1 ISO

2 Learning Outcomes
• Upon completion of this module, you will be able to:
• Discuss the history of ISO 9001 Revisions.
• Discuss the global status of ISO 9001 & changes in revision.
• Explain what companies should do with change.
• Clarify and describe common misconceptions about revision.
• Examine and manage the context of an organization.
• Explain Process Approach.
• List each phase of the Plan, Do, Check and Act Cycle.
• Define Risk Based Thinking.
3 History
• The idea behind ISO 9001 can be traced back to the British
Standard 5750 in 1979, however the ISO9000s history is as follows:
• The first version of ISO 9000 was published in 1987 and was based
on BS5750 standard. It was also influenced by Defense Military
standards.
• The second version of ISO 9000:1994 was published in 1994. This
version stressed quality assurance through preventative action.
• The third version was published in 2000 as ISO 9001:2000. This
version radically changed thinking as it held the belief that process
management should be the core of the standard. 
4 History … continued
• ISO 9001:2000 made the goals of standard crystal clear i.e. that
standard should be ‘a documented system’ not just a ‘system of
documents’. The idea was to create system efficiency that can be
measured and validated by process performance.
• The fourth version is ISO 9001:2008 standard. This edition on made
slight changes to the previous version. The goal of this revision was to
better explain 2000 edition requirements and to increase compatibility
with other management systems, such as ISO 14001.
• The fifth major revision was published in 2015. This version is called
ISO 9001:2015. Because the revision in 2008 was just a minor update
of the 2000 version, this revision sought to fill in gaps that have been
formed over the fifteen years since 2000.
5 Timeline for publications
6 Timeline for transition
7 Fundamental Concepts in ISO 9001:2015

Nigel Croft, Chairperson of the ISO subcommittee for

revising the standard, emphasizes that the revision is
based on three basic concepts:
• Process approach
• PDCA Model i.e. Plan Do Check & Act
• Risk Based Thinking
8 Process Approach
9 PDCA
10 Risk based thinking
11 Substitution of Process Approach by Risk Based
Thinking

There are concerns that risk based thinking substitutes

the process approach, which is incorrect. It is part of
the process approach itself, because before one begins
the process, one must identify any hazards and
opportunities so that they may decide which process
best meets the objectives in a given context.
12 Action Plan for Organization
 Currently accredited management systems can be adapted with some
minor modifications. In many situations, organizations should have
sufficient documentation and protocols already in place with their
presently certified management system.

 As risk is incorporated in many sections of the revision of ISO 9001,

companies should focus on establishing their risk management
protocols if they do not currently have a system in place for controlling
risks. The companies must start thinking about how to incorporate risk in
their businesses at both a strategic level as well as an operational level.

 The transitional period does not end until 2018, so organizations will have
had three years to update their systems and make sure it comply with the
revision.
13 Certification Process- Phases
Starting Point: Outline the scope of the certification program.
Pre-Audit (not mandatory): This is a gap analysis phase against standard. This helps
companies to identify what they need to do to prepare for a certification audit.
Certification Audits are actually conducted in 2 stages: 
Stage 1 Audit is a readiness review audit to prove that the organization is prepared
for certification.
Stage 2 Audit is an assessment of implementation, along with the effectiveness, and
performance evaluation of the management system of the organization. This is the
stage where certification is awarded.  A certificate is valid for 3 years and is awarded
based on the results of stage 2 audit. 
Surveillance Audits are conducted to prove that the management system maintains
fulfillment against requirements of standard and are also conducted to observe the
continual improvement of the management system.
Re-Certification Audits are done after 3 years to endorse the effectiveness of the
management system as a whole. Certificate is then reissued for next 3 years.
14 Certification Process- Implement Benefits
• Improved customer retention, satisfaction and acquisition.
• Exhibition of management commitment towards quality of services
and products.
• Improving cost control through conserving input materials.
• Reducing defects that result in complaints, therefore reducing
compensation costs.
• Increase in efficiency, productivity and profit.
• Creation of knowledge database for effective management of
company knowledge.
• Consistent outcomes which are measured and monitored.
• High Level Structure (HLS) to easily integrate with more than one
standard.
15 Benefits to customers
Some clients will only purchase or buy services or products from
certified companies since it provides them the assurance that
management systems are continuously assessed, improved and
monitored.
Some of the benefits to customers are:  
• Reduces repeated mistakes.
• Develops a complaint reporting system and improves performance.
• Improved quality products and services by internal auditing.
• Consistent and robust scheduling of production and delivery.
• Performance will be maintained with the help of external
certification body annual assessments program.
16 What can’t Companies do!
Companies cannot do following with ISO 9001 certification:  
• Companies cannot employ or change ISO’s logo. It is ISO’s brand and
intellectual property.
• Companies cannot equate ISO 9001 certification to being ISO certified.
Companies which are ISO 9001:2015 certified are not certified by ISO or by
ISO 9001 technical committee, but rather by an Accreditation Body like
UKAS.
• ISO 9001:2015 cannot be branded on company products or utilized in
literature to denote that product is certified by ISO 9001. It is not a product
certification but a company quality management system certification.
• Companies must be careful with their scope so to correctly describe their
certified activities and geographic locations. A certification is only awarded
on the defined scope. Activities of companies outside the certification
scope cannot be implied to gain benefits of ISO 9001 certification.
17 Module 7 Ending

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