Posts Tagged ‘ISO 9001 Certification’
ISO 9001 Documentation
As a third party auditor, I have seen so many examples of how not to document your quality management system. Most of the mistakes stem from lack of understanding of what the standard really does require. So many times I see companies who have paid someone to come in and document “their” system and nine out of ten times the system is either too complicated or does not reflect what they actually do. A full 90% of the non-conformances which are discovered during a surveillance audit have nothing to do with meeting the requirements of the standard, but are written against the requirements the company has imposed on themselves.
I’m here to tell you it doesn’t have to be so hard to meet the requirements of ISO 9001:2008 and manage your quality management system documentation. Hiring an outside consultant can be a great experience when the consultant facilitates the activities involved in developing your quality system, but leaves the ownership and management of the system to you. This is your system, not the consultants, and should be developed and implemented by your organization so it reflects the actual practices, processes and documentation of your organization.
There are only six required documented procedures and a quality manual that you “have to have “ , all other procedures that you develop are up to you. Don’t add procedures that do not add value to your processes. If you need a procedure to complete a process properly or a customer has required it of you, then you must have that procedure. If you want to have procedures for training purposes only, then call them just that. The key is to keep it simple and manageable, you’re in business to make a profit, not manage a monstrous quality management system. If you are not sure how to go about tackling ISO 9001 certification, call a reputable consultant, they can help set you on the right path. In the end, it is your system, and it should reflect what you do in a way that is transparent and easy to maintain.
ISO 9001 Is It Just Another Expense?
When I hear a manager say ISO 9001 is just another expense, I immediately know that this organization doesn’t have a clue what ISO 9001 is. Lip service is just that, if you put nothing into your quality management system, you will get exactly nothing in return. ISO 9001 is a quality standard which aims to guide an organization to understand its own business better so that it can meet or exceed its customer needs. By implementing a “successful” quality system the organization will see tangible improvements that lead to reduced costs and increases in market share.
How does this happen, the reduced costs and increased market share? Well if you think just because you plop a system in, you will instantly see the money, think again. This is a process, a process that develops and matures over time which is spurred on by increased awareness and understanding throughout the organization. As you learn more about your internal processes and link them to your customer needs, you will begin to reap the rewords of your efforts.
So get serious about your companies goals and how you will achieve them, (plan) your processes, work your system (Do), (Check) your progress toward achieving your objectives, and make the necessary changes along the way to keep on track (Act). If you are like so many other companies out there, you could use a little help getting started. There are plenty of quality consultants and classes that can do just that. But once you finally “GET IT; your system should become an effortless process that runs like a Swiss watch. This process should not add work or drain resources; rather it should run itself because it is how you do business every day.
Don’t get involved in ISO 9001 with the belief that it is just another expense. Make the process pay for itself by understanding, believing and promoting, and driving your goals and expectations to completion. Lead and you will succeed, or don’t and throw your money and future expectations away. One thing is for sure at the end of the day, if you don’t put your best foot forward, somebody else will.
Calibration, What’s Missing from Your System?
Quality management system standards homogeneously have requirements for controlling the devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. As a third party auditor it has come to my attention that everyone seems to miss something. It’s almost unavoidable. Perchance it’s because this process is by and large referred to as “calibration” and the rational image it invokes is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more complex, addressing apt consideration for gages, thermostats, software, jigs, timers, known-good-samples – a multiple of devices for measuring product or process. Controlling monitoring and measuring devices must, therefore, include multiple aspects.
Some areas which you should consider when setting up your system should included:
*Identifying which devices need to be calibrated and which do not (you decide based on your quality criteria and your customer requirements).
* Defining the frequencies needed to insure calibration is well controlled
* Indicating the status of equipment; calibrated or out of calibration
* Determining alternate methods of “control”
* Determining what to include in the procedure
* How will you handle certificates of calibration
* Will you use outsourced calibration services and how will you control this if you do
* Defining storage and preservation criteria in your process
* Defining recall programs and contingency plans
ISO 9001 Internal Auditing Success
The third party auditor will audit your system once or twice a year, so why do you have to conduct internal audits? The first and most obvious reason is, if you wait for the third party auditor to tell you your system is in trouble, you are missing the point of continuous improvement all together. The second reason is that the third party registrar does not consider the surveillance audit as an internal audit. The standard requires that “you” perform planned internal audits of your system based on status and importance of the processes and areas to be audited. If you do not know whether or not your quality management system conforms to your planned arrangements, or the standard, then how can you determine if you are improving? The ISO 9001 standard is based on the Plan, Do, Check, Act principle of continuous improvement. Internal Auditing is the “Check”, and without it you may never know when to act.
The internal audit process need not be a time consuming; there are many ways an internal audit can be accomplished. Every day we conduct countless audits without even knowing it. A manager who walks the plant floor may notice a process which is not working as intended, a worker may notice that the forms he, or she is using are outdated , receiving may find that the same supplier never send the correct paperwork with the products they provide; these are audits that never get documented. These audits are not planned, but they are audits none the less. The planned audits do not have to include all of the processes in your facility once a year, remember “Status and importance”. Go after the low hanging fruit first, (areas where you are having issues), then review the other areas as needed. Whatever you do, DO SOMETHING, or your entire quality system will fail to accomplish the goals and objectives you have set for your organization. My philosophy is simple, if you are going to invest the time and money to become certified, get the full value of certification or you will be wasting your resources for nothing.
ISO 9001 Paper or Software?
When setting up your quality management system it is important to understand your options and their advantages and disadvantages. I have been involved with developing and implementing ISO 9001 and AS 9100 quality management systems both through a manual paper system and an automated software system. Each option has very distinct advantages and disadvantages which can help you determine which way your organization should go.
