How to start, and the primary steps to follow, to develop and build a ISO 9001 compliant Quality Management System for ISO 9001 Certification

To get ISO 9001 accreditation your business management system must comply with ISO 9001 Quality System Requirements. You need a business system framework for running the business. Within the framework are the quality system documents you use and those that ISO 9001 requires you to adopt.

 


 

Hello Mike,

We are looking to get ISO 9001 accreditation and are seeking information to achieve that. At this stage we do not have many systems in place. Can you outline what we would need to do and how to go about getting ISO 9001 accreditation, including costs and time involved?

 


 

Dear Friend,

First send the person in your company who is in charge of your quality management system (QMS) certification to a ISO 9001 fundamentals training course and an ISO 9001 internal auditor course. Start by getting them educated in what needs to be done. A suitable one day ISO 9001 introduction course from an ISO 9001 Certifying Body (like SAI Global in Australia) is a good place to start. The ISO 9001 Internal Quality Auditor Course training is a 2-day course.

In the end your Quality Manager will also need to go to the introduction to ISO 9001 training and do an Internal Quality Auditor Course as proof that they are trained and qualified to be a ISO 9001 Quality Manager.

Once your own person is knowledgeable in the needs of ISO 9001 accreditation, understands what comprises an ISO 9001 Quality System, and knows how to build one, it is very likely that they can develop a complying ISO9001 quality system for you. They will take longer than a ISO 9001 Consultant because it is their first ISO 9001 system, but they will be capable of developing a compliant ISO 9001 QMS.

Whether you use an ISO Consultant to develop your QMS, or you use your own internal resources, normally is a matter of what you consider to be the most cost effective decision. ISO 9001 Consultants cost much more than an hourly rate employee, but will complete the QMS much faster and it will be built correctly. Most importantly, a good ISO 9001 Consultant will build into your QMS system the expertise and knowledge they know about world class business management systems. That is something that your employee can never know and will never do for you.

I find that if a company is driven by money-conscious management they get their own people to do their own QMS (and thus lose fortunes and countless successes in future). Those companies driven by long term success who want to build a business that will last get the best ISO 9001 Consultant that they can afford to build their QMS and happily pay the price.

Step 2 is to buy the ISO 9001 Standard and do a ‘gap analysis’ table top audit of your business processes and documents (you can use our ISO 9001 tabletop audit matrix at ISO 9001 Compliance Table) and identify what is missing from your current business management system.

Next you need to develop your document management framework, document numbering and document controls so that your QMS complies with ISO 9001 requirements for managing your business documents and records. Eventually you will need to update all your QMS documents with the QMS document numbering so that you can populate the document management framework and manage your paperwork.

I then write the Quality Manual (an example of the top QMS document from which all the other QMS documents cascade is at Quality Manual Lead Document) and lastly backfill the tables at the end of the Manual with the documents that you use in your business to achieve the intent of each of the ISO 9001 clauses.

When you come across necessary processes and documents needed by ISO 9001 that you do not yet have, you create them, you teach them to your people and you make them part of your future business practices forevermore.

The costs for me to do the table top audit is at senior consultant hourly rates. Allow 16 hours to do the tabletop review and provide you with a basic report.

If you want me to build the QMS I charge at senior consultant hourly rates to develop it. If I have to build the system from the documents that you already have allow two to three weeks to compile the framework, populate the framework with documents, develop new processes and write missing documents. (For a small business like yours it should take less than two weeks if you have a good business management system already, and up to three weeks if you have an average business management system.)

To these costs you need to add the cost for the Certifying Body preliminary audit and full accreditation audit, plus the certificate issuing costs. Once you are ISO 9001 accredited you have an ongoing annual certification fee to pay the Certifying Body and an annual audit from them to pay for too.

Let me know if you need more information.

 

My best regards to you,

Mike Sondalini
Managing Director
Lifetime Reliability Solutions HQ

 

PS. If you require advice on ISO 9001 quality system development, please feel free to contact me by email at info@lifetime-reliability.com

 

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