Iso 9001: Quality Management Principles: by Parmi Gajjar

ISO 9001: QUALITY MANAGEMENT PRINCIPLES
By Parmi Gajjar
Clause No.
09
Performance Evaluation
P e r f o r m a n c e e v a l u a ti o n i s t h e c r i ti c a l C h e c k s t e p i n t h e P l a n - D o - C h e c k - A c t
(PDCA) cycle that ISO 9001 is based on, and it is only through this step that
y o u c a n d e t e r m i n e i f y o u r Q u a l i t y M a n a g e m e n t S y s t e m ( Q M S ) i s f u n c ti o n i n g
p r o p e r l y, o r i f c h a n g e s a r e n e e d e d t o m e e t t h e r e q u i r e m e n t s .
Monitoring, Measurement,
9.1 Analysis and Evaluation
9.2 Internal Audit
Sub Clauses
9.3 Management Review
9.1: Monitoring, Measurement, Analysis and
This template can be used free in any
Evaluation
9.1.1 General:
 The organizations shall determine:
− What needs to be monitored?

− The methods for monitoring, analysis, and evaluation needed to
ensure the valid result.
− When the monitoring and measuring shall be performed?
− When the result of monitoring and measuring shall be analysed and
evaluated.
 Also the QMS shall be evaluated by the organizations on the basis of:
− Performance
− Effectiveness
 The organizations shall retain the approriate documented information of

the results.
Evaluation
9.1.1 General: Checklist Questions
− Show how does the organization determines:
• What needs to be monitored and measured?

• What methods for monitoring, measurement, analysis, and evaluation to
ensure valid results?
• What to perform monitoring and measuring?
• What results shall be analyzed and evaluated?
− What documented information can you show that monitoring and measurement
activities have been implemented in accordance with determining requirements?
− Show how the organization evaluates the quality performance and the
effectiveness of the QMS.
Evaluation
9.1.1 General: Implementation Guidelines
− The organization must plan and implement processes that monitor,

measure, analyze and evaluate the health of your QMS.
− The focus of these processes must be on product/service conformity,

process conformity, and improving QMS effectiveness.
− You must monitor your processes:
a) To determine and establish the capability of new processes to

conform to requirements.
b) To monitor these processes over time to verify ongoing
stability and capability to meet requirements.
c) To determine and achieve levels of continual improvement
− The monitoring and measurement techniques, sampling plans,

acceptance criteria should be documented or referenced in your
quality plan, or you could use a combination of specific practices,
procedures, documents and methods.
Evaluation
9.1.2 Customer Satisfaction:
 The organization should monitor customer perceptions of

the degree to which their needs and expectations have
been fulfilled
 The organization must determine the methods for

obtaining, monitoring, and using this information.
 Some of the methods by which monitoring of customer

perceptions can include customer surveys, customer
feedback on delivered products or services, meetings
with customers, market-share analysis, compliments,
warranty claims, and dealer reports.
Evaluation
9.1.2 Customer Satisfaction: Checklist Questions
− How does the organization monitor customer perception of the degree to which
requirements have been met?
− How does the organization obtain information relating to customer views and
opinions of products and services?
− What are the methods for obtaining and using this information?
Evaluation
9.1.2 Customer Satisfaction: Implementation Guidelines
− Information related to customer views can include customer

satisfaction or opinion surveys, customer data on delivered products
or services quality, market share analysis, compliments, warranty
claims, and dealer reports.
− Customer requirements may relate to the design, manufacture,

delivery, servicing, and support of the product, QMS, communication,
and financial requirements, etc.
− The organization should consider both external as well as internal

customer satisfaction.
− The organization must monitor trends in customer satisfaction

indicators and use these as a baseline for continual improvement.
Evaluation
9.1.3 Analysis and Evaluation:
 The organization should analyze and evaluate appropriate

data and information arising from monitoring and
measurement.
 Use the results of the analysis to evaluate the conformity of
products and services, the degree of customer satisfaction,
the performance and effectiveness of the quality
management system.
 The organization must also evaluate if planning has been
effectively implemented and the effectiveness of actions
taken to address risks and opportunities.
 The performance of external providers and the need for
improvements within the quality management system must
also be evaluated.
 Methods to analyze data can include statistical techniques.
Evaluation
9.1.3 Analysis and Evaluation: Checklist Questions
− Show how does the organization analyze and evaluates data and information
arising from monitoring, measurement, and other sources.
− Show how the output of analysis and evaluation is used to:
a) Demonstrate conformity of products and services to requirements?

