What do you include in your ISO 9001 Quality Management System to prepare it for ISO 9001 Certification and ISO 9001 Accreditation Audit?

ISO 9001 Certification will only be given to businesses that have a ISO 9001 compliant business management system. You need to show the ISO 9001 Accreditation Auditor that your company has a structured, organised, error-proof way of making your products and services right-first-time, every time.

 


 

Hello Mike,

We are looking to achieve ISO 9001 Quality Management System accreditiation and are seeking assistance to achieve that. We currently do not have a quality system in place. Can you outline what we would need to do for ISO 9001 Accreditation and how to go about it?

 


 

Dear Friend,

Thanks for making contact. At this link is the tabletop quality audit that we do as the start point of building your ISO 9001 compliant system. The tabletop ISO 9001 quality audit identifies the gaps in your existing business management processes and business documentation which do not meet the ISO 9001 quality system requirements

Typically most companies will need to add:

  • a internal auditing process,
  • a business risk assessment and management process,
  • a product and/or service non-conformance process,
  • a customer feedback and satisfaction management process,
  • a document control process,
  • a historic records management process, and
  • a failure prevention process.

Most businesses know well the products and services that they produce but do not have a fully structured business system to produce and deliver them with consistent quality. ISO 9001 makes you build such a business management system if you want to have ISO 9001 quality system certification.

From the gap analysis we then develop the management documentation framework required by ISO 9001. Basically this involves creating a document management file structure in your computer system using specific categories that relate to those in ISO 9001, such as quality manual, quality policies, procedures, work instructions and the archiving of historic records that evidence your system is operating. The quality manual provides an overview of how your quality management system looks and the information it contains. The system conformance table at the back of the quality manual shows you how all the other documents in your quality management system are interconnected to the Manual, which is the master document.

Once the quality framework is established we look at your existing business documents and place them where they belong in the structure, numbering them individually in accord with their quality framework location. The missing quality system processes are then developed and any necessary new documents written so that the quality framework structure is fully populated. Usually we write the ISO 9001 system related documents and your people create the documents that are specific to your operational processes and business practices.

We will create your business specific documents if you wish. This involves doing interviews with your staff where we ask them to explain the work processes that they follow and typing what they say into a new document showing the work process flowchart with a description of the work activities and the performance standards to be met for each task. The setting of work performance standards is the great secret of building successful quality management systems that make companies world class performers.

The table top audit for a business of your size, about 50 people, will take about two to three days. Setting up the quality framework and populating it with your existing written documents will take three to four days. Writing the ISO 9001 quality system specific documents will take two to three days. Developing your business and operational specific documents can take two to three weeks and more, depending on how much resources you have available to write them, or if you need to get us to write them for you.

I hope that you have the information you need in response to your query. Please tell me what else you want to know if you have more questions.

 

My best regards to you,

Mike Sondalini
Managing Director
Lifetime Reliability Solutions HQ

 

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

 

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