ISO 9001 vs ISO 9000
| What is ISO 9001? | What is ISO 9000? |
|---|---|
| Contains requirements | Contains principles and definitions |
| Businesses choose to get certified to it | Businesses can’t get certified to it |
| Companies can claim conformance | Companies do not claim conformance |
| Helps companies achieve ongoing improvement | Helps companies understand ISO 9001 |
| Provides globally accepted minimum processes | Provides globally accepted definitions |
This article now focuses on the question, “What is ISO 9001?” In a few words, it is a standard.
THE ISO 9001 STANDARD
A standard is an accepted way of doing something. For example, stop signs are always octagonal and that is a standard. That is the accepted way to make them. If you want to be creative and make a square stop sign, you will have difficulty finding a buyer for your product.
The ISO 9001 standard contains accepted ways of operating and improving your company. The term, “quality management system” is used many times in the standard. This refers to the processes in your organization that have an impact on your final product or service. It is everything you do including planning and everything from sales to delivery. It might be easier to state a few parts of a business that are NOT usually part of a quality management system: accounting, legal, groundskeeping, and employee party planning.
For each process in your QMS, there are rules in the standard that you must follow. This list gives you an idea of the types of requirements for your quality management system contained in the standard.
Defining, controlling, and improving the processes within your company
Establishing the role of leadership
Planning expected results and changes
Identifying and addressing risks and opportunities
Managing all resources (equipment, tools, employees)
Establishing documented information (procedures, work instructions, drawings, records, etc.)
Monitoring the system (measuring, auditing, reviewing, etc.)
Finding and fixing problems and their causes
Improving all processes
As a specific example of one requirement, read this to see what ISO 9001 requires about the scope of your quality management system (QMS).
ISO9001 4.3 “The organization shall determine the boundaries and applicability of the quality management system to establish its scope.”
That means you must determine two things:
- Which processes and product lines or services are considered part of my QMS?
- Which requirements apply to my company?
And so you would go, one by one, through the requirements to understand them and change how you run your company until you have processes that will fulfill each of the requirements.
IMPLEMENTING ISO 9001
To understand the magnitude of an ISO9001 implementation project, know that there are 19 full pages of small text like that above and biga expectation that you fulfill every requirement. It can feel impossible or overwhelming at first. But some consultants can make the process not only possible but rather comfortable. One example is Core Business Solutions- which is certified to ISO 9001 and has a program that is tried, tested, and proven to bring about results in the form of certifications for hundreds of customers each year.
“That sounds expensive!” I hear you think. But, not necessarily. At least with Core Business Solutions, each client chooses between 4 levels of support based on their budget. All you need is one person, or a few individuals, who are assigned to get it done!
CERTIFICATION OR CLAIMING CONFORMANCE
Certification means that an external auditor has:
Defining, controlling and improving the processes within your company
Establishing the role of leadership
Planning expected results and changes
Identifying and addressing risks and opportunities
Claiming conformance means that an internal auditor has:
Establishing documented information (procedures, work instructions, drawings, records, etc.)
Monitoring the system (measuring, auditing, reviewing, etc.)
Finding and fixing problems and their causes
Improving all processes
As a specific example of one requirement, read this to see what ISO 9001 requires about the scope of your quality management system (QMS).
ISO9001 4.3 “The organization shall determine the boundaries and applicability of the quality management system to establish its scope.”
That means you must determine two things:
- Which processes and product lines or services are considered part of my QMS?
- Which requirements apply to my company?
And so you would go, one by one, through the requirements to understand them and change how you run your company until you have processes that will fulfill each of the requirements.
SUMMARY
ISO 9001 is a standard filled with requirements about controlling your business processes and the quality of your products and services. Its companion, ISO 9000, was written to help users of ISO 9001 understand basic principles and terms related to quality.
Though learning and implementing the requirements can be seen as a daunting task, there are consulting firms to help guide you in your project. You do not have to “reinvent the wheel” all by yourself because there are many consultants who can make the project a smooth and effective experience.
The ISO 9001 standard’s purpose is to provide companies worldwide with a set of rules or requirements that are accepted globally. It is used for two main outcomes- certification by an external body or claiming conformance by the company itself.
If you want to learn more, visit https://www.thecoresolution.com/iso-consulting
