iso 9001 2015 dis 9.0 performance 1-04-15

ISO 9001:2015 DIS

Section 9, Performance

01/04/15 © 2014 Cavendish Scott, Inc.

www.CavendishScott.com

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Overall purpose of this presentation

• Provide a comparison between the similar requirements of ISO

9001:2008 clauses

• Provide an assessment of the intent

• Provide possible solutions for transition



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Overall purpose of ISO 9001 Section 9

The purpose of ISO 9001:2015 Section 9, Performance, is for

organizations to assess conformance and effectiveness:

– Conformance to the requirements of the standard and to the

process requirements they have defined,

– Their effectiveness of processes in achieving their planned

results,

– The overall quality performance and effectiveness of their quality

management system (QMS).



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It is about looking in the mirror.

It is about measuring, monitoring and evaluating quality objectives and

processes, customer satisfaction indicators, products and services, as

well as using internal audit results to determine if we like what we see

because if we do not, the QMS and therefore the organization is not

performing at its best and is not as effective as it should be.

Ineffective, cumbersome processes become a way of life.

When organizations are not operating efficiently and effectively,

customers are not satisfied and/or the organization is not as profitable

as it could be.

Monitoring and measurement takes planning to be effective at

portraying how the organization is doing.



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It is not just about appeasing an external auditor and passing an audit!

If the organization is truly

monitoring and measuring what is important to the business,

ensuring the QMS is integrated into their daily business operations,

monitoring and measuring its processes for effectiveness,

evaluating the results and reacting to unsatisfactory levels and trends,

then the business will improve, the audit results will take care of

themselves and the certificate on the wall will be there.

The focus and emphasis should be on improving the performance and

effectiveness of the QMS and not on just getting through another audit.



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2015 v. 2008 Comparison

ISO 9001:2015 DIS ISO 9001:2008

9. Performance

9.1 Monitoring, measurement,

analysis and evaluation

9.1.1 General

8 Measurement, Analysis and

Improvement

8.1 General

8.2 Monitoring and measurement

8.2.3 Monitoring and measurement of

processes

8.2.4 Monitoring and measurement of

product

Significant Differences

Adds: provides more details about planning for monitoring and measuring:

what, who, when, and when the results shall be analyzed and evaluated;

process and product requirements are combined

Removes: release of product moved to section 8.6



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The primary requirements for monitoring and measurement have not

changed – they are just described differently. The requirement to

determine monitoring and measurement methods for products, services

and processes still requires proactive planning, implementation,

evaluation and responding to the results of the evaluation.

Organizations are typically good at determining what, how, when, and

by whom when it comes to measuring product. The same intentional

planning is required and to be applied to measuring service

performance and process effectiveness as well.



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What do you need to do?

• Ensure you have objective evidence of planning for process monitoring and measurement, including details of what, when, how, and when the results will be evaluated. If the

• Limiting this planning and evaluation to the annual management review will not provide the benefit to the organization as intended so consider a more frequent review

• Ensure there is evidence of what actions are taken when performance in both product and process measurements are below satisfactory levels



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ISO 9001:2015 DIS ISO 9001:2008

9.1.2 Customer satisfaction 8.2.1 Customer satisfaction


Adds: “to the degree” to which customer requirements have been met;

obtaining information relating to customer views and opinions of the

organization and its products and services; market share analysis in the Note

Removes: lost business analysis in the Note



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Determining the customers’ perception of the organization’s

performance has basically not changed. However, it is now referred to

as the “degree to which customer requirements have been met.”

The primary change is adding the requirement to plan how the

organization will obtain information relating to customer views and

opinions of the organization itself and its products and services and not

just to how it met customer requirements.

As before, a proactive approach to soliciting information is expected

rather than just waiting for positive and negative feedback to appear.



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• Ensure there is a plan for obtaining customer feedback –proactively as well as reactively.

• Ensure the plan includes gathering information on the organization as well as the products and services provided.

• Ensure the plan is implemented

• Ensure the results are evaluated and appropriate follow-through activities ensue.



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ISO 9001:2015 DIS ISO 9001:2008

9.1.3 Analysis and evaluation 8.4 Analysis of data


Adds: emphasis on evaluation; enhancing customer satisfaction, ensuring

conformity and effectiveness of QMS, demonstrating that planning has been

effectively implemented, determine the need or opportunities for improvements;

Removes: characteristics of processes and the need for preventive actions



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• The 2015 revision now explicitly specifies “evaluation” along with

data analysis. The implies that not only are the measurement

results evaluated for trends, but also the overall evaluation for the

measurements undertaken.

• The additional requirements to analyze and evaluate forces a more

thorough assessment of the QMS – individual aspects as well as the

overall QMS - is expected for input to the management review.



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• Ensure monitoring and measurement activities address all the required aspects and are included in the planning for monitoring and measurement stipulated in section 9.1.1.

• Ensure the methodologies implemented are in accordance with the plan.

• Ensure the evaluations occur according to the plan.

• Ensure documented information of the results of the evaluation exist.



