ISO 9001: 2000 TRANSITION PROCESS - PART II By Neal D. Stiemert Over the past year, as a contract internal auditor and registrar, I have had the opportunity to evaluate many quality systems being upgraded to the ISO 9001:2000 standard. This month, I will share with you some of the common problems that I have observed with the transition process in each element of the standard. Section 4 General Requirements 4.1 Control of out-sourced processes - No control of outsourced processes. Outsourced processes such as painting, plating, machining, assembly or manufacturing must be controlled in accordance with your requirements. You need to provide the supplier with your requirements and assure that the supplier is performing the process in accordance with those requirements. 4.2 Quality Manual - Processes and interactions not defined in the quality manual. The sequence and interaction of your processes must be defined in the quality manual. A typical manufacturing company would have a sequence of: Sales> Purchasing> Receiving> Storage> Production> Packing> Shipping. You must then identify what functions interact with these processes. Section 5 Management Responsibility 5.4 Quality Objectives - Incomplete quality objectives. You must have objectives for your processes (see 4.2). The objectives must be measurable, have goals and be monitored on an on-going basis to demonstrate progress toward the stated goals. 5.5 Internal Communication - Personnel unaware of the quality objectives. In addition to the quality policy, all personnel must be aware of the status of the company quality objectives. The quality objectives should be posted in the facility for all personnel to review. 5.6 Management Review - Management review not covering all required elements. The new standard has additional requirements for managment review. Be certain to cover all requirements and document your conclusions in your management review minutes. Section 6 Resource Management Competence, Awareness and Training - No process for verifying training effectiveness. You must provide documented evidence that you have verified training effectiveness, this can be accomplished by testing, internal audits or performance reviews. Section 7 Product Realization 7.1 Planning of product realization - Inadequate quality planning. Many times, products are put into production with inadequate specifications, instructions or defined quality characteristics. Section 8 Measurement, Analysis and Improvement 8.2 Customer Satisfaction - No process to determine customer satisfaction. You must define your process for determining customer satisfaction; this can be done by conducting annual customer surveys. Your customer satisfaction results should be one of your quality objectives and have a measurable goal. Summary Most companies have prepared a quality manual that addresses the ISO 9001:2000 elements but have not made the necessary changes in their quality systems. Until your quality system is in compliance with the new standard, you cannot be upgraded. The deadline for compliance to ISO 9001:2000 is still December 15, 2003. I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Neal Stiemert President Independent Quality Consultants, Inc. About The Author: Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ certified quality engineer, a certified lead auditor and has over 23 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at the Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments, an RVA and RAB accredited registrar. Comment on this article