Iso 9001:2015 Quality Management System

Module 2: Auditable Clauses in ISO 9001:2015
 Upon completion of this module, you will be able to:

o List the auditable clauses of ISO 9001:2015
o Discuss the requirements of standard for the Context of Organization.
o Explain the requirements of standard on Leadership role.
o Clarify the Planning requirements for the Quality Management System (QMS).
o Describe the support functions required for the QMS.
o Explain the requirements of Operation Controls for QMS.
o Discuss the Performance Evaluation requirements related to measurement and monitoring, internal
audits, and management reviews.
o Explain the requirements of Improvement in standard's context.
 Clause 4 - Context of Organization

 Context of Organization is the new requirement of ISO 9001:2015. New requirements related context
of organization are already discussed in the earlier module's last topic. The requirements and
guidelines are expressed here in simple but meaningful terms:

o Clause 4.1 - Comprehend Organization and its Unique Context
o Clause 4.2 - Clarify the Needs and Expectations of Interested Parties related to Organization
o Clause 4.3 - Define the Scope of Organization's Quality Management System
o Under this sub-clause, organization has to take care of the following:
• Recognize and comprehend organization's context.
• Recognize and comprehend organization's context before one develops organization's quality
management system (QMS).
• Consider the external issues that are appropriate to organization's purpose and strategic direction
and think about the influence these issues could have on its QMS and the outcomes it intends to
attain.
• Consider the internal issues that are appropriate to organization's purpose and strategic direction
and think about the influence these issues could have on its QMS and the results it intends to
achieve.
• Monitor information about your organization's context.
• Consider the impact changes in context could have on your organization's quality management
system (QMS).


• Recognize the parties who influence or could influence QMS.

• Reflect how interested parties influence or could influence organization's capability to provide
products and services that meet customer requirements.
• Consider how interested parties could affect your ability to provide products and services that meet
statutory and regulatory requirements.
• Clarify and comprehend their unique needs and expectations.
• Monitor and review information about your interested parties.


• Clarify boundaries and think about what your QMS should apply to.
• Use boundary and applicability information to define your scope.
• Consider your organization's context when you define your scope.
• Document the scope of your quality management system (QMS).
• Use your scope document to describe the boundaries of your organization's QMS and to explain
what it applies to.
• Use your scope document to identify the types of products and services that will be included in your
organization's QMS.
• Use your scope document to explain that every ISO 9001 requirement must be applied unless you
can explain why it does not apply.
• Maintain the document that defines the scope of your QMS.
• Control your organization's QMS scope document.
 Clause 4.4 - Develop a QMS and Establish Documented Information
 This sub-clause is the part of Context of Organization. Organization has to develop a quality
management system and should incorporate documented information to support that. The
requirements of these clause are expressed in two different clauses:

o Clause 4.4.1 - Develop a QMS that complies with this standard
o Clause 4.4.2 - Keep QMS Documents and Keep QMS records
The organization has to take care of the following requirements under this clause:
• Keep documents required to help process operations.

• Control documents which help process operations.
• Keep records which exhibit that plans are being followed.
• Control records which show that plans are being followed.
 Clause 4.4 - Develop a QMS and Establish Documented Information

 This sub-clause is the part of Context of Organization. Organization has to develop a quality
management system and should incorporate documented information to support that. The
requirements of these clause are expressed in two different clauses:

The organization has to take care of the following requirements under this clause:
• Establish a process-oriented Quality Management System (QMS).
• Identify the processes that organization's QMS needs.

• Identify methods required to manage processes.
• Identify resources required to support processes.
• Determine process responsibilities and authorities.
• Determine risks and opportunities for each process.
• Determine methods needed to evaluate processes.
• Implement your process-based quality management system.
• Implement criteria required to operate and control organization's processes.
• Apply methods needed to operate and control your processes.
• Maintain your process-based quality management system.
• Improve your process-based quality management system.
 Clause 5 - Leadership
 The first sub-clause on Leadership is clause 5.1 which is focused on " Provide leadership by
focusing on quality and customers". Requirements are expressed in two different heads:

o Clause 5.1.1 - Offer Leadership by Encouraging a Focus on Quality
o Clause 5.1.2 - Offer Leadership by Encouraging a Focus on Customers
o The organization has to take care of the following requirements under this clause:
• Accept responsibility for organization's QMS.
• Prove a commitment to organization's QMS.

• Make sure that a quality policy is established.
• Make sure that quality objectives are established.
• Make sure that requirements are built into processes.
• Make sure that your QMS achieves all intended results.
• Communicate organization's commitment to the QMS.
• Explain why quality management is important.
• Anticipate managers to be accountable for their QMS.
• Encourage organization's personnel to support their QMS.
• Promote the utilization of risk-based thinking.
 Clause 5 - Leadership
 The first sub-clause on Leadership is clause 5.1 which is focused on " Provide leadership by
focusing on quality and customers". Requirements are expressed in two different heads:

o Clause 5.1.1 - Offer Leadership by Encouraging a Focus on Quality
o Clause 5.1.2 - Offer Leadership by Encouraging a Focus on Customers
• Anticipate human resources to focus on customers.
• Anticipate human resources to manage all related requirements.

