presentation iso 9001

• ISO 9001:2015

What is ISO 9001?

ISO 9001 is a globally recognized standard for quality management . It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).

Implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.

Why is ISO 9001 important?

With more than one million certificates issued to organizations in 189 countries, ISO 9001 is the most widely used quality management standard in the world. Within the ISO 9000 family, which defines seven quality management principles including a strong customer focus and continual improvement, ISO 9001 is the only standard that can be certified to (though certification is not mandatory).

Business benefits include:

• Customer confidence : The standard ensures that organizations have robust quality control processes in place, leading to increased customer trust and satisfaction.
• Effective complaint resolution : ISO 9001 offers guidelines for resolving customer complaints efficiently, contributing to timely and satisfactory problem-solving.
• Process improvement : The standard helps identify and eliminate inefficiencies, reduce waste, streamline operations, and promote informed decision-making, resulting in cost savings and better outcomes.
• Ongoing optimization : Regular audits and reviews encouraged by ISO 9001 enable organizations to continually refine their quality management systems, stay competitive, and achieve long-term success.

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What is ISO 9001: Quick guide to ISO 9001:2015 Quality Management Systems

Benefits of ISO 9001

•   Increased customer trust and satisfaction
• Sound quality control processes
•  Cost savings and productivity gains
•  Culture of continuous improvement

Who should use the ISO 9001 standard?

Any organization that wants to improve its quality management system, meet customer and applicable statutory and regulatory requirements, and enhance customer satisfaction can use the ISO 9001 standard. It is suitable for organizations of any size, and applies to all sectors, including manufacturing, services, healthcare, education, government, and non-profit organizations. ISO 9001 can also be used by certification bodies or other third parties to assess an organization’s conformity with this International Standard.

Is there a standard adapting the requirements of ISO 9001 to my sector?

ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:

• ISO 13485 on  medical devices  
• ISO/TS 54001 on elections at all levels of government
• ISO 18091 on   local government sector applications
• ISO 22163 on   railway  sector applications 
• ISO 29001 on  petroleum , petrochemical and natural gas -related products and services
• ISO/IEC/IEEE 90003 on  computer software

What topics does ISO 9001 cover?

The ISO 9001 standard specifies requirements for the establishment , maintenance , and continuous improvement of a quality management system , covering a wide range of topics including:

• Context of the organization : ISO 9001 requires organizations to determine the external and internal factors that affect their ability to achieve the intended results of their quality management system.
• Leadership : The standard emphasizes the importance of leadership in implementing and maintaining a quality management system.
• Planning : The quality management system must include measures designed to achieve an organization’s quality objectives and continuously improve the system’s effectiveness.
• Support : ISO 9001 addresses issues such as resources, competence, awareness, communication and documented information.
• Operation : The processes necessary to meet customer requirements and increase customer satisfaction must be planned, implemented and controlled.
• Performance evaluation : The standard requires organizations to monitor, measure, analyze and evaluate the performance and effectiveness of their quality management system.
• Improvement : ISO 9001 emphasizes the importance of continuously increasing the effectiveness of the quality management system based on the results of performance evaluation and other data sources.

Overall, ISO 9001 helps organizations address all aspects of managing the quality of their products and services , with an emphasis on customer satisfaction and constant enhancement of the quality management system.

Why is another revision for ISO 9001 under development?

The most recent revision of ISO 9001 was finalized in 2015. Ensuring that all ISO standards remain current and relevant for the marketplace is crucial. After extensive international consultation, a consensus was reached in August 2023 that revising the standard would add value. This revision aims to align ISO 9001 with the current needs of standard users and the communities they serve.

When will the next edition of ISO 9001 be published?

The revised version of ISO 9001 is expected to be published at the end of 2025.

I am certified to ISO 9001:2015. What does this revision mean for me?

The publication of the revised standard will present an excellent opportunity for you to review and update your quality management system . Take this chance to ensure that your system effectively addresses any changes and aligns well with your needs, as well as those of your customers and other stakeholders. At the time of publication, ample information will be provided about the updates made and how they may impact organizations. To stay informed and receive timely notifications, we invite you to  subscribe to our email updates .

In terms of validity of their certificates, organizations certified to ISO 9001:2015 will be granted a transition period to migrate their quality management system to the new edition of the standard.

What is ISO 9001 certification and does my organization need to get certified?

Certification to ISO 9001 is one way to demonstrate to stakeholders and customers that you are committed and able to consistently deliver high quality products or services. Holding a certificate issued by an accredited conformity assessment body may bring an additional layer of confidence, as an accreditation body has provided independent confirmation of the certification body’s competence.

As with other ISO management system standards, companies implementing ISO 9001 can choose whether they want to go through a certification process or not.

Checking that the system works is a vital part of ISO 9001. The standard recommends that an organization performs internal audits to check how its quality management system is working. An organization may decide to invite an independent certification body to verify that it is in conformity with the standard, but there is no requirement for this. Alternatively, you might invite your clients to audit the quality system for themselves.

As in other contexts, standards should always be referred to with their full reference in statements on certification such as “certified to ISO 9001:2015” (not just: “certified to ISO 9001). If you wish to use a logo to demonstrate certification, please contact the certification body that issued your certificate. See full details about use of the ISO logo .

Where can I find help with auditing ISO 9001?

Support on auditing quality management systems can be found on the website of the ISO 9001 Auditing Practices Group . This is an informal group of quality management system experts, auditors and practitioners from ISO/TC 176 and the International Accreditation Forum.

What is the ISO definition of quality?

A definition of quality is part of the core vocabulary for quality management which can be found in ISO 9000:2015   and applies to all ISO quality management standards, including ISO 9001. It says that quality is the “degree to which a set of inherent characteristics [or distinguishing features] of an object”, which in turn is defined as anything perceivable or conceivable, such as a product, service, process, person, organization, system or resource, “fulfils requirements.”

What is the difference between ISO 9001 and ISO 14001?

ISO 9001 and ISO 14001 are both International Standards for organizational management but they have different goals. ISO 9001 helps organizations improve their quality management and customer satisfaction. ISO 14001 helps organizations reduce their environmental impact and promote sustainability. ISO standards that look at different types of management systems , such as ISO 9001 for quality and ISO 14001 for environmental management , are all structured in the same way. This means that companies using one ISO management standard will find it easy to integrate other aspects of organizational management into their existing management system.

What is the difference between ISO 9001 and ISO 13485?

