Addendum 1 to iso presentation
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The document discusses changes between the ISO 9001:2008 and ISO 9001:2015 standards and actions required to upgrade an organization's quality management system. Key points include: 1. Top management must take more accountability for the effectiveness of the quality management system and ensure integration into business processes under the new standard. 2. Risk-based thinking is emphasized, requiring organizations to identify risks and opportunities related to products, services and the quality system. 3. Several changes were made to clauses around quality objectives, planning, documentation and more to incorporate an increased focus on processes, risk management and interested parties. 4. A comprehensive upgrade program is needed to address all changes between the standards and bring the organization
Addendum 1 to iso presentation
- 1. ADDENDUM 1 to ISO Presentation INTERPRETATION AND SUGGESTED CHANGES TO SYSTEM
- 2. Reference documents • ISO 9001:2008 standard • ISO9001:2015 standard • ISO 9001:2015 ppt uploaded in slideshare
- 3. Today’s Scenario • After the new version of the standard has been released, third party auditing agencies are certifying organisations in a hurry. • Some consultants are trying to reduce the importance of changes by interpreting as if standard supports status quo. • Are we going to follow these people? • Or are we going to remain passionate to the spirit of Quality System? • This slide show is an attempt to rekindle that spirit of 90s.
- 4. A Single Process in a system
- 5. 1. SIPOC- The definition of a process • Six sigma process mapping speaks about drawing SIPOC to understand process in the first level. SIPOC can be expanded as Supplier, Inputs, Process Outputs and customers. • now this is included in ISO standard with the terminology as sources of Inputs, Inputs, activities, Outputs and Receiver of Outputs. • The organisation may take note of this.
- 6. The 2008 standard has this picture
- 7. PDCA Cycle in ISO 9001:2015
- 8. 2. PDCA Picture now has requirements from interested parties • As the standard expands it scope from customer to interested parties inputs also have been shown to be emanating from interested parties. • The second new arrow mark is for organisation and its context which must incorporate risks and opportunities. • It is very interesting that on other side satisfaction of interested parties is not shown which means that needs of interested parties are taken only to serve the customer better and not to satisfy interested parties. This is a key difference between ISO and award models.
- 9. 3. Risk based thinking • In every process which is followed, there are inherent risks. They could be due to changes in materials, changes in people, customer or source of power etc. • Are these considered while implementing the standard? • If so, what are the counter measures proposed? • Again, there is no requirement for documentation of this exercise. But it is expected that FMEA could be one of the documents expected. • WHAT ARE POSITIVE RISKS? (To be debated)
- 10. Changes in clauses from 2008 to 2015 • 2008 • 4. Quality Management system • 5. Management responsibility • 6. Resource Management • 7. Product Realisation • 8. Measurement , Analysis and Improvement • 2015 • 4. Context of the Organisation • 5. Leadership • 6. Planning • 7. Support • 8. Operation • 9. Performance evaluation • 10. Improvement
- 11. How system should be defined to address 4.1 • A mechanism to review latest regulatory requirements and market changes • Nomination of suitable agencies or managers to identify the needs of interested parties • After considering issues, needs of interested parties, products and services of the organisation the scope of QMS should be defined/modified.
- 12. Process mapping • A robust system of mapping the processes is need to be introduced. • Many make flow charts mechanically with no purpose. • The maps have to make the sixdimensions of the process explicit. • Sources of Inputs, Inputs, Activities, Outputs, Receivers of outputs, Controls and measures.
- 13. Clause no 2015 2008 Actions required for upgrade programme 5.1.1 Scope of commitment enhanced to include especially a) accountability for effectiveness of QMS b) integration of QMS requirements into business processes c) promoting the use of process approach and risk based thinking d) promoting improvement e) supporting other management roles Restricted to communicating, establishing policy, objectives etc Accountability of Top Management needs to be understood as “Buck stops here” . Theoretically, any lapse in QMS implementation now can be attributed to management . Top management people need to get visibly involved in QMS and ensure integration of QMS and day to day activities. Since there is no MR, CEO should now function as de facto MR and encourage a team to supervise QMS not on an audit to audit basis but on daily basis.
- 14. Clause no 2015 2008 Actions required for upgrade programme 5.1.2 Scope of customer focus enhanced to include especially a) customer, statutory and regulatory requirements are understood b) Risks and opportunities in products are determined and addressed. It was 5.2 Restricted to ensuring customer requirements are met and enhancing customer satisfaction Top Management should document all statutory and regulatory requirements for the products and services in the markets they serve. Now this cannot be left to a routine departmental functionary. As Risk management is new in the standard, the risk assessment exercise for the products and services should be led by top management.
