 he main points from this module are as follows:

 The idea for ISO 9001 can be traced back to British standard 5750 in 1979, however the first
publication was made in 1987.

The second revision (1994) stresses quality assurance through preventive action. The third
revision (2000) was based on process approach. The forth revision (2008) was based on
alignment with other standards. The current version was published in 2015.

The current revision was presented as committee draft in June 2013, then as draft
international standard in April 2014, then as final draft international standard in July 2015.
Finally, the revision was published in September 2015.

Companies have until September 2018 to upgrade to the recent revision.

 The latest revision of ISO 9001:2015 is made based on following concepts:

o Process Approach

o Plan, Do, Check, and Act cycle

o Risk Based Thinking

 Risk based thinking does not replace the process approach. Preventive action is built into
risk based decision making.
 A certification process of ISO 9001:2015:

o Defining the scope of business i.e. physical boundaries, products etc.

o A gap analysis is performed.

o Stage 1 readiness check audit.

o Stage 2 certification audit.

o After certification, surveillance audits are done annually for three years.

o Then recertification is done after 3 years of certification issuance.

 Some of benefits of ISO 9001:2015 to business owners are: customer satisfaction,
improved efficiency, decreased defects, and high level structure for easy integration with
other standards.

Some benefits of ISO 9001:2015 to customers are: reduced mistakes, improved complaint
handling system, consistent performance etc.

Companies cannot use ISO logo on products, or cannot change it. Companies cannot say
they are ISO certified, because they are ISO 9001:2015 certified by an accredited body like
UKAS.

Processes have elements like: inputs, outputs, with what, with who, how and how many.

Inputs are raw materials and human resources.

With What includes software and process equipment used to execute activities in process.

With Who refers to human resources and their qualification to run processes.

How is the method used to carry out the process.

How Many refers to the process monitoring parameters.

Outputs are the consequence of process.

 Walter Shewhart's Plan, Do, Check and Act cycle is the basis of ISO 9001:2015 and is used to
analyze the context of an organization to plan for its optimization.

 The planning of processes, the setting of quality objectives, and planning to achieve them are part
of Plan phase in PDCA cycle.

 Do involves support activities like human resource allocation, infrastructure, equipment. Do also
involves production and operational activities. Design activities are also included in Do.

 Check is the management review, performance evaluation example inspection, internal audits etc.

 Act is continual improvement based on internal audits, non-conformities and corrective actions.

 Context of Organization is the analysis of organization’s context both internal and external.
Organizations can list their internal and external issues and identify the parties involved and their
needs and expectations.

 They can then document context by listing these issues and needs of interested parties.

 Then, they can rate each issue and need on a priority ranking scale.

 If needed, a treatment method can be provided to optimize the opportunity and to mitigate the risk.

 Risk based thinking is a thinking process that we do in our everyday life. Organizations need to
adopt it in their processes and activities.

 Risk driven approach from risk based thinking is based on recognizing risks and opportunities,
examining and prioritizing recognized risks and opportunities, planning actions to mitigate risk or
optimize opportunities, implementing a plan, assessing the effectiveness of implemented plan, and
finally, improve continually by learning from experience.