b) Assess and enhance customer satisfaction?
c) Ensure conformity and effectiveness of the QMS?
d) Demonstrate that planning has been successfully implemented?
e) Assess process performance?
f) Assess the performance of external providers?
g) Determine the need or opportunities for improvements within the QMS?
− Show where the results of analysis and evaluation are used to provide inputs to
management review.
Evaluation
9.1.3 Analysis and Evaluation: Implementation Guidelines
− You must collect and analyze QMS data that relate to the:
• Performance,
• Effectiveness,
• Efficiency of products, and services,
• QMS processes,
• Production output,
• External provider (supplier) performance,
• Use of resources,
• Cost of poor quality,
• Customer satisfaction, etc.
− You must sort and summarize the data you collect into things gone
right and things that have gone wrong and present them separately.
− Management can then focus on continual improvement of things
gone right and take corrective action on things gone wrong.
− A summary of QMS performance data must be included in your
periodic management review.
9.2: Internal Audit
9.2.1 :
The organization should conduct internal audits at

planned intervals to:
− Provide information on whether the quality

management system conforms to the organization’s
own requirements
− The requirement of ISO 9001:2015 standards and is

effectively implemented and maintained.
9.2: Internal Audit
9.2.2 :
 The organization must plan, establish, implement, and maintain an audit program, which
must include frequency, methods, and responsibilities, planning requirements, and
reporting.
 While making an audit program, consideration must be given to the importance of
concerned processes, changes impacting the organization, and the results of previous
audits.
 It must:
− Define audit criteria and scope for each audit.

− Select auditors and conduct audits for the impartial and objective audit process.
− Ensure the results of audits are reported to relevant management.
− Take necessary correction and corrective actions without undue delay.
− Retain evidence of audit program implementation and audit results.
9.2: Internal Audit
Checklist Questions
 Are internal audits being conducted at planned intervals? Do they determine whether the
QMS conforms to the requirements of ISO 9001 and to the other requirements established by
Organization? (Review records to demonstrate conformance)
 Do they determine whether the QMS is effectively implemented and maintained? (Review
records)
 Can you show audit programme(s) that takes into consideration the quality objectives,
importance of the processes, customer feedback, changes impacting the organization, and the
results of previous audits?
 What are the audit criteria and scope for the audit?
 Can you demonstrate that selection of auditors and the conduct of audits are objective and
impartial and that auditors don’t audit their own work?
 How are audit results reported to relevant management?
 Can you demonstrate that necessary correction and corrective actions are taken without
undue delay?
 Can you show documented information about the audit program and the audit results?
9.2: Internal Audit
Implementation Guidelines
− The audit process must address the responsibilities

− Audits obtain objective evidence of conformity with requirements.
− The scope of your internal audit program must cover the:
• Audit of operation processes to determine conformity of product/services and their processes to
customer and applicable regulatory requirements.
• Audit of the QMS to determine conformity to the ISO 9001 standard and organizational requirements.
• Audit of QMS processes and their interaction to determine if the QMS has been effectively implemented
and maintained
− In determining the time frame for your audit program, you should consider organization size, the complexity
of product and processes, the health of the QMS, customer, registrar, and regulatory requirements, etc.
− Consider adjusting the audit frequency and perhaps even the audit scope, of specific processes or group of
processes, when:
• You experience internal or external nonconformities.
• Get customer complaints.
• Have critical or high-risk processes.
• Have frequent or significant changes to processes and products.
− During the audit, auditors should ensure that the objectivity and impartiality of the audit are not
compromised. Auditors cannot audit their own work.
9.3: Management Review
9.3.1 : General
The Top Management of the organization should

review the Organization’s QMS at planned intervals to
ensure its continuing suitability, adequacy,
effectiveness and it should be aligned with the strategic
direction of the organization.
9.3.2 : Management review inputs
 Plan and carry out management review considering:
• The status of actions from previous management reviews,

