Need a little help converting your current ISO 9001 quality management system to the 2000 standard or QS 9000 to ISO 16949 or ISO 13485 to the 2000 standard? Feeling a little overwhelmed - don't know where to start or what to make of the differences?

Where to start

The ISO 9001:2000 standard has been out since December 2000. Also new are several other standards updated to reflect the changes to ISO 9001. These updated standards include ISO/TS 16949 and ISO 13485:2003.

The good news: it is a better standard.

• It applies to service as well as manufacturing companies.
• It is based on best business practices.
• All pieces of the old standard still apply.
• There is a stronger emphasis on continual improvement, customer, and measurable objectives.

If you haven't started your transition yet, here are a few starting places for ISO 9001:

• Order the new standard. Check our links for more information about your standard.
• Determine scope and exclusions. It is harder to exclude processes such as design and development if you perform even a part of the process.
• Define your processes. Prepare process flowcharts: they will help with several parts of the standard.
• Take some time to look at your processes for:
  • Customer satisfaction: for ISO 9001 you must actively obtain customer feedback including but not limited to complaints.
  • Training: you must measure training effectiveness. You are probably doing this in a number of ways and need to capture those measures.
  • Monitoring & Measurement: monitor and measure both product and processes.
  • Measurable objectives: objectives related to your product and processes are required and should be shared with everyone.
• Look at incorporating or referencing other programs such as Environmental Health & Safety, HACCP and GMP in your system.
• Check out websites for good ideas. Ask associates or professionals for assistance.
• Start now!
• Check our pages on ISO/TS 16949 and ISO 13485 for differences and other suggestions.

We Can Help

Quest Analytical has a simple, cost-effective, proven transition process that helps you address the following:

• Upgrade procedures to the new ISO 9001:2000 requirements and organization
• Fine-tune programs and processes already in place
• Provide the opportunity to improve processes

We can provide:

• Example documents
• Improvement tools
• Proven ways of addressing the new requirements
• Training on the standard
• Auditor training on the new requirements

How is Quest Analytical going to help me?

• We work with you over five meetings to complete and update all elements of your QMS.
• You don't have to figure out the obscure points by yourself. Our package makes it easy.
• Updating procedures and the quality manual is like a walk in the park on a spring day!
• The flow charts and spreadsheets give you a way to start cranking through the changes.
• We will walk with you through the entire process - taking out all the guesswork.