The first thing you should do is educate yourself on what ISO 9001:2000 Quality Management Standards (QMS) means, what certification entails, and how ISO certification will help your business. The best source of information is probably by purchasing a manual from your national standards association, or taking one of the many courses available through accredited certification bodies.
You can perform your own preliminary audit using audit checklists available online as a guideline, or by preparing your own audit checklist based on the manual and training you received in step 1. Use this as a chance to evaluate how things are done now, versus what you would have to change in order to get certified. A lot of companies should already have in place laboratory manuals, health and safety procedures, staff training and orientation, production process manuals, quality control and other processes that need to be documented for ISO. You can use these same manuals.
Hire a Consultant
At this point, it might be prudent to hire a consultant, even for a one-day evaluation of your company, to make sure you’re on the right track. The consultant will perform his/her own audit and interview various members of the company to get an idea of what your company does and how things are done. You can then make an educated choice whether to let them continue with the certification process and prepare your documents for you, or whether you might be able to go it alone.
Establish Staff Roles
You need to establish the roles of various managers and staff in terms of who will be performing audits, who will maintain certain documents and who will conduct management reviews and implement improvements. All auditors should receive auditor training. In a large company, it might be cost-effective to have an accredited instructor come to you. Smaller companies can take advantage of the frequently offered public courses.
Prepare Process Diagrams
Most consultants will recommend you take this organizational approach to planning your application. The act of preparing process diagrams helps you visualize all the inputs and outputs of each product your company produces. This will aid in setting up controls and documentation for each step of each process.
Take advantage of existing documentation in your company, as mentioned in step 2. You will likely find that some documents require updating or minor revisions. Implement these changes and then proceed to preparing your ISO 9001:2000 QMS Manual. In the manual, you outline how each of the QMS requirements are being met, by referring to the existing (or newly prepared) documents for daily tasks such as ordering, customer relations, production, R&D, quality control and more. This is the most time consuming step of becoming ISO certified.
Once the QMS manual is prepared and you have all documentation in place, it’s time to train the remainder of staff on the ISO process and what it entails. Passing the audit requires compliance at all levels. Ensure management recognizes their role in setting examples and motivating staff.
Performing another internal audit ensures there will be no surprises when the external (third party) auditor comes. You could consider bringing back the consultant that you hired in step 3, to make sure you have understood and addressed all of his/her concerns. By now, you should find only minor non-compliance issues, if any. Address these now, and, if necessary, perform a second internal audit.
Once you are satisfied you are complying with all the QMS requirements, you are ready for your third party audit by an accredited certification body. If you have followed the guidelines and everything is in place, you should hopefully pass your audit with flying colors!
- Don't make things more complicated than they need to be. Use existing documentation/manuals and keep the QMS Manual as simple as possible.
- Talk to as many consultants as you can at the beginning, and take an auditor training course to make sure you don't overlook anything and are very familiar with what the auditors are looking for.
What You Need
- QMS Essentials Handbook
- QMS Requirements booklet
- QMS Fundamentals and Vocabulary booklet
- A sample QMS auditor checklist