- 15. Clause no 2015 2008 Actions required for upgrade programme 5.2.1 5.2.2 Establishing Quality policy Addition Policy should support its strategic direction Addition Communication should not only be for employees but the policy should be made available to interested parties also It was 5.3 earlier Policy should support strategic direction-. This means that after every strategic meeting the Management must review the Quality policy (not just periodically). New businesses, new services and new collaborations may demand change in the policy. Just like EMS standard, ISO 9001 also has asked the policy to be made available to interested parties through website or through news letters.
- 16. Clause no 20 15 2008 Actions required for upgrade programme 5.3 Roles and responsi bilities This clause now combines what was earlier under Management Representative. QMS planning is also combined. Emphasis a) Ensuring that processes are delivering their intended outputs. b) It was 5.5 earlier Management representative post can be dissolved and can be replaced by Quality systems Manager assisted by a team. This team should have 4 functions to enable that processes will deliver the intended outputs. 1) Quality Planning 2) Quality system Audits 3) Process Measurement and analysis 4) Product Quality measurement and analysis
- 17. Clause no 2015 2008 Actions required for upgrade programme 6.1 Actions to address risks and opportu nities Determine risks and opportunities which would a) Enhance desirable effects b) Reduce undesirable effects c) Achieve improvement This was not there In the context of the external issues and internal challenges, a risk assessment frame work should be developed which would evaluate the risks and opportunities. A severity rating of 1-20 can also be defined so that those who are of high risks can be selected. The counter measures for these risks (avoidance is the best) should be given so that they can be followed. Example Diesel cars to be banned – counter measure divert the plant capacity for diesel generator production. It would require intense work to work on opportunities in the horizon. Note 1 and Note 2 can help.
- 18. Clause no 2015 2008 Actions required for upgrade programme 6.2 Quality Objective s and planning to achieve them Objectives shall be monitored and updated. Planning now has been made clear with what, when, how etc Earlier it was covered under 5.4.2 Objectives should be monitored and progress reported. Similarly, the objectives shall be updated if the situation warrants.
- 19. Clause no 2015 2008 Actions required for upgrade programme 6.3 Planning of changes Planning of changes Emphasis Allocation and reallocation of responsibilities Somewhat covered under 5.4.2 Change Management should be now a defined process. This will help proper implementation.
- 20. Clause no 2015 2008 Actions required for upgrade programme 7.1 Resources 7.1.1 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes In 7.1.1 emphasis is on Capabilities and constraints on internal resources and also external providers Emphasis from products to processes Nothing much added Social, psychological and physical now included Similar to 6.1 Similar to 6.2 Similar to 6.3 Only physical Constant updation of position of resources and external providers is needed. -- --- It is going to be a big challenge to know how social and psychological environment will be determined and provided and maintained. This is the toughest clause in the standard.
- 21. Clause no 2015 2008 Actions required for upgrade programme 7.1.5 Monitoring and measuring resources 7.1.5.1 general 7.1.5.2 Traceability 7.1.6 organisational knowledge Resources should be provided for monitoring and measurement. Surprisingly, Knowledge is separate clause under 7.1 resources and competence is separate. Partly replaces 7.6 for calibration and also traceability 7.5.3 Identification and traceability New Apart from calibration of equipment and devices, the entire monitoring of products and services should be governed with proper resources. No extra requirement as far as the calibration is concerned. Knowledge management via Libraries, standards, technical bulletins and web sites (intra company) are required to preserve and spread knowledge as a resource.
- 22. Clause no 2015 2008 Actions required for upgrade programme 7.2 Competence 7.3 awareness 7.4 communication By and large same with determination of competence required and ensuring that the competence is maintained. Except that now it says “ performance and effectiveness of Quality Management system” instead of product. Specifically highlighted for quality policy and objectives. Internal and external communication Earlier 6.2.2 but that time it was only for product. Earlier part of 6.2.2 Internal was 5.5.3 Competence should be determined not only for those affecting product quality but also for all activities concerned with QMS. This will expand the requirement of competence for areas like Admin, Vendor development and HR. Nothing much added. New system needs to be developed for external communication
- 23. Clause no 2015 2008 Actions required for upgrade programme 7. 5 Documented Information 7.5.1 general 7.5.2 Creating and updating 7.5.3 Control of documented information All types of documents namely procedures, documents and records are covered Quality Manual is no more mandated. Pretty much the same Protection of documents and access control is now included in the control. Mention of obsolete documents is deleted. Earlier 4.2.1 Earlier 4.2.3 4.2.3 and 4.2.4 Unification of the treatment for all documented information would be required. The debate on what is a record and want is a document is no more relevant. The clause now embraces electronic versions more than paper versions and hence it is needed to switch over the implementation to electronic documents.
