ISO 9001 Implementation


Question:

As Quality Manager I have been assigned the task of getting the company ISO Certified. Certification was granted in 2000, but their old system is in bad condition. The structure is incomplete, the organization and wording were created by an accountant and a shop foreman with little formal education. And it shows.

I have a copy of the ISO 9001:2008(E) International Standard, and attempting to integrate the old into the new is disheartening. Restructuring the system is the only answer, and so my question is:
Should all (8) sections, and all associated sub-sections of the ISO standard be the same in my standard?

I’m speaking in terms of the section and sub-section naming, and organization. The details of each I will define in accordance to our specific applications, but for ease of auditing am I on the right track?
Thank you for your time in this matter.

Response:

Thanks for contacting ASQ’s Ask the Experts program.  Based upon the information provided, I would suggest that you consider developing your new quality manual using the same or similar layout of sections and clauses found in ISO 9001:2008.  Although it is up to every company to select a format, or structure, for their QMS that will best support their own needs, using a format that is consistent with the layout of ISO 9001:2008 will help facilitate future audit activities.

Since your company was previously certified as mentioned in your inquiry, most of the work with regard to section and clause references should have already been completed.  Likewise, it should be noted that the structure, or format,  of ISO 9001:2000  vs. ISO 9001:2008 is essentially identical.  So, all section and clause references should already exist in your current quality manual.

To ensure that your objective of obtaining ISO 9001 recertification is accomplished in a timely and cost effective manner, I recommend that your company consider the following steps:

  1. Identify the timeline for completing the development, implementation and recertification of your QMS.
  2. Contact a Registrar to determine their costs, requirements and availability to meet your timeline for QMS recertification.
  3. Assess the availability of internal resources (personnel) that will be required for the development, implementation and maintenance of the QMS.
  4. Identify your company’s need to obtain external support from a qualified QMS consultant to assist with the recertification of your QMS.

Before beginning your QMS recertification project, it is highly recommended that your company first conduct a gap analysis of the present quality management system and all related processes.  This will greatly help to identify what actually needs to be done to meet ISO 9001 certification requirements. This information can be used to establish a realistic project timeline, and estimate required man-hours and associated costs for recertification.

Please review ASQ’s Ask the Experts, Blog for other related posts such as “The Cost of ISO 9001 Implementation”.  I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, Texas
www.astontechconsult.com

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