ISO 9001 certification seems to be the craze these days and the buzz word in many organizations. A little known fact is that the ISO organization first became more than just an idea back in 1946 when a group of 65 technical experts from 25 countries met to discuss the future of International Standardization. In 1947, the ISO organization was launched. Based in Geneva Switzerland, it has grown to be the governing body for all ISO standards currently in existence today.
The first true Quality Management Standard was launched by the ISO organization in 1987 and has been updated and upgraded to the most recent version in 2015 called ISO 9001:2015. With continuous improvement being the mandate for many growth oriented groups, its certainly possible that there will be updated versions in the years to come as the face of manufacturing and industry changes.
ISO 9001 is simply a total Quality Management System. When an organization follows the tenets of Clauses 4 through 10 in the order that they are presented, they will have considered the basic needs of a robust Quality Management system for their company. The current ISO 9001:2015 standard has been carefully compiled in a methodical way so that building your Quality Management System in steps using Clause 4 to 10 will provide the systematic approach to the beginnings of your robust Quality Management System.
Please note: ISO 9001:2015 does not tell you how to run your company. It provides an auditable framework to help you consider all the basic needs of a robust Quality Management System. Once a company has produced a stable Quality approach, then clause 10 of the ISO 9001:2015 standard becomes the key driver to continuous improvement in your company.
If you would like to learn more about how your company can become ISO 9001:2015 certified, please contact us at ISO Certification Consultants Inc.
I get this question all the time. Here are some of the common ones :
It’s costly. We can’t afford it.
Why should we spend that money.
It serves no purpose.
It’s a waste of time.
It’s a big money grab.
The auditors make the money.
We don’t get any benefit.
Our company’s philosophy is just do it. We fix problems as they come along.
Why do I need ISO to tell me how to run my company?
We don’t have time to document what we do. Time is money.
I don’t have the people or resources to spend on this.
My customers don’t require it of me so why spend the money.
I’m making good money on my product now.
How’s this going to positively impact my bottom line?
I can answer some of these questions easily. The answer to some of the other questions will require you and your organizations to seek on your own.
Business’s which stagnate typically follow the adage: “Why change how we do things. If it ain’t broke don’t touch it”. Although there is a part of me which understands this, It’s also a fact that change is inevitable and those who embrace it can ultimately prosper from it. ISO 9001 certification is no exception to this. In essence, company’s which do the same thing and never change with the times, can ultimately see their business erode and fade away over time. Newer companies with new ideas that keep abreast of the changing times ultimately fare better. So this point alone is a fairly compelling reason for ISO certification all on its own.
If you require more practical reasons I’ve outlined some of the more important ones here:
ISO 9001 Certification improves a company’s ability to compete for new business. Many larger companies are now mandating ISO 9001 certification to their suppliers as a minimum requirement to not only do business but to bid on new business.
ISO 9001 Certification provides a systematic approach to organizations. By following the requirements of Sections 4 through Section 10 of the standard, a company can develop and follow a proven system for managing the Quality Systems of a company from beginning to end. This documented and simple approach follows the PDCA (Plan Do Check Act) Methodology which is a proven approach to mitigating risk. In fact, many customers require this approach as a minimum requirement to doing business with them.
A systematic approach takes the guess work out of your business. It allows a company to make better decisions
Improved Customer satisfaction.
Improved Employee and stakeholder support and engagement.
A method for Measurement and documentation
A method for Continuous Improvement.
ISO 9001 is the basis for a number of other certifications for your organization, namely, ISO 14001 (Environmental) and ISO 45001 (Occupational Health and Safety). These three standards together form the backbone of any major company.
There are many more benefits of ISO 9001 certification. However, it’s important to note that not having a process for establishing and implementing the next levels of your organization can make your business become stagnant and ultimately uncompetitive. ISO Certification Consultants Inc. can help you with your needs.
Much has been written on the audit Process in the past. This article will break down the items which must be considered by an organization when engaging an auditor. In a previous article, “Inside the mind of and auditor” we delved into how an auditor thinks. This article will give the actual “nuts and bolts” of ISO Audit Process and how an ISO Auditor should navigate himself/herself through auditing .
The two major activities of an ISO Audit will consist of:
Review of an organizations current documents. This consists of verification of the organization’s documentation. The goal is to gage how the documentation adheres to the relevant tenets of the ISO Audit Standard.
Process Review: This is the main part of the physical audit. This is the activity whereby the ISO Auditor physically examines the organization’s adherence to the ISO Standard. An auditor will sample operations in an organization looking for evidence of conformity to relevant tenets of the ISO Standard. This is where preparation is an organization’s best friend. Having actual documentation showing the relevant connection between processes and how they support the organization’s Quality Management System, is a must. Keep in mind that an ISO Auditor is on a strict schedule. Because of time constraints, he/she only has enough time to audit one or two examples of each key process.
It’s not practical nor possible to audit and evaluate everything within the organization’ four walls. Again being prepared is your first line of defense. Excessive fumbling tends to give an auditor the sense that the Company has problems or is simply not engaged enough nor prepared for the auditor. This can have the effect of causing potential questions which could lead to a major or minor non-conformance. Poor documentation and preparedness causes the auditor to rely on asking more in depth questions of the employees themselves. Auditors will ask the same questions of the same employee operating the same equipment on either the same shift or multiple shifts. This line of questioning tends to give less consistent results and can lead to a major or minor non-conformance
Organizations which tend to fare well in ISO Audits are the ones which have definitive and planned internal audits on a weekly/monthly/Quarterly basis. These audits should be done by competent and trained employees. It’s advisable that you put your designated internal auditors through a training course to give them the essential tools to perform their own internal audits. ISO Certification Consultants Inc. through its partnership company can provide Internal Auditor training. By following a standardized approach to internal auditing, a company can avoid many of the pitfalls which lesser prepared companies fall into. A standardized approach which consists of an Audit Checklist and a standardized approach to questioning stakeholders is the methodology which helps Company’s avoid embarrassing situations during the ISO Certification audit. A systematic approach provides ongoing feedback on weaknesses in a company’s Quality Management System.
For further information and questions regarding ISO Audit, training your internal auditors please contact ISO Certification Consultants.
