A COMPLETE BEGINNER'S GUIDE TO

How to

Implement

ISO 9001
+Required documents

UPDATED AND REVISED FOR 2015

Introduction

ISO 9001 is a quality management system that provides guidance for

businesses on how to run their operations in a more efficient and effective
way. The requirements of ISO 9001 are designed to help organizations
improve their management processes and create a more consistent and
reliable product or service. To meet the requirements of ISO 9001,
businesses need to put in place a quality management system that
includes a number of key elements, such as documented policies and
procedures, regular monitoring and assessment of performance, and
corrective action plans to address any problems that may arise.

There are many benefits to implementing ISO 9001, including improved

efficiency and productivity, reduced costs, enhanced customer satisfaction,
and improved organizational morale.

ISO 9001 implementation can be daunting, but with the right tools and
advice, it can be a smooth process. This guide will help you understand the
requirements of ISO 9001, what needs to be done in order to meet them,
and how to maintain compliance.

How to Implement ISO 9001: The Definitive Guide

Implementing ISO 9001 can be a daunting task. This guide will help you
understand the requirements of ISO 9001, what needs to be done in order
to meet them, and how to maintain compliance. With the right tools and
advice, it can be a smooth process.

ISO 9001 is a quality management system standard that provides

organizations with a framework for managing and improving the quality
of their products and services. Organizations that implement ISO 9001
typically experience improved customer satisfaction, fewer quality-related
problems, and reduced costs.

If your organization is interested in implementing ISO 9001, this guide will

walk you through the process. We'll cover the basics of ISO 9001 and
explain how to develop and implement a quality management system that
meets the requirements of the standard.

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In order to meet the requirements of ISO 9001, businesses need to put in
place a quality management system that includes a number of key
elements, such as documented policies and procedures, regular
monitoring and assessment of performance, and corrective action plans to
address any problems that may arise.

There are many ways to meet the requirements of ISO 9001, but every
organization needs to tailor its quality management system to fit its
specific needs. The size, structure, and complexity of the organization will
all play a role in determining which methods are most effective.

One of the most important aspects of maintaining compliance with ISO

9001 is ensuring that the quality management system is regularly reviewed
and updated as necessary. This allows businesses to keep up with the latest
changes in the ISO standard and ensure that their quality management
system is always effective.

1. First Step: Evaluate your organization's needs and resources

Before you can begin implementing ISO 9001, you need to evaluate your
organization's needs and resources. This includes assessing the size of your
organization, its structure and complexity, and the capabilities of your
workforce.

You also need to identify the resources you have available to dedicate to
the ISO 9001 project. This might include staff, time, and financial resources.

2. Second Step: Develop a quality management system that meets the

requirements of ISO 9001

Once you've evaluated your organization's needs, you can begin

developing a quality management system that meets the requirements of
ISO 9001. This system should include documented policies and
procedures, regular monitoring and assessment of performance, and
corrective action plans to address any problems that may arise.

ISO 9001 2015 requirements

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There are a number of different chapters in the ISO 9001 standard, and
each one covers a different aspect of the quality management system. In
order to meet the requirements of ISO 9001, businesses need to
implement all of the chapters in the standard.

The following is a list of the chapters in ISO 9001 and a brief description
of each one:

Chapter 1 - Introduction

This chapter provides an overview of the ISO 9001 standard and explains
its purpose, it doesn't contain any requirements.

Chapter 2 - Normative references

This chapter lists the normative references that are used throughout the
ISO 9001 standard. This chapter doesn't contain any requirements.

Chapter 3 - Terms and definitions

This chapter provides definitions for terms that are used throughout the
ISO 9001 standard.

Chapter 4- Context of the organization

This chapter explains the concept of the "context of the organization" and
how it applies to quality management systems.

1. What is the context of the organization and why is it important?

2. How should the context be determined and documented?
3. What are some factors that can impact the context of an
organization?
4. How should changes to the context be managed?"