Option # 1 the paper system. This system is best implemented in a small to mid size organization where control is easily maintained. A paper system can get extremely convoluted in larger companies, which can result in inadequate control and subsequent non-conformances during a third party audit. The key to implementing a successful paper quality management system is to keep it simple and manageable. If your system requires excessive maintenance it will become a burden which may result in the failure of the system to yield the continual improvement objectives that it was set up to achieve.
Option # 2 the software approach. This system is advantages in both small and large companies and offers the added advantage of organization and control for your entire quality management system. By setting up your system digitally you can automatically control revisions and distribution of your documentation. You will also be able to communicate non-conformances, progress towards objectives, internal audits, calibration control, preventive actions, and supplier control and customer satisfaction. Your only real limitation with this system is the level of access your organization is capable of providing. If the rank and file is unable to access the system it does you little good. The best digital systems are internet based SaaS systems which offer access anywhere, anytime to internal and external users such as customers and suppliers.
ISO 9001 Management Rep, Who Me?
Has this just happened to you? You walk into a staff meeting and it is announced that the company has decided to implement a quality management system and you will be the proud own of this system. Does a deer in the headlights come to mind as you struggle to catch your breath. How will I ever be able to run this program and do my real job too? I have little to no experience with ISO 9001 and I don’t have the foggiest idea of how to begin, Help!
Stop panicking and Liston up. ISO 9001:2008 is the newest version of the popular international standard that many manufacturing and service industries subscribe to. Some of the requirements in ISO 9001:2008 include:
- a set of procedures that cover all key processes in the business;
- monitoring processes to ensure they are effective;
- keeping adequate records;
- checking output for defects, with appropriate and corrective action where necessary;
- regularly reviewing individual processes and the quality system itself for effectiveness; and
- facilitating continual improvement
Take a lead auditor course, or hire a professional quality management consultant to help you implement your quality system. Depending on the size and complexity of your organization and its processes, you can find a competent consultant that can help you document your system, train your employees to the system and facilitate your management reviews and internal audits.
If you opt to go it alone, the best advise, get educated to the ISO 9001 standard. Some companies use templates to document their system. This can be a great time saver if done properly. The key with using templates is to make sure you customize them to your individual processes. Another option is software applications that help organize and manage your new system. One in particular that I have found helpful is CIS Software. This software application is an on line SaaS system which includes all of the required criteria of the ISO 9001 standard.
What ever you do, “KEEP IT SIMPLE”. Do not invent processes and producers that you will never use, these will be the land mines that will sabotage your certification efforts.
ISO 9001 Done Right, Done Wrong, What is the Ultimate Goal?
I have had the chance, as a consultant and Lead QMS Auditor, to see ISO 9001 in companies big and small in many industries such as manufacturing, service, technology, aerospace, warehousing and others. I’ve grown to understand a few things that seem to make all the difference in how ISO 9001 impacts an organization, either positively or negatively.
In the worst of circumstances, some companies regard their ISO 9001 certification as an accessory that has been uncomfortably inserted into the fabric of the organization. In these companies, ISO 9001 is something to present to an auditor once a year. When the annual audit comes due, everyone rushes around to tidy up the place because “we can’t allow them to see how we really live”. Somehow they placate the auditor enough to come away with an extensive list of corrective actions to address, while still retaining their certification. Once the auditor leaves, the “QMS” is quickly shoved aside so it is out of the way of the “actual” business that needs to get done.
Somewhat better are those companies who at least try to keep up with everything through the year unless an “emergency” comes up or everyone becomes too busy. Unfortunately the crisis-of-the-month and the too-busy-with-the-customer excuses are quite routine and, worse, acceptable justification to “work around the system”. In too many cases these short term lapses become the standard operating procedure. Once the dust settles things get mostly caught up until the next “all hands on deck” is signaled. These companies commonly think of ISO as a “necessary evil” that has to be tolerated.
On the flip side, there are a significant number of ISO 9001 certified organizations who appear to “get it” when it comes to achieving real value from their ISO 9001 quality management system and have incorporated it into their daily business processes. In these companies, the management team has learned how to use the requirements imposed by the standard to their advantage by solving real problems and consistently achieve real improvements in business objectives. These organizations actually achieve real benefits by using the standard as a lever for improving both customer satisfaction and their own bottom line.
I have worked with many ISO 9001 success stories over the years and have come to realize that there are a few unmistakable similarities in how they were able to reached their goals .
In either case, the “magical prescription” to achieve genuine value from IS0 9001 are a direct result of:
- Keeping it simple (K.I.S.S)!
- Focusing on business importance!
- Never doing anything just to please an auditor!
My Customer Wants Us Certified to AS9100, HELP!
You are a small business owner who has just been told you must become certified to AS9100 in order to continue to receive business from your largest customer. You have been putting this off for some time, hoping you would be able to wait until the economy gets better. Now what, you have a deadline and you haven’t got a clue how to get there from here? The best advice, find a competent consultant and get some training to the standard.
Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you. A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration. Key services you will require, if you have no idea what you are doing or how you will do it are as follows:
1. Required documentation development and implementation
2. Training: Quality policy and objectives, Management review, Corrective and Preventive action, Internal auditing, AS9100 Overview, Risk analysis, Overview of the Complete QMS, Collecting and analyzing data.
3. If software is being used to facilitate and run your quality system, you will also need training and implementation services for this.
4. Implementation of a competency, awareness and training program, internal audit, corrective and preventive action programs, management review and overall continual improvement programs.
5. Conduct internal audits for entire system (all processes), one high level internal audit to the AS9101C checklist in preparation for registration audit.
This is just a short list of services that you may need to accomplish your goal of certification to AS9100. Depending on the size and complexity of your organization and processes more may be needed. A good consultant can help you determine your individual needs.
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.