• Anticipate human resources to manage appropriate risks and opportunities.
• Anticipate human resources to emphasize on improving customer satisfaction.
 Clause 5.2 - Provide leadership by establishing a suitable quality policy
 The second clause is related to offer leadership be establishing an appropriate quality policy.

o Clause 5.2.1 - Provide Leadership by Formulating Quality Policy of the Organization
o Clause - 5.2.2 - Provide Leadership by Implementing Quality Policy of the Organization
• Establish a relevant quality policy.
• Ensure that it supports company's purpose.

• Ensure that it deals with business context.
• Formulate organization's quality policy.
• Make a commitment to meet applicable requirements.
• Have a commitment to continual improve QMS.
• Enforce the developed organization's quality policy.
• Maintain and keep company's quality policy.
 Clause 5.2 - Provide leadership by establishing a suitable quality policy

 The second clause is related to offer leadership be establishing an appropriate quality policy.

o Clause 5.2.1 - Provide Leadership by Formulating Quality Policy of the Organization
o Clause - 5.2.2 - Provide Leadership by Implementing Quality Policy of the Organization
• Document company's quality policy.
• Communicate organization's quality policy.
• Apply organization's quality policy.
 Clause 5.3 - Offer Leadership by Defining Roles and Responsibilities

 The third clause is 5.3, which on the leadership role in defining the roles and responsibilities.

o Allocate QMS roles, responsibilities, and authorities.
o Communicate those QMS roles, responsibilities, and authorities.

o Make sure that every one understand his/her role, responsibilities and authorities.
 Clause 6 - Planning
 The first sub-clause is 6.1 which is on defining actions and measures to control risks and capitalize
opportunities.

o Clause 6.1.1 - Consider risks and opportunities when you plan your QMS
o Clause 6.1.2 - Plan how you’re going to manage risks and opportunities
o Under this clause, organization has to comply with following requirements:
• Plan the development of company's QMS.
• Recognize the risks and opportunities that could influence the performance of organization's QMS
or disrupt its operation.
• Consider how the company's context could influence how well its QMS is capable to attain planned
results.
• Consider how the company's interested parties could influence how well its QMS is capable to
achieve planned results.
• Identify what one needs to do to manage the risks and opportunities that could affects the
performance of company's QMS or disrupt its operation.
 Clause 6 - Planning
 The first sub-clause is 6.1 which is on defining actions and measures to control risks and capitalize
opportunities.

o Clause 6.1.1 - Consider risks and opportunities when you plan your QMS
o Clause 6.1.2 - Plan how you’re going to manage risks and opportunities
o Under this clause, organization has to comply with following requirements:
• Consider company's risk treatment options.
• Identify measures to address risks and opportunities.
• Identify actions that one can take to address the risks and opportunities that could impact the
performance of company's QMS or halt or deteriorate its operation.
 Clause 6.2 - Setting Quality Objectives and Establish plans to attain them
 The second clause is about setting quality objectives and developing plans to achieve them.

o Clause 6.2.1 - Develop quality objectives for all appropriate areas
o Clause 6.2.2 - Make Plans to Attain Objectives and Assess Results

o Under this sub-clause, organization has to take care of following:
• Define the criteria for identifying quality objectives.
• Resolve quality objectives in all relevant areas.

• Communicate organization's quality objectives.
• Document organization's quality objectives.
• Monitor organization's quality objectives.
• Update organization's quality objectives.
 Clause 6.2 - Setting Quality Objectives and Establish plans to attain them
 The second clause is about setting quality objectives and developing plans to achieve them.

o Clause 6.2.1 - Develop quality objectives for all appropriate areas
o Clause 6.2.2 - Make Plans to Attain Objectives and Assess Results

o Under this sub-clause, organization has to take care of following:
• Establish and develop plans to attain quality objectives.

• Plan how the company is going to assess results.
 Clause 6.3 - Plan changes to your quality management system

 The third sub-clause is related to planning of changes to organization's quality management system.
This is what we can name it as change management. In this clause, one has to take care of the
following issues:

o Think about the purpose of the changes one plans to make.
o Reflect responsibilities and authorities whenever one make changes.
o Contemplate the outcomes that changes could potentially result in.
o Consider the provision of resources whenever one make changes.
o Reflect the integrity of organization's QMS whenever any change is made.
 Clause 7 - Support
 The first sub-clause 7.1 is about supporting organization's QMS by offering the required resources.
There are six sub-clauses within this clause clause 7.1. The two sub-clauses within this sub-clause
are:

o Clause 7.1.1 - Offer Internal and External resources for Company's QMS
o Clause 7.1.2 - Provide Relevant People for QMS and its processes
o Organization has to take care of the following issues within this clause:
• Identify the resources that company's QMS requires.

