What are new in ISO 9001:2015

ISO released a newer version of ISO 9001 in last September. As per most people, the standard is a totally new change with respect to the older version.
The main change would be realizing the load of paper work or documents required to run the system and removing that item from the system. But, still they need any documented evidences to prove that we are doing the thing.

The other is, realizing the requirement of identifying any risks related with the organization and acting on them. Although it was there previously it was not highlighted as a clause or with the word "risk". But in the new version they have given a much weightage on that.

Previously it was Process Approach and PDCA cycle. Now it is "Risk based thinking".

The major changes at glance are as below.

The changes inside the new version of ISO 9001 : 2015 are listed below with comments.

1. The “context of the organization” must be determined. They require a context analysis, as well as the stakeholder identification and the understanding of their expectations.
2. The “leadership and commitment” replaces “Management commitment”. Although it seems like a small change, the new standard has added a requirement for top management to take accountability for the effectiveness of the QMS and QMS must be merged to business processes.
3. The idea of "Management Representative" is removed from the Standard. The commitment to quality through strong and visible leadership is strengthened. All the leaders must involve within the QMS activities.
4. The “Risk Management” has become the foundation of the standard. (Previously it was process approach and PDCA)
5. Requirement for a “risk - based approach” replaces preventive action. This implies the need for risk assessment and risk management activities related to company managerial decisions and below. The Preventive actions are to be taken before starting a process and part of the routine.
6. The clause “Preventive Actions” is removed but the requirement of Preventive actions are highlighted in “Quality Objectives and planning to achieve them” and in “Risk – based approach”
7. “Documented Information” replaces procedures and records. (There is no longer a specific requirement to have a Quality Manual, but documented information should be available when required)

8. The “needs and expectations of the interested parties” must be determined. This includes customers, and all other stake holders.
9. The term "goods and services" replaces "products".

10. The design and development process has reduced its segments. (Previously it was Planning, Inputs, Outputs, Review, Verification, Validation and changes. Now it is Planning, Inputs, Controls and changes)
11. The purchasing process has been replaced by “Control of externally provided products and services” which also includes outsourced processes.
12. The customer property has been replaced by “property belonging to customers or external providers” which also includes external providers’ properties residing inside the premises.