The International Standards ISO 9001 and ISO 13485 both define requirements for quality management systems, but one has a much broader user group than the other. ISO 9001 provides a quality management framework that can apply to organizations of any size or sector. ISO 13485, on the other hand, has been developed specifically for the medical device industry with a focus on regulatory compliance. The standard helps ensure the safety and effectiveness of medical devices, including risk management, traceability and process validation. Compared to ISO 9001, it contains additional requirements specific to organizations involved in the life cycle of medical devices, whereas elements of ISO 9001 that are not relevant as regulatory requirements are not part of ISO 13485.

In short, while ISO 9001 sets out a general framework for quality management, ISO 13485 provides specific guidance for the medical device industry .

General information

• Status  :  Published Publication date  :  2015-09 Corrected version (fr)  :  2015-09 Stage : International Standard to be revised [ 90.92 ]
• Edition  : 5 Number of pages  : 29
• Technical Committee : ISO/TC 176/SC 2 ICS  : 03.100.70   03.120.10  
• RSS  updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Climate action changes.

Edition 2024

ISO 9001:2008

Iso 9001:2008/cor 1:2009.

• 00 Preliminary
• 10.99 2012-10-05 New project approved
• 20 Preparatory
• 30.00 2013-06-03 Committee draft (CD) registered
• 30.20 2013-06-04 CD consultation initiated
• 30.60 2013-09-12 Close of comment period
• 30.99 2013-11-12 CD approved for registration as DIS
• 40.00 2014-05-09 DIS registered
• 40.20 2014-07-10 DIS ballot initiated: 12 weeks
• 40.60 2014-10-12 Close of voting
• 40.99 2015-02-17 Full report circulated: DIS approved for registration as FDIS
• 50.00 2015-05-05 Final text received or FDIS registered for formal approval
• 50.20 2015-07-09 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
• 50.60 2015-09-11 Close of voting. Proof returned by secretariat
• 60.00 2015-09-11 International Standard under publication
• 60.60 2015-09-22 International Standard published
• 90.20 2020-07-15 International Standard under systematic review
• 90.60 2020-12-03 Close of review
• 90.93 2021-05-20 International Standard confirmed
• 90.92 2023-11-16 International Standard to be revised
• 90.93 International Standard confirmed
• 90.99 Withdrawal of International Standard proposed by TC or SC
• 95.99 Withdrawal of International Standard

ISO 9001:2015/Amd 1:2024

Will be replaced by, iso/cd 9001.

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ISO 9001:2015 (QMS) Awareness Training

Description  

ISO 9001:2015 is a globally recognized standard for Quality Management Systems (QMS) developed by the International Organization for Standardization (ISO). It provides a framework for organizations to establish and maintain an effective QMS that meets customer and regulatory requirements while continuously improving their processes and systems. The standard is applicable to all types of organizations, regardless of their size or industry.

Based on a set of principles, including customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management, ISO 9001:2015 ensures that the QMS is aligned with the organization's overall goals and objectives.

ISO 9001:2015 emphasizes the importance of risk-based thinking, which involves identifying potential risks and taking appropriate actions to mitigate them. Additionally, organizations are required to monitor and measure their performance using a variety of metrics, such as customer satisfaction, process effectiveness, and product or service quality.

This ISO 9001:2015 (QMS) Awareness PPT training presentation is designed to create awareness of the world's most popular standard among management and staff, new hires, and potential auditees. It can also be used to supplement your materials for the training of QMS professionals and internal auditors.

The presentation covers what ISO 9001 is, its benefits, the high-level structure, the certification process, the audit approach, and offers practical tips on how to handle an audit session. By the end of the training, your employees will be well-informed and comfortable with ISO 9001, allowing them to support the implementation and maintenance of an effective QMS in your organization.

NOTE: This training package includes: 1. ISO 9001:2015 (QMS) Awareness PPT training presentation (PowerPoint format, in new 16:9 widescreen) 2. ISO 9001:2015 (QMS) poster (PDF format, in color and monochrome, printable in A3 size)

3. ISO Certification Audit poster (PDF format, in color and monochrome, printable in A3 size)

Learning Objectives​

​Provide background knowledge on ISO 9001 .

Gain an overview of the ISO 9001 structure.

Define the ISO 9001 certification process.

Describe the audit approach and learn useful tips for handling an audit session.

Contents  

1. Overview of ISO 9001

ISO Standards Contribute Directly to the U.N. Sustainable Development Goals (SDGs)

What are Standards?

What Standards are Not

Why are Standards Important?

Why an ISO Standard?

What is a Management System?

The ISO 9000 Series

What is ISO 9001?

How Does ISO 9001 Work?

Where Does ISO 9001 Come From?

Why is a Quality Management System Important?

Advantages of Certification

Accreditation & Certification Bodies

Development of ISO 9001

Quality Management Principles

Why was ISO 9001 Revised?

Key Improvements to ISO 9001:2015

The Plan-Do-Check-Act (PDCA) Process Model

Emphasis on Process Approach

Risk-based Management

Benefits of the New ISO 9001:2015

2. ISO 9001 Structure

Framework of Annex L

High-Level Structure (HLS)

The ISO 9001:2015 Structure is Based on the High-Level Structure for Management System Standards

HLS: The Same Core Elements

ISO 9001:2015 Approach is Based on the PDCA Cycle

PDCA and ISO 9001:2015 Clause Structure

ISO 9001:2015 Key Clause Structure (4-10)

Context of the Organization

Performance Evaluation

Improvement

​The PDCA Cycle is the Engine of Continuous Improvement

Continual Improvement

3. ISO 9001 Certification Process

Becoming ISO 9001:2015 Certified

Aligning/Transitioning to ISO 9001:2015

ISO 9001:2015 Certification Process

What Does Certification Assure?

4. Audit Approach

What is a Quality Audit?

What is an ISO Audit?

What Are Audits Used For?

Types of Quality Audits

Internal Quality Audit

Principles of Auditing

Audit Focus

Audit Approach

Audit Emphasis

Review of Documented Information

Audit Findings

5. Handling an Audit Session

Rights of Auditee

Rights of Auditor

How to Handle an Audit Session?

