MANUALS PREPARATION TO DOCUMENT

QUALITY MANAGEMENT SYSTEM AS PER

9001:2015 STANDARD

Speaker: Ankur Dhir

REGIONAL DIRECTORATE, CHANDIGARH

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ABOUT THE FACULTY

• ANKUR DHIR –
• Electronics and Communication Engineer ,
MBA IN TQM
• Lean and ISO management Consultant
• Lead Assessor 9001, 14001, 45001, 27001,
50001
• Master Trainer ZED
• Member ASQ, QCI , NSC, QCFI
• Empaneled Trainer Quality Council of India ,
National Productivity Council, National Safety
Council

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 What is ISO 9001?
ISO 9001 is a standard that sets out the requirements for a
quality management system. It helps businesses and organizations
to be more efficient and improve customer satisfaction.

A new version of the standard, ISO 9001:2015, has just been launched,
replacing the previous version (ISO 9001:2008).

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What’s new in ISO 9001: 2015?

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 What is a Quality Management System?
• A quality management system is a way of defining how an organization can
meet the requirements of its customers and other stakeholders affected by its
work.
• ISO 9001 is based on the idea of continual improvement.
• It doesn’t specify what the objectives relating to “quality” or “meeting
customer needs” should be, but requires organizations to define these
objectives themselves and continually improve their processes in order to reach
them.

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 Who is ISO 9001 for?
• ISO 9001 is suitable for organizations of all types, sizes and sectors.

• In fact, one of the key improvements of the newly revised ISO 9001:2015 was
to make it more applicable and accessible to all types of enterprises.

• Smaller companies that do not have staff dedicated to quality can still enjoy the
benefits of implementing the standard – ISO has many resources to assist them.

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 Why Industries need QMS?

 QMS affects every aspect of an

organization's performance.
 To meet the customer’s
requirements
 Counter meeting organization's
requirements, which ensure
compliance with regulations
 To utilize cost and resources
efficiently
 Creating room for expansion,
growth and profit
 Increasing Brand Value and
Reputation of the Organization

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Development of ISO 9001: 2015

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 What benefits will it bring to my
business or organization?
Implementing a quality management system will help you:
• Assess the overall context of your organization to define who is affected by your
work and what they expect from you. This will enable you to clearly state your
objectives and identify new business opportunities.
• Put your customers first, making sure you consistently meet their needs and
enhance their satisfaction. This can lead to repeat custom, new clients and
increased business for your organization.

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 ISO 9001: benefits
• Work in a more efficient way as all your processes will be aligned and
understood by everyone in the business or organization. This increases
productivity and efficiency, bringing internal costs down.
• Meet the necessary statutory and regulatory requirements.
• Expand into new markets, as some sectors and clients require ISO 9001
before doing business.
• Identify and address the risks associated with your organization

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 Why was ISO 9001 revised?
• All ISO standards are reviewed and revised regularly to make sure they remain
relevant to the marketplace.

• ISO 9001 has been updated to take into account the different challenges that
businesses now face.

• For example, increased globalization has changed the way we do business and
organizations often operate more complex supply chains, and there are
increased expectations from customers.

• ISO 9001 needs to reflect these changes in order to remain relevant.

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Process Approach

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 What are the key improvements?
Structure
ISO 9001:2015 now follows the same overall structure as other ISO
management system standards (High-Level Structure), making it easier for
anyone using multiple management systems.
See Annex SL of ISO/IEC Directives Part 1 (the rules for developing ISO
standards) for further information.

Focus on risk-based thinking

This has always been part of the standard, but the new version gives it
increased prominence.
More information can be found on the Website run by ISO/TC 176/SC 2, the
group of experts behind the standard (www.iso.org/tc176/sc2/public).

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 What benefits does the
new version bring?

The new version of the standard brings the user a number of benefits.
ISO 9001:2015:
• Puts greater emphasis on leadership engagement

• Helps address organizational risks and opportunities in a structured

manner
• Uses simplified language and a common structure and terms, particularly
helpful to organizations using multiple management systems
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organizations

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Process Approach & High Level Structure (HLS)

4
Context of the Organization 4

Leadership 5
1 6
0
Planning 6
A P
Support 7

Leadership Operation 8
5
Performance Evaluation 9

C D 7 Improvement
1
0
9
8

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 Should I be certified to ISO 9001?
• Certification - when an independent certification body audits your
practices against the requirements of the standard – is not a
requirement of ISO 9001, but is a way of showing stakeholders that you
have implemented the standard properly.

