1. Welcome to ISO 9000 for Managers
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Welcome to
ISO 9000 for Managers

2. The ISO 9000 movie
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ISO 9000 for Managers

3. 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.
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ISO 9000 for Managers

4. 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
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ISO 9000 for Managers

5. 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 –
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ISO 9000 for Managers

6. 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
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ISO 9000 for Managers

7. Process model 5. Management Process Input Requirements Output Product
6. Resources
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ISO 9000 for Managers

8. 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)
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ISO 9000 for Managers

9. 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
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ISO 9000 for Managers

10. 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!
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ISO 9000 for Managers

11. 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:
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ISO 9000 for Managers

12. 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!
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ISO 9000 for Managers

13. 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!
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ISO 9000 for Managers

14. 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.
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ISO 9000 for Managers

15. 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!
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ISO 9000 for Managers

16. 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
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ISO 9000 for Managers

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

18. 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
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ISO 9000 for Managers

19. 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
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ISO 9000 for Managers

20. 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
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ISO 9000 for Managers

21. Plan-Do-Check-Act Resource management (and product realization)
NEXT Measurement analysis and Improvement
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ISO 9000 for Managers

22. 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
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ISO 9000 for Managers

23. 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
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ISO 9000 for Managers

24. 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
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ISO 9000 for Managers

25. 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.
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ISO 9000 for Managers

26. Questions
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ISO 9000 for Managers

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

28. 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 is the recognized international standard for CSR.
The ISO 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 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 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.
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ISO 9000 for Managers

29. 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 (Under development, 2007)
PMI: PMBOK PMP > certified PMP
Prince 2 > certified foundation. Note practitioner more equal to PMP
IPMA >
ISO 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.
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ISO 9000 for Managers

30. ISO 27000 IT security 27001:2005 Certification Requirements.
27002:2005 Control requirements.
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31. Evaluation (Customer satisfaction)
Evaluation of current presentation (5 min.):
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ISO 9000 for Managers

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

33. Thanks!
Happy Christmas!
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ISO 9000 for Managers