Some times it is because they have not put in the required effort, others just do not read the requirements of the ISO 9001 standard or misinterpreted its requirements. This is why it is always best to employ a consultant who has been through the process many, many times before. A consultant will guide you through the process avoiding the numerous pitfalls like over-documentation or insufficient coverage of the ISO 9001 Standard.
Would you go for a driving test without having read the highway code? Of course not.
As a Senior lead auditor with the UK’s largest certification body for many years I would estimate that one in ten organisations visited did not have a copy of the appropriate ISO 9001 standard for which they were seeking registration, some had a copy but openly admitted that they had never read it, others had read it, didn’t understand it, and just did what they believed to be in the standard. Many businesses just forget to carry out internal audits or carry out the ISO 9001 standard training of their employees to give them a basic understanding of what ISO 9001 is all about.
When these applicants failed their initial registration audit they seemed shell shocked and could not understand how they could fail. Quite simple, it is rather like turning up for an “A” level exam having not read the syllabus, failed to do any home or course work and expecting to pass. A good consultant will ensure that your business does not fall into any of these traps.
The U.K. British Standards Institute, estimates that 45% of the companies who fail to achieve certification do so because of documentation deficiencies. The ISO 9001 is very specific about what documents have to be produced and which records have to be kept.
The remaining 55% of failures are in-part related to documentation in areas such as policies and procedures for process, inspection, testing and measurement. Employing a consultant would have prevented failure and the additional costs of a full registration body re-assessment.
The ISO 9001 standard is very specific about what documents must be controlled and in general you will find that they fall into the following three areas
Documents which describe the Quality Management System within your organisation
Documents of external origin which you use in the process of producing your product or service such as ISO standards, drawings, specifications etc.
Records which you must keep are generally recorded on forms, in books or in electronic format, all of which must be controlled.
If documentation control is an issue that concerns you then take a look at the Easy ISO 9001 software, it will take care of this for you and much more.
Based on our experience, we believe that ISO 9000 certification will become increasingly important, particularly if companies are to remain competitive in the global economy.
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