1 Summary

2 The main points from this module

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.
3 The latest revision of ISO 9001:2015 is made based
on following concepts:   

Process Approach
Plan, Do, Check, and Act cycle
Risk Based Thinking
Risk based thinking does not replace the process
approach. Preventive action is built into risk based
decision making.
4 A certification process of ISO 9001:2015:  

Defining the scope of business i.e. physical boundaries,

products etc.
A gap analysis is performed.
Stage 1 readiness check audit.
Stage 2 certification audit.
After certification, surveillance audits are done annually for
three years. 
Then recertification is done after 3 years of certification
issuance. 
 Some of benefits of ISO 9001:2015 to business owners are: customer
5 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.
6 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.
7 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.    
8 Module Ending

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