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 ISO9001 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. Basically, 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, grounds keeping, 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 organisation 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 fulfil 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 big expectations that you fulfilevery requirement. It can feel impossible or overwhelming at first. But there are consultants who can make the process not only possible, but rather comfortable.

“That sounds expensive!” I hear you think. But, not necessarily. At least with Compassrose, 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

Another decision you need to make, is the end goal: 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:

1. Which processes and product lines or services are considered part of my QMS?
2. 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 fulfil 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.

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