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ISO 9001 2015 Overview presentation

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Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.

Published in: Leadership & Management
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ISO 9001 2015 Overview presentation

  1. 1. ISO 9001:2015 What is new – an overview (Presented for ASQ India members) Govind Ramu, P.Eng. ASQ Fellow ASQ CMQOE, CQE, CSSBB, CQA, CSQE, CRE
  2. 2. Agenda • Key advantages • Key changes Executive Summary • Interested parties identification • Process approach • Leadership requirement • Documented information • Organizational knowledge • Risk Based Thinking • Transition Strategy • ISO 9001:2015 Certification - Transition Timeline • Q & A – 15 Min
  3. 3. Key advantages of new revision • Better alignment with other management systems (IMS friendly) • Less emphasis on documentation* and more emphasis on process • Requirements of QMS integration into organization’s business process, tying business strategy with QMS • Emphasis on “Risk based thinking”, “process approach” and improvement • Making the standard relevant to recent developments – data protection, knowledge retention challenges, etc. • Recognition of influence of “People” component in a QMS and address competence, awareness and communication QMS= Quality Management System, IMS= Integrated Management System *Depends on size, type, activity, process, product, service, complexity, competence requirement
  4. 4. ISO 9001:2015 Key changes Executive summary Requirements ISO 9001:2008 (Previous version) ISO 9001:2015 (Effective Sep 2015) Top Management requirements Limited requirements directly under top management. Quality Management Representative share additional management requirements Additional requirements moved under Top management. Management representative role eliminated Context of the organization and interested parties No requirement Understanding operating environment, interested parties requirements, internal and external issues relevant to organizations strategic direction Risks and Opportunities No requirement Actions to address risks* and opportunities for improvement** from internal and external issues. Integration and implementation of actions into QMS (Risk based thinking) Corrective and Preventive action Corrective and Preventive action were two sections of requirements Risk based thinking and Corrective action. (Prevention first). Also a Leadership responsibility to promote Organizational Learning No requirement Organization knowledge – determine, maintain, address changing needs and trends, continue to capture new knowledge Process Approach Implied expectation on “process approach” to process definition and management Explicit requirements on “process approach”. as a leadership responsibility to promote Services Implied expectation that QMS requirements are applicable to products (and services) Explicit requirements that QMS requirements are applicable to products and services. *Risk can include positive and negative factors for consideration (new interpretation) **Improvement can include innovation and re-organization
  5. 5. Interested parties identification Your Organization • Customer • Employees • External providers • Owners • Shareholders • Bankers • Regulators • Union • Partners • Society • Competition • Opposing groups Ref: ISO 9000:2015 3.2.3 Interested party
  6. 6. Mapping interested party requirements to business process Interested Party Requirements Which business process will cover? Note: If there is no existing process addressing a given requirement – point this as a GAP and recommend a process to be developed. If a process exists, name that process in this cell.
  7. 7. What is the process approach? “The systematic management of processes and their interactions to achieve intended results” All organizations use processes to: • set interrelated or interacting activities • transform inputs into outputs • build in checks to meet objectives and promote continuous improvement The process approach integrates processes into a complete system to achieve strategic and operational objectives Courtesy: Slide from ISO TC 176/SC2/ N1290
  8. 8. Single Process Schematics (simplified version) Source: ISO 9001:2015 Figure 1 (Page viii), ISO TC 176/SC2/ N1290 To use the process approach an organization should: • understand and define the processes needed to meet its objectives • recognize that the processes are unique to its own context • integrate all of the processes and their interactions into a system that utilizes risk-based thinking
  9. 9. Leadership requirement  Taking accountability for the effectiveness of the quality management system  Compatible with the context and strategic direction of the organization  Ensuring the integration of the quality management system requirements into the organization’s business processes  Promoting the use of the process approach and risk-based thinking  Communicating the importance of effective quality management and of conforming to the quality management system requirements  Ensuring that the quality management system achieves its intended results  Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;  Promoting improvement
