ISO Standards  >  QMS ISO 9001

QMS ISO 9001

qms iso 9001

A step-by-step guide for implementing QMS ISO 9001 to create a culture of compliance

Enforcing QMS ISO 9001 to improve efficiency and productivity while boosting employee morale

qms iso 9001
qms iso 9001 video

What is QMS ISO?

QMS ISO 9001 is the Global Standard for Quality Management Systems, published in 1987. ISO 9001 is a process approach and designed to help organizations ensure that they meet the needs of customers and other stakeholders by having a framework that helps to ensure the quality of goods and services. This standard is based on seven quality management principles including strong customer focus, the involvement of top management, and a drive for continual improvement.

Request an Online Demo

Related Assets

Why QMS ISO is important?

More than a million companies from 160 countries have now applied the ISO 9001 standard requirements to their QMS, regardless of size or industry. Implementing a QMS ISO affects every aspect of an organization’s performance including:

  • Boost revenue: ISO 9001 can help your organization increase efficiency, improve customer satisfaction and retention

  • Better credibility: A QMS based on ISO 9001 facilitates supplier onboarding, particularly for those in the public sector

  • Enhanced customer satisfaction: You can increase customer confidence to deliver products and services by understanding your customers’ needs and mitigating errors

  • Greater operating efficiency: You can minimize operational costs by following industry best-practice and focusing on quality

  • Effective decision-making: You can quickly take steps by detecting and identifying problems to prevent repeating the mistakes in the future

  • Improved employee engagement: Ensure that everyone works on one agenda by improving internal communications and involving employees in designing a process that results in greater productivity

  • Effective process integration: You can find improvements in efficiency more easily by examining process interactions, thereby reducing errors and benefiting from cost savings

  • An unrelenting improvement culture: Establish a systematic approach to identifying and exploiting opportunities to improve

  • Boost revenue: ISO 9001 can help your organization increase efficiency, improve customer satisfaction and retention

  • Better credibility: A QMS based on ISO 9001 facilitates supplier onboarding, particularly for those in the public sector

  • Enhanced customer satisfaction: You can increase customer confidence to deliver products and services by understanding your customers’ needs and mitigating errors

  • Greater operating efficiency: You can minimize operational costs by following industry best-practice and focusing on quality

  • Effective decision-making: You can quickly take steps by detecting and identifying problems to prevent repeating the mistakes in the future

  • Improved employee engagement: Ensure that everyone works on one agenda by improving internal communications and involving employees in designing a process that results in greater productivity

  • Effective process integration: You can find improvements in efficiency more easily by examining process interactions, thereby reducing errors and benefiting from cost savings

  • An unrelenting improvement culture: Establish a systematic approach to identifying and exploiting opportunities to improve

Benefits of QMS ISO

An ISO 9001 QMS can streamline your business processes, minimize errors, unleash valuable management time and improve internal communications. By adopting this approach companies can get benefit from enhanced employee morale, better customer retention and greater revenues. Here are the key benefits of using the ISO 9001 framework:

  • Determine Risks and Opportunities

    The easiest way to address quality issues is to prevent them from occurring in the first place. To achieve this goal, ISO 9001 identifies potential risks to your business and controls them in a structured way that leads to fewer surprises, better planning, efficient decision-making and better relationships with customers, suppliers, and employees

  • Avoid Problems from Reoccurring

    A QMS aligned with ISO maintains records of problems, identifies their root causes and comes up with permanent solutions. The result is better quality and lower costs

  • Improve Employee Morale

    ISO requires you to define tasks (who does what), eliminate skills gaps in your business and communicate your quality policies to employees to eliminate waste and produce the highest quality of products and services

  • Improve your Control over the Business

    QMS ISO will help your organization to monitor, measure, analyze and evaluate the effectiveness of your quality management system. Thus performance metrics will be generated for gaining insight into your business and make better decisions

Elements and Requirements of QMS ISO

The ISO 9001 standard, a structure of ten clauses, covers four key areas:

  • Management Commitment: the areas where your management team needs to focus on, be involved with and be accountable for within the QMS.
  • Resource Control: how resources such as people, infrastructure and facilities should be assigned to ensure the best possible performance.
  • Product Quality: Product details on how your business will operate to provide a high-quality service or product.
  • Assessment, Evaluation and Development of the system: Determine how your Management System is operating as expected, enabling the continual improvement of your system.
qms iso 9001 requirements
ISO 9001 for Medical Device

Understanding AI, ML and more in Software as Medical Device (SaMD) with a GMP ISO Expert

iso 9001 quality management

What is a Quality Management System according to ISO 9001?

ISO 9001 is an internationally approved set of requirements for developing the processes, rules, policies, and procedures to provide products and services that meet customer needs and improve customer satisfaction. The QMS standard is agreed upon by a majority of member countries and maintained by the International Organization for Standardization so that it can be acknowledged and accepted internationally as the global standard for the processes to be used worldwide for the QMS.

