Implement an ISO 9001 based Quality Management System
Phase One – Planning and Setup
This phase contains all the steps to become informed and get ready, including assessments and project plans, team setups and employee kickoffs.
Phase Two – Documentation and Development
This phase is where the structure of the organization’s processes is determined, existing documentation is reviewed and optimized, and newly created processes are developed where required.
Phase Three – Training and Implementation
This phase is where the now documented and structured organization is communicated to all employees in an organized and efficient manner, and evidence that the management system is being followed 100% of the time is created.
Phase Four – Assessment and Monitoring
This phase contains the different activities necessary to assess the progress of the QMS implementation and to correct any items that are nonconforming. It includes internal management system audits and may include a third party certification audit if applicable.
What is a Management System?
A management system is the organization of an organization. It includes the organizational structure along with the framework of policies, procedures and processes used to ensure that the organization can fulfill all tasks required to achieve its objectives. But it’s much more than that. A good management system should influence the culture of the organization and separate you from the pack, giving your organization the opportunity to become best in class.
What is a Quality Management System?
A Quality Management System is just a management system with a focus on the customer, the quality of its products and services, and the continual improvement of the management system itself. This is the most common focus of a management system, since it promotes those things that make an organization successful. Once you have your common management system developed, it’s much easier to add on other feature focuses as well, such as Health & Safety, Environmental, Security, etc.
What is ISO 9001?
ISO 9001 is an international standard that describes the criteria for a quality management system that focuses on the customer, product and/or service quality and continuous improvement. ISO stands for the “International Organization for Standardization“, the foremost internationally recognized standard making body in the world. Organizations around the world can meet the criteria in the ISO 9001 standard and become certified by a 3rd party registrar, who conducts compliance audits independent of the customer or the organization it audits.
Why should I be interested in implementing ISO 9001?
There are two basic reasons why organizations implement the ISO 9001 quality management system standard. This first is that we live in a global market, and customers need to find suppliers that are trustworthy and professional. The ISO 9001 standard is recognized world-wide and certification can be used to show existing and potential customers that your organization is operating at an internationally acceptable level of professionalism. The second is that a well structured organization is both efficient and effective, ensuring lower costs, higher quality and the meeting of whatever goals or objectives they set out to achieve. The end result for the private sector may be higher, sustainable market and profits; for the public sector, more resources and expanded services.
Where can I get the latest ISO 9001 standard?
You can purchase the ISO 9001 standard in hard copy or digital form from many places such as the Standards Council of Canada (SCC), the American Society for Quality (ASQ) or straight from the ISO website itself.
Do I have to become certified to ISO 9001?
The answer to that question is a resounding NO! You can build a quality management system based on the ISO 9001 standard using it to ensure good management practices, and complete your own management system audits internally. But keep in mind that periodic audits of the management system helps to keep everyone’s responsibilities fresh in their minds and creates consequences if and when any portion of the management system is not being adhered to. If you aren’t being audited by a 3rd party registrar, your internal audit program will need to be professional and report directly to senior management. One way to keep your internal audit professional without being tied to certification or a 3rd party registrar is to have HUMAN either lead your internal audit team or conduct the internal audit in its entirety. We practice auditing WITH employees instead of against them and provide a safe and invigorating audit environment that elicits employee ideas and celebrates success!
How long does it take to properly implement a Quality Management System?
That depends on different factors such as the size of your organization, whether you want to become certified or not, other special projects taking up resources, etc. Keep in mind that a management system, regardless of the focus, is an organizational-wide endeavour, and although most of your employees won’t have additional day to day activities, everyone will and should be affected during the implementation. An implementation done too quickly can hinder normal operations and still be ineffective because people have not had the chance to normalize themselves to the structure. Whereas one that is left to go on for months and even years has no sense of urgency and can languish, allowing a half-hearted implementation, which is worse than none at all.
HUMAN has found a sweet spot to be from 8 – 12 months for organizations to fully implement their quality management system, including certification by a third party registrar. This allows for the steps of implementation to be completed in a structured manner, along with 3 months of practice once the system has been documented, before starting internal audits and completing any corrective actions that may come out of them.