• Provide the resources that company's QMS needs.
 The first sub-clause 7.1 is about supporting organization's QMS by offering the required resources.
There are six sub-clauses within this clause clause 7.1. The two sub-clauses within this sub-clause
are:

o Clause 7.1.1 - Offer Internal and External resources for Company's QMS
o Clause 7.1.2 - Provide Relevant People for QMS and its processes
o Organization has to take care of the following issues within this clause:
• Provide the people that company's QMS needs to be effective.
• Furnish the people that company's need so as to operate processes.

• Hire the people that company's need so as to control processes.
 The other two sub-clause of 7.1 are:


o Clause 7.1.3 - Furnish the Infrastructure that Company's processes must have
o Clause 7.1.4 - Furnish the relevant environment for Organization's Processes
o The organization has to take care of the following issues under this clause:
• Identify and determine the infrastructure that the processes and the organization need.
So as to support process operations and attain conformity of products and services.
• Furnish the infrastructure that organization and its processes need.
 The other two sub-clause of 7.1 are:


o Clause 7.1.3 - Furnish the Infrastructure that Company's processes must have
o Clause 7.1.4 - Furnish the relevant environment for Organization's Processes

o The organization has to take care of the following issues under this clause:
• Identify and determine the environment that organization and its processes need.
So as to support process operations and attain conformity of products and services.
• Furnish the environment that the processes need.
 The last sub-clause 7.1.5 of clause 7.1 is about providing monitoring, measuring, and trace-ability
resources. It is further described in two different sub-clauses, and the last of clause of 7.1 is also
discussed in the given tabs.

o Clause 7.1.5.1 - Arrange Suitable Monitoring and Measuring resources
o Clause 7.1.5.2 - Organize Suitable Measurement Traceability resources
o Clause 7.1.6 - Provide Knowledge to Facilitate Process Operations

o Under this clause, organization has to manage following requirements:
• Identify monitoring and measuring resource requirements.
• Determine the monitoring and measuring resources that organization need so as to be certain
that one can offer products and services that meet all suitable requirements.
• Offer appropriate monitoring and measuring resources.


• Determine the company's measurement traceability requirements.
• Offer reasonable measurement traceability resources.


o Under this clause, organization has to manage following requirements on Organization's knowledge:
• Identify the knowledge that one organization needs to have.

• Attain the knowledge that one organization needs to have.
• Furnish organizational knowledge available to the scale needed.
• Monitor suitable trends and modifications in knowledge and information.
• Keep the organizational knowledge that has been attained.
This is clause related to Organization Knowledge. In this course, there is a separate topic on
Organization Knowledge in which this topic is elaborated in detail.
 The other three sub-clauses of clauses 7 are discussed:


o Clause 7.2 - Support QMS by ensuring that people are competent
o Clause 7.3 - Support QMS by explaining how people can help
o Clause 7.4 - Support organization's QMS by managing communications

o Organization has to make arrangements for the following requirements
• Identify those under organization's control who do work that influences quality.
• Clarify organization's quality competence requirements.

• Attain competence whenever shortcomings are discovered.
• Document the competence of those whose work influences quality.
• Evaluate the effectiveness of actions taken to acquire competence.



• Aware personnel about organization's QMS.
• Share information about company's QMS with the people who carry out work that is under
organization's control.


• Support organization's QMS by managing QMS communications.
• Resolve how internal communications will be handled.

• Resolve how external communications will be handled
 Clause 7.5 - Support your QMS by Controlling Documented Information

 Clause 7.5 is about the control of documented information.

o Clause 7.5.1 - Incorporate Documented Information
o Clause 7.5.2 - Manage the Creation and Revision of Documented Information
• Identify how extensive documented QMS information should be.
• Think about activities when one develops documents and records.
• Think about individuals when one develops documents and records.
• Reflect on those processes when one develop documents and records.
• Take into account products when organization establish documents and records.
• Take into account services when organization establish documents and records.
• Consider size of company when organization establish documents and records.
• Incorporate all the documents and records that company's QMS needs.
• Incorporate all internal documents and records that company's QMS needs.
• Incorporate all external documents and records that company's QMS needs.
 Clause 7.5 - Support your QMS by Controlling Documented Information

 Clause 7.5 is about the control of documented information.

o Clause 7.5.1 - Incorporate Documented Information
o Clause 7.5.2 - Manage the Creation and Revision of Documented Information
o Under this clause, organization has to manage the following:
• Organize and control the creation and update to documented information.
• Ensure that organization’s QMS documents and records are appropriately identified and explained.
• Ensure that organization’s QMS documents and records are appropriately formatted and
presented.
• Ensure that organization’s QMS documents and records are appropriately reviewed and approved.
 The clause 7.5.3 is related to Control the management and utilization of documented information. It
is further discussed in two sub-clauses:

