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ISO 9001 True or False?
Everyone has their interpretation of the ISO 9001 standard. Let’s discuss some common misunderstandings, some of these myths, urban legends or perceptions of different requirements that may still exist:
Myth: Implementing and maintaining ISO 9001 is expensive.
- False: it does not have to be expensive. A company simply needs to document its management system based on what it already does and put in place the programs required to improve on them.
Urban Legend: 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 (for example, internal audit coordinator, corrective action coordinator, ISO coordinator).
- False: the ISO 9001 system covers an entire business, starting with customer requirements, review and acceptance of those requirements, executing those requirements, measuring and monitoring processes to ensure requirements are being met and then, ultimately, delivery of a product or service that meets those requirements to ensure customer satisfaction.
Perception: a quality manual has to plagiarize the ISO 9001 standard.
- False: the ISO 9001 standard states, “The organization shall establish and maintain a quality manual that includes:
- The scope of the quality management system, including details of and justification for any exclusions,
- The documented procedures established for the quality management system, or reference to them, and
- A description of the interaction between the processes of the quality management system.”
Perception: it is mandatory to have a document—for example, work instruction, flow chart, procedure—for every process in the company.
- False: ISO 9001 states, “NOTE 2 of the standard, the extent of the documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.”
This is just a short list of reasons why organizations struggle with ISO 9001 implementation. Do you have some of these myths, urban legends, misconceptions in your organization?
ISO 9001 Horror Stories
Some of the horror stories about ISO 9001 implementations include companies who have binders of procedures, work instruction, and forms (generally with a layer of dust on top) and have been trying to implement ISO 9001 anywhere from one to five years unsuccessfully. Some have spent fifty-thousand dollars and others more than two hundred-thousand dollars on internal resources and/or consultants. Some have had a prior quality manager that wrote a management system for them and then left the company and no other employee knew how to continue the quality management system requirements. Some have gone through three quality managers each of them defining, adding to the last management system, or changing requirements that result in confusion.
In many instances, we find that companies who have invested considerable time and money in the process of certification that they have a hard time letting go of it even when it has proven not to be effective or useful for them. A company must decide if they want to chase bad money with good money when faced with this problem. If you are one of these companies, consider letting the existing management system go and documenting a new and effective management system from scratch.
How many of you have an ISO 9001 implementation horror story to tell. The fact is there are far too many of you. This is your opportunity to share your story with other organizations that are just starting out. Sharing your story may help someone else avoid the pit falls of your experience and reap the rewards of your eventual success. Lets not act like capital hill, now is the prefect time to show solidarity and help our economy move forward. With each success there is a certain amount of blood sweat and tears that goes along with it. If it is possible for us to help just one organization become stronger by our lessions learned, this is the time and form to share.
What Should You Look For When Selecting ISO 9001 Templates For Your QMS?
ISO 9001 templates are the fastest, easiest and most cost-efficient way to begin your ISO 9001:2008 implementation. But let’s be perfectly clear, buying a set of templates and inserting your company name in them, “WILL NOT” make your company ready for certification. ISO 9001:2008 is more than a set of required procedures; it is a whole business process management system which is unique to each organization. The finest ISO 9001 templates can provide substantial advantages that will save time and money, but organizational participation and commitment to the success of the quality management system is the driving force which separates the successful implementation and maintenance of a quality management system from the unsuccessful.
There are many templates out there that promise certification, which may or may not happen depending on how the templates are implemented and the degree that an organization customizes them to fit their unique business needs. Make sure that the templates you select provides, at a minimum, the following:
- A Quality Manual
- All required procedures
- Flow charts for generic processes
- Training materials to help customize the templates
- Templates that are designed to highlight requirements that the company can customize.
- Forms- Internal Audit , Management Review , Competency, Training and Awareness , Corrective Action, Risk Assessment for Preventive Actions
- Consulting services to help customize the templates to meet individual needs (Should be included in the cost).