You are required to submit the following documents in order to fulfill this
chapter's requirements:

• Procedure – Context of the Organization

• Form – Context Log
• Form – List of interested parties and their needs and expectations

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 • Form – Swot analysis model
• Form- PESTEL analysis model

Chapter 5 - Leadership

This chapter explains the role of leadership in quality management systems

and provides guidance on how leaders can create a culture of quality. It
includes the following topics:

1. The role of leadership in quality management

2. Creating a culture of quality
3. Setting the direction for the organization
4. Communicating with employees
5. Promoting employee engagement
6. Managing organizational change

You are required to submit the following documents in order to fulfill this
chapter's requirements:

• Leadership Process
• Quality management and continuous improvement process
• Quality policy
• List of quality objectives

Chapter 6 - Planning

This chapter explains the importance of planning in quality management

systems and provides guidance on how to develop effective plans. It
includes the following topics:

1. The role of planning in quality management

2. Developing quality objectives
3. Creating a quality policy
4. Planning the implementation of the quality management system
5. Planning for continual improvement

The ISO 9001 standard includes a section in this chapter on risks and
opportunities, which explains how businesses can identify and manage
potential risks and opportunities. It includes the following topics:

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 1. What are risks and opportunities?
2. How can risks be identified?
3. How can opportunities be identified?
4. How should risks and opportunities be managed?

You are required to submit the following documents in order to fulfill this
chapter's requirements:

– Risks and opportunities management procedure

– Registry of Risks and Key Opportunities

Chapter 7 - Support

This chapter explains the role of support in quality management systems

and provides guidance on how to effectively provide resources. This
includes having the right resources in place and making sure everyone
understands their roles and responsibilities.

It includes the following topics:

1. The role of support in quality management

2. Providing human resources
3. Providing infrastructure
4. Providing the environment for work
5. Planning and managing change

You are required to submit the following documents in order to fulfill this
chapter's requirements:

Infrastructure and Work Environment

• Procedure – Maintenance
• Form –Maintenance Record

Human Resources

• Procedure – Competence, training, and awareness

• Procedure – Training
• Human Resources Management Process

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 • Form – Annual Training Plan
• Form – Employee Training Matrix
• Form – Employee Training Record

Monitoring and measurement

• Procedure – Equipment Validation Control

• Form – Calibration Schedule & Log
• Form – List of Gauges & Measuring Instruments (if applicable)

Documented Information and records

• Procedure – Control of Documents

• Procedure – Control of Records
• Form – Master List of Controlled Documents
• Form – ML of External Origin Documents

Communication

• Procedure – Communication
• Form – Communication Channels
• Form – Communication Work Plan
• Form – Communication Form
• Form – External Communication Log

Chapter 8 - Operation

This chapter explains the role of operation in quality management systems

and provides guidance on how to effectively carry out processes. This
includes ensuring that processes are planned and carried out in a
consistent manner.

It includes the following topics:

1. The role of operation in quality management

2. Carrying out processes
3. Control of externally provided processes
4. Continual improvement of operation
5. Planning for product and service realization

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You are required to submit the following documents in order to fulfill this
chapter's requirements:

Marketing, Prospection, and Commercial (If applicable)

• Marketing, Prospection and Commercial Processes

• Customer Identification Form
• Customer Requirements Review Form
• Checklist for Client Requirements Review
• Form – Order Review

Purchasing process and evaluation of external service providers

• Procedure – Purchasing
• Procedure – Outsourced Processes
• Procedure – Quoting and Orders Process
• Procedure – Receiving, Storage and Dispatch Process (If applicable)
• Form – Approved External Provider List
• Form – EPCAR: EXTERNAL PROVIDER CORRECTIVE ACTION REPORT
• Form – EPCAR Log
• Form – External Provider Evaluation
• Form – External Provider Quality Survey Form
• Form – Incoming Inspection Report

Accounting & Special Process (If applicable)