Auditee's Conduct

Interacting with Auditors: Do's

Interacting with Auditors: Don'ts

You may also be interested in the following Management System Standards (sold separately):

ISO 13485:2016 (Medical Devices - QMS) Awareness Training

ISO 14001:2015 (EMS) Awareness Training

ISO 19011:2018 Auditing Management Systems Training

ISO/IEC 20000-1:2018 (SMS) Aw areness Training

ISO 20400:2017 (Sustainable Procurement) Awareness Training

ISO 22000:2018 (FSMS) Awareness Training

ISO 22301:2019 (BCMS) Awareness Training

ISO 26000:2010 (Social Responsibility) Awareness Training

ISO/IEC 27001:2022 (ISMS) Awareness Training

ISO 31000:2018 (Risk Management) Awareness Training

ISO 37000:2021 (Governance of Organizations) Awareness Training

ISO 37001:2016 (ABMS) Awareness Training

ISO 37301:2021 (CMS) Awareness Training

ISO 41001:2018 (FM) Awareness Training

ISO 45001:2018 (OH&S) Awareness Training

ISO 50001:2018 (EnMS) Awareness Training

ISO 55001:2014 (Asset Management) Awareness Training

What is ISO 9001? The Absolute Beginner’s Guide (Free Templates!)

ISO 9001; you may have heard of it. You may be somewhat afraid of it. And, if you’re reading this article, chances are you’re probably at least somewhat confused about how to actually implement it.

It’s possible you even Googled something like “what is ISO 9001?”. Perhaps you felt you knew at one point, but the important bits never really stuck.

Well, with the 2015 updates to a whole range of ISO standards, it’s a lot less scary.

Before now, if you wanted to implement any ISO standard, you’d have to undertake a lengthy process involving unwieldy paper manuals and cumbersome bureaucratic procedure.

In short, ISO 9001 was hardly agile .

Now, you have far more flexibility to implement ISO 9001 the way that works for you best; with BPM software like Process Street to make things streamlined and simple.

This is why we’re presenting you with this handy overview of ISO 9001, including all of the essentials you need to get started.

We’ll cover how to combine structured compliance with the rapid process improvement of a startup, including:

Free ISO 9001 Templates

What is iso 9001 the most popular qms standard, benefits of implementing iso 9001, quality management with iso 9001: key principles, iso 9001 certification: is it necessary, agile iso 9001 in 5 simple steps, more iso resources.

Before we dive in, here’s some free templates to help you hit the ground running!

The first step to understanding how to utilize ISO 9001 for your company is to look at an example of how a successful QMS works when in practice.

This Process Street template provides an easy-to-follow outline of a QMS Mini-Manual up to the standard of ISO 9001:2015:

The template is free to use. All you need to do is sign up for a free Process Street account, which only takes a couple minutes, and you can get started right away.

This next ISO-9000 Marketing Procedures template is another handy version of the QMS outline, but written for marketing companies :

Here’s a list of all of our ISO 9001 templates, to make things easier for you:

• ISO 9001:2015 and ISO 14001:2015 Integrated Management System (IMS) Checklist
• ISO 9001 Marketing Procedures (Mini-Manual Example)
• ISO 9001 Internal Audit Checklist for Quality Management Systems
• ISO 9001 QMS Mini-Manual Structure Template
• ISO 9004:2018 Self-Audit Checklist

ISO 9001 is a specific standard, perhaps the most famous of all of the ISO standards. It is specifically designed to help companies implement and maintain quality management systems.

It’s basically a standard that is supposed to help organizations be more efficient and successfully meet the needs of their customers .

At least one million companies and organizations in 170+ countries are certified to ISO 9001, and even more will informally utilize the standard in one way or another.

What does ISO 9001 look like?

So what is ISO 9001, exactly? ISO 9001:2015 follows the Annex L management system standard (MSS) and is structured into 10 sections, three of which are introductory and of little importance when trying to understand the core principles of ISO 9001.

That leaves 7 main sections:

• Context of the organization
• Performance evaluation
• Improvement

There’s a lot of ground to cover for each of these; if you’re interested you can head over to my article on quality management for an in-depth look at each section.

An ISO 9001 certification can open up a lot of business opportunities for you and your company. For instance, when bidding for contracts, an ISO 9001 certification is commonly a requirement.

It was shown in a recent study by the American Society for Quality, that every $1 invested into your QMS results in an average increase of $6 in revenue, $3 in profits, and a reduction of $16 in QMS costs.

When a company implements a strong quality management system, it can help to:

• Boost product efficiency
• Lower the overall waste of resources, money, and time
• Execute better production consistency for products and services
• Better customer satisfaction and retention
• Allow for companies to market themselves more successfully
• Improve employee onboarding
• Strengthen company growth
• Regularly improve upon company processes and products

Quality management is central to ISO 9001. The heart of quality management is the quality management system (QMS).

Simply put, a QMS is a set of standard operating procedures (that’s a fancy way of saying processes) for measuring the level of quality of all kinds of aspects of your business.

It’s basically like a system for business process management , except with a focus on quality control.

No two QMS will be the same. Each business will have different needs, as well as a different definition of “quality”. That’s fine! That’s how things should work. It’s also how ISO 9001 works; being flexible in how each company defines its own requirements for a QMS.

What ISO 9001 does, is provide a set of guidelines to help you build and implement a successful QMS.

ISO 9001 is designed around the principles of continuous improvement; one of the most important concepts to understand here is PDCA (sometimes written PDSA).

Plan, Do, Check, Act. (Or: Plan, Do, Study, Act).

There are some important differences (expanded in our article on the Deming cycle ) between PDSA and PDCA, but they’re both frameworks for continuous improvement, and they’re both ways of understanding ISO 9001.

To understand how to build a QMS, it’s important to understand continuous improvement. PDCA/PDSA aren’t the only ways you can implement continuous improvement, but they’re a great start.

For a more detailed look into the inner workings of a QMS, check out our quality management system article.

ISO 9001 certification is like a badge of honor, that basically communicates to your clients that you’ve gone through the rigour of being certified by an ISO lead auditor or inspector.

However, it’s only necessary in certain situations. Simply put, if you don’t know if your company needs ISO 9001 certification or not, you probably don’t need it.

Rather it’s an assurance that your company is able to perform to a specific quality standard, consistently, and will help you leverage new clients as well as certain government contracts.

So, you can implement a QMS without needing an ISO 9001 certification! Certification is basically an extra step you can take to validate your QMS.

How to self-audit with ISO 9001

An ISO 9001 audit is basically a way of making sure the requirements of the standard have been properly implemented. There are two main types of audit :

• Internal audits (informal audits performed inside of an organization to measure internal strengths and weaknesses)
• External audits (formal audits, often performed by request of a client, or in order to obtain ISO certification)

If you’re looking to implement a QMS, it’s worth looking into performing a self-audit (or internal audit).

