Key changes in ISO 9001 version 2015 include the following

key changes:

o Building a quality management system that is well matched to each

organization’s particular needs.

o Top management must be involved in the management system in

order to make comprehensive enterprise strategy.

o The prevalence of risk-based thinking across the standard enables

the entire management system to be used as a preventive instrument, which will
continually boost improvement.

o Less enforcing requirements for records and documentation. The

enterprise can now decide independently what documented information it
requires and what is the appropriate format.

o Integration with other important and widespread management

system standards.

 Certification Process - Phases

 Starting Point: Outline the scope of the certification program.

Pre-Audit (not mandatory): This is a gap analysis phase against standard. This

helps companies to identify what they need to do to prepare for a certification
audit.

Certification Audits are actually conducted in 2 stages: 

o Stage 1 Audit is a readiness review audit to prove that the

organization is prepared for certification.

o Stage 2 Audit is an assessment of implementation, along with the

effectiveness, and performance evaluation of the management system of the
organization. This is the stage where certification is awarded.  A certificate is
valid for 3 years and is awarded based on the results of stage 2 audit. 
 Surveillance Audits are conducted to prove that the management system
maintains fulfillment against requirements of standard and are also conducted to
observe the continual improvement of the management system.

Re-Certification Audits are done after 3 years to endorse the effectiveness of

the management system as a whole. Certificate is then reissued for next 3 years.

 Certification Process – Implementation Benefits

o Improved customer retention, satisfaction and acquisition.

o Exhibition of management commitment towards quality of services

and products.

o Improving cost control through conserving input materials.

o Reducing defects that result in complaints, therefore reducing

compensation costs.

o Increase in efficiency, productivity and profit.

o Creation of knowledge database for effective management of

company knowledge.

o Consistent outcomes which are measured and monitored.

o High Level Structure (HLS) to easily integrate with more than one
standard.

 Process Approach and PDCA Cycle

 A process is usually defined as reproducible, interacting activities that
together convert an input into an output. The elements in the process approach
cycle are discussed below:

o With What means the infrastructure i.e. process equipment,
software, hardware, and supporting devices. 

o With Who means the human resource i.e. personnel, training, and
qualification needed to carry out the process. 

o How is the procedure or work instructions that explain how the
process will be carried out and describe the entities responsible entities for the
process.

o How many? These are the process monitoring parameters like

action plan, trends, production reports. This also counts as evidence for PDCA. 

o Input is something that starts the process. Input can be workers,

event, resources, or supplies. For example, a maintenance requisition starts the
process for maintenance. 

o Output is a consequence of the process, or its result. Output should

comply with the expectation of a customer both in-house or external. Normally
outputs are goods, services, or the input into other in-house process.


 Organizational Processes Examples

 Some of the examples of organizational processes are shared below:

o Training process o Assembly process

o Information o Marketing process

management process
o Customer
o Maintenance process communications process

o Information o Purchasing process

management process
o Internal auditing
o Planning process process

 Determinants of a Process
 Some of process determinants are following:


 Plan, Do, Check & Act is a cycle that was devised by Walter Shewhart and
propagated by Edward Deming. PDCA is an iterative four-step managing technique
utilized in industry for the continual improvement of processes.
 Plan – This step includes the establishment of the objectives and
processes essential to provide outcomes that are in line with needed output.

Planning of the QMS starts with the initial documentation of the Quality Manual,
control of documents and records, Quality Policy and Quality Objectives, plan to
achieve policy & objectives, Additional planning on how to realize the product or
service, including what resources are
required and how they will be used, is the
last step in the early planning.
 Do – This step includes the execution
of the plan, performance the process, and
production the product. At this point,
companies must gather process statistics for
recording and examination in the next steps
of Check And Act.

Raw material or service needs must be

specified.

Designs development, the purchasing

process, and raw materials must be verified against requirements.

The process of creating the merchandise or service must be implemented.

Defects must be incorporated in non-conformities and be dealt with. The
procedure and the instrument to monitor and inspect the product and processes
must be controlled.

All undertakings of creating and delivering the

product or service to clients are required to be
completed in Do phase.

 Check – Examine the real results of ‘Do’ step,

and check it against the expected results of the plan
phase.

It is mandatory to check and measure not merely the

product to make sure it fulfills requirements, but
moreover to check and measure the processes as
well. Analysis of data, internal audits, external audits & Management Review are
mandatory in ISO 9001. All these extensive
processes are part of ‘check’ phase in PDCA
cycle. 

 Act – If the Check analysis reveals that the Plan that was

applied in Do phase is a progressive improvement to the
earlier results, then the present ‘Do’ should become the
new standard for how the organization should Act going
forward.
 If the Check analysis reveals that the Plan that was applied in Do phase is not an improvement,
then the prior standard will remain.

 In both cases, i.e. improvement or no improvement, more learning is needed and that will inform next
PDCA cycle. Corrective actions and action plans that resulted from output of management review
meetings and internal audits are part of the Act phase in PDCA cycle.

