iso 9001 2015 dis 6.0 planning slides

ISO 9001:2015

Planning – Risks and Objectives

10/21/14 © 2014 Cavendish Scott, Inc.

www.CavendishScott.com

1

Overall Purpose

• Explain the differences between the Planning processes

of ISO 9001:2008 and ISO 9001:2015 DIS

– The Planning process is integral in the establishment and growth

of any Quality Management System (QMS).

– Requirements for Planning include Formal activities for the

planning of risks, opportunities, objectives and changes.



2

2008 vs. 2015 DIS Comparison

ISO 9001:2008 ISO 9001:2015 DIS

5.4 Planning

5.4.1 Quality objectives

5.4.2 QMS planning

6 Planning for the QMS

6.2 Quality objectives and planning to

achieve them

6 Planning for the QMS

6.1 Actions to address risks and

opportunities

6.3 Planning of changes

Significant Differences

The organization shall plan actions to address risks and opportunities and how

to integrate and implement these actions into the QMS and evaluate the

effectiveness of these actions

Requirement to plan changes to the QMS in a systematic manner



3

What has not been changed

• The requirement for the organization to have

objectives that are consistent with the quality policy

and are measureable.

• Ensuring that the integrity of the quality management

system stays intact when changes are made.

• The quality management system is continually

improved.



4

Risks and Opportunities

• The 2008 version requires that preventive actions are

determined and taken to eliminate the causes of

nonconformities in order to prevent their occurrence.

• While 2008 gives the direction that actions need to be

taken, the 2015 draft redefines this and states that

risks for both internal and external issues for

interested parties and their requirements that are

relevant to the quality management system are to be

taken into consideration.



5

External Risks

Some of the sources for external risks that might be

relevant to the QMS:

– Technology,

– Suppliers,

– Customers,

– Changes in statutory or regulatory requirements

• including those of local, state, national or international agencies



6

Internal Risks

• Equipment

• Training of Personnel

• Capacity

• Technology

• Control of processes

• Capability



7

Addressing Risks

• Once the risks and opportunities have been identified

the organization needs to:

– Give assurance that the quality management system can

achieve its intended results

– Prevent or reduce, undesired effects;

– Achieve continual improvement



8

Planning for risks

• The organization not only needs to plan actions to

address the risks and opportunities that have been

identified but also plan how to:

– Integrate and implement the actions into its QMS

processes

– Evaluate the effectiveness of these actions



9

Taking Actions

• Similar to the preventive action requirements in 2008,

the actions that are taken to address the risks and

opportunities shall be proportionate to the potential

impact on the conformity of products and services of

the organization.



10

Options for risks and opprotunities

• Options to address the identified risks and

opportunities can include:

– Avoiding the risk

– Taking the risk in order to pursue an opportunity

– Eliminating the source of the risk

– Changing the likelihood or consequences

– Sharing the risk

– Retaining the risk by informed decision



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Objectives

• As in 2008, quality objectives must be established at

relevant functions and levels. However quality

objectives for relevant processes are also required.

• Also similar to 2008, quality objectives shall:

– Be consistent with the quality policy

– Be measureable



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Objectives - New

• What’s new for objectives for 2015?

– They shall take into account applicable requirements

– They shall be monitored

– They shall be communicate

– The shall be updated as appropriate

– They shall be relevant to conformity of products and

services as well as the enhancement of customer

satisfaction

– The organization shall also retain documented information

on the quality objectives



13

Achieving Objectives

• While planning on how to achieve its quality

objectives, the organization shall determine:

– What will be done

– What resources will be required

– Who will be responsible]

– When it will be completed

– How the results will be evaluated



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Planning of Changes

• When the organization determines the need for

changes to the QMS, the changes shall be carried out

in a planned and systematic manner

• The organization shall consider

– The purpose of the change and any of its potential

consequences;

– The integrity of the QMS;

– The availability of resources;

– The allocation or reallocation of responsibilities and

authorities.



15

Customer Feedback

• ISO 9001:2008 has the requirement to determine,

collect and analyze data in order to determine

customer satisfaction.

– Satisfaction not required to be discussed during

Management Review.

• ISO 9001:2015 DIS has changed the requirement for

customer feedback to be reviewed during

Management Review has changed to the information

of the quality performance, including trends and

indicators of customer satisfaction.



16

Significance of Customer Satisfaction

• The significance of the change is that the

determination of customer satisfaction is not made by

an individual based on only the analysis of data, but

instead made in an environment where it can be

discussed by management to ensure that appropriate

decisions are made and actions taken on both the

data as well any anecdotal information that is

available.



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Why Analyze Customer Satisfaction Information?

• Ensure that decisions are made on the complete

customer base and not just individual customers.

• Strategic direction given by management to ensure

that customer satisfaction is not only acceptable but

also improved upon.



18

Supplier Evaluation

• The ISO 9001:2008 requirement to just analyze data

for suppliers has changed.

• The ISO 9001:2015 requirement is to have the quality

performance, including trends and indicators, reviewed

during the Management Review process for external

providers and other relevant interested parties.



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Supplier Evaluation (cont.)

• This ensures that the data is analyzed, and that it is

discussed, appropriate conclusions are made, and

actions are taken based on the information that has

been gathered.

• This ensures that the organization considers not only

external providers while reviewing the QMS for its

suitability, adequacy and effectiveness, but other

companies, agencies or individuals that are relevant

and interested.



20

Conclusion

• Proposed additional influences will need to be

considered, reviewed and discussed during

Management Review.

• QMS is reviewed by management for suitability,

adequacy, and effectiveness taking into consideration:

– external and internal issues,

– customer satisfaction,

– external providers,

– other relevant interested parties, and

– the strategic direction.



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For more information please contact us!

• Colin Gray

– [email protected] 303 668 2500

• Emily Myers


• Dave Moskal


• Diana Lough


Or visit our Website for current status:

www.cavendishscott.com10/21/14 © 2014 Cavendish Scott, Inc.


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iso 9001 2015 dis 6.0 planning slides

Leadership & Management

cavendish scott

planning risks

planning of risks

quality management system

quality objectives

external risks

actions requirement

preventive actions