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ISO 9001 - 2015-Training Material
ISO 9001 - 2015-Training Material
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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).
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Who is ISO 9001 for?
• ISO 9001 is suitable for organizations of all types, sizes
and sectors.
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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.
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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• The term "product" has been replaced by "goods & services"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"
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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.
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Context of the Organization
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Leadership
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Planning for the Management System
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Support
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Improvement
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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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