For a more in-depth look at ISO audits, check out our ISO audit piece.

If you’re looking for a complete, actionable, and totally free ISO 9004:2018 self-audit checklist , you can grab that here:

ISO 19011:2018—Guidelines for Auditing Management Systems standard defines an audit as:

“[the] systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [a set of policies, procedures or requirements] are fulfilled.” – ISO 19011:2018 – Guidelines for Auditing Management Systems

Since the 2015 changes to ISO standards, you can do agile ISO. In other words, you can use a BPM software like Process Street to build and manage your QMS.

Agile ISO is all about breaking free from the shackles of old-fashioned ISO and empowering your standard operating procedures with the digital tools for rapid process improvements.

To understand how the new ISO changes allow you to be more flexible with your QMS, check out our piece on agile ISO .

How to use Process Street to implement ISO 9001

Before we go any further, watch this quick video introduction to Process Street :

Now you’re primed with the Process Street basics, let’s unpack how that can help you with ISO 9001.

Process Street makes it easier for you to build processes, and it’s even easier for your employees to start using them. It’s literally as simple as following a checklist .

First you create a template, and then run checklists from those templates. The templates are the “process model”, and the checklists are each individual instance of the model.

You can also hook all of these processes into your other digital tools by using the third party automation platform Zapier (there are over 1500+ apps you can connect with).

So here’s what you need to do to start using Process Street for agile ISO compliance:

• Step 1: Build your processes in Process Street

Figure out what processes you’re using internally, and have your team members (the ones using them) build them out in Process Street themselves. It’s quick and easy, and by doing it this way you cultivate a sense of process ownership. Keep things simple, and focus on the most important steps. You can improve things over time.

• Step 2: Create your folder architecture

Check out our post on process libraries for inspiration on this one, but the basic idea is to use folders, subfolders and tags to keep things organized and easily readable. Permissions also help to keep sensitive data private. You can move the templates your team has created into the relevant folders.

• Step 3: Design your meta processes

This can be stuff like processes for improving other processes, risk assessment processes, how to create new processes, process style guides etc. Your meta-processes are for managing your other processes. Here are some examples:

• FMEA Template: Failure Mode and Effects Analysis
• The Process for Optimizing a Process
• Step 4: Write your policies

This may be boring, but it’s important. Context of the Organization, Operations, Support, etc. The best way to do this is by drafting a simple structure and getting feedback from relevant individuals in your company.

• Step 5: Create your first official document

And that’s it! Agile ISO is as simple as that.

When you use Process Street for ISO 9001, you don’t have to update each physical copy of your procedure documents every time you want to make a small improvement.

Instead, you can do it in seconds by editing and creating new and improved processes that are easy to follow and completely ISO compliant!

If you’re interested in more resources for ISO and standard operating procedure , I’ve listed some great articles below:

• What is an ISO Audit? Free ISO 9000 Self-Audit Checklist (ISO 9004:2018)
• Processes, Policies and Procedures: Important Distinctions to Systemize Your Business
• ISO 26000 for Corporate Social Responsibility: How to Get Started
• Agile ISO: How to Combine Compliance with Rapid Process Improvement
• 20 Free SOP Templates to Make Recording Processes Quick and Painless
• What is Quality Management? The Definitive QMS Guide (Free ISO 9001 Template)
• What is ISO 9001 Certification? How to Get Certified (For Beginners)
• How to Write an Actionable Policy and Procedure Template (ISO Compliant!)

We also have even more ISO checklists beyond ISO 9000:

• ISO 19011 Management Systems Audit Checklist
• ISO 45001 Occupational Health and Safety (OHS) Audit Checklist
• ISO 27001 Information Security Management System (ISO 27K ISMS) Audit Checklist
• ISO 14001 Environmental Management Self Audit Checklist
• ISO 14001 EMS Structure Template
• ISO 14001 EMS Mini-Manual Procedures
• ISO 26000 Social Responsibility Performance Assessment Checklist
• SWOT Analysis Template

Disclaimer:

Process Street is not affiliated or in partnership with the International Organization for Standardization (ISO). The materials on Process Street’s website are provided on an as-is basis and are for educational purposes. Process Street makes no warranties, expressed or implied, and hereby disclaims and negates all other warranties including, without limitation, implied warranties or conditions of merchantability, fitness for a particular purpose, or non-infringement of intellectual property or other violation of rights. Further, Process Street does not warrant or make any representations concerning the accuracy, likely results, or reliability of the use of the materials on its website or otherwise relating to such materials or on any sites linked to this site.

Have any questions about implementing any of the standards of ISO 9000? Leave a comment below, and we’ll get back to you!

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Oliver Peterson

Oliver Peterson is a content writer for Process Street with an interest in systems and processes, attempting to use them as tools for taking apart problems and gaining insight into building robust, lasting solutions.

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ISO 9001 Implementation: A Step-by-Step Guide

ISO 9001 is a globally recognized standard that specifies the requirements for establishing, implementing, maintaining, and continually improving a Quality Management System (QMS) in any organization.

ISO 9001 helps organizations consistently provide products and services that meet customer and regulatory requirements. It is based on seven quality management principles , and it aims to help organizations be more efficient, monitor and improve processes, reduce costs, and increase customer satisfaction. 

The seven quality management principles are:

• Customer focus
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision-making
• Relationship management

This standard’s operating principle is the Plan-Do-Check-Act (PDCA) cycle which is a quality management methodology that aims to continuously improve processes.

An Overview of ISO 9001:2015

ISO 9001:2015 is the final edition of ISO 9001. This version was last reviewed and confirmed in 2021 and remains current. 

ISO 9001’s first three clauses are introductory:

• Clause 1: Scope
• Clause 2: Normative references
• Clause 3: Terms and definitions

The remaining are as follows:

Clause 4: Context of the Organization

Organizations should analyze and determine relevant internal and external factors which affect their strategies, objectives, and results. 

This clause involves: 

• Defining the scope of the QMS
• Considering the organizations’ strategic objectives
• Main products and services, risk tolerance, and any regulatory
• Contractual or stakeholder obligations.  

