Methodology

The development and implementation of an ISO 9000 Quality System will occur in five phases. Each phase is independent, though they must follow in sequence. Your company will have the ability to control the timing of each phase as well as provide the option to complete a phase separately and independently of Field Experts.

Prior to the commencement of the project we recommend that your company appoint a person who, regardless of other duties, will be given the authority to act as liaison with Field Experts during the course of the project.

The five phases are outlined below:

Phase One

The first step will require Field Experts to become oriented to the operation of your company. During a site visit to your facility, Field Experts personnel will review the internal and external structure of the organization and provide an introductory overview of ISO Quality System requirements. It is this detailed descriptive information which will provide the skeletal structure from which Quality System documentation will be developed. Phase One will culminate with the creation of schedules for the development of further project phases.

Phase Two

During the transition from phase one to phase two staff will be required to have completed all ISO Quality System information requirements. At this point Field Experts will commence the development and creation of the policies and procedures detailing the operation of your firm. At the midpoint of this phase we will coordinate a review of the progress of the project and facilitate the completion of information gathering and review the information supplied. This phase will require an open and constant channel of communication between Field Experts and your company liaison (through fax or other electronic media). This will ensure that the effectiveness of the draft documentation will be assessed on an ongoing basis.

Phase Three

At the completion of the second phase draft copies of the policy, procedure and work instruction manuals will be ready for review and approval by the company liaison. Your organization will have the opportunity to review and approve the manuals to ensure they accurately describe the activities being carried out at the facility. During a third site visit Field Experts will review the Quality System manuals with the appointed liaison and other management staff as well as compare the manuals to the practices of the entire organization. Final changes will then be made to the manuals in preparation for the completion of the final text. The completed manuals will provide the basis for training staff in phase four of the project.

Phase Four

At this point, employees will be trained on the complete set of policies, procedures and work instructions comprising the Quality System. A detailed review of the policies, procedures and work instructions will take place during this phase and company employees will be given an opportunity to evaluate and amend the documentation. This is the final opportunity for fine tuning prior to the system audit.

The final session will discuss in general terms the implementation process for the policies and procedures. The audit process will include an evaluation of the main reasons for failure and seek to eliminate these potential pitfalls.

Each of the training sessions (approximately two hours in length) will be provided to groups of employees as per their department or area within the organization. This phase of the program is optional and can be carried out internally without utilizing Field Experts.

Phase Five

The final project phase is comprised of a simulated third party audit of the Quality System. Once the system has been implemented for a minimum of thirty days, trained employees will carry out a number of internal audits of the elements of the Quality System.

During this process, Field Experts will undertake a complete pre-certification audit of the Quality System. This detailed audit will include a review of the policy and procedure manuals as well as a complete site audit of the actual operation. This process is designed to afford your organization the opportunity to correct any potential problems in the system before the actual certification audit takes place. It also provides both management and staff a practice run of how the actual certification audit process will occur.

The pre-certification audit will include:

• a review of the policy and procedures manuals to determine compliance with the ISO certification requirements;
• an on-site pre-certification audit utilizing the standard third party auditing methods;
• a written report of the audit recommending changes for any nonconformities that would impede certification.

The next step in this process is to register with a certifying body which will undertake the certification audit. This process can take place at any point in the process prior to this phase; however, it is not a component of the process that should be rushed. The decision on who will carry out the certification is typically left to the latter part of the process to ensure that the auditor can meet your requirements.
This is the most critical step of the process and involves the actual third party audit of the Quality System. The cost and timing of this component is entirely dependent on each company and the registration authority.

The final element involves implementing any adjustments to the Quality System based on the comments of the auditors. Field Experts does not charge for this service during this phase of the process and will work with your organization to ensure all adjustments are made to meet the needs of the auditing body.

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