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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 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.
A global medical device manufacturing company specializes in designing, manufacturing, and marketing advanced silicone-filled breast and body shaping implants. Its…
ISO 9001:2015 is a quality management standard that helps you setup processes and workflows for quality control in your organization.…
Any business, be it B2C or B2B, exists to solve its customers’ pain point(s). Only those businesses that successfully deliver…
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
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
The ISO 9001 standard, a structure of ten clauses, covers four key areas:
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.
The ISO 9001 QMS is based on seven principles including:
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.
Employee engagement
Employees at your organization are the most vital asset, and their knowledge and experience need to be understood in the QMS.
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.
Supplier Relationship Management
We need to manage the relationship between ourselves and our suppliers if we want to improve their products and services.
Customer Success
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:
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.
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
Is Your Internal Communication Related to QMS (ISO 13485) Adequate?
Checklist | September 27th, 2021
Review and Update Your QMS with 50 Mandatory SOPs as per ISO 13485:2016
Checklist | April 7th, 2021
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
In 2018, the US FDA had announced its plans to harmonize FDA Quality System Regulations (QSR) with ISO 13485:2016 quality…
Regulatory authorities such as the FDA (and standards like ISO)…
When a leading global manufacturer—that produces forgings, material handling equipment,…
Our goal of creating this Buyer’s Guide is simple and…
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