• Procedure – Accounting Process

• Procedure – Special Processes

Design and development process (If applicable)

• Design and development process

• Form – Design Control Form
• Form – New Product Development Sheet
• Form – Product Design Change Request
• Procedure – Design & Development Process

Realization of products and services Process

• Procedure – Operations Process

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 • Procedure – Identification and Traceability
• Procedure – Control of Customer or External Provider Property

Change Management Process

• Procedure – Change Management

• Form – Change and Disposition

Chapter 9 - Performance evaluation

This chapter explains the role of performance evaluation in quality

management systems and provides guidance on how to effectively
monitor and measure performance. This includes setting up methods for
gathering data and analyzing it to see if improvements need to be made.

It includes the following topics:

1. The role of performance evaluation in quality management

2. Monitoring and measurement
3. Analysis and evaluation of data
4. Taking corrective and preventive action
5. Managing nonconformities
6. Continual improvement through performance evaluation

7- internal audit, its role is to assess how well the organization is following
the quality management system as outlined in the standard. This includes
reviewing documentation, interviewing employees, and observing
processes. All findings will be reported to management so that they can
make any necessary corrections.

8- Management review: This section explains the role of management

review in quality management systems and provides guidance on how to
effectively conduct these reviews. This includes setting up a schedule for
reviews, preparing for the review meeting, and conducting follow-ups after
the meeting.

Management review is another key element of quality management

systems. These reviews are conducted on a regular basis (typically
annually) and are used to assess the performance of the system and

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identify opportunities for improvement. The management review meeting
should include a review of the previous year's performance, an assessment
of the current year's performance,

It includes the following topics:

1. The role of management review in quality management

2. Planning for management review
3. Conducting the management review meeting
4. follow-up after the management review meeting
5. Continual improvement through management review

You are required to submit the following documents in order to fulfill this
chapter's requirements:

Customer satisfaction process

• Customer Claims Management Procedure

• Customer complaint Form
• Form – Customer Satisfaction Survey
• Customer satisfaction process
• Procedure – Management Review
• Form – Management Review Meeting Minutes
• Procedure – Internal Audit
• Form – Internal Audit Report
• Form – Internal Audit Log

Chapter 10 - Improvement

This chapter explains the role of improvement in quality management

systems and provides guidance on how to effectively make changes. This
includes identifying opportunities for improvement and taking action to
implement changes.

It includes the following topics:

1. The role of improvement in quality management

2. Identifying opportunities for improvement
3. Planning and implementing improvements

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 4. Evaluating the results of improvements
5. Continual improvement through feedback and review

You are required to submit the following documents in order to fulfill this
chapter's requirements:

• Procedure – Control of NC Outputs

• Procedure – Corrective Action & Improvement
• Form – Nonconforming Material Disposition
• Form – Corrective Actions log

3. Third Step: Implement the quality management system

After the quality management system has been developed, it needs to be

implemented throughout the organization. This process typically includes
training employees on the new system, updating organizational
procedures, and putting in place new methods for monitoring and
assessing performance.

4. Fourth Step: Audit your QMS.

An internal audit is a key part of quality management systems. It is used to

assess how well the organization is following the quality management
system as outlined in the standard. This includes reviewing documentation,
interviewing employees, and observing processes. All findings will be
reported to management so that they can make any necessary corrections.

5. Fifth Step Maintain your ISO 9001 certification

Once your organization has been certified to ISO 9001, you need to
maintain your certification by regularly reviewing and updating your
quality management system. This ensures that your organization always
meets the latest ISO 9001 requirements

Conclusion

ISO 9001 is a complex standard, and businesses need to make sure that
they have the resources and expertise in place to implement it effectively.

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Hiring an external consultant can be a helpful way to ensure that your
organization has the support it needs to successfully implement ISO 9001.

This is the end of the guide. We hope you found it helpful! If you have any
questions, please feel free to contact us. Thank you!

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