 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.
 lause 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 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).
o Clause 4.2 - Clarify the Needs and Expectations of Interested Parties related to Organization
Under this sub-clause, organization has to take care of the following:
- 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.
o Clause 4.3 - Define the Scope of Organization's Quality Management System

Under this sub-clause, organization has to take care of the following:

- 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

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.

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.

o
o Clause 5 - Leadership
o 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

 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 5.1.2 - Offer Leadership by Encouraging a Focus on Customers

The organization has to take care of the following requirements under this clause:

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

 The organization has to take care of the following requirements under this clause:

• 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 - 5.2.2 - Provide Leadership by Implementing Quality Policy of the Organization

The organization has to take care of the following requirements under this clause:

• 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 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.

o Clause 6.1.2 - Plan how you’re going to manage risks and opportunities
 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 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.

o Clause 6.2.2 - Make Plans to Attain Objectives and Assess Results

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 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.

o Clause 7.1.2 - Provide Relevant People for QMS and its processes

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

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.

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

 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.
 he 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 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.

o Clause 7.1.5.2 - Organize Suitable Measurement Traceability resources

. Under this clause, organization has to manage following requirements:

• Determine the company's measurement traceability requirements.

• Offer reasonable measurement traceability resources.

 Clause 7.1.6 - Provide Knowledge to Facilitate Process Operations

 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.

6 - Provide Knowled
 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 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.

ge to Facilitate P
o Clause 7.1.2 - Provide Relevant People for QMS and its processes

 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.

rocess Operations