o Clause 7.5.3.1 - Control Organization's QMS documents and records
o Clause 7.5.3.2 - Control how QMS documents and records are controlled
o The organization has to take care of the following requirements:
• Choose and maintain the QMS documents and records that one needs.
• Choose and maintain all the documentation that one needs so as to protect the confidentiality,
integrity, and use of information.
• Choose and maintain all of the documentation that is mandated by ISO 9001.
• Control and maintain the QMS documents and records as per QMS needs.
• Control and maintain all the internal documentation that company's QMS needs.
• Control and maintain all the external documentation that company's QMS needs.
 The clause 7.5.3 is related to Control the management and utilization of documented information. It
is further discussed in two sub-clauses:

o Clause 7.5.3.1 - Control Organization's QMS documents and records
o Clause 7.5.3.2 - Control how QMS documents and records are controlled
o • Control how company's QMS documents and records are controlled.
• Control how company's QMS documents and records are created.
• Control how company's QMS documents and records are identified
• Control how company's QMS documents and records are distributed.
• Control how company's QMS documents and records are accessed.
• Control how company's QMS documents and records are retrieved.
• Control how company's QMS documents and records are stored.
• Control how company's QMS documents and records are utilized.
• Control how company's QMS documents and records are changed.
• Control how company's QMS documents and records are protected.
• Control how company's QMS documents and records are preserved.
 Clause 8 - Operation
 The first clause 8.1 is related to development, implementation, and control of QMS operational
processes

o Plan the application and control of operational processes.
o Prepare operational process implementation and control plans.
o Utilize organization's plans to apply and control operational processes.
o Control planned operational process alterations and modifications.
o Keep appropriate operational process documents and records.
 Clause 8.2 - Determine and Document Product and Service Requirements


o Clause 8.2.1 - Communicating with Customers and Managing Customer Property
o Clause 8.2.2 - Clarify all Product and Service Requirements and Capabilities
o Clause 8.2.3 - Review Product and Service requirements and Record Results
o Clause 8.2.4 - Modify Documents when Product and Service Requirements Alters
o The clause 8.2.1 is related to communication with customers and management of customer
property, under which an organization is required to do following:
• Communicate with customers.
• Furnish information to customers.
• Attain and get information from customers.
• Manage customer property.
• Control property supplied by customers.


o Organization has to take care of following issues in this sub-clause:
• Identify requirements for products and services offered to customers.
• Verify that you can actually meet product & service requirements.


o This sub-clause is further divided into two clauses;
Clause 8.2.3.1 - Verify requirements before Organization accepts Orders from Customers
• Analyze and assess product & service requirements before accepting order.
• Clarify differences and variations between basic proposal and final order.
• Confirm and verify that one has to meet product and service requirements.
Clause 8.2.3.2 - Document review of Product and Service requirements
• Document and maintain results of product and service requirement reviews.
• Document and maintain new or modified product and service requirements.


o Under this sub-clause organization has to take care of the following:
• Amend all appropriate documented information to exhibit changes in customers' service and
products requirements.
• Retain and control documents and records that explain new or changed product and service
requirements.
 Clause 8.3 - Develop a Process to Design and Develop Products and

Services
 Within this clause, organization has to take care of many issues. As design and development is a
critical part of the Quality management system, since within this phase customer requirements are
internalized in the product design.

o Clause 8.3.1 - Make a Suitable Design and Development Process
o Clause 8.3.2 - Project planning of Design and Development activities for Products and Services
o Clause 8.3.3 - Identify Inputs of Design and Development for Product and Services
o Within this sub-clause, organization has to take care of the following issues:
• Develop a suitable design and development process.
• Apply an appropriate design and development process.

Services

o Clause 8.3.1 - Make a Suitable Design and Development Process
o Under this sub-clause organization has to take care of the following issues:
• Plan organization's design and development stages and controls.
• Consider complexities of design and development process.
• Consider requirements for design and development process.
• Consider expectations design and development process.
• Consider participation of parties for design and development process
• Consider interfaces of design and development process.
• Consider responsibilities of design and development process.

• Consider documentation design and development process.
• Consider resources of a design and development process.

Services

oClause 8.3.1 - Make a Suitable Design and Development Process
o Organization has to take care of the following issues under this sub-clause:
• Clarify your product and service design and development inputs.
• Define the resource needs of product and service design and development needs.
• Control organization's design and development input documents and records.
 Continued...
 The other sub-clauses of Design and Development are discussed here:

o Clause 8.3.4 -
Specify how Design and Development process will be Controlled
o Clause 8.3.5 - Clarify how Design and Development Outputs will be produced
o Clause 8.3.6 - Review and Control all Design and Development Changes
o Under this sub-clause, organization has to take care of the following issues:
• Control product and service design and development activities.
• Control how design and development results are identified.
• Control how design and development reviews are performed.
• Control how design and development validations are carried out
• Control how design and development verification are completed

• Document product and service design and development activities.
 Continued...

o Clause 8.3.4 -
• Control product and service design and development outputs.

• Make sure that outputs can be compared against input requirements.
• Make sure that outputs are capable of supporting product provision.
• Make sure that outputs include or refer to acceptance criteria.
• Make sure that outputs can be used to validate proposals.
• Control design and development output documents and records.
 Continued...

o
Clause 8.3.4 -
• Identify changes during or subsequent to design and development.

