Implementing an ISO 9001 system represents a major change and commitment to quality. All of that effort can represent a significant strategic shift for a business – from quantity to quality. And this could make sure your business gets more effective in achieving desired results. How do you become ISO 9001 compliant?
First, what does ISO mean? ISO comes from the Greek word ‘isos’ for equal, it is not an acronym. It is pronounced — ISO standard — ISO is one word, not the I.S.O. standard. ISO 9000 is a family of standards or best practices focused on ensuring that an organization continuously deliver products or services meeting the customer’s quality requirements. It is published by the International Organization for Standardization and governed by the International Accreditation Forum, and local Accreditation Boards.
It’s also important to know that ISO (International Organization for Standardization) is not actually involved in granting ISO certifications. ISO creates standards, they are not in the business of enforcing them. Other organizations actually handle the process of granting ISO certification.
Worldwide, the International Accreditation Forum (IAF) is the organization that handles all the facets associated with granting ISO 9001 Certification. The IAF works with national or regional bodies like ANAB in the U.S., which in turn accredit registration bodies that go out and audit organizations for compliance to the ISO 9001 standard.
Here in the U.S., the American National Standards Institute (ANSI) and the American Society of Quality cooperate to form the ANSI-ASQ National Accreditation Board, known as ANAB. They accredit registration organizations, attempting to ensure consistency and compliance with ISO 9001 registration auditing.
When you hire an ISO auditor for ISO 9001 certification, be sure to verify that they are accredited by ANAB or whatever the equivalent of ANAB is in your country or region (you can find a list of members at the IAF website). And your registration certificate should have the ANAB and the IAF logos on it. Without them, you are not truly ISO 9001 certified.
There are many reasons why you need ISO 9001 certification, but a shift in focus to performance drive greater effectiveness. Developing, implementing and maintaining your quality management system (QMS) to meet ISO 9001 quality standards can be crucial to the core issues of a business — getting results.
The shift in focus is designed to help:
But to do this you need to put a framework in place that spotlights performance and performance improvement.
To effectively build an ISO 9001 compliant program and meet the requirements, your organization should carry out a strong process that must start at the top with strong management commitment to quality:
Once you’ve identified your company’s need for compliance, it is essential for top management to get on board. Management can ensure that quality is documented, demonstrable, effective and maintained.
The appropriate personnel should then review the various standards in their industry and work to meet those requirements. Personnel can then develop, implement and maintain a set of quality systems and procedures to satisfy ISO 9001 requirements. It is not just about the requirements, it’s about the results and how ISO 9001 can make your company more competitive.
To build an ISO 9001 compliant program and meet the requirements, your organization can begin with effective training for how to create well-defined processes. You will first want to learn how to identify the objectives necessary to deliver top results. Best practice for building ISO 9001 programs is to perform a Gap Analysis so you will understand what is needed to put those processes to work.
Consider assessing your current state against the standard using an ISO 9001 Gap Analysis. Note the various gaps in your processes, resources, and objectives. If you have been in business for some time, you will probably have many process in place already, but there will be some gaps. It is important to know what those gaps are so that you can plan on what development has to be completed. An ISO Gap Analysis is basically a full systems audit on how ready your organization is for ISO 9001.
The ISO 9001 Gap Analysis is an assessment of your QMS which results in a series of action items (Gaps) that forms the basis of the QMS Project Plan, resources needed, and target dates.
After you’ve implemented the ISO program, you should monitor and measure the processes against your own objectives. You can build an effective management system that objectively shows what you’re doing right and wrong. To learn how, you can take advantage of an Internal Auditor skills class and learn how to bridge the gap and move toward continual performance improvement.
With ISO 9001 compliance you can improve the overall organizational performance of your business. And this can save money while satisfying your customers and increasing profit. Starting an ISO 9001 project is like any other. Priorities need to be established and responsibilities for various milestones assigned. It can be a simple process if you are organized with sufficient experience with the ISO 9001 standard, QMS processes, and the best practices that go along with them.
Obtaining ISO 9001 certification for your Quality Management Systems can appear like a difficult task, but becoming ISO 9001 compliant doesn’t have to be.