• Changes in external and internal issues relevant to QMS,
• The adequacy of resources,
• Opportunities for improvement, and
• The effectiveness of actions taken to address risks and opportunities
 The organization must also consider information on quality performance and effectiveness, including:
• Trends in non-conformities and corrective actions,

• Customer satisfaction and feedback from relevant interested parties,
• Monitoring and measurement results,
• Audit results,
• The extent to which quality objectives have been met,
• Process performance,
• Conformity of product and services,
• The performance of external providers
9.3.3 Management review outputs
 Outputs from the management review must

include:
• Decisions and actions related to opportunities

for improvement,
• Any need for changes to QMS, and
• Resource needs.
 The organization should retain documented

information as evidence of the results of
management reviews.
Checklist Questions
 What is the frequency that top management reviews the organization’s QMS? How
is the QMS deemed suitable, adequate, and effective?
 What kinds of information are reviewed in management reviews?
 Show that management reviews include decisions and actions relating to:
• Continual improvement opportunities;

• The need for changes to the QMS including resource needs.
 Show what documented information you have as evidence of management

reviews.
I m p l e m e n ti n g G u i d e l i n e s
− Procedure for management review as it has specific − Responsibilities and timelines should accompany these
requirements for management review inputs, value- decisions and actions.
adding review activities, and outputs. − The performance of these actions must be followed up at
− Top management must plan the review of all agenda subsequent management review meetings.
items with some regularity and take timely action to − You must also identify what specific documents are
change or improve any part of it, including the quality needed for effective planning, operation, and control of
policy and objectives. this process.
− The Top Management can incorporate QMS agenda − Management review records must include topics
items into regular monthly or quarterly operational discussed, decisions, responsibilities for corrective or
meetings. improvement actions and related timelines, provision of
− Management review input should preferably be in resources, and follow-up actions from previous
summary form, showing QMS and operational management reviews.
performance measured against the business and quality
plans, customer and regulatory objectives, and goals.
− Review decisions and actions must relate to improving
products and processes or even creating new ones.
Thank you

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ISO 9001: QUALITY MANAGEMENT PRINCIPLES

9.2 Internal Audit

 The organizations shall determine:

− What needs to be monitored?

 The organizations shall retain the approriate documented information of

− Show how does the organization determines:

• What needs to be monitored and measured?

− The organization must plan and implement processes that monitor,

− The focus of these processes must be on product/service conformity,

− You must monitor your processes:

a) To determine and establish the capability of new processes to

− The monitoring and measurement techniques, sampling plans,

9.1.2 Customer Satisfaction:

 The organization should monitor customer perceptions of

 The organization must determine the methods for

 Some of the methods by which monitoring of customer

9.1.2 Customer Satisfaction: Implementation Guidelines

− Information related to customer views can include customer

− Customer requirements may relate to the design, manufacture,

− The organization should consider both external as well as internal

− The organization must monitor trends in customer satisfaction

 The organization should analyze and evaluate appropriate

− Show how the output of analysis and evaluation is used to:

a) Demonstrate conformity of products and services to requirements?

The organization should conduct internal audits at

− Provide information on whether the quality

− The requirement of ISO 9001:2015 standards and is

− Define audit criteria and scope for each audit.

− The audit process must address the responsibilities

The Top Management of the organization should

9.3.2 : Management review inputs

 Plan and carry out management review considering:

• The status of actions from previous management reviews,

• Trends in non-conformities and corrective actions,

9.3.3 Management review outputs

 Outputs from the management review must

• Decisions and actions related to opportunities

 The organization should retain documented

 What kinds of information are reviewed in management reviews?

• Continual improvement opportunities;

 Show what documented information you have as evidence of management

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