Posts Tagged ‘iso 9001’
ISO 9001 Lesson Learned
ISO 9001:2008 is the foundation of many of the quality management standards now available to organizations worldwide to help organize and maintain product and service integrity. The standard in and of itself, does not tell you “HOW “ to do anything but rather it tells you what quality programs and processes you need to establish to meet the requirements of the standard. For example: The standard has numerous passages which state the organization “SHALL” develop and implement something to comply with the standard. The organization “SHALL”:
- determine the processes needed for the quality management system and their application throughout the organization.
- determine the sequence and interaction of these processes.
- determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
The quality management system documentation “SHALL” include:
- documented statements of a quality policy and quality objectives
- a quality manual
- documented procedures and records required by this International Standard
- documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
As you can see, nowhere in these requirements does the standard tell you exactly how to carry this out. Where many companies fall short when trying to interpret the actual intent of these requirements, is the planning process. How much documentation is enough and how will we satisfy these requirements so that what we say we do is actually what we do. A lot of the confusion comes from not understanding the standard, and then ultimately doing too much or too little. Most of the non-conformances that the third party auditor will eventually find, (90%), are written against the self imposed requirements of an organization, not against the standard itself. For example: Some companies buy document templates and insert their name here and there, but never modify the documents to meet their individual process needs. Every company is different, so you cannot buy a caned quality system without modifying it to your particular needs.
Get educated to the standard and or hire a business management consultant that can guide you through the process. ISO 9001 as well as most of the other standards out there does not have to complicated or overly time consuming. Get the most out of your system, and avoid the pit falls generated by lack of understanding.
ISO 9001 Follow-up For Effectiveness
The ISO 9001:2008 stand requires follow-up for effectiveness when corrective or preventive actions have taken place. Many companies do a great job of identifying corrective and preventive actions, some even excel at following through and completing these actions. But where most organizations fall short, is following up to see if what they have enacted, actually had the desired affect and corrected or prevented something from happening again or in the future.
Some organizations do follow-up for effectiveness, but never take the time to record the results of this activity. There are several areas in the ISO 9001:2008 which actually require follow-up actives take place:
1. Section 8.2.2 Internal Audit states 
follow-up actives shall include the verification of actions and the reporting of verification results.
2. Section 8.5.2 Corrective Action states that a documented procedure shall be established to define requirements for reviewing the effectiveness of the corrective actions taken, and records of the results of actions taken.
3. Section 8.5.3 Preventive Action states that a documented procedure shall be established to define the requirements for reviewing the effectiveness of the preventive actions taken, and records of the results of actions taken.
If you are certified to ISO 9001 or some other quality management system, my question to you is this; Why wouldn’t you want to know if the time and energy you put into implementing a corrective or preventive action actual paid off? If you are going to invest the time and money to have a quality management system which is certified to a standard, shouldn’t you get something out of it? Without the data to support your decisions, aren’t you just spinning your wheels?
Supplier Quality Management Benefits, Responsibilities
There are benefits to creating strong relationships with suppliers from a customer’s perspective especially if a standalone supplier quality management function exists. Supplier measurement can take place, risk mitigation exercises (both reactive and proactive) can be accomplished and information and improvements can be shared for common gain. A supplier quality management function can create a community for all those involved , Account Managers, Supply chain Consultants, Supplier Performance Managers, in which they can integrate knowledge and deliver profit generating opportunities for both organizations through the exploration of additional, above and beyond current contract business opportunities .
Executive involvement is vital to the success of aligning the relevant strategic players to accomplish objectives and form the basis of building partnerships and ultimately unlocking value for both organizations. The Procurement functions should take the central role in coordinating supplier relationships, at the same time as owning and coordinating the process, authority and technology.
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 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.
The Templated Quality System: Mistakes Made
Time and time again I walk into an organization to audit their quality management system and I find that the overall processes and controls are well understood and executed, but the documentation just doesn’t match actual practices. Templates are great tools to help an organization meet the documentation requirements of ISO 9001, AS9100, or any standard. The problem is, most companies buy the templates and insert the name but never modify the templates to their particular processes. The results from such miss use of this tool are non-conformances found during a surveillance or registration audit.
Templates can help save time and help an organization cover all of the requirements of the standard, but they can hurt and organization if they are not used properly. Plan your processes and understand the standard that you have chosen to become certified to. Knowing what is required and what is not can help you to modify the templates to reflect your organizations actual practices. Most non-conformances, about 90% to be exact, are written against what the organization has required of itself or documentation that does not match the processes, not the standard. So if you are thinking of buying a template system, know what you are getting into and spend the time to modify them to match your processes.