Clause 5: Leadership

Leadership and commitment are two important traits that should be demonstrated by the top management, who are mainly responsible to:

• Taking accountability for the effectiveness of the QMS 
• Ensuring the compatibility of the QMS within the context of the organization
• Communicating the process within the organization and making sure it is understood and applied
• Integrating the QMS requirements into the organization’s processes
• Assigning roles and responsibilities and also directing and supporting staff to contribute to the QMS

Clause 6: Planning for the Quality Management System

Organizations should establish strategic objectives and guiding principles for the overall QMS process. Clause 6 of ISO 9001 outlines the requirements for planning the QMS of organizations. It covers more on the actions to address risks and opportunities, quality objectives and how to achieve them, and the needed changes.

Clause 7: Support

In order to function, organizations need various resources such as people, equipment, infrastructure, etc. In this clause, requirements specifically cover the resources, competence, awareness, communication, and documented information.

Clause 8: Operation

This clause is concerned with the phase when organizations put into operation the planned QMS. It includes:

• Operational planning and control
• Determination of requirements for products and services
• Design and development of products and services
• Control of externally provided products and services
• Production and service provision
• Release of products and services
• Control of nonconforming process outputs, products, and services

Clause 9: Performance Evaluation

The primary purpose of this clause is to establish a system of monitoring, measurement, analysis, and evaluation of the QMS's performance. It requires permanent monitoring of the system. 

Clause 10: Improvement

This clause includes identifying and implementing changes needed to improve the process and meet customer requirements. Management systems can be continually improved by using quality policies, objectives, and audit results, monitoring of events, indicators, risk analysis, corrective actions, and management reviews.

How to Implement ISO 9001

The key implementation steps of ISO 9001 are:

Step 1 – Seek Senior Management Support

The implementation of ISO 9001 requires the support and commitment of senior management and their active involvement in the process. They need to understand the benefits of ISO 9001 and then allocate the necessary resources for its implementation. 

Step 2 – Understand the Requirements of ISO 9001 

Before implementing the ISO 9001 standard, it is important to get familiar with the standard, understand its requirements, and learn its basic structure, principles, and concepts. Implementers need to read the standard, review the requirements of the ten sections, which cover different aspects of a quality management system, and identify the requirements that apply to your organization. Understanding the requirements of the standard is crucial for a successful implementation.

Step 3 – Conduct a Gap Analysis 

Once there is an understanding of the requirements of ISO 9001, the next step is to identify the gaps between your organization's current practices and ISO 9001 requirements. Organizations should develop an action plan to address the gaps, and they should define roles and responsibilities for implementing the action plan. The gap analysis will help to identify the areas where your organization needs to improve to meet the standard. 

Step 4 – Establish a Quality Management System 

Establishing a QMS requires a structured and systematic approach and involves several actions. To establish a QMS, organizations need to identify the key responsibilities within the organization and determine roles among the staff. 

The next step is to develop policies, procedures, and strategies, which will guide the implementation and creation of documents such as the quality manual. Furthermore, organizations should also establish measurable specific objectives, which should be communicated to all employees and should regularly be tracked.

Step 5 – Implement the Quality Management System 

Organizations should implement a QMS based on the policies, plans, and objectives established previously. They should carefully follow all the requirements and implement all the necessary activities. 

Step 6 – Monitor and Measure Performance 

To ensure that your quality management system is effective, organizations need to monitor and measure its performance, which can be done through established metrics and key performance indicators (KPIs). They should monitor and measure the performance of the processes, products, and services and conduct internal audits to identify areas where your organization can improve.

Step 7 – Seek for Certification

The ISO 9001 certification process can be initiated once the QMS has been operational for three or six months. The organization's QMS should first be evaluated by an accredited auditor. If everything has been successfully implemented in accordance with all ISO 9001 requirements and effective thus far, the organization will be granted the ISO 9001 certification.

Step 8 – Continuously Improve the Quality Management System

Continually analyze the results of monitoring and measurement activities to identify opportunities for improvement. Implement corrective and preventive actions to address issues and prevent them from occurring in the future. Continuously improve your quality management system to ensure that it remains effective.

Challenges of ISO 9001 Implementation

Implementing ISO 9001 can be a challenging process, especially if organizations face difficulties such as: 

• Resistance to change
• Lack of management commitment
• Limited resources
• Lack of awareness and understanding 
• Lack of competency
• Poor design and development process
• Insufficient documentation
• Inadequate team support

Training and Certification of Professionals

PECB training courses are tailored to increase the skills and expertise of professionals and help overcome challenges that may come up when implementing ISO 9001.

PECB offers four ISO 9001 Quality Management training courses:

• ISO 9001 Introduction
• ISO 9001 Foundation
• ISO 9001 Lead Implementer
• ISO 9001 Lead Auditor

About the Author

Vlerë Hyseni is the Digital Content Officer at PECB. She is in charge of doing research, creating, and developing digital content for a variety of industries. If you have any questions, please do not hesitate to contact her at: [email protected] .

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ISO 9001:2015 Revision Overview

Aug 14, 2014

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ISO 9001:2015 Revision Overview. August 2013. Introduction. This presentation has been developed by the Communications and Product Support group of ISO/TC176/SC2, the ISO subcommittee responsible for the ISO 9001 and ISO 9004 standards, among others

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ISO 9001:2015 Revision Overview August 2013

Introduction • This presentation has been developed by the Communications and Product Support group of ISO/TC176/SC2, the ISO subcommittee responsible for the ISO 9001 and ISO 9004 standards, among others • It provides basic information about the revision to ISO 9001, free of charge, to interested parties, and will be updated periodically as the revision progresses

Disclaimer • Any claims or statements made by the presenter based on this presentation represent their own opinions and/or interpretation, and are not formally endorsed by ISO or its subcommittee TC176/SC2, responsible for the ISO 9001 revision • This presentation includes information related to the status of the revision process as of JULY 2013 • Further changes are likely as the revision process progresses, so you should NOT make changes to your management system at this stage

Outline A change to ISO 9001 is coming Why this change is taking place (rationale for the changes) What users of ISO 9001 should know Timeline – target is to publish in September 2015 (ISO 9001:2015) Organizational Opportunities Product Support Expect further updates as this process evolves

ISO Facts ISO = International Organization for Standardization Based in Switzerland Made up of over 100 National Standards Bodies (“NSB’s”) Almost 20,000 standards in the ISO portfolio All standards are based on INTERNATIONAL CONSENSUS ISO standards are usually developed by its Technical Committees (“TC’s”) and Sub-committees (“SC’s”) ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001 ISO 9001:2015 is being developed by a specific SC2 Working Group (“WG24”) WG24 is composed of international experts nominated by their NSB or from formal liaison member to ISO (typically industry associations) WG23 is responsible for Communications and Product Support

