ISO 9001 : ISO 13485 : AS9100 : Barile Consulting Services LLC

How to Gain ISO 13485 Certification for your Medical Device Company.

David Barile — Wed, 11 Jul 2012 14:51:30 +0000

If your company makes medical devices, then you need to know how ISO 13485 can help you to develop a comprehensive management system for designing and making all medical devices.

How does ISO 13485 help with Quality control for your manufacturing business?

ISO 13485 requires that a business show that they have a quality management system in place that meets their customer’s requirements for their products and that this system is being maintained and running smoothly.

You must be able to meet the current regulatory and other requirements, as well as streamline your company’s ability to consistently manufacture a product with a safe design that meets both manufacturing regulations and your customer’s requirements.
If your medical device manufacturing company has a good quality management system in place that has been incorporated into your company’s goals, then this provides an excellent way to reduce and avoid disparity in your finished products. Being able to do that will save you money and make your company more efficient.

ISO 13485 Makes Your Medical Device Company Globally Competitive

Being complaint in ISO 13485 will also make you more competitive globally, as it is required in Europe and in Canada and without it you won’t be able to market your medical devices to the countries within the European Union.
The bottom line is that if you want your Medical Device manufacturing company to be able to produce a consistently well-made, safe and regulatory passing product, as well as be competitive world-wide, then you need to get ISO 13495 certified.

New ISO 9001 Software makes it easy to maintain the Quality Management system.

David Barile — Wed, 11 Jul 2012 14:41:23 +0000

ISO 9001 certification is a reliable method that businesses are becoming certified in so that they can better keep track of the quality of their products, their capabilities and if their customers are getting the things they need through special audits and quality control procedures.
Because of the complexity of the ISO 9001 process can be complicated if a company isn’t properly prepared and doing that manually can be a nerve wracking experience. Therefore, it is very helpful to find special computer software, as well as applications for tablets or smartphones that can help your business get through this important process.

ISO 9001 software makes the certification process easier.

Computer programs contain all the proper ISO 9001 forms and any needed instructions for businesses to properly comply with the ISO 9001 certification process. They can work in your favor to make your job less stressful and easier when you are putting together your quality management process for the ISO 9001 certification procedure.

These special computer software programs are available both for regular computers, as well as in the for of apps for smart phones and tablets. This way you can easily carry the program around with you as you go from each department to get the required information you need, punch it into the program, and then use all your facts you have gathered to write up the required reports, etc. that you need to do as part of the ISO 9001 certification process.
You can also find DVDs and programs that offer pre-written templates that you can use to fill out during the certification process to give you a head start and save you time and money.

Some of these computer programs include ISOXpress, Paradigm 3 ISO 9001, ISO Documentation Software and more, as well as several apps that are available on iTunes app store. Take a look at these and other similar programs and see if they can make the process of your ISO 9001 certification easier to understand and accomplish. Document Control Software

AS9100 Certification is Critical for Quality Control in the Aerospace and Defense Industries.

David Barile — Tue, 10 Jul 2012 21:07:35 +0000

The AS9100 is a quality management system that is meant for the industries of aviation, space and defense, which means that it will affect all defense contractors as it is implemented.

What does AS 9100 Do for the Aerospace and Defense industries?

It covers the various requirements for the places that supply and regulate these industries, as well as their customers and is meant to help reduce errors in the supply lines, bring down costs, continue to improve the quality of products, and standardize requirements and qualifications in these industries so they are more aligned and everyone is on the same page with the finished products.

This means that if defense contractors want to continue to get awarded contracts for doing business with the aerospace industry or other similar places, they need to make sure that their products comply with the requirements of AS 9100. So, any company expecting to continue to do business needs to look into the steps to AS 9100 compliance now to be sure of future contracts without a break in their business supply lines.

How to get AS 9100 certification

In order to become registered and AS 9100 compliant a defense contractor should follow these steps:

• Review the AS 9100 standards
• Put together a team to oversee the training process
• Review their current processes and procedures and see how they align with AS 9100
• Select a registrar to facilitate the certification process
• Align the business’ policies and procedures to AS 9100
• Implement the new quality management system as needed
• Apply for AS 9100 certification

Doing these things in order to become AS 9100 compliant will help any defense contractors continue to be competitive in getting aerospace industry jobs.