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Read this article carefully. It would assist you understand what the ISO 9001 certification actually is!! Our definition for the ISO 9001 Standards is:
- Control over what is happening in your organization
- Clarity of information
- Control over working processes and the product realization
Implementing the ISO standard will provide you with answers for questions that nobody in your organization is able to answer. Or does not want to…
Before we start, this is an introduction for the implementation process - during this article we will refer you to more specific articles with more specific information to your more specific questions. You are also welcomed to send us mails with questions regarding the implementation process. We can't promise anything but we will sure try.
In this article we would present you some alternative solutions for achieving the certification for the ISO 9001 Standard. Note: The certificate is merely a reward received at the end of the implementation process; the process itself is what brings growth to the organization. In other words, do not do it only for the certification. If you chose to implement a quality management system according to the ISO 9001 requirements - try to get the most of it for your organization. We highly recommend adopting the ISO standard. While it might not be shining and glamorous, it brings a lot of knowledge and, most importantly, it is the best know-how for your organization – it is a control tool in your hands. We would present the basic elements of the implementing process and some alternative solutions for achieving the requirements and certification for the ISO 9001 Standard. The solutions are here to make the process more easy and flowing. Implementing the ISO standard is a strategic decision. It is a less measurable project when compared to something like implementing a new product, a new service or a new machine on the production line. The outputs of the project do not manifest themselves like a sales commission, an end of installation or delivered merchandise. Only after a period of time will the employees feel the difference and understand that the process provides order to the organization. It’s important to understand that it’s not an overnight process. It takes time and requires devotion.HOW TO MANAGE THE PROJECT? At this point, it’s likely that some questions arise such as “what is the ISO?”
The ISO 9001 Standard is a list of requirements guarantying that all organizational processes are:
- Defined
- Organized
- Documented
- Controlled
- Reported
- Measured
In other words – establishing a Quality management system according to the ISO 9001 Standard."So, what is the difference with what we are doing today"?
As we mentioned before, implementing the ISO 9001 Standard is a strategic decision usually made by the top management – therefore we assume that the top management lack something – information about what is going on, order with the processes and other useful and essential reports - processes that would promote the quality management system – otherwise they would not invest so much time and money and human resources…
"What do you do with the ISO?" First, let's understand the meaning of the process. The following outlines the general points required in order for the management to commit to the process of implementing the ISO 9001 Standard and establishing a Quality management system. The ISO 9001 Standard requires that the management makes a written commitment in what become documented files. The following are the specific requirements: - Quality manual – this is a required document specifying the basic definitions of your quality management system. The document must include: the organization profile (can include organizational structure), the quality policy, a description of the general process, the quality management system scope – what processes or products are under the quality management system, a description of the interactions between the quality management system and the processes, the quality objectives and list of exclusions – the list of requirements that are not relevant to your organization due to its nature (product or processes). Review the next solutions for documenting your quality management system and your quality manual as well - prepared templates, easy to implement: the9000store.com
- Quality procedures – these are set of required procedures by the ISO 9001 Standard. The purpose of these procedures is to ensure that certain minimum requirements are being preceded. In these procedures you must specify the processes maintained in order to achieve the requirements. These procedures include the next: management responsibility, control of documents, control of records, internal audit, corrective action, preventive action and nonconformities treatment. Review this next article about the quality procedures requirements - it is more specific and detailed. These documented procedures are required by the ISO 9001 Standard. That means that you must maintain them and prove that you perform the requirements.
- Resource management – a list of requirements set to the resource management in your organization. The ISO 9001 Standard divides the requirements into three main subjects: human resources management, infrastructure management and work environment management. Curious about the requirements? We have them all right here on this article.
- Product realization – a list of requirements set to the realization processes. The realization processes is referred as six main processes: planning the product, managing the customers' requirements, design and development, purchasing, service provision and the control over monitoring and measuring devices. Learn more about how to achieve the ISO 9001 Customer's review requirements at this article.
- Measurement analysis and improvement - a list of requirements set to measurement analysis and improvement within the organization's processes. The purpose is to gather and analyze information regarding your product and to objectively prove the quality of your products. The requirements include: monitoring and measurement – set the processes required to perform measurements, the control of non conforming product – set the processes to deal with any non conformance detected in the organization, analysis of data – perform analysis of date gathered regarding your products, improvement – set the processes to maintain continual improvement. Turn to this page more specific details.
After documenting all the requirements you need to implement (in some cases) new processes in order to achieve the requirements. It means that beside the documented procedures, you must prove that your organization follow what you had defined. Throughout this web site you will find several articles specifying these requirements and solutions to maintain. Review the solutions - they might assist you, save you some valuable time and research.QUALITY MNUAL AND THE MANAGEMET RESPONSIBILITY The management must confirm its commitment (in a documented file) for implementing the ISO 9001 Standard within the organization. That is not a recommendation but a requirement. This written commitment must include: - A statement regarding the quality management policy. This is something akin to: "the management sees, as a main and central goal, providing the customers with high quality products/services according to high standards, the company's is obligated to the working procedures and to the fully satisfaction of our customers. The responsibility of the management is expressed in defining principles and to affix ways and methods to achieve this goal....”
- The quality objectives
- The level of improvement required form the organization
- How and when the management will analyze the progress of the Quality management system.
It is hard to understand at the beginning. "What do you mean by 'a documented commitment'?" Well folks, it's your lucky day. Some other folks took the time to make it easier for you. Take a look at the next web site that provides you with already prepared ISO 9001 Documented templates for you to implement: Qualitymanualtemplates.com. They hold a large number of solutions to help understand and implement the ISO 9001 Standard better. We reviewed their products and they appear to be pretty much satisfying according to the standard requirements. Maybe it will be clearer for you after visiting their site. By the way, their solution support the ISO 9001:2008 Standard requirements.Let's get back to the issue. The purpose of this documented commitment is to confirm that the management is serious about implementing the ISO standard in the organization and wants to establish a quality management system (QMS). I prepared here some example points that the commitment must include: - The customer is the central aspect of our organization. Everything that we do is dedicated to our customers.
- In order to validate our intentions, the management is committed towards realizing and executing the quality management system. First, quality objectives must be defined. The objectives must obtain constant long term improvement. From the objectives, the management derives measurable goals. The management will provide resources for achieving these goals (want to understand more about constant long term improvement? check this article).
- All employees are committed to work and act according to the requirement of the ISO standard. The management will define processes procedures, forms and reports.
- The management will define the organizational structure. In this structure, every function will have defined boundaries. After creating these definitions, the management will ensure that all functions are performing their tasks (need more information about this subject? well, we have it right over at this article).
- The management will define a list of quality procedure as required by the ISO 9001 Standard in order to maintain the quality management system (learn more about quality procedures over here).
- In order that any function will know what to do, the management will define a list of working procedures which will be controlled (need more information about this topic? read at this article).
- The management is committed to dedicate all resources needed to assist the QMS: instructions, a new computer station, new softwares, new forms, etc (overview the ISO 9001 requirements for trainings - you would be surprise).
- The management will establish a reporting system about the progression of the QMS in which every function will submit a report of its progress within the QMS.
- Management review: the management will meet periodically to examine the QMS progress. In this meeting, results of internal audits will be presented, customer complaints will be reported, results of satisfactory analysis will be reviewed and, if needed, decisions will be taken in order to achieve changes or improvements.
Still a bit confused? Well, it's only natural. In any way you may check the next web site for more detailed guide lines on your long long way: Qualitymanualtemplates.com. SUMMARY - Implementing the ISO 9001 Standard is a strategic decision. Only after a period of time will the employees feel the difference. It’s important to understand that it’s not an overnight process.
- In this article we reviewed the main elements of implementing the ISO 9001 Standard.
- The ISO 9001 Standard is a list of requirements guarantying that all organizational processes are: Organized, Documented, Controlled and Reported.
- The ISO 9001 Standard requires documenting the following: quality manual, quality procedures, resources management, product realization and Measurement analysis and improvement.
- In order to start the process, the organization needs to seek assistance. There exists a wide variety of options to receive professional advice.
- Outsource Consultancy: bounded by high costs, it’s sometimes recommended that an outsider reviews the organization because of his or her objective views about the organizations inner workings.
- Self Implementation: this can be difficult but is a low cost alternative. In this situation, it’s recommended to use guides and form templates in order to speed up the process.
- A combination both options: outsource consultancy along with self implementation. It is possible to use the outsource consultancy as a guide while someone from within the organization performs the documentation.
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