Principles of QMS

The ISO 9001 QMS is based on seven principles including:

qms iso 9001 leads to customer satisfaction

Customer-driven

At the initial stage, you must be focused on what your customers’ needs are if you are trying to provide quality products and services that meet customer needs. Thus, it improves customer satisfaction.

iso 9001 qms improve emplyoee engagement

Employee engagement

Employees at your organization are the most vital asset, and their knowledge and experience need to be understood in the QMS.

iso 9001 qms for decision making

Evidence-based decision-making

Appropriate management cannot be done if we don’t know how a process is actually working. Depending on our decisions on facts, we can better manage and improve the QMS.

iso 9001 qms supplier management

Supplier Relationship Management

We need to manage the relationship between ourselves and our suppliers if we want to improve their products and services.

  • qms iso 9001 leads to customer satisfaction

    Customer-driven

    At the initial stage, you must be focused on what your customers’ needs are if you are trying to provide quality products and services that meet customer needs. Thus, it improves customer satisfaction.

  • iso 9001 qms improve emplyoee engagement

    Employee engagement

    Employees at your organization are the most vital asset, and their knowledge and experience need to be understood in the QMS.

  • iso 9001 qms for decision making

    Evidence-based decision-making

    Appropriate management cannot be done if we don’t know how a process is actually working. Depending on our decisions on facts, we can better manage and improve the QMS.

  • iso 9001 qms supplier management

    Supplier Relationship Management

    We need to manage the relationship between ourselves and our suppliers if we want to improve their products and services.



three manufacturing companies case study

Customer Success

Success Story of Three Manufacturing Companies Using the CQ EQMS Solution to Modernize Quality Processes

three manufacturing companies case study
Read Case Study

How QMS ISO Help Organizations?

ISO 9001 provides a working and practical QMS for improving and monitoring all areas of your business. Achieving the ISO 9001 standard is not only establishing a set of procedures but also with the right support and the knowledge of your employees, you will build a system to improve all areas of your business. Implementing an efficient and robust ISO 9001 QMS will help you to focus on the essential areas of your business and improve efficiency. This leads to improving your customer acquisition and retention. Some of the major advantages of ISO 9001 include:

  • Right fit for both small and large organizations
  • Improved internal management
  • Reduce wastage
  • Better efficiency, productivity and profit
  • Enhanced customer retention and acquisition
  • Strong outcomes, measured and monitored
  • Harmonious with other ISO standards
iso 9001 qms for organization
CQ ISO 9001 QMS requirements

What Makes CQ different?

ComplianceQuest’s QMS solution goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 QMS requirements. CQ reduces the effort involved in maintaining your ISO 9001:2015 quality system by automating the required processes while maintaining full traceability. It also enables a complete view of your organization’s data regarding the performance and effectiveness of your quality and compliance management system.

All the QMS processes in one software, excellent choice.

We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.

Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.

Laura Granados,
QMS Systems Development Consultant

itek
itek

Automate your Entire ISO 9001 QMS Requirements and Create a Culture of Compliance with CQ's QMS ISO 9001

Request an Online Demo



Related Checklists

Quality-centric Companies Rely on CQ QMS

  • affinivax mono
  • verily mono
  • 3m logo mono
  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • janssen mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Frequently Asked Questions

  • The QMS is important because it involves all of the activities that an organization does to provide services and products centered on the customer, and this is the reason why organizations are in business. A QMS incorporates the essential processes to provide consistent results to your customers and other stakeholders, which will provide confidence in your organization and facilitate improvement and growth. Therefore, it is recommended to create your QMS by implementing the requirements of a standard to ensure customer satisfaction and improvement.

  • The implementation of an ISO 9001 QMS provides an organization with plenty of benefits in many ways. According to research, clients that adopted ISO 9001 gained benefits such as improved quality of products or services, reduced mistakes and a higher number of new customers. Below are a few key advantages of ISO 9001 implementation:

    • Better efficiency: Companies that embrace ISO 9001 improve their processes because of the guidelines provided by the standard to enhance training and interactions for troubleshooting and to safeguard resources within your organization.

    • Enhanced company image: By being certified for an internationally recognized standard companies will be able to leverage a system that is focused on meeting and exceeding customer requirements.

    • Create a culture of continual improvement: ISO 9001 QMS enables continual improvement that could save time and money and increase revenues. Thereby, you will be constantly improving processes and results.

  • To become ISO 9001 certification needs planning, commitment and resources. QMS ISO advises a simple 3-step process:

    • Gap Analysis: A consultant to review and document the current processes and procedures, emphasize on any areas that did not meet the requirements of the standard

    • Implementation: Track the impact of any changes that have been made to the existing processes and procedures

    • Certification: An auditor to annually check and ensure that all of the documented processes are being followed

Astronut

Related Insights

Medical Device Manufacturer Invests in new Backbone of Quality Management— ComplianceQuest’s AI-powered EQMS
Case Study | May 31st, 2023

Medical Device Manufacturer Invests in new Backbone of Quality Management— ComplianceQuest’s AI-powered EQMS

ChoiceSpine Implements Unified Quality Platform, Accelerates Path to Market

View All Resources

Connect with a CQ Expert

Learn about all features of our Product, Quality and Safety suites. Please fill the form below to access our comprehensive demo video.

contact-img

Please confirm your details

In Need of Smarter Ways Forward? Get in Touch.

Get a Demo Today
spinner
Request Demo