ISO 9001 Project Manager's Implementation Guide

This a general workflow guide for the tasks needed to be performed to create a quality management system. These have been broken into five distinct phases. These are general guidelines intended to give some direction and order for an ISO certification project. This is not intended as a complete program for your company’s own unique needs.

These phases towards certification can be run concurrently. For example, training of personnel can begin well before the completion of Phase 1 and the approval and implementation of documented processes can be done as soon as the identified processes have been completed.

• Phase 1: Review & design
• Phase 2: Training
• Phase 3: Implementation
• Phase 4: Analysis & Modification
• Phase 5: Certification

The length of time for certification can vary widely. These are dependent upon factors such as the size and complexity of an organization and the resources, such as time and personnel, the company is willing to dedicate.

Phase 1: Review and design

Phase 1 is the initial gathering and review of existing documentation and undocumented processes within the organization. This includes any and all regulatory requirements depending upon the nature of the business conducted. Major steps in Phase 1 are:

• Review of any existing documentation to examine suitability
• Mock audit and facility tour to identify all needed processes
• Modification and creation of Quality Manual
• Modification and creation of procedures, forms and work instructions

Phase 2: Training

Training is an essential part of any organization. Training should include the theory behind quality management systems as well as its application to the organization. While training is listed as Phase 2, training will begin as soon as possible and be an integral part of the system implementation. This list should be considered a bare minimum. Other training will be dependent upon the nature and complexity of the organization.

• Employee overview
• Top management
• Internal quality auditors
• Management representative

Phase 3: Implementation

Implementation of the system will begin as soon as the first documents are approved. The key to effectively implementing a quality system is to involve personnel in the identification and design of those processes that comprise the quality system. Early involvement by all levels of the organization’s personnel will ensure a more effective establishment of the system. Implementation activities involved are:

• Approval of documentation
• Implementation of processes
• Fine-tuning of processes
• Operation of the quality system

Phase 4: Analysis and Modification

By the time Phase 4 has begun, the company is operating their work through the quality system. The organization is in complete charge and control of the system with an eye for identifying weaknesses or need improvement to the system. Phase 4 consists of:

• Modification of system as required.
• Internal audit (conducted by the company’s internal auditors)
• Corrective/Preventive actions
• Changes to documentation and processes

Phase 5: Certification

These are the actual activities coordinated between the company and the registrar. By this time it is assumed the company has fully implemented it’s quality system. All actions, measurement systems, documentation and the production of records are in place and functioning. This is the time where the company needs to perform its self assessments and corrective actions. Certification activities include:

• Internal audits
• Pre-assessment audit (conducted by registrar)
• Corrective actions of system as required
• Certification audit
• Corrective action
• Issuance of certificate