Newly version of ISO9001:2015 has been released is September 2015 with main changes had

focused on its new structure, new content, risk approach and Quality Management Principles.
However, it still maintains on current focus of effective process management to produce
desired outcomes, with additional of application the new High-Level Structure of ISO Directives
to enhance compatibility and alignment with other management system standards. The new
standard requirement also adopts the simplified language and writing styles to aid
understanding and consistent interpretations of requirements. Increased requirements for top
management commitment and involvement has been clearly determined. The new 2015
revision of ISO 9001 the world’s most recognized quality management standard brings in some
very significant changes in comparison to its previous version. ISO 9001:2015 is compliant with
Annex SL Directives (it is aligned with other management system standards) it makes it much
easier to integrate with other management system. The new standard is based on NX SL the
new high-level structure HLs that brings a common framework to all management system
standards, this helps to keep consistency alignment different management system standard
offer matching sub-classes against the top-level structure, and apply common language across
all standards with the new standard in place organizations. It will find it easier to incorporate
their quality management system into the core business processes and gain greater business
benefit the new 2015 version downsizes those eight QMS principles to seven organization
contexts. The new standard expects you to understand organization’s context before
establishing its QMS the environment culture values purpose and interested parties are all
examples of things you might need to consider before developing an acceptable QMS total
responsibility for the QMS will be lifted form management representatives and share
throughout the organization, with top management maintaining accountability documented
information. The new ISO 9001 2015 standard has merged documents and records into
documented information. Documented information refers to information that must be
controlled and maintained within their supporting medium. While the previous terms have
been eliminated two new terms have taken their place retain and maintain, in short procedures
have been changed to maintain information and records refers to retain information Quality
Manual is not a mandatory document along with six mandatory procedures from ISO 9001:2008
version the revision no longer requires certified organizations to maintain an up to date quality
manual, be aware. However, that the documentation requirement is still part of the standard it
is still necessary to document, maintain and preserve relevant information a quality manual
therefore remains one possibility for fulfilling this requirement albeit not the sole solution. Risk
based thinking has always been implicit in ISO 9001 it is about anticipating and preventing
undesired outcomes. Why through the effort of planning or reviewing activities we do these
things to prevent future mistakes. The new standard expects organizations to identify and
address risks explicitly and to identify upper that might better their abilities to provide products
and services satisfying to the customer. Exclusions any requirement may be excluded if it
cannot be applied. However, treaty decide a requirement cannot be applied you must be
prepared to explain why; objects, outputs, products and services, an object is anything
conceivable or perceivable in theory this will significantly expand the scope of the standard. The
term product is now referred to as output, the old product definition has been expanded into
three separate definitions output product and service. Other clarifications and modifications
the phrase products and services has replaced the term product service has been given a whole
new definition of its own. This should help clarify that ISO 9001:2015 applies to a variety of
services customer property has been modified to include products services and processes
belonging to all types of providers including customers, continual improvement now refers to
enhancing performance indefinitely in other words improvement no longer has a finish line.
Organizations must now identify acquire and share knowledge product realization has been
moved to the section denoted as operations. Management representative has been dropped
responsibilities previously held by a management representative can now be reassigned to an
individual or a group preventive action has been replaced by risk based thinking equipment has
been replaced by resources to provide a higher level of flexibility. The new standard considers
knowledge like any other resource to be managed by identification of the knowledge necessary
to carry out the activity in compliance with the QMS and to achieve the defined objectives and
conclusion. The management focus is vital for any system to survive and will be reinforced by
making quality a responsibility of all rather than the sole responsibility of a management
representative.