Posts Tagged ‘ISO 9001 software’
The Internal Audit and Follow-up for Effectiveness

O.K. now that you have defined your internal auditing process, and have a few audits under your belt, what have you learned that will actually help you improve your organization? Corrective and preventive actions have been assigned, responses have been logged, and actions have taken placed. Did the actions taken, improve the process? This is probably the biggest stumbling block I have seen as a third party auditor, follow-up for effectiveness. Did anyone review the effectiveness of the corrective or preventive action; did it accomplish what you intended? If you do not go back and review the results of the actions taken, you have missed the boat on continual improvement. To merely find areas for improvement without making sure that they have been addressed and actual improvements have been made, is never going to move your company closer to sustained success.
Your business management system can be the best possible way to propel your organization to a new level of profitability and success, use it effectively! Make your quality management processes work for you and you will realize actual benefits that will lower costs, improve cycle times, reduce scrap, and improve customer satisfaction. You can skate by with your paper certificate, but wouldn’t you rather get something for your money?
Time Saving, Money Saving ISO 9001, AS 9100 Alternatives

There are now products and services available that make it possible to work together with one or more of your staff online to create and write or revise the necessary procedures that are required by an ISO 9001 or AS 9100 system. Your staff can be at different locations or even at their own desks within your company. There is no need to meet in a conference room, since the conference room is virtual (on the Internet). This approach reduces costs dramatically and results in a better and more efficient working relationship.
First, this technology makes it possible to work at your pace and at your schedule to meet the project’s deadline;
Second, there are no flight, hotel or meal costs! Huge cost reduction;
Third, you can work with your ISO consultant and multiple managers at your facility or at your facilities across the nation in one meeting;
Training is the most important feature of any management system. The better trained the better performance you can expect from your staff. This technology can also make it possible for your ISO 9001 consultant to provide training online to one or many of your employees at the same time. This training can be at your schedule and because the training is performed online, there is no travel, hotel or other expenses.
ISO 9001 Is Steeped With Myths and Misconceptions

