Frequently Asked ISO 9001 Questions

Q: What is ISO 9001?
ISO is a kind of acronym for the INTERNATIONAL ORGANIZATION for STANDARDIZATION. They gather input from business leaders and quality groups around the world to create internationally accepted standards for quality.

The ISO 9001:2000 standard (formerly 9001, 9002, and 9003) is the most widely accepted quality standard in the world for manufacturers, and is the result of years of painstaking global consensus-building.

Q: Why should my company be ISO certified?
ISO 9001, when implemented correctly, causes the quality of your products and services to continually improve …almost automatically! Its built-in problem checking and correction elements steer your business down an ever-narrowing channel of quality, slowly weeding out imperfections and process glitches from your business operations. Things will go smoother and smoother over time, and your employees will have an increasingly more positive morale.

The ISO 9001 standard also focuses on your customers’ PERCEPTION of your quality. This means that by satisfying the requirements of ISO, over time more and more of your customers will maintain a positive opinion of your company.

And of course, the ISO standard provides a globally acceptable method for proving to the world that your company is trustworthy, conscientious, and deserving of their valuable contracts and hard earned capital. In today’s global market, many manufacturers experience significant growth as a result of their ISO certification.

Q: How much does it cost?
Costs will depend on the size and logistics of your company. By implementing an efficient quality system you can save money and manpower for your company. Outsourcing to a consulting firm such as ours to set up your quality system, train your employees and keep your system running smoothly is a cost efficient alternative to hiring full-time staff for QA (Quality Assurance). Contact us for a free estimate.

Q: How does it work?
Basically, your company creates a system for controlling the quality of your products and services. This is called a Quality System. This include a Quality Manual, which outlines certain criteria for work processes and commitments by Management to maintain and improve these processes.

Many companies outsource consulting firms (such as ours) to set everything up, train the employees, and keep everything running smoothly, as an alternative to hiring costly additional full-time QA (Quality Assurance) employees.

As part of your Quality System, the ISO standard requires you to have a qualified individual spot-check everything once in a while to make sure the system is working. These people are called internal auditors. The auditor goes around your facility, talking to people and inspecting things like calibration stickers and documentation. You can train someone in-house for this, or you can schedule your consultant to come out and do the audits once or twice per year, reporting any problems found so you can fix them.

Also once or twice a year, an RAB (Registrar Accreditation Board) Certified Auditor is sent out by your Registrar for a "Surveillance" audit. This auditor cannot be closely affiliated with your consultant, lest there be a conflict of interest.

Just like with internal audits, any problems found by the Surveillance Auditor(s) are reported to you so you can fix your system. However with these audits,  if you don't fix minor problems within a reasonable time, or if problems are found which completely negate the effectiveness of your quality system,  the Auditor may recommend to the RAB that your certification be discontinued.

At that point, you'd have to remove all references to the RAB and ISO Certification from your company's websites, marketing materials, business cards, etc., until you get re-certified. It's far better to have the internal auditor find these problems first, and help you fix them.

Q: Do we have to change how we operate?
Usually, not much. Most companies already have some system of quality control in place, or they probably wouldn't still be in business.

The real trick is to find ways to provide measurements and evidence of the system's effectiveness without forcing employees to spend costly man-hours jumping through hoops and documenting everything they do "for ISO". That kind of simplification up front can save your company loads of money. (...and happens to be our specialty here at QA California!)

Q: What is a Registrar?
Your Registrar is your link to ISO certification. You are free to choose your own Registrar. You should discuss Registrar criteria with your quality consultant. 

Basically, ISO creates a quality standard. Then, accreditation bodies like the RAB audit and certify Registrars according to the new standard. These Registrars, in turn, send out  surveillance auditors periodically to verify your company's continued compliance with the standard.

Good Registrars also provide information and other helpful, ISO-related services.

Q: What is the RAB?
The Registrar Accreditation Board is a for-profit company that handles the certification of Registrars and Auditors for ISO. (All our auditors and trainers are RAB certified.)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
       


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