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Typical Implementation Steps
The following outline represents the typical process that is employed to ensure that your company will meet the requirements of a Quality System Standard quickly and efficiently.
1) Training and Confirmation of Upper Management Commitment
First confirmation of upper management commitment is achieved as part of a formal training session. This ensures that key managers understand and fully support the implementation process and the standard's requirements. A management representative as well as a document and data control manager are also selected at this time.
2) Gap Assessment
Secondly we compare and document your process against the requirements of the appropriate level of ISO 9000, QS 9000, ISO Guide 25, Malcolm Baldrige, etc. This assessment quickly determines where your system needs improvement. Formal and informal (undocumented) systems are reviewed for compliance.
3) Develop and Adopt a Project Plan
After completing a gap assessment, we develop a written plan that defines how you will set up your system and get it running in the shortest time and at the lowest cost possible . This include who will write the needed documents, how training will be carried out, initial auditing, when the registration body will be selected, and target dates for pre-assessment and registration audit. We recommend forming inter-disciplinary teams for implementation including a steering committee. The plan is then approved by the upper management.
4) Select the Registrar
Now it is time to select a registrar. There are dozens of registration bodies ("registrars") operating in the United States. We will support you in selecting one that is properly accredited, experienced in your industry, compatible with your company's style, and priced competitively.
5) Create the system to support the requirements
Next we create the system to support the requirements. Standards require you to have a Policy Manual, procedures, and a number of work instructions / forms. These must fit your process and include solutions to the "gaps" you identified. Each document that is completed will go through a formal review, release, training and immediate follow up audit process. The documents are generally developed by teams after specific training and discussion on the intent of the element has been conducted. A unified document format is also adopted as part of this process that the teams will reference.
6) Audit the System
Next we highly recommend auditing the system on a planned and scheduled basis using trained employees to be internal quality auditors. This process kicks off 2-4 weeks after the procedures are released. The Teams address deficiencies with corrective actions, and follow up on corrective actions to make sure they are effective.
7) Fine Tune the System
After auditing the system it is important to make sure employees are using the corrective action processes. We will help check edit procedures and work instructions as the need for the changes that will arise. Your company should then follow through on internal quality audits and adjust the system accordingly. Finally we will review the system at the top management level to solve problems, look for improvement opportunities, and maximize the benefits of the process.
8) Conduct a Pre-Assessment
Before completing the registration audit you will need to have your registration body conduct a "pre-assessment" of your system. This provides a final "quality check" on your system and gives your employees invaluable experience at undergoing a quality system audit-- before it "counts." It also helps you identify areas that need work before you undergo the "real thing."
9) Registration Audit
Finally it is time for the registration audit. Your registration body assesses your system for compliance with the requirements of the standard. They will then provide a verbal report of their findings at the close of the audit.
The overall timing for this type of implementation strategy is dependent on the current state of your Quality system, the complexity of your products and services, the standard you are working toward and, most importantly, the resources you can supply to the effort. Typical implementation times range from 6 months to 2 years.
Synergists, Inc. has a proven track record for helping companies meet their organizational goals and objectives. We look forward to spending the time to understand your goals and objectives to build an elegant plan to meet them!
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