Why do so many companies shy away from becoming certified to ISO 9001? For one thing, ISO 9001 is steeped with myths and misconceptions. Let’s examine some of these.
- Perception: My Quality Manual has to plagiarize the ISO 9001 standard: False, if you have referenced the standard in your manual, why would you need to recreate it again? What would be the purpose? The only requirements stated in the new ISO 9001:2008 standard are: a scope which includes any exclusions you may have, the procedures or reference to the procedures for your management system and complete description of the interaction between the various processes that are required to operate your business.
- Perception: I must have a document (work instruction, flow chart, procedure, etc.) for every process in my company: False, The extent of the documentation that your organization will require depends on the size and complexity of your organization and how well your employees are trained to do their jobs. The only time a procedure is required is when someone cannot do their job without it. If your procedures are collecting dust, get rid of them, they will come back to bite you.
- Perception: Implementing and maintaining ISO 9001 is expensive: False, a quality system done right is both a money saver and time saver. The use of ISO 9001 software and other tools have made the job of implanting and maintaining a well run quality management system an effortless task.
- Perception: The ISO 9001 system is a Quality System (belongs in the quality department or is the responsibility of the quality manager), or many organizations feel they need to hire somebody full time to manage the ISO 9001 system (internal audit coordinator, corrective action coordinator, ISO coordinator, etc.): False, the quality management system belongs to everyone in the organization and can be assigned to any individual within the organization. Many companies assign the plant manager or supply chain manager as their management representative. Keep in mind this system belongs to everyone and everyone must participate to make it successful.
A Better Way to Manage Internal Audits and Management Reviews
Many organizations struggle with how to manage and maintain their internal audit and management review processes. While no one sets out to deliberately miss manage these processes, they can take on a life of their own. So, how do you better manage these processes? The ISO 9001 standard does not expressly tell you how, but it does tell you what is expected. Does the standard say you have to actually meet to satisfy this clause of the standard or does it tell you that you have to review the necessary criteria at set interval? If it were possible for top management to review all of the in-puts and out-puts of a management review and assign actions with follow-up, without actually sitting in a meeting, how much more time could be spent on actually improving your systems?
Meeting/audit module in CIS Software is a powerful management action item tool and may be used for many other functions other than just meetings and audits. Because of its design and ability to assign action items to a manager or group of managers and to follow-up on these action items until completion, this module is truly invaluable.
By using the meeting/audit module, there is no need to hold follow-up meetings to review and ensure that previous action items from a meeting or internal audit were completed. Since holding these follow-up meetings is the normal management approach in most organizations, this module alone will cut your valuable meeting time by more than 30 %.
Furthermore, the meeting/audit module includes special tools for Process Auditing. Since the management meetings are all shown on the master calendar and audits may be scheduled monthly, quarterly or yearly, the internal audit plan is always at the click of a mouse. Furthermore, the auditor and auditee is always informed of these audits on their personal calendar and on the master calendar
Business Management Software For Sustained Success
Business management software has become a great way to improve an organizations business processes and communications while reducing the amount of time and effort it take to manage the system. Years ago everything was done via telephone, in person or by way of formal letter. In the past few years things have become more immediate with the advent of the internet, e-mail and other software applications such as cis software. We are now able to communicate instantly from anywhere in the world, how great is that!
But what are the real tangibles that come with this new technology? Lower costs from reduced travel needs? Faster resolution of critical business issues? Improved communications with customers and suppliers to make the act of doing business more responsive? Or, is it just the knowledge that your overall business management systems are working 24/7 whether you are there or not? My vote would be, all of it. There is no need to struggle with how to implement and maintain a quality management system that not only meets the requirements of iso 9001, or any standard for that matter, but actually reduces costs and improves productivity.
ISO 9001 Software Solutions For Obsolete Documentation
A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed. CIS software can reduce the need for a system based on the production of hard copy documentation, therefore reducing the possibilities for nonconformance’s due to obsolete documentation use. A CIS consultant can open up whole new possibilities for an organization struggling with document control, and much more.
If the only documentation available for use is always current and all obsolete documents are stored in a history tab (Unavailable for use), then the auditor will never be able to write another corrective action based on the use of obsolete documents. Wouldn’t that be great! And just think, how much time will that save when you no longer have to hunt down all the obsolete documents in your facility before the auditor arrives. Bliss
Preventive Action Is Alot Cheaper Than Corrective Action
While corrective action is the result of something going wrong (an incident), preventive action seeks to identify possible issues before they become failures or incidents. Preventative action is a lot cheaper and is often easier to implement than corrective action – which only happens after the event.
When a possible non-conformity is raised by whatever means, the owner of the area in which it is raised must:
- Determine a solution to reduce the risk identified by completing the preventive action to determine how to reduce the risk to an acceptable level
- Submit the preventive action to management for consideration and if approved it will be implemented.
- If the preventive action is not accepted then the owner of the area must determine another solution to address the issues raised.
CIS software is an incredible tool for implementing and following up for effectiveness of preventive actions. This tool can effectively automate the continuous improvement process of any organization that seeks to stay ahead of the competition and deliver the best possible services and products to its customers.
ISO 9001 vs. Six Sigma
Six Sigma is a statistically-based process that strengthens organizational ability for ongoing business process improvement. “Six Sigma” or “six standards of deviation” endeavors to reduce defects to a rate of 3.4 defects per million defect opportunities by identifying and eliminating causes of variation in business processes. In defining defects or errors, Six Sigma focuses on developing a clear understanding of customer requirements and is therefore very customer focused.
ISO 9001 and Six Sigma serve two different purposes. ISO 9001 is a quality management system, while Six Sigma is a strategy and methodology for business performance improvement. ISO 9001, with guidelines for problem solving and decision making, requires a continual improvement process in place but does not indicate what the process should look like. Six Sigma can provide the needed improvement process. However, it does not provide a template for evaluating an organization’s overall quality management efforts whereas ISO 9001 does.
ISO 9001 Business Management System; Corrective vs. Preventive Action
Corrective and Preventive Action Processes are two different processes within ISO 9001 requirements.
There is a great deal of confusion between the 3 areas covered under the ISO 9001 standard, corrective action, preventive action and preventive maintenance.
Corrective action treats a nonconformity or problem that has already occurred. The problem exists. The nonconformity lives and needs to be addressed.
Preventive maintenance focuses on the care of machines. It is a system that protects machines from breaking down. ISO 9001 auditors do not look at preventive maintenance as preventive action. Preventive maintenance is important for the infrastructure (resource management) section of the ISO 9001 standard.
Preventive action determines and eliminates potential causes of non conformities. This means the non conformity has not yet happen. If you act to prevent a problem from occurring then this is a preventive action. The ISO 9001 standard requires you to take preventive action to eliminate potential nonconformities.
There are ISO 9001 software applications that can help guide an organization through this murky area within the ISO standard. A certified CIS consultant can show an organization just how simple it is to report, track and follow-up on corrective and preventive actions. If that’s not enough, there are also ISO 9001 templates available to help clarify the standard requirements for these and other areas of your business management system. So if you are looking to start a new quality management system, or just take your old system and reengineer your process to promote continual improvement, help is not far away.
What Is The Role Of ISO 9001?
The objective of any standard, whether it relates to the manufacture of cars, airplanes, machinery, or the delivery of a service – transportation, hospitals, etc. – is the same. Standards are designed to promote, facilitate and enable consistency in a process or product; to provide assurance that the process or product output will meet requirements; to provide a uniform and predictable output every time a set of procedures are executed. Because standards assist buyers and consumers in establishing confidence levels in the products and services they procure, standards facilitate fair trade practices.
Without satisfied customers, an organization’s future is at risk! To keep customers satisfied, the organization needs to meet and/or exceed their requirements. The ISO 9001 standard provides a universally recognized, tried and tested framework for taking a systematic approach to managing the organization’s processes, so that they consistently turn out product that satisfies customers’ expectation.
So, who shall survive the resent economic down turn, and who will succumb to it? Small businesses are in a unique situation to position themselves for the future. Obtaining certification need not be a costly time consuming process. There are many business consulting firms available today that are uniquely equipped to provide the newest and lest expense tools and guidance to help an organization of any size obtain certification. So if you believe that ISO 9001 is something that can help your company meet the changes of today’s world, you don’t need to spend hundreds of thousands of dollars to get there, and don’t let anyone tell you that you do.