• Review changes and modifications during or subsequent to design and development.
• Control changes and modifications during or subsequent to design and development.
 Clause 8.4 - Monitor and Control External Processes, Products, and Services
 This clauses is further divided into following sub-clauses:

o Clause 8.4.1 - Verify External Products & Services Fulfills Requirements
o Clause 8.4.2 - Establish Controls for Externally Supplied Services and Products
o Clause 8.4.3 - Explicate Requirements to External Suppliers
o Under this clause, organization has to take care of following issues:
• Establish controls for external processes, products, and services.
• Control organization's externally provided processes, products, and services.
• Determine criteria to select, evaluate, and monitor external providers.
• Utilize developed criteria to select external process, product, and providers.
• Utilize developed criteria to monitor the performance of external providers.
• Utilize developed criteria to assess organization's external providers.

• Examine controls for external providers, processes, products, and services.
• Examine the potential impact that externally provided processes,products, and services could have
on your organization's ability to consistently meet external requirements.
• Examine the controls that external process, product, and service providers have implemented and
think about how effective their controls actually are.
• Establish controls for external providers, processes, products, and services.
• Apply controls for external providers, processes, products, and services.


• Elucidate what you expect from external providers.
• Elucidate organization's process requirements.
• Elucidate organization's product requirements.
• Elucidate organization's service requirements.
• Elucidate organization's equipment requirements.
• Elucidate organization's interaction requirements.
• Elucidate organization's competence requirements.
• Elucidate organization's methodological requirements for supplies.
• Elucidate organization's monitoring and control requirements.
• Elucidate organization's verification or validation requirements.
• Discuss organization's requirements with external providers.
 Clause 8.5 -Manage and control production and service provision activities
 This clause is further divided into three sub-clauses:

o Clause 8.5.1 -
Develop controls for production and service provision
o Clause 8.5.2 - Point Out outputs and Control their Unique Identity
o Clause 8.5.3 - Protect Property belonging by Customers and External Providers
• Apply controlled conditions.
• Apply controlled conditions for production.
• Apply controlled conditions for service provision.
• Apply controlled conditions for delivery process.

• Apply controlled conditions for post-delivery process.

oClause 8.5.1 -
• Utilize suitable means to identify outputs.
• Identify outputs throughout production.
• Identify outputs throughout service provision.
• Control the unique identify of your outputs.
• Control output identity if traceability is required.

oClause 8.5.1 -
• Point out property owned by customers and external providers.
• Verify property owned by customers and external providers.
• Protect and safeguard property owned by customers and external providers.
• Monitor property owned by customers and external providers.
• Document property owned by customers and external providers.

 Continued...
 The other sub-clauses under this clause 8.5 are as under:

o Clause 8.5.4 -
Preserve Outputs through Production and Service Delivery
o Clause 8.5.5 - Elucidate and Meet all Post-Delivery Requirements
o Clause 8.5.6 - Control changes for production and service Delivery
o Under this clause, organization has to take care of the following issues:
• Preserve and protect outputs during production and service provision.
• Take into consideration for utilizing identification methods to preserve outputs.
• Take into consideration for utilizing packaging methods to preserve outputs.
• Take into consideration for utilizing handling methods to preserve outputs.
• Take into consideration for utilizing storage methods to preserve outputs.
• Take into consideration for utilizing transmission methods to preserve outputs.
• Take into consideration for utilizing transportation methods to preserve outputs.
 Continued...

o Clause 8.5.4 -
• Explain organization's post-delivery requirements.
• Identify activities that must be performed after product delivery.
• Identify activities that must be performed after service delivery.
• Meet with organization's post-delivery requirements.

 Continued...

o Clause 8.5.4 -
• Review and assess modifications in production and service provision.
• Document review results, actions taken, and authorizations.
• Control modifications in production and service provision.

o Clause 8.6 - Implement Plans to Control Product and Service Release
o Clause 8.7 - Control nonconforming outputs and Actions taken to be Documented
• Develop planned arrangements to confirm products at each stage.
• Confirm that product requirements were fulfilled at appropriate stages.
• Develop planned arrangements to verify services at each stage.
• Confirm that service requirements were fulfilled at suitable stages.

o Clause 8.6 - Implement Plans to Control Product and Service Release
o Clause 8.7 - Control nonconforming outputs and Actions taken to be Documented
o Under this clause, there are two sub-clauses:
Clause 8.7.1 - Identify and Control Nonconforming Output to Avoid Unintended Application
Under this sub-clause, organization has to take care of the following issues:
• Identify outputs that do not conform to their requirements.
• Assess nonconforming outputs and examine their impact.
• Take appropriate action to control nonconforming outputs.
• Verify conformity when nonconforming outputs are corrected.
Clause 8.7.2- Document Nonconforming Outputs and the Actions Taken
Under this sub-clause, organization has to take care of the following issues:
• Document organization's nonconforming products and outputs.
• Document the actions and decisions taken to avoid the unintended use or supply of nonconforming
outputs.
 Clause 9 - Evaluation
 The first clause is related to monitoring, measurement, analysis and evaluation. The Clause 9.1 is
further divided into different sub-clauses discussed below:

o Clause 9.1.1- Plan how to Monitor, Measure, Analyze, and Evaluate
o Clause 9.1.2 -Find out how well Customer Needs and Expectations are being fulfilled
o Clause 9.1.3 -Evaluate and Assess Performance, Effectiveness, Conformity, and Satisfaction
o In this sub-clause organization has to take care of the following:
• Plan how the company is going to monitor, measure, analyze, and evaluate organization's QMS.
• Monitor, measure, analyze, and evaluate QMS performance and effectiveness.

