The Value of ISO 9001

Updated 4 May 2012 A. Ochs

ISO 9000 is about managing your business in such a way that it is continually becoming more competitive. Registration does not mean you have achieved perfection; it does mean that when something goes wrong the problem is viewed as an opportunity to improve.

ISO 9000 outlines the requirements for a comprehensive Quality System. These are good, common-sense business practices including:

  • Employees who know what needs to be done
  • Clear policies understood by all
  • Processes capable of meeting requirements
  • Clear and honest communication with customers
  • Suppliers who understand and meet requirements
  • A staff trained and developed to meet the needs of the business

These are the practices that are needed to meet customer expectations. These are also the main requirements of the ISO 9000 requirements. To become registered, a company must implement a quality system to address these points. To do that you must:

  • Examine the existing systems
  • Improve and optimize the systems
  • Modify the systems to meet the standard requirements
  • Document the system
  • Train staff and begin using the documented processes

 

What Will the Finished Quality System Look Like?

 

A Quality Manual will describe briefly how your Quality System meets the requirements of the standard.

Procedures for each of the points will describe each process.

Work Instructions will describe how specific tasks are done.

Records will be kept, demonstrating that documented procedures were followed.

Job descriptions, procedures and work instructions will clearly describe what employees are responsible for in their position.

An Internal Audit program will continually evaluate the quality system and highlight areas for improvement.

Management on a regular basis will review information from corrective actions, internal audits and registration audits. Management will be well informed on the Quality System performance and able to take action for continual improvement.

 

Starting your project

 

The first step in an implementation project is to determine where your current quality system is compared to the requirements of the standard. Quest can do this for you by auditing your company’s current system and providing you with a Gap Report. The Gap Report details the things that you have in place that meet the standard, and shows you the things that must be added or modified to bring your company into conformance.

Putting together a plan

Once you know what needs to be done to bring your current system into conformance you are able to put together an implementation plan. Our Quality Systems Specialists assist clients by presenting various approaches that may be used, and helping determine what approach best meets your registration goals. There are a number of ways we can structure your project and our involvement in the project. Quest can provide any combination of the following:

  • A Quality Systems Specialist to be the project manager
  • Guidance for your steering team, providing direction and technical guidance for the project
  • Assist implementation teams during development of the quality system
  • Train internal auditors
  • Provide auditing assistance During the planning process we work with you to determine where your company would benefit most from our assistance

 

Implementing the Quality System

 

The implementation plan will be your guide for the rest of the project. It will outline how to proceed, and the timeline for completion of the various stages. It will generally follow these steps:

  • Teams determine new processes to meet the standard
  • The teams document the new process, develop required records, forms and work instructions
  • The teams train staff on how the new process works
  • When the new processes are complete, the Internal Audits and Management Review Meetings begin
  • The system is used for 2 or 3 months before your registration audit

 

Registration

 

Registration After you have collected records, completed a cycle of Internal Audits and Management Review, you are ready for your Registration Audit! Quest Analytical can help you successful and efficiently implement your ISO 9000 system. Contact us for more information.

 

3 comments

  1. This is a great job laying out the process in a straight forward and easy to understand manner. There’s a lot of wonderful information and I really believe the key value was summed up early “Registration does not mean you have achieved perfection; it does mean that when something goes wrong the problem is viewed as an opportunity to improve.” This is so true and is the heart of ISO.

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