Archive for the ‘ISO 9001 Certification’ Category
ISO 9001: Determine the necessary competence for personnel performing work affecting conformity to product requirements (Section 6.2.2 a)
There are two excellent reasons to train employees to your quality management system and your processes:
• Every employee can have potential impacts on the QMS; and
• It is a requirement of ISO 9001:2008 and virtually any well functioning quality system
Each person and function within your facility plays a critical role in the quality management system. For this reason, your training program should cast a wide net. Every employee and manager should be aware of the quality policy; the significant impacts of their work activities, key quality roles and responsibilities, procedures that apply to their work, and the importance of conformance with ISO 9001 requirements. Employees should understand the potential consequences of not following the requirements of the QMS (such as poor product performance, reduced customer satisfaction, and loss of business).
All personnel should receive appropriate training and support to be competent at their work.
Training should be tailored to the different needs of various levels or functions in the facility. However, training is just one element of establishing competence, which is typically based on a combination of education, training, and experience. You should establish criteria to measure the competence of individuals performing tasks that can impact on the quality of your products.
Training is needed both in technical work and for general awareness on the part of all employees
To define requirements for each job position questions to ask:
- “What job-specific knowledge area(s) must be well understood by someone in this job?”
- “What manual, mental or interpersonal skills must an employee have to do this job well?”
- “What natural abilities or talents must someone possess to be effective in this job?”
The result from this exercise is a list of competencies for the job that can be used for hiring purposes and subsequent training and development plans. Once the list is prioritized to include only the most critical competencies, you will need to document them in some appropriate manner (job descriptions, training matrix, or other means).
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.
Finding an ISO 9001 Auditor that fits the needs of your company
Finding an ISO auditor that fits well with your company is fundamental to a successful certification experience. You want to work with a person that you are comfortable with and that is comfortable with you! Here are some tips that you can follow to find an auditor that you know you will work well with your company:
Try to find a registrar that has somebody who can answer your questions, someone that you feel comfortable with and meets your financial requirements. Make sure the registrar has auditors with experience in your area. What good is a registrar that has an auditor that lives down the street from you if they’ve only audited service processes? They’ve never audited a machine shop, and you’re a machine shop.
You want an auditor that fits you and your company and gives you good observations and opportunities for improvement as they audit. Ask to talk with your potential auditor. It’s always nice to be able to converse with somebody so you get to know who they are before you meet them. If they are in the area, maybe they can drop in just to talk to you, just to put a face to the name.
Some registrars have auditors all over the United States and even some overseas. Be careful when you are trying to find an auditor close to you. Sometimes you are going to find that the auditor you like isn’t close to you. If you like that person, and are willing to pay travel expenses, the registrar should be happy to send that person to you.
Remember you are the customer, make sure you exercise your right to selecting the auditor that best fits your needs.
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.
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 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?
ISO 9001 Helping Select and Manage Your Suppliers?
When you purchase products or services from a supplier, you have two primary considerations:
1. Will the supplier you eventually select provide the best overall value or service which is consistent with your requirements?
2. Does the supplier have the ability to consistently provide the quality desired?
For consideration one – as the customer, you must specify criteria and quality objectives for the product. Through the use of your own quality management systems, you then confirm that delivered product meets your specifications.
For the second consideration – you may want the supplier to have a quality management system of their own to insure consistent controls are in place. How much control? To answer this, you need to consider the following questions:
· What (goods or services) will you be purchasing?
· What significant impact could these products have on the products you make and sell to your customers?
· What are the risks to your business if you experience a major upset as a result of a product non-conformance caused by these products?
· What do you know about the character and past performance of your supplier?
ISO 9001:2008 provides requirements for the purchasing process that your organization can implement, to develop and improve relationships with suppliers. These requirements include:
· Establishment of criteria and quality objectives for products or services you expect to purchase
· And quality management system controls that you require your suppliers to develop to meet your organizational requirements.
Supplier surveillance audits are very advantages when working with a supplier who’s product could have an major impact on your continued success. By periodically auditing these suppliers to your requirements, you will be ensuring that their quality management system continues to meet the needs of your organization. Even with the best of relationships, changes can occur that may cause unforeseen catastrophic results. Keeping your supplier close and monitoring their quality system will strengthen the relationship and reduce the chances of a major upset.
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!