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ISO 9001:2015 DIS ISO 9001:2008

9.2 Internal Audit

9.2.1 (untitled)

9.2.2 (untitled)

8.2.2 Internal audit


Adds: Considerations when planning an internal audit now includes quality

objectives, customer feedback, and changes impacting on the organization.

Removes: The requirement for a documented procedure.



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9.2 Internal Audits

The overall intent of internal audits has not changed – the intent is still

to determine whether or not the quality management system conforms

to the requirements of the standard as well as the organization’s own

requirements. This falls into the “check” aspect of the Plan-Do-Check-

Act approach.

Section 9.2.1 states: The organization shall conduct internal audits at

planned results to provide information on whether the quality

management system…b) is effectively implemented and maintained.

• This implies that the internal audits must determine the processes

audited within the QMS are effective: planned activities are realized

and planned results are achieved.



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• There are no process changes for Internal Audits or changes to how

they are planned and performed.

• “The management responsible for the area being audited” is now

identified as “relevant management” implying that results may be of

importance to areas of the organization other than just the area

being audited.



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The emphasis on auditing quality objectives, customer feedback, and

changes impacting on the organization provides a significant difference

to the expected audit results. And of course, a third-party auditor will

expect to see evidence of audit results for these areas.

– Quality objectives: increased consideration implies a focus on

planning for quality objectives, assessing appropriateness of the

objectives, the method for collecting the data and its analysis

and evaluation, actual performance levels indicating process

effectiveness (or not), and follow-up activities to the evaluation of

the results.



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– Customer feedback: specifically auditing customer feedback ties

into the determination of customer satisfaction. The internal

audit should be able to confirm that customer satisfaction, as

demonstrated by satisfaction survey results and/or other

indicators, is truly indicative of or takes into consideration

feedback received, product returns, etc.

– Change management: this will require a thorough assessment

of top management’s commitment to integrate the QMS into

strategic planning and how the QMS is included when changes

are planned and implemented.



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• Your QMS should already have a documented procedure on planning and performing internal audits. Although a procedure is no longer required, there is no downside to keeping your procedure in place. A properly written procedure demonstrates the process is defined and implemented. All that is necessary is a revision to:

– address the new requirements for consideration

– that relevant members of management are notified of results and not just the management of the area audited

• Ensure your internal auditor(s) are competent to assess all aspects of quality objectives, customer feedback and its ties to customer satisfaction, and management’s commitment to include the QMS in planning for changes



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• Use the internal audit to add value to the organization with regard to process monitoring. Employees typically share or unknowingly point out information regarding problems, cumbersome activities, etc. They live with these situations either because no one listens, or they believe they cannot do anything about it. Be sure the internal auditors recognize that personnel tolerating repeated problems, extra work required to fix the mistakes of others etc., indicates ineffective processes and should be included in the internal audit documented information.

• Ensure the internal audit reports include assessments of process effectiveness, based upon process monitoring and measurements and customer feedback, where applicable, as well as the overall QMS



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ISO 9001:2015 DIS ISO 9001:2008

9.3 Management review

9.3.1 (untitled)

9.3.2 (untitled)

5.5.6 Management review

5.6.1 General

5.6.2 Review input

5.6.3 Review output


Adds: review input considerations including customer satisfaction, changes in

external and internal issues that are relevant to the QMS and its strategic

direction, issues concerning external providers and other relevant interested

parties, and actions taken to address risks and opportunities; adds requirement

to retain documented information as evidence of the results of management

reviews Removes: removes customer feedback as an input



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9.3 Management review

Management review remains an important activity for top management

to review and evaluate the QMS at planned intervals to ensure the

QMS continues to be suitable, adequate and effective.

It is important that top management considers internal and external

influences that can impact the context of the organization, and how the

strategic direction of the company is aligned with the QMS. Evidence

of this is included in the management review documented information.

Management reviews must also assess the performance of the QMS

and consider opportunities for improvement as well as the status of risk

and opportunities.



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There are no changes to the management review process.

Changes to input requirements include:

• The strategic direction of the organization is included when

addressing changes in external and internal issues,

• Customer feedback is now an overall assessment of the customer

satisfaction,

• Issues concerning external providers and other relevant interested

parties,

• Adequacy of resources necessary to maintain an effective QMS

• The effectiveness of actions taken to address risks and

opportunities,

• New potential opportunities for improvement



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Changes to output requirements include a more broad description of

the decisions and actions related to:

• Any need for changes to the QMS.

Documented information (records) providing evidence of the results of

management reviews implies that more evidence of follow-up activities

must be maintained as opposed to only maintaining records of the

“meeting minutes”.



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What you need to do

• Adjust templates for management review meeting agendas to

ensure all required inputs are included

• Keep track of action items from the previous management review

meetings as the status of those actions must be reviewed.

• Ensure documented information of the results of management

reviews includes follow-up activities. Having just a record of what

occurred during the meeting is no longer sufficient.



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We are here to help!

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.com01/04/15 © 2014 Cavendish Scott, Inc.


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