o
Clause 9.1.1- Plan how to Monitor, Measure, Analyze, and Evaluate
• Develop methods that can be utilized to monitor perceptions.
• Monitor how well customer needs and expectations are fulfilled.

o
• Analyze organization's monitoring and measurement results.
• Analyze and asses suitable data and information.
• Utilize analytical results to assess performance.
• Utilize analytical results to assess effectiveness.
• Utilize analytical results to assess conformity.
• Utilize analytical results to assess satisfaction.
 Clause 9.2 - Utilize Internal Audits to Evaluate Conformance and Performance


o Clause 9.2.1 - Audit Organization's Quality Management System at Planned Intervals
o Clause 9.2.2 - Establish an Internal Audit program for the Organization
o In this sub-clause, organization has to take care of the following issues:
• Conduct and perform internal conformance audits at pre-determined planned intervals.
• Determine if the organization's QMS fulfill requirements.
• Examine and evaluate the effectiveness of organization's QMS.
 Clause 9.2 - Utilize Internal Audits to Evaluate Conformance and Performance


o Clause 9.2.1 - Audit Organization's Quality Management System at Planned Intervals
o Clause 9.2.2 - Establish an Internal Audit program for the Organization
o In this sub-clause, organization has to take care of the following issues:
• Plan the development of your internal audit program (programme).
• Establish a program that can find out if QMS meets requirements.
• Establish a program that can determine if QMS is effective.
• Establish organization's internal audit program.
• Develop internal audit planning requirements.
• Develop internal audit reporting requirements.
• Develop internal audit responsibilities.
• Develop internal audit schedules.
• Develop internal audit methods.
 Clause 9.3 - Carry out Management Reviews and Document the Results
 There is a separate topic on management review in this course, which covers the different aspects
of management review in detail. The guidelines and requirements of standard are discussed here:

oClause 9.3.1 - Review Suitability, Adequacy, Effectiveness, and Direction
o Clause 9.3.2 - Plan and Conduct Management Reviews at Predetermined Planned Intervals
o Clause 9.3.3 - Generate Management Review Outputs and Maintain Documented Results
o In this sub-clause following issues should be taken care of:
• Review organization's QMS at regular intervals.
• Review the suitability of organization's QMS.
• Review the adequacy of organization's QMS.
• Review the effectiveness of organization's QMS.
• Review the direction of organization's QMS.

• Plan organization's management review activities
• Schedule organization's reviews at predetermined planned intervals.
• Review organization's quality management system.

• Generate suitable and appropriate management review outputs.
• Document the results of organization's management reviews.
 Clause 10 - Improvement
 The first clause on improvement is related to the determination of improvement opportunities and
making improvements. The first clause 10.1 says to take into consideration means of improving
customer satisfaction. In which following should be done:

o Take into consideration opportunities to support innovation.
o Take into consideration opportunities to take corrective action.
o Take into consideration opportunities to transform organization's operations.
o Take into consideration opportunities to make incremental changes.
 Then the clause says to determine and choose opportunities for improvement.
o Determine opportunities to fulfill customer requirements.
o Take into consideration opportunities to enhance customer satisfaction.
 Then the clause concludes on fulfilling customer requirements and improving satisfaction.
 Clause 10.2 - Control Nonconformities and Take Appropriate Measures and

Corrective action
 The second clause on improvement is related to control of non-conformity and taking measures and
corrective actions to address that.

o Clause 10.2.1 - Correct Nonconformities and Address Causes and Consequences
o Clause 10.2.2 - Document Organization's Nonconformities and the Actions that are Taken
o Under this sub-clause, one needs to address following:
• React and respond to organization's nonconformities.
• Control and correct organization's nonconformities.
• Evaluate and assess the need to eliminate causes.

