for the sustained success of an organization -- A quality management approach ISO 10001:2007, Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations ISO 10002:2004, Quality management — Customer satisfaction — Guidelines for complaints handling in organizations ISO 90003:2004 Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software ISO 10005:2005 Quality management systems — Guidelines for quality plans ISO 10006:2003 Quality management systems -- Guidelines for quality management in projects ISO 10007:2003 Quality management systems — Guidelines for configuration management ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment ISO/TR 10013:2001 Guidelines for quality management system documentation ISO 10014:2006 Quality management — Guidelines for realizing financial and economic benefits ISO 10015:1999 Quality management — Guidelines for training ISO 10017:2003 Guidance on statistical techniques for ISO 9001:2000 ISO9001:1994 – 2000 -2008 13/04/2017 ISO 9000 for Managers

Main elements Process model Continual improvement Document what you do – Do what you have described – Prove that you did it! 4. Quality Management System 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 13/04/2017 ISO 9000 for Managers

Process model 5. Management Process Input Requirements Output Product 6. Resources 13/04/2017 ISO 9000 for Managers

Plan-Do-Check-Act Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. NEXT: Quality management system (And Management responsibility) 13/04/2017 ISO 9000 for Managers

Main elements Process model Continual improvement Document what you do – Do what you have described – Prove that you did it! 4. Quality Management System 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 13/04/2017 ISO 9000 for Managers

Documentation requirements Quality manual Quality policy Quality objectives Glue everything together Procedures Work instructions (as needed) Records QA manual and the procedures and work instructions DOCUMENT WHAT YOU INTENT TO DO Records document that you did it! 13/04/2017 ISO 9000 for Managers

Documentation requirements Quality manual Procedures (Mandatory) Control of documents Control of records Internal audit Control of nonconforming product Corrective action Preventive action Work instructions (as needed) Records Documents includes all business documents: 13/04/2017 ISO 9000 for Managers

Documentation requirements 4.2.3 Control of documents Documents required by the quality management system shall be controlled. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. e) Means backup! 13/04/2017 ISO 9000 for Managers

Documentation requirements Work instructions (as needed) From the ISO9001:2008 standard: d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. Records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system; shall be controlled. … Records shall remain legible, readily identifiable and retrievable. Work instructions needed: Coding standards, test standards, Records: Backup is needed Next: Management responsibility! 13/04/2017 ISO 9000 for Managers

Main elements Process model Continual improvement Document what you do – Do what you have described – Prove that you did it! 4. Quality Management System 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 3 most important factors for successful ISO9000 implementation: Management support. 13/04/2017 ISO 9000 for Managers

Management responsibility Customer focus Quality policy Planning - Quality objectives Responsibility, authority and communication Internal communication Management review Responsibility: Normally requires: e.g. organization chart, job descriptions.. Management review: Compile all documented information and ACT: implement improvements, ensure resources, Update QA manual, It take time to implement but when implemented it is easily maintained: 4 meetings a year will do it. NEXT: Resource management! 13/04/2017 ISO 9000 for Managers

Main elements Process model Continual improvement Document what you do – Do what you have described – Prove that you did it! 4. Quality Management System 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 13/04/2017 ISO 9000 for Managers

Plan-Do-Check-Act Quality management system (And Management responsibility) NEXT: Resource management (and product realization) ### Check time 17/33 slides ### 13/04/2017 ISO 9000 for Managers

Resource management Provision of resources Human resources Infrastructure and Work environment 6.1 Provision of resources a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2. Human resources Shall have relevant skills/training 6.3 Infrastructure Shall be relevant for the production of the product. NEXT: Product realization 13/04/2017 ISO 9000 for Managers

Main elements Process model Continual improvement Document what you do – Do what you have described – Prove that you did it! 4. Quality Management System 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 13/04/2017 ISO 9000 for Managers

Product realization Planning of product realization Customer-related processes Review of requirements related to the product Customer communication Design and development (Planning, input and output) Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing Production and service provision Control of monitoring and measuring equipment Review of requirements related to the product: e.g. the organization has the ability to meet the defined requirements. Review: a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Verification: to ensure that the design and development outputs have met the design and development input requirements (Internal process) Validation: that the resulting product is capable of meeting the requirements for the specified application or intended use (Customer process) NEXT and last: Measurement, analysis and improvement 13/04/2017 ISO 9000 for Managers