• For some companies, third- party certification may be a requirement. For

example, some governments or public bodies may only contract suppliers
that have been certified to ISO 9001.

• ISO does not perform certification. For more information about the
certification process, see www.iso.org and the publication ISO
9001:2015 – How to use it.

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 How do I get started with ISO 9001:2015?
Key tips
Tip 1 – Define your objectives. Why do you want to implement the standard?

Tip 2 – Ensure senior management is on board. It is crucial that everyone is

supportive of the initiative and its objectives. The publications Reaping the
benefits of ISO 9001 and ISO 9001: Debunking the myths may help with this.

Tip 3 – Identify your organization’s key processes for meeting your objectives
and customers’ needs. Within each of these processes, ensure you understand
your customers’ requirements and can guarantee that these are met. This will
form the basis of your quality management system.

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 Quality Management Principles
"A quality management principle is a comprehensive and fundamental rule /
belief, for leading and operating an organisation, aimed at continually
improving performance over the long term by focusing on customers while
addressing the needs of all other stake holders".

The seven principles are ...

1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making, and
7. Relationship management.
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 Examples of success with ISO 9001
ISO 9001 is used successfully all over the world. In 2013 alone, over one
million certificates to the standard were issued across 187 countries, and
many other companies and organizations have used the standard without
seeking certification.

Success with ISO 9001 can take many forms. For some enterprises, it is all about
attracting new clients, while others see it as the blueprint for internal
efficiency.

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 Sénégalaise Des Eaux
One step ahead of customer needs
“We have been using ISO 9001 since 2002 and it helps us anticipate and meet the needs of
our customers. At the beginning, the most important thing was providing sufficient water for
the client. Then, when this was satisfied, the focus turned to the quality of the water and
services.

“Now, we meet with consumer associations every six months to ensure we can adapt to
our customers’ needs. At the moment, for example, it is all about the diversification of
payment methods, using mobile phones or other services to make money transfers.”

Mamadou Dia
CEO of Sénégalaise Des Eaux
Sénégalaise Des Eaux supplies drinking water to approximately five million citizens in some
of the largest towns in Senegal.

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 Baltika Breweries
Optimizing operations
“ Using production systems based on ISO 9001, ISO 14001 and ISO 22000 allows us to
optimize operations between factories and better integrate many of the companies
we have acquired.

“In addition, by asking suppliers to implement robust quality management systems, we

ensure the ingredients we use are of consistently high quality.”

Dr. Isaac Sheps

CEO of Baltika Breweries from 2011 to 2014
Baltika Breweries is a leader in the Russian beer market and part of the Carlsberg Group.

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 Other standards in the 9000 family
There are many other standards in the ISO 9000 series that can help you reap
the full benefits of a quality management system and put customer satisfaction
at the heart of your business.

• ISO 9000 contains detailed explanations of the seven quality management

principles with tips on how to ensure these are reflected in the way you
work. It also contains many of the terms and definitions used in ISO 9001.

• ISO 9004 provides guidance on how to achieve sustained success with your
quality management system.

• ISO 19011 gives guidance for performing both internal and external audits
to ISO 9001. This will help ensure your quality management system delivers
on promise and will prepare you for an external audit, should you decide to
seek third-party certification.

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What do you understand by QMS?

L1
Level 1 (L1)
Policy,
Vision, Mission,
QM
L2
Level 2 (L2)
Procedures

L3
Level 3 (L3)
Forms, Formats, Work Instructions, Guidelines,
Standards, Specification, Checklists, Standards,
Training Material, etc.

L4 Level 4 (L4)
All Filled up and Completed Documents Stored in
Hard / Soft Format, etc.

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 Introduction of Quality Documentation?

Why everyone is approaching to Standard Operating Procedures (SOP)?

What is a difference between “Procedure” and “Work Instruction” ?

