what are changes in ISO 9001 2015 version against ISO 9001 2008 version

Focus of ISO 9001 is to provide sustainable platform to an organization on which organization can run its business with the aim of enhancing customer satisfaction and continual improvement.

To remain compatible with changing circumstances in which organization operates, changing business environment, challenges of business, changing trends of customer needs and expectations etc. ISO 9001 standard is reviewed at every 6 – 8 years and gets revised with inclusion of necessary preventive actions to cop up with potential challenges an organization may face. it also provides model for dealing with existing challenges and prevent them recurring again.

ISO 9001 2015 represents a new structure which contains 10 clauses. This 10 clause structure will be consistent with other management system standards like ISO 14001, ISO 27001 etc.

Management standard 10 clause structure is

  1. Scope
  2. Normative reference
  3. Terms and definitions
  4. Context of organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

This structure will be common in upcoming ISO standards related to management such as quality management,  environmental management, information security management etc..

 

Conceptual changes in ISO 9001 2015 with respect to earlier standard- ISO 9001 2008

  1. Contains requirement of product and service both. Earlier standard were referencing product word in the standard. This was creating confusion to service industry that ISO 9001 may not be compatible to them.
  2. Great inclusion of term “Organizational Context” This will help organization in understanding that systems of other organization which are performing better than them will not necessarily fit in organization willing to implement ISO system. Many times organizations are bench marking with systems of leading organization of their field. Such bench marking may or may not result in achieving intended outcomes. This happens because context of both organizations are different. Context covers Positive and negative factors of organization that affects intended outcome of system. Context includes external issues arising from legal , technological, competitive, market, culture, social and economic environments, Context also includes internal issues arising from values, culture, knowledge and performance of organization. If context is to be defined in one line then it is “Present condition of organization under which it operates”. Condition of each organization is different so as context is also different and as context is different output of management system is also different. Hence systems shall be developed in any organization which is compatible with their context.
  3. Clear alignment of process approach & PDCA cycle. Clause 4 to 7 are focusing upon planning of Quality Management system, Clause 8 focuses upon doing, Clause 9 focuses upon checking and clause 10 focuses upon Acting and improvement.
  4. ISO 9001 2008 standard was containing clause of preventive action. ISO 9001 2015 standard is not containing same. ISO believes that a management standard is preventive itself. Hence a separate clause of preventive action may not be required. Rather a Risk based approach shall be adopted by which potential non conformities ( Risks ) shall be identified and preventive actions can be implemented to prevent occurence of potential non conformity.
  5. Earlier ISO 9001 2008 standard was containing two terms related with documentation. 1. Document & 2. Record. This terminology is changed in new version ISO 9001 2015. Now standard has replaced those two words with new word “Documented information”. For document to be prepared standard addresses “Maintain documented information “. For records to be prepared standard addresses ” Retain documented information “.
  6. Supplier / Vendor is replaced with word External provider. Now external provider is not limited to supplier / service provider only. It may be a group company which is providing resources to organization. It may be some resource which is rented / highered by organization. So external provider is a broader concept w.r.t. supplier/vendor.
  7. ISO 9001 2015 standard throws light on Top management ‘s responsibilities are converted in Leadership . Top management shall take leadership for Quality management system and shall take over all accountability for effectiveness of the quality management system. Top management may deploy resources for implementation, monitoring and measurement of Quality system but if the system is not effective then Top management is primarily accountable.
  8. ISO 9001 2015 standard focuses on Risk based thinking. As many risks organization can identify, as much organization becomes proactive in preventive non conformities ocuring very first time it self. Risk based approach is a superior tool in implementing all possible controls which in turn gets integrated in business processes. This improve probability of achieving intended outcome of quality management system i.e. enhancing customer satisfaction, complying with product and legal requirements and achieving improvement more consistently.
  9. ISO 9001 2015 talks about purpose and strategy of the organization. Based on purpose to be achieved, strategy of organization will very. Also as strategy varies, context of organization varies. Based on context of organization Risks and actions to control them will vary and so as total implementation of Quality management system varies. So ISO 9001 2015 providers a vibrating system where if Purpose of strategy changes, it affects on system developed and its effectiveness.
  10. ISO 9001 2015 focuses on organization knowledge. Organization knowledge can be treated as virtual library which contains all the knowledge/ information necessary to run process successfully and improve same. organization knowledge is enhanced with negative experiences such as complaints, feedbacks, system non conformities, product non conformities, non achievement of planned activities etc. Organizational knowledge widely helps in defining new system with stronger process control and more probability of of achieving intended output.
  11. ISO 9001 2015 focuses upon enhancing awareness of people about policy, objectives, procedures of organization, benefits of following these procedures and consequences if such procedures are not followed. once all persons are aware of the these things, quality system can be effectively implemented and maintained.
  12. ISO 9001 2015 broadly emphasis on change control. Change control covers System change control, product change control and planning change control. Change control shall be approved by relevant authority after validating consequences of changes and their effect on integrity of the quality management system and product performance.
  13. ISO 9001 2015 demands consistently that quality management system must be effective and achieve its intended purpose. if it is not achieved then corrective actions shall be implemented and Risk management shall be updated based on corrective actions initiated.
  14. Data analysis of ISO 9001 2008 is broaden with terminology Monitoring, measurement, analysis and evaluation. This clause has additional information/data which needs to be analysed and evaluated for improvement of quality management system.

Above are some notable changes. However as entire structure of ISO 9001 2015 standard is changed with respect to ISO 9001 2008, it is required to undergo a systematic training in understanding clause wise requirements and their implementation methodology. We as leading consultants for ISO 9001 2015 certification in india can help organization in understanding changes of ISO 9001 2015 with respect to ISO 9001 2008. We can help organizations in implementation of ISO 9001 2015 system by modification of existing ISO 9001 2008 system is organization is already certified with ISO 9001 2008. if organization is not certified with ISO 9001 2008 then we can help organization in fresh implementation of ISO 9001 2015 system.

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