Choosing a qualified consultant is no easy task. The importance of taking the time to make a thoughtful selection cannot be underestimated. Your choice could end up affecting the efficiency and effectiveness of your business operations.

1. Understand the reasons for using a consultant
Why do organizations use consultants? An organization may realize it lacks the expertise, time, experience, or objectivity to perform the work without outside assistance.

2. Identify the services you need from consultants
Competent consultants should not only be able to plan the activities, document your processes, and recommend system improvements, but also suggest good practices, teach on-site classes, and conduct internal audits.

3. Decide on the selection criteria
You must agree on the criteria for selecting the right consultant for your organization. Some factors to consider include experience, credentials, skills, availability, accessibility, cost, and references.

4. Find prospective consultants
Now it's time to locate possible candidates. There isn't a single directory of consultants, so you may consider prior use, referrals, associations, consulting guides, advertisements, trainers, certification bodies, and the Internet.

5. Request a proposal
Ask the consultant candidates to submit proposals for your evaluation. To help them propose the appropriate services, include the following information in your request: scope, timing, methods, fees, and expenses.

6. Choose the consultant
Evaluate the proposals using the agreed selection criteria. Know in advance who will participate in the evaluation and make the recommendation. You want the decision fully supported so the consultant can work effectively with your organization.

7. Negotiate the terms
Confirm the consulting fees and estimated expenses. Although negotiating the terms of the agreement remains to be done, you will make your initial decision based on the available facts. Remember, consultants may reduce their quoted rates to win your business.

8. Prepare the agreement
It is very important to get a written agreement. Make sure everyone has the same understanding and expectations. The agreement could be a legal contract or simply a letter of understanding. The bigger the job, the more formal the agreement.

9. Manage the consultant
Even an expert consultant needs to be managed well. Ensure that the primary contact at your organization fully accepts this coordination role. Any issues or misunderstandings must be promptly resolved.

10. Evaluate the results When the project completes, evaluate the results. Were the deliverables acceptable? Were they produced on schedule? Did the outcome satisfy the objectives? Assess the consultant’s performance. Did the consultant do a good job of planning? Was the plan followed without significant deviation? Were you kept informed throughout the project? Did the consultant work well with others and foster teamwork?

Summary
If thoughtfully selected and wisely used, a consultant can be a valuable partner in setting up or improving your quality management system. However, remember that the system is owned by your organization.

Are you aware of the new ISO 10014:2006, Quality Management - Guidelines for Realizing Financial and Economic Benefits? It provides guidelines for achieving financial and economic benefits from the application of the ISO 9000 quality management principles:

1. customer focus
2. leadership
3. involvement of people
4. process approach
5. system approach to management
6. continual improvement
7. factual approach to decision making
8. mutually beneficial supplier relationships

Economic benefit is generally attained through effective management of resources and implementation of processes for improving the overall worth of an organization. Financial benefit is the result of organizational improvement expressed in monetary form and realized by cost-effective management practices.

ISO 10014:2006 is directed to top management of an organization and complements ISO 9004 for performance improvements. It provides examples of achievable benefits and identifies management methods and tools that are available to help gain those benefits.

Annex A includes a self-assessment as a gap analysis and prioritization tool. The questionnaire describes five maturity levels for assessing your current management system and determining which principle should be selected for improvement.

A specific improvement cycle is displayed for each quality management principle that lists activities for each Plan-Do-Check-Act stage. Achievable benefits are identified as outputs for each principle.

Please note that ISO 10014:2006 consists of guidelines and recommendations, and is not intended for certification, regulatory, or contractual use.

ISO 15378:2006 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products (which consistently meet customer requirements, including regulatory requirements and other standards applicable to primary packaging materials).

The title of ISO 15378 is Primary Packaging Materials for Medicinal Products -- Particular Requirements for the Application of ISO 9001:2000, with Reference to Good Manufacturing Practice (GMP).

ISO 15378:2006 is an application standard for the design, manufacture, and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 14063:2006, Environmental Management - Environmental Communication - Guidelines and Examples, gives guidance to an organization on general principles, policy, strategy, and activities relating to both internal and external environmental communication.

It utilizes proven and well-established approaches for communication, adapted to the specific conditions that exist in environmental communication. It is applicable to all organizations regardless of their size, type, location, structure, activities, products and services, and whether or not they have an environmental management system in place.

ISO 14063:2006 is not intended for use as a specification standard for certification or registration purposes or for the establishment of any other environmental management system conformity requirements. It can be used in combination with any of the ISO 14000 series of standards, or on its own.