The ISO9000 family of standards are among the International Organization for Standardization’s (ISO) most widely known standards. The ISO9001 standard is implemented by just under one million organizations in over 176 countries.and is now the international reference for quality management requirements in business-to-business dealings.
The ISO9001 standard is primarily concerned with “quality management”. This means what the organization does to fulfill:
- the customer’s requirements, and
- applicable regulatory requirements, while aiming to
- enhance customer satisfaction, and
- achieve continual improvement of its performance in pursuit of these objectives.
The vast majority of ISO standards are highly specific to a particular product, material, or process. However, the standards that have earned ISO9000 a worldwide reputation are known as “generic management system standards”.
“Generic” means that the same standards can be applied to any organization, large or small, whatever its product including whether its “product” is actually a service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department.
“Management system” refers to the organization’s structure for managing its processes – or activities – that transform inputs of resources into a product or service which meet the organization’s objectives, such as satisfying the customer’s quality requirements, complying to regulations, or meeting environmental objectives.
SatiStar has performed over 1600 management system implementations for clients ranging from 6 employees to those with hundreds of locations, and tens of thousands of employees.
Scope And Deliverables
The principal project outcomes are as follows:
- A documented and cohesive set of procedures that will in turn improve the routine capability of the organization to execute core business processes.
- Quality goals, and clear responsibility and accountability for those goals
- Metrics for key performance indicators that are linked to your business plan
- An internal audit and management review process that will identify nonconformances versus the ISO9001:2015 standard as well as areas in which the quality management system is not delivering meaningful results toward achieving quality goals.
- Accredited registration of your ISO9001:2015 management system.
In addition, this work typically identifies several process improvement opportunities as well as a number of actions that will reduce waste, scrap and rework within your operations.
What We Will Do
Block Flow Diagramming Session
This session represents the kickoff meeting for the project. At this meeting which can last anywhere from an hour to half a day, we review the existing documentation that you have put together, and we perform a block flow diagram (BFD) analysis. This analysis will identify the full scope of your operations from an ISO9001 perspective, a perspective that will include your suppliers, any subcontractors, your customers, and all the facilities and processes within your operations.
Process Flow Diagrams
Your manual will be created using SatiStar’s process flow diagramming technology. This technology enables us to eliminate 70% or more of the text that is normally found in text based quality manuals. SatiStar’s process documentation specialists will interview the individuals within your organization who actually do the work. This is your system. We simply hold the pen to record in your employees’ words what they do. Interviews typically take between 20 minutes to 2 hours for each individual process. In all there are typically 18-30 processes captured to create your quality system.
SatiStar will create ISO9001 compliant policies and procedures and assemble these documents into a quality manual for your approval. Implementation of the quality system as described by the manual, can often commence while the manual is still being created.
SatiStar’s methodology eliminates a separate gap analysis. We integrate a gap analysis within the process mapping and quality manual creation activities. In this way, we eliminate considerable time, cost and rework from the overall project. That in turn enables us to get you registered much more quickly.
Implementation Coaching and Support
The overall quality management system implementation process takes about two months, but you can choose to implement the system at any pace that is comfortable. During this phase of the project, we work with you to transform your quality manual into a working quality management system. SatiStar’s implementation approach is to prioritize those elements of your quality system for which no ISO compliant element is currently in place. One caveat must be brought to your attention with regard to implementation – more rapid implementations have better success and produce much higher quality results. If you plan to extend the implementation time frame beyond 6 months our experience is that it will be hard to maintain sufficient organizational momentum and enthusiasm towards registration. This makes it harder for you to keep the project viable, and avoid considerable rework.
SatiStar’s qualified auditors will conduct the audit, which will take between one and several days to complete (depending on the size and complexity of your organization). The audit will be documented in an audit binder that we will create. Any corrective actions that are required will be written up by our auditor and placed within the audit binder. The auditor will then review with your quality system representative exactly what each corrective action refers to, and will discuss detailed actions that will rapidly and effectively close out the corrective action request. Coaching will also be provided on how to respond to corrective action requests.
SatiStar will facilitate a management review meeting. We will create an agenda for this meeting that complies with the requirements of the standard, and will demonstrate how such a meeting can be conducted so that it becomes an effective tool for action and quality improvement. A record of the management review meeting and the actions arising from that meeting will be required to meet the requirements of the ISO9001 standard.
SatiStar will provide coaching on how to pass an audit, and will help remove the stress from the event by providing strategies and techniques for working with the auditor effectively. We have a perfect record of successful registrations. In 100% of the registrations that we assist clients with, the registrar makes a clear recommendation for registration at the time of the external audit. What remains is to clear up the few remaining findings, to receive the registration certificate, and of course to maintain the system.
What We Need You To Do
Although SatiStar does most of the technical work, ultimately it is up to the client to implement and “live” in the new ISO9001 management system processes.
- Select a Quality System Representative who will ensure that the management system processes are implemented and maintained.
- Provide an “ISO War Room” where we can conduct training, coaching, interviews and planning sessions.
- Participate in the block flow, process flow diagramming, management review meeting and in the internal audit events.
- Provide SatiStar’s personnel with access to your facilities, personnel and data as required.
- Provide us with any required Safety, Security and other training to enable us to work on your premises.
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