10.4: DOCUMENTATION AND REGISTRATION/CERTIFICATION
ISO 9001:2000 registrants are familiar with the phrase “quality manual and standard operating procedures.” A company cannot comply with registration requirements if there is no approved quality manual/standard operating procedures/working formats and records. The quality manual documentation should be completed by the top management to ensure commitment at all the appropriate levels within the organization. The quality policy, goals, and objectives defined in the quality manual must be verifiable. The applicable procedures should be established and documented by the company prior to the certification process. Normally, the development of a quality manual and applicable procedures is the most time-consuming factor, and the time may vary from small to large organizations. However, documentation time can be greatly reduced using these sample quality manuals and standard operating procedures. Users should go through this text and review their current systems in order to incorporate changes in these electronic files, which may take 4 to 12 weeks. It is expected that the documented quality standards will be in place and implemented at least three months prior to the registration audit.