One last thing, make sure that the templates you are buying were designed by a professional with hands on experience implementing and auditing to ISO 9001:2008 quality systems.
ISO 9001:Why Do You Need Procedures and Process Control?
Why do you develop and implement policies and procedures in the first place? By adopting policies and procedures, organizations are generally trying to tackle one or more of the following organizational requirements:
- Decrease training time;
- Increase consistency;
- Fulfill compliance requirements for ISO 9001 or some other standard;
- Risks management assessment;
- Improve Communications, internally and externally;
- Preserve and convey knowledge;
- Document continual improvement and manage change;
- Decrease non-conformance rate;
- Streamline access to information; and/or
- Make duplication and growth easier.
If your organization is struggling with how to get started with documenting and organizing your quality management system, you’re not alone. As a Quality management consultant and lead quality management systems auditor, I see so many companies who just don’t get it. If you do a poor job documenting your quality management system you’re in for a lot of pain and heart ache. A competent auditor can tell in five minutes if an organization understands their own system.
So why not start with a firm understanding of how to develop and maintain your system, sounds like common sense, right? If you need help there are many consultants and training programs that can help get you started. Choose wisely and you will find that not only will you be prepared for certification, but also you just might make the improvements that do save money, time, and pain.
ISO 9001 and Training: What Do I Need to Know?
ISO 9001 is not just satisfying the documentation requirements and your of and running. Training everyone to the standard and their part in the process is key to your success. If everyone in your organization has a working knowledge of the requirements and process of becoming certified, you can begin to develop the roles and responsibilities and the documentation. Once you have identified the roles and responsibilities and have developed the necessary documentation, you need to begin the training to each of the defined processes.
Here is the best part, by developing a robust training program you can reduce the amount of work instructions required to manage your processes. . The amount and extent of an organizations documentation, above and beyond the required documentation called out in the standard, is directly related to the amount and extent of the training an organization provides to its work force. This is not to say that you will not need some work instructions. Some training that you will need to consider while implementing your quality management system:
- ISO 9001 Introduction
- Corrective/Preventive Action
- Root Cause Analysis
- Introduction To Process Mapping
- Documentation Training
- Internal Auditing
- Quality Policy Training
- Job Specific Training
- Management Review Training
What Happens Now That I Have My Certification?
At last we have attained certification, boy am I glad that is over. If this is what you are thinking right now, you have missed the point. Certification to ISO 9001, AS 9100 or any standard does not have a start and end point, (Implementation and Certification). Becoming certified is a continuous process which if implemented and attained correctly, with the right mind set, will result in lowering costs, and ongoing improvements for your business.
Never think that once you have reached your goal of certification that you are finished, now the hard part begins. Now you must live your quality management system day in and day out. Your processes must continue to be audited and improved, tracked and reviewed, trained and understood by all. This is your chance to reap the rewords of your planning, doing, checking and improving to become a world class organization and not just a another company with a certificate on the wall.
If you truly want to get the most out of the money and time spent to get that certificate, I suggest that you focus your attention on maintaining your system to reach peak performance. You will save money, improve relations with your customers, and knock the socks off of your competition. So why not take this certification and make it work for you?
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?
Your Internal Auditing Process, Does It Hurt Or Help Continuous Improvement?
A Quality audit is the process of organized inspection of a quality management system carried out by an internal or external quality auditor or an audit team. It is an important part of organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly-defined internal quality monitoring procedures linked to effective corrective and preventive actions. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards a process approach of the actual effectiveness of the Quality Management System and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined objectives, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
Internal audits should always be performed with the intension of improving the overall systems being audited, never as a fault finding or witch hunt practice designed to punish. If internal audits are properly executed with a spirit of open communication and real process improvement, this process can be the single most important driver for continual improvement. Done wrong, the internal quality audit processes can create a culture of fear which will hinder continual improvement. It is important that everyone within the organization clearly understands the objectives of quality auditing and their role in them.
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.