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Section 9

ISO 9001:2015- Impacts

on organisation

1

Structure Change (1)

• There are now 10 main clauses as follows:-

• 1) Scope 6) Planning

• 2) Normative References 7) Support

• 3) Terms and Definitions 8) Operation

• 4) Context of the 9)Performance Evaluation

organization 10) Improvement

• 5) Leadership

• Many requirements are now located differently

• Organizations may have to align their management systems

with the structure of the revised standard,

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More Generic and Service Sector’sApplicability (1)

• Product has been replaced by the term“products and services”

• when referring to customer’s deliverables.

• Moreover, Standard Clauses have been revisedsignificantly to reduce prescriptive nature ofcertain requirements which were derived fromhardware sector’s practices

3

Context of the Organization (1)

• A new Clause 4 has been structured to include1) the understanding of the organization andits context 2)

• the understanding of the needs andexpectations of interested parties

• 3) determining the scope of the QMS takinginto consideration of the above 1) and 2)items.

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Context of the Organization (2)

• Together these clauses require the organization todetermine the issues and requirements that can impact onthe planning of the QMS and can be used as an input intothe development of the QMS. This would result in abroader business outlook that would imply a moredetailed operational planning.

• Since this change reflect greater business focus in the• ISO 9001:2015 Standard, when determining the scope of

QMS, the organization shall consider not only internalissues but look into external issues as well.

5

Revisiting the scope

• Compared to ISO 9001:2008 Standard, ISO

9001:2015 Standard spells out clearly whatshall be included in the QMS scope i.e.products and services provided, mainprocesses to deliver the products and servicesand the sites involved

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Embedding Process Approach (1)

• “Process Approach” has been made a very explicitrequirement in the ISO 9001:2015 Standard.

• This change sends a very clear message to clients that

“Process Approach” is a must, not an option.

• top management to make sure that QMS areintegrated into business processes

• It is believed that this focus would “result in a holistic

system with the primary objective of meeting customer

• requirements and enhancing customer satisfaction”.

7

Risk and Preventive Action (1)

• “Preventive Action” is no longer a clause in theISO 9001:2015 Standard as the a formalmanagement system is acting as a preventivetool. The risk-based thinking and risk-drivenapproach to preventive action is now introducedin the development and implementation of QMS.

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Documented Information (1)

• Documented Information has replaced“Document” and “Record” terms and there isno mandatory documented procedurerequired.

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Impacts

• ISO/FDIS 9001:2015 comes with a new structure, as well aswith some revised principles, terms and new/revisedrequirements. Yet, the companies implementing the

standard may need to understand the paradigm of changeswell beyond a simplistic revision of some terms anddocumentation.

• Instead, the new revision is to be felt and perceived as aneffort to encourage a business case where a QMS resideswithin, or is built into, the very processes that really outputproduct, which results in a holistic system with the primary

objective of meeting interested parties' requirements andenhance their satisfaction.

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Impacts

• The transition related to risk based thinking ismore than a change of documents, but impliesintelligently and proactively revisiting currentapproaches to addressing risks andopportunities.

• Without appropriate leadership andcommitment, any changes undertaken may bringdesired outcomes only accidentally with limited,if any chances for sustained improvement!!!

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End of Section 9

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