  10. 10. Documented information The organization shall maintain documented information to the extent necessary to support the operation of processes (4.4)  Scope  Quality Policy  information determined by the organization as being necessary for the effectiveness of the quality management system  information of external origin determined by the organization  Where requirements for products and services are changed, relevant documented information is amended Note: There is no requirement for the structure of an organization’s QMS documentation to mirror that of this international standard. ISO 9001:2015 Annex, A new look- QP Sep 2014,
  11. 11. Documented information • No requirement for a quality manual (7.5). There is no longer a requirement for mandated procedures. • When creating and updating documented information the organization shall ensure appropriate: b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); (7.5.2) • it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). (7.5.3) Summary: appropriate, protected. • Dominance of electronic information in the last several years.
  12. 12. Organizational knowledge The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. • This knowledge shall be maintained, and made available to the extent necessary. • When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge. Summary: knowledge assessment, maintenance, dissemination, dynamic, acquisition, and accessibility- Knowledge management
  13. 13. Risk Based Thinking  Balance risks and opportunities • Analyse and prioritize your risks what is acceptable? what is unacceptable? • Plan actions to address the risks how can I avoid, eliminate or mitigate risks? • Implement the plan; take action • Check the effectiveness of the action; does it work? • Learn from experience; improve Courtesy: Slide from ISO TC 176/SC2/ N1283
  14. 14. Risk Based Thinking Organization and shall determine risks and opportunities • in accordance with the requirements • that can affect conformity of products and services and the ability to enhance customer satisfaction • give assurance that the quality management system can achieve its intended result • prevent, or reduce, undesired effects • achieve continual improvement • integrate and implement the actions into its quality management system processes • evaluate the effectiveness of these actions • post-delivery - associated with the products and services • Effectiveness of actions management review
  15. 15. Transition Strategy Purchase a copy of ISO 9001:2015 Standard. Register the external document in the system. Read and understand transition guidance documents, from ISO TC 176/SC2 website, ASQ ISO 9001 knowledge center site, and your registrar organization Compare the changes to the ISO 9001: 2008 and develop key list of major changes. Review impact assessment with your, internal quality auditors and extended QMS Team (Process owners) Present key changes of the current standard to your management team Publish newsletter for all employees general awareness that the ISO 9001 standard revision and implementation plan Let your registrar know when your organization is planning this transition (year 1,2 or3) If ISO 9001 is contractually required by your customers, let them know of your transition plan. Let your supplier quality function enquire your key supplier’s transition plan during the periodic audits. Start making any required changes to your existing documentation Develop a high level training. Conduct training for internal auditors and process owners Conduct gap analysis based on the release standard Present the gap to management team at management review or a special scheduled meeting. Planning Communication Execution Obtain management commitment for addressing the gaps in a timely manner Also see: http://www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf
  16. 16. ISO 9001:2015 Certification - Transition Timeline September 2015 start of 3 years transition period to September 2018 •Certifications to ISO 9001:2008 will no longer be valid after September 2018 2018201720162015 September 2015 Published International Standard Courtesy: Slide from ISO TC 176/ SC 2/ N1282
  17. 17. Q & A
  18. 18. References and bibliography • ISO 9000:2015 - Quality management systems -- Fundamentals and vocabulary • ISO 9001:2015 - Quality management systems -- Requirements • TC 176 SC2 home page • ASQ ISO 9001:2015 knowledge center • All Hands on Deck (Govind Ramu) • Quality in Outsourcing 2.0 (Govind Ramu)
  19. 19. Single Process (detailed version) Sources of Inputs Inputs Process Outputs Customer Interested parties? Person – Skills – Knowledge – Training – Qualification/Re-qualification Interim and End Products, Characteristics (Information), Process Yields, throughput, Cycle time, process time (data, analysis) Machine (Hardware & Software) (H/W & S/W) – Selection criteria – Capability – Qualification – H/W-S/W integration – Maintenance – Calibration – Safety Material – Initial Qualification – Incoming Quality Control – Preservation/Expiration – Material stability – Important Consumables, – Direct and Indirect Materials Method – Work Instruction – Non-Documented Instructions – Handling, Error proofing – Setting, Alignment, measurement – Process condition Process Steps, Controls: SPC, OCAP, Process Changes Environment – Temperature – Humidity – Ergonomics – Clean room Particle count – Electro Static Discharge (ESD) – Hazardous substances Measurement – Measurement Equipment Selection criteria – Measure System Analysis and stability Measurement sequence Feedback from output Ref: Process audit– memory aide – Govind Ramu

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