• ISO 9001_2015

• Great things happen when the world agrees.

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 What is ISO 9001?
• ISO 9001 is a standard that sets out the
requirements for a quality management system. It
helps businesses and organizations to be more
efficient and improve customer satisfaction.
• A new version of the standard, ISO 9001:2015, has just
been launched, replacing the previous version (ISO
9001:2008).

• Technical ISO/TC 176, Quality management

and quality assurance, Subcommittee SC 2 ,
Quality systems(ISO/TC 176/SC 2)
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 What is a quality management system?
• A quality management system is a way of defining how an
organization can meet the requirements of its customers
and other stakeholders affected by its work.

• ISO 9001 is based on the idea of continual improvement.

• It doesn’t specify what the objectives relating to “quality” or

“meeting customer needs” should be, but requires
organizations to define these objectives themselves and
continually improve their processes in order to reach them.

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 Who is ISO 9001 for?
• ISO 9001 is suitable for organizations of all types, sizes
and sectors.

• In fact, one of the key improvements of the newly

revised ISO 9001:2015 was to make it more applicable
and accessible to all types of enterprises.

• Smaller companies that do not have staff dedicated to

quality can still enjoy the benefits of implementing the
standard – ISO has many resources to assist them.

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 Why was ISO 9001 revised?
• All ISO standards are reviewed and revised regularly to make sure
they remain relevant to the marketplace.

• ISO 9001 has been updated to take into account the different challenges
that businesses now face.

• For example, increased globalization has changed the way we do

business and organizations often operate more complex supply
chains, and there are increased expectations from customers.

• ISO 9001 needs to reflect these changes in order to remain relevant.

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 Change in Structure
• The term "product" has been replaced by "goods & services"

• New language such as ‘context of the organization’ ‘risk based thinking’ &
‘documented information. Two new clauses related to the context of the organization
have been added (4.1 & 4.2)

• The requirement to use process approach has been made more explicit by adding a new
clause (4.4.2)

• Greater emphasis on risk based approach which has replaced preventive action

• Current requirement for six mandated procedures deleted - new requirement for
organizations to maintain ‘documented information’

• The terms "document" & "records" have been replaced with "documented information"

• The term "continual improvement" has been replaced with "improvement"

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 1.1.Introduction
• In this International Standard, the following
verbal forms are used:
• — “shall” indicates a requirement;
• — “should” indicates a recommendation;
• — “may” indicates a permission;
• — “can” indicates a possibility or a capability.

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 1.2.QM PRINCIPLES
• The quality management principles are:
• — customer focus;
• — leadership;
• — engagement of people;
• — process approach;
• — improvement;
• — evidence-based decision making;
• — relationship management.

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1. SCOPE
Current specific requirements regarding exclusions have been
deleted.

2. Normative References
There are no normative references. However, the number for this
clause has been included to maintain alignment.

3. Terms & Definitions

Clause has been expanded to include revision of current terms
with reference to the new ISO9000 standard regarding terms &
definitions to be released

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 Context of the Organization

• New requirement that the organisation has determined

the internal & external issues such as legal,
technological, competition, social, economic etc (4.1)
• •The needs & expectations of ‘interested parties’
(stakeholders) needs to be included (4.2)
• •Risks & opportunities must be determined (risk
register)
• •Quality Manual no longer a requirement

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 Leadership

• Objectives have been moved to Clause 6

• •Management Review has been moved to
Clause 9
• •There is no longer a requirement for a
Management Representative

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Planning for the Management System

• New requirement to integrate into the QMS

actions taken to address risks & opportunities
• •Quality Objectives expanded to include what
will be done, resources required, who will be
responsible, when it will be completed &
evaluation of results.

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 Support

• Includes resource management, control of

monitoring & measuring equipment, control of
documents & records (now documented
information)
• •New requirement for external communication
• •Current clause on human resources (6.2) has
been split into organisational knowledge &
competence & includes extra emphasis on
intellectual knowledge & knowledge gaps.
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 Operation

• Covers current clause 7 (product realisation)

• •Current purchasing clause has been
reworded to ‘control of externally provided
products & services’
• •New requirement to cover unplanned
changes that can affect production or service
provision.
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 Performance Evaluation

• Includes part of the current clause on

measurement, analysis & improvement,
together with the current management review
requirements.

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 Improvement

• Includes the remainder of clause 8

• Preventive action has been deleted in favour
of numerous mentions on risk management

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SO 9001:2015, Quality management systems
ISO 14001: 2015, Environmental management systems
ISO/TS 16959:2016, Automotive quality management systems (will be
based on ISO 9001:2015)
AS9100C:2016, Aerospace quality management systems (will be based on
ISO 9001:2015)
ISO/IEC 27001, Information technology: Security techniques, Information
security management systems
ISO 30301:2011, Information and documentation: Management systems for
records
ISO 22301:2012, Societal security: Business continuity management
systems
ISO 20121:2012, Event sustainability management systems
ISO 39001, Road-traffic safety (RTS) management systems
ISO 55001, Asset management

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Annex SL: What’s in a name?
A frequent question that pops up asks what the “SL” stands
for in Annex SL. But SL is not an acronym–it’s merely a part
of ISO’s numbering scheme.

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