Plan-Do-Check-Act Resource management (and product realization) NEXT Measurement analysis and Improvement 13/04/2017 ISO 9000 for Managers

Main elements Process model Continual improvement Document what you do – Do what you have described – Prove that you did it! 4. Quality Management System 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 13/04/2017 ISO 9000 for Managers

Measurement analysis improvement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action NEXT: AUDIT and certification 13/04/2017 ISO 9000 for Managers

Audit and Certification IBNORCA Accreditation 1. Part audit Company Certification Company 3. Part audit Accreditation vs. Certification NEXT: Plan-Do-Check-Act 2. Part audit / Project audit Buyer of Services / products 13/04/2017 ISO 9000 for Managers

Plan-Do-Check-Act Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. 13/04/2017 ISO 9000 for Managers

Questions 13/04/2017 ISO 9000 for Managers

Next presentation Overview about the standards in Question: SA8000/ISO 26000, PMBOK/ISO 10006 (and for information ISO 27000, ISO 14000) 13/04/2017 ISO 9000 for Managers

Overview: CSR Corporate Social Responsibility Social accounting, auditing, and reporting Social Accountability SA8000/ISO 26000, References: PMIS.biz: SA8000_vs_ISO26000 Social accounting The UN has developed the Principles for Responsible Investment Social Accountability International's SA8000 standard ISO 26000 is the recognized international standard for CSR. The ISO 14000 environmental management standard The term CSR came in to common use in the early 1970s, and is related to the term stakeholder, meaning those on whom an organization's activities have an impact. The SA 8000 in short: * International human rights, * No Child labour allowed, * No forced Labour, * Health and safty Requirements * Association rights, * Anti discrimination, * Working hours, Salary shall meet industry minimum standards, *Management system (as ISO 9001) ISO 26000 and SA8000 covers almost the same scope. However, the purpose of the standards are different: The ISO standard is a guidance standard, whereas, the SA8000 may be used as a management standard: That may be implemented in a company and be certified against. ISO 26000 standard is a nice source of information on Social Responsibility and it provides a lot of information (more than 80 pages) on how to implement Social Responsibility as an integrated part of any Business. Were as SA8000 is much more operational and easy to implement in to a ISO 9000 Quality management system. SA8000:2008 is much easier to approach as it is only a document of 10 pages. 13/04/2017 ISO 9000 for Managers

PMI:PMBOK - PMP Project Management Institute (PMI) Project Management Body Of Knowledge PMP Certified personal (Project Management Professional) European equivalents: APGM:Prince2 (Foundation, Practitioner) IPMA (Level D, C, B, A) ISO equivalent: ISO 10006 ISO 21500 (Under development, 2007) PMI: PMBOK PMP >300.000 certified PMP Prince 2 > 200.000 certified foundation. Note practitioner more equal to PMP IPMA > 110.000 ISO 9001 + PMBOK = IS10006 The Project Management Institute, or PMI as it is known, is the world’s leading not-for-profit professional association for project management dedicated to the advancement of the profession of project management. PMBOK is PMI’s Project Management Body of Knowledge. It describes the sum of knowledge generally accepted within the profession of project management. “Generally accepted” means that the knowledge and practices described are applicable to most projects, most of the time, and that there is widespread consensus about their value and usefulness. The overall purpose of the PMBOK is to provide a common lexicon within the project management profession and practice for talking and writing about Project Management. 13/04/2017 ISO 9000 for Managers

ISO 27000 IT security 27001:2005 Certification Requirements. 27002:2005 Control requirements. 13/04/2017 ISO 9000 for Managers

Evaluation (Customer satisfaction) Evaluation of current presentation (5 min.): 13/04/2017 ISO 9000 for Managers

Planning Next session Planning of next session, time and location: Suggestion: 20/01/2011. 13/04/2017 ISO 9000 for Managers

Thanks! Happy Christmas! 13/04/2017 ISO 9000 for Managers