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Quality
Management System Development
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CLIENTS : EXPERIENCE : HOME : CONTACT |
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ISO 9001-2008 is the latest revision to an internationally recognized standard for a certified Quality Management System (QMS). It provides your company with the framework and guidance that assists with the standardization of common processes that your company typically performs day in and day out. The ISO Standard itself is focused on continual improvement and customer satisfaction in a way that allows for changes to the QMS that improve product and/or service quality.
Both Manufacturing and Service organizations can benefit from registration through: |
What is ISO
9001-2008? |
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Products and services that more consistently meeting customer requirements Cost reduction via more efficient processes that are less likely to produce a nonconforming part or service A stronger relationship with stakeholders like your staff, supply sources and customers Emphasis on statutory and regulatory requirements that supports risk management Worldwide recognition that a certified Quality Management System exists at your site |
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If you would like more information regarding typical timing and costs for implementing an ISO 9001-2008 QMS, CONTACT ME to start the process.
ISO 13485-2003 is another international standard that specifies the requirements for a Quality Management System (QMS) that addresses the organizations’ ability to provide medical devices and related services to consistently meet both customer and regulatory requirements applicable to the device(s). Because this standard is intended to harmonize the medical device regulatory requirements with those associated with ISO 9001-2008, it includes some requirements specific to medical devices and excludes some associated with ISO 9001 that are not focused upon regulatory aspects.
Because of the exclusions within ISO 13485, a company seeking certification to this standard cannot also claim that they comply with ISO 9001-2008. Typically a dual certification is acquired to ensure that both QMS attributes stated in ISO 9001-2008 and regulatory requirements defined in ISO 13485-2003 are continually improved.
ISO 13485 also requires that the organization establish, document and maintain a risk management process throughout the life-cycle of the device that identifies hazards associated with the medical device, to include the following elements: |
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Risk analysis Risk evaluation Risk control Production and post production information |
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The requirement for risk management is best addressed for medical devices through the application of ISO 14971:2007 which provides manufacturers and remanufactures with the framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices. The approach to risk management using ISO 14971 is comparable to performing a failure mode and effect analysis (FMEA) found in Health Care assessments (Joint Commission) and in the design/manufacture of automotive products.
If you would like more information regarding typical timing and costs for implementing a dual ISO 9001-2008 and ISO 13485-2003 Quality Management System, CONTACT ME to start the process.
Ever since the first ISO Standard in 1987 arrived there has been a requirement for internal auditing of the Quality Management System by trained, competent auditors from within the organization itself. Until ISO 9001-2000, most of the auditing was done using lengthy checklist with prescriptive questions to be asked by the auditor. The audits focused mostly on compliance to a single clause or group of clauses in the standard rather than the process in which the work was performed. This is hardly the way a business actually runs.
The ISO 9001-2000 standard was a major revision resulting in a “process approach” to align the QMS with how businesses really operate. This revision required a rethinking of how audits should be performed and launched a whole new approach to auditing that looks at inputs to a process, activities within a process and the outputs of a process. It also sparked the need to move away from the typical checklist questions to more of a conversational type of audit. The auditing standard that defines process auditing in the class that we offer is the same information that governs the auditors that work for your Registrar; ISO 19011-2002. Process auditing is taught by a real certified RAB/QSA auditor with years of experience in manufacturing and service industries.
Remember that internal auditing should be a value added activity to departments, divisions and Top Management. If your audits are not giving you the feedback needed to improve processes, reduce risks to your company or add to the financial bottom line, then I would suggest that you have an opportunity for improvement before you. The Audit Program is as important as the Hiring Process, the Purchasing Process and the Manufacturing or Service Process all rolled together.
If your Internal Audit Program is not providing you with actionable areas for improvement, then they are not of value and you really do not know what is going on in your company.
If you would like more information regarding Internal Process Auditor training, CONTACT ME to start the process.
Whether ISO registered or not, all organizations large and small generate deficiencies requiring Corrective Action. It’s inevitable that a process will encounter some source of variation that generates a manufacturing, administrative or service nonconformance that needs either immediate correction or a permanent corrective action to ensure that it will never raise its ugly head again. Over the years as a Quality Professional, I’ve witnessed mostly casual responses to nonconformances that include everything from, “well this was just a onetime occurrence” to “we need all new equipment” to make this problem go away.
Very little takes place in the way of training to arrive at a permanent “SOLUTION” for a problem. There always seems to be time to work on a temporary “fix” (band aids, duct tape, hose clamps), but never enough time to truly investigate the cause of the problem and eliminate it forever!!!
All organizations expect corrective action to be effective, but rarely do they take the time to teach their people how to go about the investigation of a problem and support them throughout the implementation phase. So, problems continue resurface because the real source or cause of the problem is much deeper than what people thought.
After reviewing multiple methodologies and asking myself, “what’s simple to learn, easy to use and works”, I continue to come back to 8D Root Cause Analysis. The approach began during the Second World War and was later popularized in the 60’s and 70’s by the Ford Motor Company. It remains the standard in industries that require a thorough structured problem solving process.
8D stands for 8 Disciplines. It contains all the necessary aspects of problem investigation and solution management into a single structured process that anyone can learn and use. It is used to identify, correct and eliminate problems and can be applied to every area in your organization where nonconformances exist. The class establishes a standard practice for identifying the source of the problem, with an emphasis on facts rather than opinions.
The steps or stages of 8D Root Cause Analysis includes: |
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D1: A Team Approach D2: Describing the Problem D3: Verifying Temporary Fix(s) D4: Root Cause Analysis - this is where 5Y takes place D5: Development of a Permanent Solution D6: Implement & Validate Permanent Solution(s) D7: Preventing Recurrence D8: Problem Closure and Team Recognition |
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8D methodology will begin to move your organization from a few “fire fighting experts” to an organization of “problem solving experts” having the skill to move outside of their respective departments and empower other employees with the techniques to reach solutions to their problems. It’s a skill that must be used to be learned. It’s a social event aimed at improvement. It is even used by some clients for workplace accident investigation.
If you would like more information on how to use 8D Root Cause Analysis to eliminate the cause(s) of problems in your organization, CONTACT ME to start the process.
The available Training Videos are the ones that are specifically produced for your location using people out of your own organization to provide the training. Yes!!! These are either DVD format or web based flash videos that can be accessed via your own intranet connection or via a standard DVD player. The videos are recorded at your location with HD video and audio equipment and a teleprompter to eliminate the fear of talking into the camera while trying to remember the subject.
Video Benefits: |
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Videos offer subject matter consistency that is often missed during on-the-job training Can be viewed by the employees at convenient times, including at home without a trainer present Work well when the review of a complicated process needs to be revisited again Permits the inclusion of your own documentation when forms and records are required Is cost effectively edited when the process, equipment or documentation changes |
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Welcome To Our Company – Management and Employees Employee Orientation: What to Expect – Hr Manager and respective Department Heads Health Care Benefit Package – HR Manager or Health Care Provider Management/Employee Operating Procedures – from respective Department Heads Health & Safety Guidelines – from respective Department Heads |
| If you would like more information regarding Training Videos for your business, CONTACT ME to start the process. |
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