Posts Tagged ‘iso 9001 training’
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 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?
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 Documentation
The first step in implementing an ISO 9001 system is to document your management system by developing the required documentation which consists of a quality manual and six required procedures:
1. Control of documents
2. Control of records
3. Internal audits
4. Control of nonconforming product
5. Corrective action
6. Preventive action
The ISO 9001:2008 standard also allows you to further simplify you documentation by combining some of these procedures:
- Control of documents and records
- Corrective and preventive action
So, instead of six individual documents you might have four. Now, depending on the size and complexity of your organization and your employee training programs, you will need to add any additional procedures necessary to meet your organizations objectives and customer requirements.
Documentation can sometimes become a mine field during a registration audit because some organizations over document their system because they believe they have to detail everything. If your organization has little or no ISO 9001 training it is best to get training or hire a good ISO 9001 consultant who can help you develop your quality management system documentation. Don’t just spin your wheels, get help and save time and money!
Making the Grade
Once your business has been up and running for a few years, it is easy to take some of the day-to-day practices for granted. Often times, people will become complacent and important details may be overlooked. One of the best ways to check the status of your company and ensure that all of your ducks are in a row is with an ISO Internal Audit.
Through this auditing system, you will get an objective view of all of your business practices and record keeping. There are several companies that provide certified third-party auditors that can help you get a gauge on your business and point out areas that aren’t up to snuff. No matter what product or service you are providing, it is important to maintain quality records and documentation, and an internal audit can ensure that you are doing just that.
Benefits of ISO 9001 Certification
If you are unfamiliar with ISO 9000 standards for quality management, you may be wondering why it benefits your business to meet these standards. ISO standards are designed to ensure that your employees are working to their full potential and that your clients are satisfied. Reforming your business to qualify for ISO 9001 certification will garner both internal and external benefits.
Some of the basic requirements for certification include implementing a set of procedures to cover the basic processes of your business, as well as having a system for checking these procedures. You will also be held accountable for maintaining accurate records and performing continuous reviews of your employees and business practices.
Finding Outside Help For Your ISO 9001 Quality Management System Development
Business management consulting can offer a variety of assistance on ISO 9001 quality awareness training, system evaluation, documentation writing/review and internal auditor training. One sign of an experienced consultant is someone who actively engages all appropriate levels of personnel in the process. Experience within your marketplace, specific standard knowledge and the right “chemistry” are other considerations. Using a consultant will increase your cost. However, the guidance and experience of the consultant may reduce the time it takes for you to achieve your ISO 9001 certification.
Registrars are not allowed to consult. They cannot advise you on how to solve a problem. They do highlight where problems exist. The strict separation of auditing and consulting is a fundamental ethical requirement of all ISO 9001 Registrars. Selecting the right Registrar for your situation is critical. Cutting corners at this stage could jeopardize your entire quality initiative. You need to find a Registrar that will work with you as a partner, take the time to learn your organization’s needs within the context of your ISO 9001 effort and reflect your passion for quality.
Seven Steps To Implentation of ISO 9001
For a successful implementation of your Quality Management System, the following seven steps are recommended:
- Fully engage top management – Determine and define why you want to implement ISO 9001, Determine and define your mission, vision, and values in your organization , Define your organization’s stakeholders : customers, suppliers, stockholders, employees, society, etc., Define your quality policy, and , Define and align organizational objectives and related product/service quality objectives.
- Identify key processes and the interactions needed to meet quality objectives
- Implement and manage the QMS and its processes (using process management techniques
- Build ISO 9001-based QMS-Identify ISO 9001 requirements, Map these requirements with your implemented QMS, where applicable, Make a gap analysis : identify where in your existing system the requirements are fulfilled, and where they are not, Include in your QMS processes the activities, procedures and controls needed.
- Implement the system, train company staff and verify effective operation of your processes
- Manage your QMS- Focus on customer satisfaction, Monitor and measure the operation of your QMS, Strive for continual improvement, Consider implementing business excellence models in the company operations.
- If necessary, seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity