Experience with a variety of industry standards including:
ISO 9001, ISO 14001, ISO/IEC 17025, ISO/TS 16949, AS9100, ISO 13485, and CPSIA.
ph: 248-568-5877
BobBreme
Implementation of an effectively documented Management System makes good sense for any organization. It reflects commonsense practices, which may or may not be well established. As consultants and trainers, our job is to help identify company processes, properly document them, train employees, and ensure methods of control of the processes, and finally to drive your company through the registration process quickly and efficiently.
Bob Bremer Enterprises will leave you with a system that is easy to operate, flexible, allows conducting of business activities, eliminates waste and yet is valuable enough that your Customers can be satisfied and assured of consistent products or services. Management is also provided with the necessary information and tools to evaluate and improve their organization. This is your system, not ours, and you should know how to maintain it after registration. You will help implement the management system. Our Goal is a WIN-WIN Relationship.
ISO 9001:2008 is the latest version of this international standard for Quality Management Systems (QMS) that traces back to the old military standards. The ISO 9001 standard is like the “mother” standard and the basis for many other types of Quality Management Systems, most notably the automotive ISO/TS 16946, Laboratory ISO 17025, and the Environmental ISO 14001 standards. These standards and others are developed and revised by, or in conjunction with, the International Organization for Standardization (commonly referred to as ISO) and other industry specific organizations. ISO develops numerous international standards which you probably see and use every day. The size of your credit cards and the film speed for your camera are common ISO standards.
The ISO 9000 standard can be, and has been applied to all types and sizes of companies throughout the world. Third party groups (Registrars) are responsible for evaluation and registration of organizations to the standard. ISO 9001 is open to interpretation by the organization, and many organizations already address the many of the requirements such as contract review, purchasing, production and service, inspections, delivery, etc. But what we find is there are no documented and consistent methods of ensuring that the products and services continue to meet the needs and expectations of the customer. Therefore, it is important for the organization to correctly interpret the standard as it relates to their activities so that the intent of the requirements is properly addressed. Bob Bremer Enterprises can help clarify and correctly interpret the requirements while providing potential solutions determined through years of experience.
ISO 9001 is specifically designed to improve customer satisfaction, as well as provide continual improvement opportunities which encourage more efficiency, less waste and more profitability. It is not intended to make your business overly focused on unnecessary documentation, records keeping, or extra work that does not provide value to your organization or to your customers. BBE can help ensure your system works for your organization and not against your organization. Bob Bremer Enterprises prides itself on its ability to quickly understand your organization and document a flexible system that does not tie your hands or require wasteful activities.
ISO/TS 16949 (TS 16949) was developed for the automotive industry and has just been revised in 2009. This version will be replacing the 2002 version. All of the requirements listed in ISO 9001 are included in TS 16949, but the requirements have been “beefed up” with industry “additives” or specifications that apply to only certain automotive-related organizations. BBE can help you understand your organization’s applicability.
ISO/IEC 17025 is specifically tailored for Testing and Calibration Laboratories. The latest version of ISO 17025 was released in May of 2005. The standard, like others, is based on the ISO-9001 standard. Many of the same requirements are addressed in both standards. But 17025 provides the guidelines for establishing quality management systems for the unique requirements of testing and calibration laboratories.
The unique activity requirements of ISO 17025 assure that laboratories follow well established practices, most frequently related to ASTM (American Society for Testing Materials), the American National Standards Institute (ASNI), and NIST (National Institute of Standards and Technology) guidelines or other guidelines that may be specific to an industry or product.
Most businesses come in contact with laboratories for either the calibration of their own inspection gages and equipment or for actually performing the necessary testing to give confidence their products meet all necessary requirements. Therefore, the labs become the experts and it is important that customers to the labs can depend on the results of testing and calibration activities. Laboratories are important in maintaining the unbroken link back to the standard (NIST).
Unlike most companies that are "registered" by their registrars, labs are "accredited" to ISO/IEC 17025. Call for assistance in choosing a qualified registrar that meets your customers' expectations. Bob Bremer Enterprises can help implement a strong, yet simple Laboratory Management System (LMS) or assist to steer you to an accreditation body that will suit your needs.
ISO 14001 is not a very big standard -- only 6 major sections -- but the workload for implementing an Environmental Management System (EMS) can be very extensive depending on your type of business activities. Many companies make the mistake of operating two separate systems, one for their QMS and another for the EMS, but smart companies may benefit from merging their systems together for added efficiencies.
Questioning the value of an EMS? An effective EMS dovetails with the new “GREEN” industries and often companies find far more cost benefits from implementing an effective EMS than their ISO 9001 system. Key to any good Environmental system is the identification of how your organization impacts the environment. Bob Bremer Enterprises provides help identifying environmental aspects, development of appropriate programs, On-Site Standards Overview, Internal Auditing or Supporting Training and Maintenance Services after registration.
Some Quality Management Systems for specific industries include ISO 13485 Medical Devices and SAE AS9100 Aerospace Industry. Both of these standards are industry-specific but still based on the ISO 9001 QMS standard. They are gaining wide popularity as customers recognize the importance of maintaining a documented system to help assure the quality of their product and meeting customer specifications. The Boeing Company is strongly promoting the SAE AS9100 Aerospace standard as a requirement to their suppliers for doing business. The government and other OEMs have adopted and are strong proponents of appropriate management systems as a requirement for doing business. BBE can help your identify your customer expectations and implement an effective system.
Need a FORM or Document? Frequently organizations develop forms and supporting documentation that is just plain overkill and hard to implement throughout the facility. Through years of experience, BBE has developed some products that effectively address the needs of many clients in a simple and straightforward manner. We calls these "Tools".
BBE will be making some of the most common tools (Forms/Documents) available for purchase. They can be easily assimilated into your Quality Manangement System and often allow for the elimination of similar less effective forms. Check back later for listing of those available TOOLS.
In the meantime, use the Contact Us page to let BBE know what you are looking for.
COMMON ISSUE
Often, BBE becomes involved with companies that try to take on the implementation of a new management system on their own. The common issues include implementation taking a year or more and development of extensive documentation and duplication. But let's face it -- if ISO is not your business, how effective can you be and how many resources are available for this project?
A recent customer manufacturing rubber products in California for the oil industry spent time on their own and then got the wrong help. By the time Bob Bremer got involved with this company, many months had passed and they still did not feel any closer to their objective.
After a three day visit, Bob Bremer was able to get their Quality Manual reworked, identify their Quality Objectives and Processes, establish an Action Plan, and provide training and explanations that clarified the many questions and mis-understandings this company had been dealing with for months.
After this first visit, the company indicated they had a much better understanding of the process and they could see the simplicity that Bob was incorporating into the system that had become unwielding. After working their Action Plan, the company was ready for successful registration to ISO 9001 in less than 3 months.
For most companies, implementation does not need to take 9, 10 or more months, and the system needs to work with the culture of the organization. Make a bad system, and the company will forever waste time and money trying to maintain it.
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ph: 248-568-5877
BobBreme