 When to Use Plan–Do–Check–Act

 PDCA cycle should be used in following cases:

o When opting for continuous improvement.

o When initiating a new improvement project.

o When making a new or modified design of a process, product or

service.

o When defining a repetitive work process.

o When preparing data collection and analysis so as to verify and

prioritize problems or root causes.

o When applying any change.

 PDCA Cycle and ISO 9001:2015

 PDCA is an integral part of ISO 9001:2015 (Quality Management System
i.e. QMS). Companies going for ISO 9001 will automatically integrate PDCA cycle.
 Plan and Do in ISO 9001:2015

o Plan

oPlanning is one of the vital parts of the QMS and begins

with re alizing
the

context of the organization and the expectations of interested parties (Clauses

4.1 & 4.2), which is then utilized to define the QMS scope and the processes
(Clauses 4.3 & 4.4).
 Then commitment of leadership in the company guides the organization to a
customer focus by outlining organizational roles and responsibilities and by
instituting a quality policy to focus on QMS (Clauses 5.1, 5.2 & 5.3).

Then planning identifies and addresses the risks and opportunities of the QMS,
including setting and planning for quality objectives and changes to support
continual improvement (Clauses 6.1, 6.2 & 6.3).

The final layer of planning is to recognize and define the support structure to
perform plans. This comprises resources (Clause 7.1), recognizing competence
(Clause 7.2), awareness (Clause 7.3), communication (Clause 7.4) and to have
the system for creation and control of documented information (Clause 7.5).

 Do

 Plans are meant to be carried out.

Controls need to be recognized for the operations, product or service

requirements to be recognized (8.2), designs to be developed (8.3), controls
placed on external providers (8.4).

The course of producing the product or service needs to be applied with control
of product and service release (8.5 & 8.6), any non-conformity requires to be
addressed (8.7).

Finally the actions of making and supplying products or services to the clients
have to be done.

 Check

 There are numerous places in the standard to check the processes of the
QMS to make sure they are effective as per plan. The ISO standard requires
enterprises to monitor, measure, analyze and evaluate the products or services
 to make sure that the processes employed are satisfactory and effective, and
that customer satisfaction is achieved (Clause 9.1). Internal Audits (Clause 9.2)
are required as a means of measuring the effectiveness of the QMS. The
Management Review procedure (Clause 9.3), analyses and evaluates all the
collected information related to QMS and helps to identify solutions to resolve
any issues or problems.

 Act

 Action in ISO 9001 includes the actions required to address any concerns
revealed in the check step. Improvement (Clauses 10.1 & 10.3) is the main
purpose for these action items (Clause 10.1), which occurs when removing
nonconformity and taking Corrective Actions (Clause 10.2) to eradicate the
reasons of current and foreseeable nonconformities.

After the “Act” phase, some changes are likely to begin in the initial “Plan” of
the QMS which marks the beginning of the cycle again.

Clauses 4.4 Develop a QMS and Establish Documented Information

4.4.1 Develop a QMS system that complies these standards.

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

 Establish a process-oriented Quality • Determine methods needed to evaluate

Management System (QMS). processes.

• Identify the processes that organization's • Implement your process-based quality

QMS needs. management system.

• Identify methods required to manage • Implement criteria required to operate and

processes. control organization's processes.

• Identify resources required to support • Apply methods needed to operate and control
processes. your processes.

• Determine process responsibilities and • Maintain your process-based quality

authorities. management system.

• Determine risks and opportunities for each • Improve your process-based quality
process. management system.
 4.4.2 Keep QMS Documents and 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 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:

Clause 5.1.1 - Offer Leadership by Encouraging a Focus on Quality

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:

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. • Anticipate managers to be accountable for their
QMS.
• Prove a commitment to organization's QMS.
• Encourage organization's personnel to support
• Make sure that a quality policy is established. their QMS.
• Make sure that quality objectives are • Promote the utilization of risk-based thinking.
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.
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.

Clause 5.2 - Provide leadership by establishing a suitable quality policy

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 5.3 - Offer Leadership by Defining Roles and Responsibilities

The third clause is 5.3, which on the leadership role in defining the roles and responsibilities.

 Allocate QMS roles, responsibilities, and authorities.

 Communicate those QMS roles, responsibilities, and authorities.
 Make sure that everyone 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.

Clause 6.1.1 - Consider risks and opportunities when you plan your QMS
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 6.1.2 - 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.
Clause 6.2.1 - Develop quality objectives for all appropriate areas
Under this sub-clause, organization has to take care of following:

 Define the criteria for identifying quality • Monitor organization's quality objectives.
objectives.
• Update organization's quality objectives.
• Resolve quality objectives in all relevant areas.
• Communicate organization's quality objectives.
• Document organization's quality objectives.

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:
Think about the purpose of the changes one plans to make.
Reflect responsibilities and authorities whenever one make changes.
Contemplate the outcomes that changes could potentially result in.
Consider the provision of resources whenever one make changes.
Reflect the integrity of organization's QMS whenever any change is made.