1. Quality Policy (Objectives of the Organization)

2. Vision / Mission (Where we want to see ourselves in future)

3. Quality Manual (Collection of Principles from Standards)

4. Quality Procedures (Set of requirements from functions)

5. Forms / Formats (Structured form if Information)

6. Checklist / Check Sheet (What is the difference?)

7. Standards (What something should be?)

8. Work Instructions (How to perform specific Task Correctly?)

9. Specifications (Statement of precise requirement)

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 Steps for Implementing a Quality Management
System—the Successful Way!
In quality management, it’s a popular saying that if something is not
written, it didn't happen. Businesses which follow a management
system need a well-conceived and systematized Quality Management
System (QMS). Many organizations failed to manage a QMS while
others managed it well.
The Importance of Hierarchical Organization
An organization is spirited when working with controlled documents. A
suggested hierarchy for QMS documentation management is:
1.Quality Manual
2.Policies
3.Procedures
4.Work Instructions
5.Lists
6.Checklists
7.Forms

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 Steps for the Creation of an Effective QMS
The steps required for the conceptualization and implementation of a QMS
include the following:

1. Define and Map Your Processes

Process maps creation will force the organization to visualize and define
their processes. In the process, they will define the interaction sequence of
those processes. Process maps are vital for appreciating the responsible
person. Define your main business process and converse the flow.
2. Define Your Quality Policy
Your Quality Policy communicates the duty of the organization as it is about
the quality. The mission may be what customers need, a quality mission.
When constructing quality management system, consider the commitment
towards customer focus. It may be Quality, Customer Satisfaction, and
Continuous Improvement.

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ISO9001:2015 is divided into the following clauses:

1.Scope: Scope and application of the standard.

2. Normative References: ISO9000:2015 standard is referred to.
3. Terms & Definitions: Those defined in ISO9000:2015 apply.
4. Context of the organization
5. Leadership Clauses 4 to 10
6. Planning are the requirements
7. Support for certification
8. Operation
9. Performance evaluation
10. Improvement

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DOCUMENT PYRAMID

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 ISO 9001 Mandatory Requirements — Documents and Records
Mandatory documents and records required by ISO 9001:2015
•Scope of the QMS (clause 4.3)
•Quality policy (clause 5.2)
•Quality objectives (clause 6.2)
•Criteria for evaluation and selection of suppliers (clause 8.4.
1.Monitoring and measuring equipment calibration records
2.Records of training, skills, experience and qualifications
3.Product/service requirements review records
4.Record about design and development outputs review
5.Record about design and development inputs
6.Records of design and development controls
7.Records of design and development outputs
8.Design and development changes records
9.Characteristics of product to be produced and service to be
provided
10.Records about customer property

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1.Production/service provision change control records
2.Record of conformity of product/service with acceptance criteria
3.Record of nonconforming outputs
4.Monitoring measurement results
5.Internal audit program
6.Results of internal audits
7.Results of the management review
8.Results of corrective actions

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TYPICAL QMS MANUAL CONTENTS AND EXAMPLE

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Non-Mandatory Requirements — But Often Included
1.Procedure for determining context of the organization and interested
parties
2.Procedure for addressing risks and opportunities
3.Procedure for competence, training and awareness
4.Procedure of equipment maintenance and measuring equipment
5.Procedure for document and record control
6.Sales procedure
7.Procedure for design and development
8.Procedure for production and service provision
9.Warehousing procedure
10.Procedure for management of nonconformities and corrective
actions
11.Procedure for monitoring customer satisfaction
12.Procedure for internal audit
13.Procedure for management review

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3. Define Your Quality Objectives
All Quality management systems must have objectives. Each employee must
appreciate their influence on quality. Quality objectives are derivative of your
quality policy. It is measurable and set up throughout the organization.
The objective may be in the form of critical success factors. This helps an
organization in emphasizing the journey towards accomplishing its
mission. These performance-based measures deliver a gauge to determine
compliance with its objectives.

Some Critical Success Factors are:

• Financial Performance
• Product Quality
• Process Improvement
• Customer Satisfaction
• Market Share
• Employee Satisfaction

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 4. Develop Metrics to Track and Monitor CSF Data
Once critical success factors are known, measurements and metrics keep
track of advancement. This can be done through a data reporting procedure
used to collect specific data. Share the processed information with leaders. A
process goal is to enhance customer satisfaction index score. There needs to
be a goal and a measure to establish achievement of that goal.

5. Define Defects for Every Process

Defects are non-conformances that happen as a product flaw or a process

deficiency. Whenever a defect occurs it needs to be measured and corrected.
Identify the required corrective action. When defining your defects:

• Determine operation volume

• Determine defects in product and process
• Define a process to record defects
• Define a process to report defects in specified formats

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 6. Develop Documents and Records
QMS needs to have some documented information and formats. Start with
the minimum required document set and add when needed.
• Create mandatory document information as per business model
• Create essential Quality policies, procedures, and forms
• Create documented information and formats (records) for each defined
process
7. Define Quality Process
Your quality procedure includes internal audit, Management review,
Corrective and preventive action process and communication processes.