• Develop and establish corrective actions to address causes.
• Implement and apply corrective actions to eradicate the causes.
• Review and assess the effectiveness of corrective actions taken.
 Clause 10.2 - Control Nonconformities and Take Appropriate Measures and

Corrective action
 The second clause on improvement is related to control of non-conformity and taking measures and
corrective actions to address that.

o Clause 10.2.1 - Correct Nonconformities and Address Causes and Consequences
o Clause 10.2.2 - Document Organization's Nonconformities and the Actions that are Taken
o Under this sub-clause, one needs to address following:
• Document the nonconformities as these are reported.
• Document the actions which are made to resolve nonconformities.
• Document the organization's corrective action results.
 Clause 10.3 - Enhance and Improve the Suitability, Adequacy, and

Effectiveness of Company's QMS
 The last clause on improvement is related to the enhancement of the Quality Management System
for its suitability, adequacy and effectiveness. The requirements of these clauses under the pretext
of enhancing the Suitability, Adequacy, and Effectiveness of Company's QMS are:

o Consider and take into account evaluation, analytical, and outputs of management reviews.
o Utilize results to verify that unfulfilled QMS requirements; which must be addressed.
o Improve and enhance the adequacy, suitability, and effectiveness of company's QMS.
 The main points from this module are as follows:


o Clause 4.2 - Clarify the Needs and Expectations of Interested Parties related to
Organization
o Clause 4.4 - Develop a QMS and Establish Documented Information
o Clause 4.4.2 - Keep QMS Documents and Keep QMS records


o Clause 5 - Leadership
o Clause 6 - Planning
o • Clause 5.1 - Offering leadership by focusing on quality and customers
• Clause 5.1.1 - Offer Leadership by Encouraging a Focus on Quality
• Clause 5.1.2 - Offer Leadership by Encouraging a Focus on Customers
• Clause 5.2 - Provide leadership by establishing a suitable quality policy
• Clause 5.2.1 - Provide Leadership by Formulating Quality Policy of the Organization
• Clause - 5.2.2 - Provide Leadership by Implementing Quality Policy of the Organization
• Clause 5.3 - Offer Leadership by Defining Roles and Responsibilities

o Clause 5 - Leadership
o Clause 6 - Planning
o • Clause 6.1 - Defining Actions and Measures to control risks and capitalize opportunities
• Clause 6.1.1 - Consider risks and opportunities when you plan your QMS
• Clause 6.1.2 - Plan how you’re going to manage risks and opportunities
• Clause 6.2 - Setting Quality Objectives and Establish plans to attain them
• Clause 6.2.1 - Develop Quality Objectives for all appropriate areas
• Clause 6.2.2 - Make plans to attain objectives and assess results

• Clause 6.3 - Plan changes to your quality management system

o Clause 7 - Support
o Clause 8 - Operation
o • Clause 8.1 - Development, Implementation, and Control of QMS Operational Processes
• Clause 8.2 - Determine and Document Product and Service Requirements

• Clause 8.2.1 - Communicating with Customers and Managing Customer Property
• Clause 8.2.2 - Clarify all Product and Service Requirements and Capabilities
• Clause 8.2.3 - Review Product and Service requirements and Record Results
• Clause 8.2.4 - Modify Documents when Product and Service Requirements Alters
• Clause 8.3 - Develop a Process to Design and Develop Products and Services
• Clause 8.3.1 - Make a Suitable Design and Development Process
• Clause 8.3.2 - Project planning of Design and Development activities for Products and Services
• Clause 8.3.3 - Identify Inputs of Design and Development for Product and Services
• Clause 8.3.4 - Specify how design and development process will be controlled
• Clause 8.3.5 - Clarify how design and development outputs will be produced
• Clause 8.3.6 - Review and control all design and development changes
• Clause 8.4 - Monitor and Control External Processes, Products, and Services
• Clause 8.4.1 - Verify External Products & Services Fulfills Requirements
• Clause 8.4.2 - Establish Controls for Externally Supplied Services and Products
• Clause 8.4.3 - Explicate Requirements to External Suppliers
• Clause 8.5 - Manage and control production and service provision activities
• Clause 8.5.1 - Develop controls for production and service provision
• Clause 8.5.2 - Point Out and identify outputs and Control their Unique Identity
• Clause 8.5.3 - Protect Property belonging by Customers and External Providers
• Clause 8.5.4 - Preserve Outputs through Production and Service Delivery
• Clause 8.5.5 - Elucidate and Meet all Post-Delivery Requirements
• Clause 8.5.6 - Control changes for production and service Delivery
• Clause 8.6 - Implement Plans to Control Product and Service Release
• Clause 8.7 - Control nonconforming outputs and Actions taken to be Documented
• Clause 8.7.1 - Identify and Control Nonconforming Output to Avoid Unintended Application
• Clause 8.7.2 - Document Nonconforming Outputs and the Actions Taken
 Clause 8 - Operation
 • Clause 7.1 - Supporting Organization's QMS by Offering the Required Resources
• Clause 7.1.1 - Offer Internal and External resources for Company's QMS
• Clause 7.1.2 - Provide Relevant People for QMS and its processes
• Clause 7.1.3 - Furnish the Infrastructure that Company's processes must have
• Clause 7.1.4 - Furnish the relevant environment for Organization's Processes
• Clause 7.1.5 - Provide monitoring, measuring, and trace-ability resources
• Clause 7.1.5.1 - Arrange suitable monitoring and measuring resources
• Clause 7.1.5.2 - Organize suitable measurement traceability resources
• Clause 7.1.6 - Provide knowledge to facilitate process operations
• Clause 7.2 - Support QMS by ensuring that people are competent