ISO 9001:2015 - Development Process Agreement on the need for revision* “Systematic Review” and “New Work Item” Agreement on the scope and objectives (“Design Specification”)* Working Drafts (“WD’s”) Preliminary drafting by international experts nominated by ISO member bodies WD’s are very rough documents - not normally made widely available Committee Draft (“CD”)* Once preliminary WDs have reached an acceptable level of maturity, they are “uprated” to CD that is formally circulated to ISO Member bodies NSB’s are expected to convene national interested parties to comment on CD Draft International Standard (“DIS”)* Published after approval of CD by formal ballot, and incorporation of pertinent comments Final draft international standard (“FDIS”)* Published after formal approval of the DIS, and incorporation of pertinent comments International Standard Published after approval of the FDIS Subject to “systematic review” every 5 years * = Balloted by ISO member bodies

ISO 9001 A change is coming

Background Information • ISO Standards are reviewed every five years to ensure they stay up-to-date – revisions are part of the ISO process and are to be expected • A formal global review of ISO 9001 was completed in 2012 among ISO member bodies. This resulted in a decision to revise the standard • As with all ISO standards, this will be a consensus process • All ISO’s National Member Bodies (NMBs) and official liaison members nominate experts to participate in the drafting process • Drafts of ISO 9001 will circulated for comments and balloted at appropriate stages by NMBs • Work on the revision has already begun

What is being considered? • International experts nominated by ISO member bodies looked at a number of items to help guide revision activities: • an extensive web-based user survey • new quality concepts and ideas for inclusion in ISO 9001 • revised quality management principles • formal interpretations of ISO 9001:2008 • support and guidance notes

ISO 9001:2015 Revision Scope

Design Specification Strategic Intent • Take account of changes in quality management systems practices and technology since its last major revision (2000) and to provide a stable core set of requirements for the next 10 years or more • Ensure that requirements in this standard reflect the changes in the increasingly complex, demanding, and dynamic environments in which organizations operate • Ensure that requirements are stated to facilitate effective implementation by organizations and effective conformity assessment, as applicable

Design Specification Change Criteria • Increase confidence in an organization's ability to provide conforming goods and/or services • Enhance an organization's ability to satisfy its customers • Enhance customer confidence in quality management systems based on ISO 9001

Reasons For The Changes • In the last 25 years, many other Management Systems Standards have come into use world wide • Organizations that use multiple Management System Standards are increasingly demanding a common format and language that is aligned between those standards

Reasons For The Changes • Decrease the emphasis on Documentation • Increase the emphasis on Achieving Value for the Organization and its customers • Increase emphasis on Risk Management to achieve objectives

ISO 9001:2015 Revision What users should know

What is changing? • New concepts are being considered • The customer remains the primary focus • A new common ISO format has been developed for use across all Management System Standards Please note that since the contents are under development, there may be further changes

High Level Structure - Common Text Annex SL • Mandated by ISO’s Technical Management Board (TMB) • High level structure, identical core text and common terms and core definitions for use in all Management System Standards • Purpose - Enhance the consistency and alignment of different management system standards • Organizations who implement a single system addressing multiple standards (e.g. QMS, EMS, ISMS etc) will see the most potential benefit

High Level Structure (HLS) 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization • Understanding the organization and its context • Needs and requirements • Scope • Management System 5. Leadership • General • Management commitment • Policy • Roles, responsibility and authority 6. Planning • Actions to address risks & opportunities • Objectives and plans to achieve them 7. Support • Resources • Competence • Awareness • Communication • Documented information 8. Operation • Operational planning and control 9. Performance evaluation • Monitoring, measurement, analysis & evaluation • Internal audit • Management review 10. Improvement • Non conformity and corrective action • Continual Improvement

Applying Annex SL to ISO 9001:2015 • The objective is to develop the revised ISO 9001 standard using the new structure as the foundation • TC 176/SC2 plays an active role in ISO’s Joint Technical Coordination Group that is responsible for the development of Annex SL and any difficulties in applying Annex SL will be referred back to this group and to ISO/TMB

Annex SL • The high level structure and common text without ISO 9001:2015 management specific text is public information • It can be found at www.iso.org/directives Please note that Annex SL on its own should not be used to make changes to your management system

Future Relevance of ISO 9001:2008 (9001 WW Survey Result)

ISO 9001 - New Concept Importance How important is it to incorporate the following concepts into ISO 9001?

World-wide Survey - Key User Inputs • ISO 9001, as it is, must change to continue be relevant • Integrate with other MSS (EMS etc.) • Provide one integral approach to the management of the organization for Leadership commitment & understanding, strategic planning, management buy-in • Need to work with ISO/CASCO and IAF to ensure efficiency/effectiveness of audits and address problems in certification audits • Include tools and risk management ISO Input For Future (

Weak Areas of Implementation ISO 9001—Its relevance and impact in Asian Developing Economies: Project initiated by UNIDO, funded by Norad and supported with technical inputs by ISO and the IAF. • Emphasis on continual improvement • Constant focus on preventive actions • Root cause analysis and weak preventive actions • Use of process approach • Handling of Customer Complaints Guidance Documents? White Papers? VoDs?

What product support can I expect? • Transition plan (timeframe for certification) • Supporting guidance documents • Correlation annex (map of the changes) • FAQs (Frequently asked Questions) • ISO Quality Systems website updates • Other ISO 9001 related products • Summary of changes between ISO 9000, ISO 9001 and ISO 9004

Users Should Know • The Committee Draft (CD) is the first opportunity for the draft standard to be scrutinized by a wider audience, beyond the nominated experts in WG24 • National Member Bodies of ISO are required to VOTE on the CD, and may provide comments • Comments received will be addressed during the WG24 meeting in November2013 • Work is currently on schedule according to the Project Plan, with a planned publication date of September 2015

ISO 9001:2015 Revision Timeline for the changes

ISO 9001:2015 Timeline + Transition period for certification

Other Important Information • Impact on other standards that are part of the family • Expect changes to industry-specific standards to follow as these are updated over time • Expect changes to supporting documents as these are modified in the future • Expect further news updates as this process evolves

ISO 9001:2015 Revision What organizations can do

I need to ensure my Organization . . . • Knows what is going on and is ready to implement the new requirements • Takes full advantage of the revision of ISO 9001 to improve business performance • Remember, don’t make any changes yet!

