Section 8

ISO/FDIS 9001:2015- Cl. 9-

Performance Evaluation
Cl.10 Improvement
Performance evaluation &
Improvement
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs.
9.3.3 Management review outputs

10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

12 October 2016 | Company presentation www.intertek.com

9.1 Monitoring, measurement, analysis and
evaluation

{The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis and evaluation
needed to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be
analysed and evaluated.
The organization shall evaluate the performance and the
effectiveness of the quality management system.

The organization shall retain appropriate documented information as

evidence of the results.}

12 October 2016 | Company presentation www.intertek.com

 9.1.2 Customer satisfaction
The organization shall monitor customers perceptions of the degree to
which their needs and expectations have been fulfilled. The
organization shall determine the methods for obtaining , monitoring and
reviewing this information.

Examples can include:

Customer surveys
Customer Feedback
Meetings with Customers
Market share analysis
Compliments
Warranty claims
Dealer reports

12 October 2016 | Company presentation www.intertek.com

 9.1.3 Analysis and evaluation of data

The organization shall analyze and evaluate appropriate data arising

from monitoring, measurement .
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management
system;
d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and
opportunities;
f) the performance of external providers;
g) the need for improvements to the quality management system.

Note: Methods to analyse can include statistical techniques

12 October 2016 | Company presentation www.intertek.com

 9.2 Internal Audit

{9.2.1 The organization shall conduct internal audits at planned

intervals to provide information on whether the quality
management system;
a) conforms to
1) the organizations own requirements for its quality
management system; and
2) the requirements of this International Standard;
b) is effectively implemented and maintained. }

12 October 2016 | Company presentation www.intertek.com

 9.2 Internal Audit (Contd)

9.2.2 {The organization shall:

a) plan, establish, implement and maintain an audit programme(s), including
the frequency, methods, responsibilities, planning requirements and reporting,
which shall take into consideration the importance of the processes concerned,
changes affecting the organization and the results of previous audits
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of
the audit process;
d) ensure that the results of the audits are reported to relevant
management}
e) take appropriate correction and corrective action without undue delay;
f) {retain documented information as evidence of the implementation of the
audit programme and the audit results. }

Note: Ref ISO 19011 for guidance

12 October 2016 | Company presentation www.intertek.com

 Key changes

To replace Section 8.2.2 Internal audit

A documented procedure is no longer required. Requirements
for documented information instead.
Key factors to influence audit planning redrafted; reference to
quality objectives and related risks added. Risk based
approach underlined
Stronger emphasis on the results being reported to relevant
management and becoming an input data for decision making
ensure that the results of the audits are reported to relevant
management for evaluation; system approach maintained
Responsibility for taking appropriate corrective action without
undue delays transferred from the management responsible for
the area being audited to the organisation itself

12 October 2016 | Company presentation www.intertek.com

 9.3 Management review

General

{Top management shall review the organization's quality management

system, at planned intervals, to ensure its continuing suitability,
adequacy, and effectiveness } and alignment with the strategic
direction of the organization..

12 October 2016 | Company presentation www.intertek.com

 9.3 Management review

9.3.2 Management Review Inputs

{The management review shall }be planned and carried out taking in to
{consideration}
a) {The status of actions from previous management reviews
b) Changes in internal and external issues that are relevant to the QMS}
c) Information on the performance and effectiveness of the QMS ,
including trends in
Customer satisfaction and feedback from relevant interested parties
The extent to which quality objectives have been met
Process performance and conformity of products and services
{Non conformities and corrective actions
Monitoring and measurement results
Audit results}
The performance of external providers
d)The adequacy of resources
e)The effectiveness of actions taken to address risks and opportunities
(6.1)
f) Opportunities for improvement

12 October 2016 | Company presentation www.intertek.com

9.3 Management review

9.3.3 Management Review Outputs

{The outputs shall include decisions }and actions {related

to}
{A) Opportunities for improvement
B) any need for changes to the QMS}
C) resource needs.
{The organization shall retain documented information
as evidence of the results of management review}

12 October 2016 | Company presentation www.intertek.com

Key changes

To replace Sections 5.6 Management review.

> Stronger emphasis on the need to allign management review with the
needs of the changing business environment and the strategic
direction of the organization. Business flavour added.

> Input platform extended; the following input data added: monitoring
and measurement results; supplier and external provider issues.

> The output section redrafted, now more flexible and opportunities
sensitive, focused on improvement opportunities and relevant
needs for changes to the QMS to emrace these opportunities

12 October 2016 | Company presentation www.intertek.com

10 Improvement

10.1 General
The organization shall determine and select opportunities for
improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction.

These shall include:

a) improving products and services to meet requirements as well as
to address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality
management system.

Examples of improvement can include . correction, CA, continual

improvement, breakthrough change, innovation and re-organization

12 October 2016 | Company presentation www.intertek.com

 Section 10.2 Nonconformity and corrective
action
10.2.1
{When a nonconformity occurs}, including from complaints, {the
organization shall}:
{a) react to the nonconformity, and as applicable
1) take action to control and correct it; and
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause/s of the nonconformity,
in order that it does not recur or occur elsewhere, by
1) Reviewing and analyzing the nonconformity;
2) determining the causes of the nonconformity, and
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken; and
e) update risks and opportunities determined during planning, if
necessary;
e) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities
encountered}
12 October 2016 | Company presentation www.intertek.com
Section 10.2 Nonconformity and corrective
action

10.2.2

{The organization shall retain documented information as evidence of

a) the nature of the nonconformities and any subsequent actions
taken; and
b) the results of any corrective action. }

12 October 2016 | Company presentation www.intertek.com

 Key changes

To replace Section 8.5.2 Corrective action

A documented procedure is no longer required. Requirements for
documented information instead.
Correction added as an immediate response react to the nonconformity,
and as applicable 1) take action to control and correct it; and 2) deal with the
consequences(FDIS:2015). Makes it clearer to further differentiate with the
next steps- undertaking and implementing the necessary corrective action
Adds the aspect of prevention determining if similar nonconformities exist,
or could potentially occur (FDIS:2015). Helps apply holistic approach and
identify and cure systemic problems
Stronger emphasis on the improvement purposes of corrective actions,
viewed as an instrument of change by adding make changes to the quality
management system, if necessary. (FDIS:2015).

12 October 2016 | Company presentation www.intertek.com

Key changes (Contd)

Emphasis on the proportionality principle Corrective actions shall be

appropriate to the effects of the nonconformities encountered. Cost-benefit
sensitive approach underlined.
Preventive action does not appear. Yet, the preventive focus has been
well enforced throughout the whole standard through risk based thinking

12 October 2016 | Company presentation www.intertek.com

10.3 Continual Improvement

{ The organization shall continually improve the suitability, adequacy and

effectiveness of the quality management system}

The organization shall consider the results of analysis and evaluation,

and the outputs from management review, to determine if there are
needs or opportunities that shall be addressed as part of continual
improvement.

12 October 2016 | Company presentation www.intertek.com

 End of Section 8

12 October 2016 | Company presentation www.intertek.com