Introduction to ISO 9001
Did you know that ISO does not stand for International Standards Organization?The International Organization for Standardization, an international agency composed of the national standards bodies of more than 160 countries, took on the Greek word ‘isos’, which means ‘equal’, as a short name for the organization. ISO 9001 is the international standard that defines the requirements for a quality management system (QMS). Companies use this standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. The current version of ISO 9001 was released in September 2015.
- ISO 9000:2015: Quality Management Software Systems – Fundamentals and Vocabulary (definitions)
- ISO 9004:2018: Quality Management – Quality of an Organization – Guidance to Achieve Sustained Success (continuous improvement)
- ISO 19011:2018: Guidelines for Auditing Management Systems
What is ISO 9001
ISO 9001 is the standard that has the requirements for a quality management system (QMS). These requirements represent the minimum risks to customer satisfaction that need to be addressed before a company that provides ISO registration can determine through an audit of the QMS that an ISO registration certificate can be issued.
Why Implement ISO 9001
The reasons to implement ISO 9001 are layered according to the level of awareness within a particular company.
Marketing and Sales
Historically when ISO first started gaining popularity it was a method to show potential customers that they could have greater confidence in a company’s ability to consistently provide quality products. An army of consultants appeared on the scene to show companies how to write procedures that could pass ISO 9001 registration audits, get the ISO certificate, hang the banner on the building and improve marketing and sales efforts as a result.These paper based systems were time consuming to maintain, usually in a last minute frantic effort before the auditor showed up, and due to these challenges it was hard to argue there was much value added at all.
Customer Satisfaction
As things improved, and especially with the introduction of quality management software for manufacturing, it was easier to process QMS workflows and generate data that could then be used for trend analysis that drove continuous improvement. In the early days, most software was costly and only available to larger companies, or smaller companies that managed to find TLM on the internet.With the ability to create a closer connection between people, procedures, and data analysis, the risks that could impact customer satisfaction could be addressed effectively, and at least for larger companies that could afford QMS Software, ISO 9000 quality management systems started actually adding value more often than not.
Evolution
As companies improved their ability to implement their iso 9000 quality management system, so too did the standard itself evolve and the language changed to focus on risk, while giving more flexibility in implementation of how those risks were addressed. When viewed in this context, the standard itself was never really a problem, in fact, it has always been a valuable insight into the most common risks that can contribute to products or services that your customers are not happy with.
Using these risks as a systematic method of improving your business is the real reason to implement a total quality management iso 9000 system at your company, which forces the focused process building and decision making that will cause your company to evolve and its ability to consistently meet customer needs to improve.
All the other benefits are a direct result of this evolution, and include:
- Increased efficiency
- Improved company image
- Improved customer satisfaction
- Evidence-based decision-making
- Improved employee morale
- Consistency
- Improved supplier relationships
- Creation of a culture of continual improvement
- Meets requirements for government contracts
When to Implement ISO 9001
First let’s look at the costs based on the expected time and how many people might be involved.
- Companies of up to 10 employees – up to 3 months.
- Up to 50 employees – 3 to 6 months.
- Up to 200 employees – 6 to 10 months.
- More than 200 employees – 10 to 20 months.
If you compare the cost of 2 people over a 3 month period compared to maybe 40 over 20 months, we can see a huge difference in cost of doing it sooner, rather than later.
There is also the question of how soon do you want the benefits?
Implementing ISO 9001 using QMS software for manufacturing is going to make more sense when there are enough employees where coordination between them is important, as is preserving the initial process building and organizational knowledge that makes the business work, along with enough employees to take on the effort.
LMBS recommends as soon as possible with these considerations in mind, which amounts to a general range of 5-25 employees. This is when putting an ISO 9001 based quality control software for manufacturing in place would make the most sense to us.
How to Implement ISO 9001 in 7 Easy Steps
These are the recommended steps for Easy ISO 9001 QMS Software implementation:
- Install Total Lean Management (TLM) QMS Software
- Complete free training at the TLM Training Center for:
- Doc Control Training No 1 – Web App
- Doc Control Training No 2 – Main TLM App
- Load, edit, and release TLM Template procedures for QMS workflows such as:
- Load, edit, and release procedures and work instructions needed for what your business does.
- Conduct an internal audit using the ISO requirements checklist in TLM
- Address any gaps, and select your ISO 9001 Registrar
- Schedule your certification audit.
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