Organizational Opportunities • Integrate their activities within the scope of multiple Management System Standards • Decrease the emphasis on documentation when this is not mandated or does not add value

ISO 9001:2015 Revision Product Support

ISO 9001:2015 - Product Support • Formal Transition Plan for certified organizations • Supporting guidance documents will be modified as needed (see www.iso.org) • Correlation Annex – showing the changes from ISO 9001:2008 to ISO 9001:2015 • Website with FAQs • Other products will be developed as needed to support the new requirements • Relationship between ISO 9001 and ISO 9004 will be updated and clarified

Supporting Guidance Documents Introduction and Support Package: • Guidance on the Documentation Requirements of ISO 9001:2015 • Guidance on some of the new, changed and frequently used words found in the ISO 9000 family of standards • Guidance on the Concept and Use of the Process Approach for management systems • Guidance on Outsourced Processes • Implementation Guidance for organizations currently using ISO 9001:2008 • and more…

Stay Tuned!Additional updates and information will be made available as the change process proceeds

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• QMS Quality Manual Template Everything you need to jump start your ISO 9001 documentation.
• Project Plan Start out on the right track with a proven foundation for setting up ISO 9001.
• Gap Analysis Will show where your existing processes do not meet the ISO 9001 standards.
• Quality Policy & Objectives Help Top Management with an easy-to-use structured approach.
• Documented Information How to maintain & retain your documents & records.
• Checklists Our checklists will ensure your QMS conforms to ISO 9001 requirements.
• Internal Audit All the tools you need to perform internal audits for ISO 9001.
• Procedures Written by quality management experts, why reinvent the wheel?
• Management Review Your management review meetings will be flawlessly executed.
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• ISO 9001 + ISO 14001 + ISO 45001 Don't try to manage it all alone! Our IMS is proven to work.
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• Project Plan Start out on the right track with a proven foundation for setting up ISO 14001.
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• Internal Audit All the tools you need to perform internal audits for ISO 45001.
• Management Review Leaving a lasting impression on Top Management, your management review meetings will be flawlessly executed.
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• Learn about ISO 9001 QMS Every ISO 9001 clause explained 'The Most Comprehensive Guide to ISO On The Internet'.
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ISO 9001 Implementation Guide

Iso 9001 implementation guide [tips & tricks].

Here, we will provide practical guidance, including tips and tricks on implementing ISO 9001.

This is written for the Project Manager. We aim to help you deliver a smooth ISO project and avoid mistakes along the way.

If you are looking for specific steps in a project plan, please see: What Are The Steps For ISO 9001 Certification?

Introduction

Where to begin, how long does it take, managing the change, top management commitment, the implementation team, management review meetings, choosing your registrar, overcoming obstacles, communicate regularly, using an external consultant, implementation methodology.

As anyone who has experienced the implementation process can attest, developing an ISO 9001 quality management system can seem intimidating. However, knowing how to address the implementation challenges in advance makes developing a successful management system much more realistic and will save unnecessary or costly problems in the future.

You should develop a project plan that includes all the actions necessary to create a process-based quality management system that can be used to manage risk, satisfy customers, add value, and prevent defects while conforming to the relevant ISO standard.

Begin with the assumption that you are already doing most of what ISO requires; you probably are! Start by reviewing your existing quality systems, policies, procedures, and processes that you have in place at the moment.

Then, compare those with what ISO 9001 asks for . You may be surprised how much you already do. The standard will allow you to keep the things that work for you while refining those that do not.

Many people talk about the high cost of implementing management systems, but this is a false assumption. If you do it right and understand the standards, then implementation should not be a problem since 75% of your management system is already in place in some form.

A culture shift will start during the early development and implementation phase. By involving and consulting with employees and stakeholders at this early stage, you can more easily secure their buy-in by assigning responsibility and utilizing their skills, knowledge, and experience to help develop the QMS.

Many factors can affect the time required to implement a management system.

The size and complexity of your organization, the extent to which the quality management system will be introduced within the business, whether the implementation is assisted by a consultant or done in-house, the maturity of existing processes and documentation, the availability of resources, and the commitment of Top management and staff.

Experience suggests that, due to these factors, 12 to 18 months is a realistic and achievable time frame to develop a management system.

N.B. This time period includes the time to gather necessary documented evidence that should clearly demonstrate successful implementation to an External Auditor.

Why Reinvent the Wheel?

The organizational migration from a pre-certification state to one that operates within the rigors of an ISO-based management system is not a casual task. Processes must be tightened, and staff interactions, responsibilities, and accountability often change. Such changes are unlikely to succeed without the dedicated support of executive and operational management.

The greatest resource of any company is its people, so strategies for managing both real and perceived change or concerns and attitudes should be addressed during the initial planning of the management system.

It is likely that during the first few months, top management will need to reinforce its requirements positively on a routine basis to ensure that staff maintain motivation and do not lapse back into old habits.

Iterative adjustment of new or existing management system documentation should also be expected as staff become accustomed to the requirements and suggest usability improvements. Instant business or operational improvements may initially be observed.

Top management commitment is 100% essential. We cannot stress this enough.

Implementation takes time, money, and other resources. Make sure you have the commitment of top management before continuing the project. Be sure that top management is solidly behind in developing the quality management system; without that commitment, the implementation process becomes almost impossible.

Top management should demonstrate their initial commitment to the implementation project by ensuring that:

• The implementation mandate is communicated and understood
• Appropriate resources are made available
• An appropriate budget is made available

Understand why your organization is implementing a quality management system.

Is it because a client or the market requires you to register? Is it for internal benefits? Is the motivation coming from top management?

Whatever the reasons for implementation, keep them visible during the implementation project. This will help retain commitment and focus on the end goal.

Top management can consist of one or more people. Still, they must have cross-functional influence to integrate the quality management system with current business processes and ensure compatibility with your organization’s strategic direction.

Top management should consider creating an Implementation Team to assist in developing the new management system. This decision should be based on the size of the organization or facility wimplementing the quality management system.

This implementation team should consist of key individuals from various divisions, departments, and operating work areas within your organization who are familiar with the facility and its processes. Diversity among team members will bring together a pool of expertise and ideas to develop and implement the management system.

One key moment in the implementation process is defining the individual responsibility of management and employees for introducing different elements into the current working process. That is why the company's most experienced employees should be involved in this process.

Following this methodology, a team of experienced and engaged key personnel should be formed at the beginning of the implementation process. The Implementation Team should include personnel with the authority to devote resources to the project and remove roadblocks.

The Implementation Team should meet on an ‘as needed’ basis according to the project timeline. When the team meets, they must address the items on their action/task list.