• Clause 7.3 - Support QMS by explaining how people can help
• Clause 7.4 - Support organization's QMS by managing communications
• Clause 7.5 - Support QMS by controlling documented information

• Clause 7.5.1 - Incorporate Documented Information
• Clause 7.5.2 - Manage the Creation and Revision of Documented Information
• Clause 7.5.3 - Control the management and utilization of documented information
• Clause 7.5.3.1 - Control Organization's QMS documents and records
• Clause 7.5.3.2 - Control how QMS documents and records are controlled

o Clause 9 - Evaluation
o Clause 10 - Improvement
o Under this clause, organization has to take of the following sub-clauses:
Clause 9.1 - Measurement, Monitoring, Analysis and Evaluation

Clause 9.1.2 -Find out how well Customer Needs and Expectations are being fulfilled
Clause 9.1.3 -Evaluate and Assess Performance, Effectiveness, Conformity, and Satisfaction
Clause 9.2 - Utilize Internal Audits to Evaluate Conformance and Performance

Clause 9.2.1 - Audit Organization's Quality Management System at Planned Intervals
Clause 9.2.2 - Establish an Internal Audit program for the Organization
Clause 9.3 - Carry out Management Reviews and Document the Results
Clause 9.3.1 - Review Suitability, Adequacy, Effectiveness, and Direction
Clause 9.3.2 - Plan and Conduct Management Reviews at Predetermined Planned Intervals
Clause 9.3.3 - Generate Management Review Outputs and Maintain Documented Results
 Clause 10 - Improvement
 Under this clause, organization has to take of the following sub-clauses:
Clause 10.1 - Take into consideration means of improving customer satisfaction
Clause 10.2 - Control Nonconformities and Take Appropriate Measures and Corrective action
Clause 10.2.1 - Correct Nonconformities and Address Causes and Consequences
Clause 10.2.2 - Document Organization's Nonconformities and the Actions that are Taken
Clause 10.3 - Enhance and Improve the Suitability, Adequacy, and Effectiveness of
Company's QMS

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Module 2: Auditable Clauses in ISO 9001:2015

 Upon completion of this module, you will be able to:

o Discuss the requirements of standard for the Context of Organization.

o Explain the requirements of standard on Leadership role.

o Describe the support functions required for the QMS.

o Explain the requirements of Operation Controls for QMS.

o Explain the requirements of Improvement in standard's context.

 Clause 4 - Context of Organization

 Clause 4 - Context of Organization

• Recognize the parties who influence or could influence QMS.

 Clause 4 - Context of Organization

• Keep documents required to help process operations.

 Clause 4.4 - Develop a QMS and Establish Documented Information

• Establish a process-oriented Quality Management System (QMS).

• Identify the processes that organization's QMS needs.

• Accept responsibility for organization's QMS.

• Prove a commitment to organization's QMS.

• Anticipate human resources to focus on customers.

• Anticipate human resources to manage all related requirements.

• Establish a relevant quality policy.

• Ensure that it supports company's purpose.

• Maintain and keep company's quality policy.

 Clause 5.2 - Provide leadership by establishing a suitable quality policy

• Document company's quality policy.

• Communicate organization's quality policy.

• Apply organization's quality policy.

 Clause 5.3 - Offer Leadership by Defining Roles and Responsibilities

o Communicate those QMS roles, responsibilities, and authorities.

• Plan the development of company's QMS.

o Under this clause, organization has to comply with following requirements:

• Consider company's risk treatment options.

• Identify measures to address risks and opportunities.

• Define the criteria for identifying quality objectives.

• Resolve quality objectives in all relevant areas.

• Establish and develop plans to attain quality objectives.

 Clause 6.3 - Plan changes to your quality management system

o Reflect responsibilities and authorities whenever one make changes.

o Contemplate the outcomes that changes could potentially result in.

o Consider the provision of resources whenever one make changes.

o Reflect the integrity of organization's QMS whenever any change is made.

• Identify the resources that company's QMS requires.

• Provide the people that company's QMS needs to be effective.

• Furnish the people that company's need so as to operate processes.

 The other two sub-clause of 7.1 are:

So as to support process operations and attain conformity of products and services.

• Furnish the infrastructure that organization and its processes need.

 The other two sub-clause of 7.1 are:

o Clause 7.1.4 - Furnish the relevant environment for Organization's Processes

So as to support process operations and attain conformity of products and services.

• Furnish the environment that the processes need.

o Clause 7.1.5.2 - Organize Suitable Measurement Traceability resources

o Clause 7.1.6 - Provide Knowledge to Facilitate Process Operations

o Clause 7.1.5.2 - Organize Suitable Measurement Traceability resources

o Clause 7.1.6 - Provide Knowledge to Facilitate Process Operations

• Determine the company's measurement traceability requirements.

• Offer reasonable measurement traceability resources.

o Clause 7.1.5.2 - Organize Suitable Measurement Traceability resources