- 24. Clause no 2015 2008 Actions required for upgrade programme 8 8.1 Operational Planning and control Determine how to control the processes in line with planning done in clause no 6. Criteria for both processes and products mentioned. Documented information necessary to the extent of creating confidence that processes have been carried out and for conformity of products. It covers outsourced processes also. Link to higher level plan was absent. Outsourced processes was not covered. Operational plan has to be in alignment with the plan for the QMS or business. Operational planning extends to processes and products which means those processes which are not linked an output like a product but which are essential for QMS like Training are also covered now.
- 25. Clause no 2015 2008 Actions required for upgrade programme 8.2 Requirements for Products and services 8.2.1 customer communication 8.2.2 Determining requirements 8.2.3 Review of requirements 8.2.4 changes to requirements Customer property now merged in this clause. Establishing contingency actions is new. No addition No addition Changes should be intimated to all Earlier 7.2.1 7.2.2 and 7.2.3 What are contingency actions? Change notification to be strengthened
- 26. Clause no 2015 2008 Actions required for upgrade programme 8.3 Design and development of products and services 8.3.1 General 8.3.2 Design and Development planning 8.3.3 Design and Development Inputs 8.3.4 Design and Development Controls Involvement of customers and users in the design process mentioned No additional requirement The requirements in Design are consolidated and explained in one clause 7.3 7.3.1 7.3.2 --- System to involve users and customers to be strengthened
- 27. Clause no 2015 2008 Actions required for upgrade programme 8.3.5 Design and Development outputs 8.3.6 Design and development changes Referencing to “monitoring and measuring requirements” added instead of only acceptance criteria No addition Actions taken to adverse impacts added explicitly 7.3.3 7.3.7 Acceptance criteria was only for product whereas monitoring and measuring will encompass
- 28. Clause no 2015 2008 Actions required for upgrade programme 8.4 Control of Externally provided processes , products and services 8.4.1 General 8.4.2 type and extent of control 8.4.3 information for external providers Expanded to externally provided processes instead of limiting to purchasing activity External process should remain within control of QMS No significant addition 7.4 7.4.2 This needs efforts to bring outsourced processes within the ambit of QMS. Consolidated review is required to be done to cover the communication to vendors
- 29. Clause no 2015 2008 Actions required for upgrade programme 8.5 production and service provision 8.5.1 control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers Implementation of actions to prevent human error added No additional requirement No additional requirement 7.5 7.5.1 7.5.3 7.5.4 Poka Yoke to be started
- 30. Clause no 2015 2008 Actions required for upgrade programme 8.5.4 Preservation 8.5.5 Post Delivery activities 8.5.6 Control of changes 8.6 Release of products and services No additional requirement New requirements explicitly stated now that the company should carry out post delivery activities as agreed or as required by regulatory requirements. Obvious requirement stated for emphasis. No addition 7.5.5 8.2.4 System for warranty provision exists however system for recycling and disposal need to be developed. Changes not only in design but in production documents need to be regulated
- 31. Clause no 2015 2008 Actions required for upgrade programme 8.7 Control of non conforming products 8.7.1 8.7.2 Terminological change done as Correction, segregation, containment informing the customer and obtaining permission Retain documented information about the non conformity and resolution of the same 8.3 8.3 Suitable changes need to be done in documents
- 32. Clause no 2015 2008 Actions required for upgrade programme 9 Performance evaluation 9.1 Monitoring , measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation Language simpler and more clear to indicate the way measurement needs to be organised. No additional requirement Language made clear about analysis 8.1 8.2.1 8.4 Quality plans can be synchronised with the requirement. Those having Control plans may not require any action.
- 33. Clause no 2015 2008 Actions required for upgrade programme 9.2 Internal audit 9.2.1 9.2.2 9.3 Management review 9.3.1 9.3.2 Inputs 9.3.3 outputs No significant addition No significant addition Effectiveness of actions taken to address risks and opportunities No addition 8.2.2 5.6 As a logical step management review needs to review status of counter measures to risks
- 34. Clause no 2015 2008 Actions required for upgrade programme 10 Improvement 10.1 General 10.1.1 10.2.1 Non conformity and corrective action 10.2.2 Documentation 10.3 Continual improvement Preventing and reducing undesired effects added Corrective action explained clearly The intent behind this clause is not clear. Earlier the preventive action was clear but now we need to debate and find suitable way to implement the clause. 8.5.1 Some take a view that since the risks are already identified, the preventive action clause is no ore needed. Then the preventive action can be maintained under 10.3