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8. Determine Training Needs

Everyone needs to exhibit competency in the job. Training is only the start and
can happen on the job, it can be a classroom or e-learning. Some important
training areas are- Internal auditor competence, Corrective Action training.
Failure Modes Effects Analysis (FMEA) training.

9. Use Quality Management System

Using the QMS means producing the best quality product. In the process
•Collect non-conformance and record them.
•Review this data for corrective and preventive action.
•Review FMEAs for risk and actions, as and when required.
•Perform internal audits and conduct management reviews.

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10. Measure, Monitor and implement activities to Improve the
Performance
Using quality management system means collecting data. Analyze this data to
check if the collected data is good to use and if the intended results can be
derived. You need to:
• Track Quality Objectives and its performance
• Define few new performance yardsticks
• Determine improvement chances in the data by recognizing trends, patterns,
or correlations.
If you have identified trends through data, then it is time to act. The goal is to
bring improvement and this occurs by:
• Arranging your improvement opportunities
• Choosing prospects that make a difference
• Supporting ‘commitment to quality’ to attain better results

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 Measuring Systems and Tools

For assuring greater accuracy levels, calibration is required. It is to ensure that

measuring systems refrain from inducing errors in the involved processes. A
proper calibration of manual as well as electronic measuring devices is a must.
Especially for pre/ post- calibration readings that are recorded for more critical
features.
The measurements conducted at this stage are important parts of Gauge
Repeatability and Reproducibility. These are generally expressed in the form of
a percentile of measurement error.
While certain quality management systems use Six Sigma for removing the
causes of defects/ errors. Six Sigma is used for minimizing variations in
manufacturing processes. Others include trace audits and varied statistical
tools for reducing costs and increasing profits.

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 Tools to be used in QMS
Process Maps or Flow Charts
It is important to create a flowchart (process map), it is a popular statistical
tool. It helps in streamlining the overall manufacturing process. Easy to
understand and very useful, it helps in the visualization of the entire process.
It helps in identifying all possible problems that may occur. A properly
constructed flow chart showcases quality checkpoints, documentation
expectations. It also shows other parts of the formal control plan.
The control plan is approved or signed off by quality assurance leaders. All
concerned departments approve the final process steps and flowchart. The
critical steps of FMEA come thereafter.

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 Role of Current Good Manufacturing Practices

Most businesses need assurance that their products and processes follow
the specific requirements. Also for requirements of identity, strength, and
purity. The creation, implementation, and maintenance of cGMP compliance
is a tough task. Involvement of a devoted management team, routine audits,
and committed employees is a must. cGMP also requires a well-written and
effective quality management system. Companies that follow these
regulations presume their suppliers and vendors to do the same.

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 Benefits of Getting ISO Certification
Based on the list of mandatory and non-mandatory requirements for certification,
it seems that the task is too daunting! However, data has shown that companies
have greatly benefited from getting ISO certified.

• Customer satisfaction – To satisfy a customer’s needs, the company must first

identify their market and its needs. By having insight regarding the needs of their
market, companies are able to continuously deliver products and services that
fulfill the needs of their market.

• Integration of internal policies and procedures – Collating all Quality

Managements Systems (QMS) documents and having is certified as compliant by
ISO aims to streamline the company’s processes and procedures.
• Improved company image and reputation – getting or even attempting to get
ISO 9001:2015 certification is no easy feat. As mentioned earlier, having this
certification puts a company in the ranks of other companies from around the
world that follow the same quality standards.

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• Company culture that is aimed towards continuous improvement
– a company that complies with the ISO 9001:2015 have procedures that aim
to improved products and services; it also aims to promote the professional
development of its employees and the company culture.

• Opportunities for partnerships

– because getting ISO-certified impels that they meet international

standards of practice, there are certain companies that make ISO certification
as a requirement to become an accredited supplier in their organization.

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ISO 9001 Certification Process

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 Conclusion
Make sure every employee understands the vision. Look for methods to
guarantee that all internal processes are consistent. Employees must have
the training to comprehend the standardization.
Successful quality enterprises need continuing Senior Leadership. It
needs support through a well-defined structure, processes, and
transitions. Stakeholder engagement is essential to the effective
application of a quality management system.

ISO 9001:2015

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 ISO 9001

ISO 9001

ISO 9001 ISO 9001

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ANY QUESTIONS ?????

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