There are no specified time periods for conducting management review meetings. However, they are essential during the management system's initial development and implementation stages and should be conducted on an as-required basis. Our 18-step implementation methodology takes advantage of three separate management reviews.

There is much merit in conducting management review meetings following internal and external audits to review the findings and plan for follow-up/corrective actions. Some organizations may also find it beneficial to perform a management review meeting before an external surveillance or certification audit to identify gaps that can be filled before the external audit(s) are conducted.

A member of top management must chair the management review meetings. The meetings provide helpful insight into the implementation processes and enable management to respond accordingly. It is imperative that the management fully understand and appreciate the management review requirements under clause 9.3 .

The Project Manager typically undertakes the secretarial duties.

The attendees of management review meetings should include senior managers and other staff who operate within the boundaries of the occupational quality management system. The internal auditor(s) should also attend.

Start with Expert Templates, them Make Them Yours

The registrar is a third-party certification auditor who will formally assess your management system and issue a certificate if the system meets the requirements of ISO 9001:2015. When choosing a registrar, you should consider their industry experience, geographic coverage, price, and service level offered.

The key is to find a registrar who can meet your requirements and certify against the standards.

Your registrar selection criteria should include:

• Must have clients from our industry (i.e., your competitors)
• Must offer resumes of their auditors for your review
• Must deliver well-crafted nonconformity statements (seek examples)
• Must not offer advice (seek objective evidence of system weakness instead)
• Must protect your intellectual property

Organizations view their registrations differently. Some prefer having multiple business units or locations on a single certificate. You can register one department or the entire organization.

The scope of certification must precisely and clearly reflect the activities covered by your organization's quality management system. No single business-related activity should exist outside of the scope.

Many organizations experience some expression of negativity about the intention to implement a quality management system. This can come from management, employees, or other interested parties such as shareholders. Such concerns can jeopardize an ISO 9001 management system even before implementation has begun.

‘We don’t know what a management system is’.

It is important to explain any management system's fundamental aims and benefits to all interested parties early in the process—perhaps by giving a presentation to the management teams or placing the information on a notice board, featuring it on your organization’s intranet, or in a newsletter.

‘We don’t have the time or the resources to implement a management system.’

This is a common concern, and there is no single, straightforward answer. However, a management system will help your organization become more efficient by reducing defects and avoiding risk.

The time and resources needed to implement a management system should be viewed as an investment that will produce high yields in terms of cost savings and thus make the organization more profitable. Many organizations have already invested in a management system and are reaping the benefits.

Does the management system have to be implemented across the whole organization? It does not have to be implemented across the whole organization. It can be piloted or implemented in one part and then rolled out to other sites/facilities or operational areas as and when required.

What about training?

Whether carried out by external parties or undertaken in-house, training can be relatively inexpensive and can be scheduled to avoid any operational disruptions. This is particularly true where a ‘train the trainer’ approach is applied (i.e., a person or small group is trained to carry out further training within the organization).

Will it cost money?

Implementing a management system almost invariably entails some costs. These vary considerably and depend upon the organization's size, the number of sites involved, the number of employees, and the level of in-house expertise.

If costs are a major concern, a simple cost-benefit analysis will help estimate potential savings. A walk around your site will probably highlight a number of no-cost or low-cost opportunities that will produce significant cost savings and thus offset the initial cost of implementing the management system.

Everyone in your organization is key to its success, and their full involvement enables their skills to be used to the maximum benefit for themselves and you. Make sure you have good internal communication channels and processes within the organization. Staff need to be involved and kept informed of what is going on.

Clearly lay out a plan of activities and time scales. Make sure everybody understands them and their role in achieving them. Give some thought to how departments work together. The people within your organization must not work in isolation but work as a team for the benefit of the customers and the organization.

Do not ignore the impact of introducing a quality management system on your stakeholders, customers, and suppliers. Speak to them to understand how they view your business and how they feel improvements could be made.

Effective communication can ensure engagement and assist in embedding principles into working practices.

• Before beginning your review, let employees know what is happening and encourage them to start thinking about the part they can play
• Communicate with employees (e.g., using a notice board, internal memos, meetings, intranet, team briefings, and letters)
• Ask employees for their ideas. Usually, those doing a job daily will have ideas about how things can be done more effectively. Ensure that these ideas are acknowledged and are not ignored
• Be open, let employees know that some decisions are not set in stone
• Provide feedback, both good and bad
• Make sure employees understand and believe in any procedures introduced as part of the management system through suitable training
• Set up short but frequent management team meetings and ensure line managers are brought into the process

Effective communication benefits everyone, professionally and personally. These skills should be embedded within your organization. It requires a commitment, but the return on the investment is well worth the time and energy.

Don’t Try to Manage It All Alone!

Asking an external consultant to help may significantly reduce the time spent on implementing your management system. The consultant will review your company’s existing practices, processes, controls, and documentation using the ISO 9001:2015 standard as the assessment criteria.

A consultant’s familiarity with the requirements of management system standards can save you time and money. It will ensure you achieve effective quality practices and successful management system certification.

You must provide the consultant with a clear brief as part of the written contractual agreement. There may be cases where you need to get specialist advice and assistance, particularly in the areas of compliance, risks, handling corrective action, and auditing.

When seeking outside help, ensure potential consultants have the necessary experience and qualifications.

Choose a management system specialist who is familiar with your sector's particular issues and understands staff needs.

We recommend constructing a Project Plan broken down into high-level steps, and using Implementation Checklists to manage the sub-tasks and evaluate the completeness of the quality management system’s development.

Each of the steps is divided into separate sub-tasks in the Implementation Checklist that should be completed sequentially.

Benefits of Using a Project Plan

• Compliance Confidence:  Ensure that all necessary steps are taken to meet ISO 9001 standards
• Enhanced Organization:  Maintain a clear and structured approach to project management
• Improved Accountability:  Assign roles and responsibilities to ensure everyone knows their tasks
• Clear Communication:  Keep stakeholders and management updated with regular progress reports
• Stakeholder Engagement:  Foster buy-in from stakeholders and management, ensuring their support throughout the process
• Certification Success:  Increase your chances of successful ISO certification with a well-documented and organized approach

Instead of trying to create everything you need to follow this process from scratch, use ours. We have procedures, templates, checklists, process maps, forms and gap analysis tools to help you control your documented information without missing a single input or output.

Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our templates.

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ISO 9001:2015 (QMS) Awareness Training (PowerPoint PPTX)

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