Our Process

Our 14-Step Process guides your organization through the development, implementation, and registration of your quality management system (QMS). This structured process ensures your project occurs in a timely and efficient manner. We combine planning, training, and follow-up consultation to ensure knowledge is transferred to your organization and activities are implemented successfully.

1. Management Orientation

Executive staff is introduced to standards, procedures, and certification/regulatory requirements as they apply to executive management and company/departmental processes and interactions.

Deliverable: Management Understanding of Certification/Approval Process

2. Gap Assessment

A baseline set of observations is generated to identify the gap between what is required for certification/compliance and where the organization stands. This is a macro-level analysis performed in a relatively short period of time by a team of two or more auditors.

Deliverable: Gap Assessment Report

Note: we are able not only to asses the gaps but provide the corrections to the gap(s)

3. Management Planning

The executive staff walk through the results of the Gap assessment together, assessing the resources and allocations necessary for a successful program and developing an action plan for certification/compliance.

Deliverable: Action Plan

4. Responsibility Matrix

The Executive Management Consultant, together with the organizations senior management, prepare a responsibility matrix that defines each applicable clause of the standard and specifies the individual(s) with primary and secondary responsibility for accomplishing conformance with that clause.

Deliverable: Responsibility Matrix

5. Form and Train the Steering Committee

The consultant prepares selected executives and department heads to serve as the company’s steering committee. At this point, the organization’s ISO management representative is identified. The recommended follow-on training to members of the steering committee is decided on a case-by-case basis.

Deliverable: Steering Committee Selection and Training

6. Process Mapping

In “war room” style, the consultant and the organizations steering committee members and/or their delegates flowchart every function of the organization’s operation, from the time a request for proposal or quotation arrives to the time the product or service is delivered. This flowchart, in its final form, allows the identification of all processes of the QMS, along with their sequence and interaction. It also aids both your personnel and the third-party auditors during the certification audit.

Deliverable: Process Mapping of Company Operations

7. Identify Specific System-Level Procedures

Using the applicable standard/regulation, the responsibility matrix, and the Process Mapping, the consultant and the steering committee together identify procedures that must be documented to achieve certification.

Deliverable: List of System-Level Procedures to Be Documented

8. Walk Through, Document

Individuals responsible for each flowchart, as identified in the responsibility matrix, must then document. To help prepare the procedures for audit review, The consultant will help develop a company-specific documentation, read and review representative flowcharts and documented procedures, perform a walk-through of sample procedures to confirm accuracy and adequacy, provide suggestions for improving the documentation, based on the walk-through, repeat the process after corrections are made by the organization’s staff.

Note: Our philosophy is to use the certification process as a series of opportunities for improvement, and this is the phase where the organization can make the most significant improvements while aligning the QMS with business strategy. When flowcharting, we use and teach techniques to improve processes by identifying and eliminating redundancy, non-value-added activities, and superfluous paperwork.

9. Write Quality Policies

The consultant will assist management in establishing and documenting high-level policies that may be required.

Deliverable: Draft of Quality Policies

10. Flowchart, Improve, and Document Work Instructions

The consultant briefs personnel in formatting, writing, and preparing work instructions. Your personnel then write the instructions, train other staff members in their use, and implement and audit the instructions. The consultant will review instructions and assist your personnel in preparing them, if needed.

Deliverable: Work Instructions Writing

Note: If requested, The consultants/technical writers will help write and audit the instructions. However, we recommend that the customer undertake the bulk of this effort to demonstrate to the larger organization the level of management commitment. “Ownership” of the new or revised procedures is further reinforced by your personnel performing the training and auditing. The Kent Group can review a selected sample of instructions to ensure that the process was fully understood and properly implemented.

11. Train Personnel and Conduct Internal Audits

Throughout the program, and work instructions are introduced into the system, the consultants can participate in initial internal audits. They can also help develop appropriate audit checklists and templates for records and integrate the process into the master audit cycle. During this phase, the customer realizes numerous opportunities for systems improvements and simplification of documentation. The customer’s personnel should be trained in how to recognize systems/processes/functions that affect end-product or service quality, and how quality-related functions interact with and affect the organization’s overall quality system. The goal is to develop a smooth and coherent internal audit system, an initial set of audit records, and improved procedures and instructions.

Deliverable: Documented and Validated Internal Audit System

Note: To demonstrate management commitment, the customer should perform the bulk of this effort. In addition, ownership of the new internal audit system by your personnel reinforces buy-in at all employee levels during internal audits.

12. Perform Preassessment

Throughout the program, and work instructions are introduced into the system, the consultants can participate in initial internal audits. They can also help develop appropriate audit checklists and templates for records and integrate the process into the master audit cycle. During this phase, the customer realizes numerous opportunities for systems improvements and simplification of documentation. The customer’s personnel should be trained in how to recognize systems/processes/functions that affect end-product or service quality, and how quality-related functions interact with and affect the organization’s overall quality system. The goal is to develop a smooth and coherent internal audit system, an initial set of audit records, and improved procedures and instructions.

Deliverable: Preassessment Audit Report

Note 1: The consultant can provide advice for remedial action, while a Certification Body is prohibited from doing so. NOTE: Prior to the third-party certification audit, the system must have been fully implemented, with records available to provide evidence of compliance with the standard/regulation (e.g., records of internal audits).
Note 2: The consultant can assist in identifying a Certification Body according to your certification objectives and customer desires.

13. Take Corrective Action and Review Results

The customer corrects nonconformities and notifies the consultant of actions taken and dates completed. The consultant spends one day (or more, if necessary) confirming that nonconformities found during the preassessment audit were properly corrected as per certification requirements. If all items are corrected and no new nonconformities are uncovered, The consultant then reviews the actions and signs off that the facility is ready for a certification audit.

Deliverable: Corrective Action Review

14. Certification Audit

The consultant can remain on-site during the certification audit to help answer questions and correct non conformances before the registrar’s auditors leave.

Deliverable: Assistance During Certification Audit

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