Sapphire QMS Associates

Business-focused Quality Solutions

ISO 9001 Engine

The ISO 9001 Engine……………..Management Responsibility

 

One thing that all businesses have in common in management.  Management directs and drives the 5 person service provider and the 50,000 person manufacturer. 

ISO 9001 recognizes the importance of management and devotes an entire clause to it.  As usual, it is all common sense.   Common sense with objective evidence……..

Here are the five specific actions the standard requires:

1.       Communicate the importance of meeting customer as well as statutory and regulatory requirements

While this may seem to be something that every employee should know without being told, it is critical that management emphasize that this is the foundation of doing business.  It is far too easy to let the minutia of the day to overshadow the customer, statutory and regulatory requirements.  People simply forget.

 

2.       Establish a Quality Policy

The Quality Policy provides the framework for the QMS and Quality objectives.  It must include a commitment to comply with and continually improve the Quality Management System. 

Don’t carve the policy in stone!  It is a living document that must be reviewed and updated in light of current business and customer needs.

Ensure that everyone in the organization knows and understands the policy and the importance of it.  Each person should be able to paraphrase it.

The Quality Policy keeps you grounded in reality.  Refer to it often.

 

3.       Establish Quality Objectives

What gets measured, gets done. 

You get to choose the objectives, but they must me measurable and consistent with the Quality Policy.

 

4.       Conduct Management Reviews

Management reviews provide a time to step back, assess and plan. The output of the review must include any decisions and actions related to the improvement of the QMS, product, or service per customer requirements and resource needs.

Small business owners often view this as overkill.  After all, they are hands on every day, why do they need to conduct formal reviews? 

That fact alone is a key reason to conduct the review:  take yourself from ground level to 50,000 feet so that you can see the interconnections and opportunities for improvement.

The reviews must include:

-       Audit results (not just that you conducted them)

-       Customer Feedback (not just complaints)

-       Process and product conformity

-       Status of Corrective and Preventive Actions

-       Follow up actions

-       Changes that could affect the QMS (this keeps the system and practice in sync)

-       Recommendations for improvement

 

5.       Ensure the availability of resources

 

Management has three additional duties:

1.       Define and communicate responsibilities and authorities.  People have to know what is required of them and who to go to for guidance and instruction.

 

2.       Assign a management representative. 

The management representative must be a member of management with the authority to ensure that the QMS processed are established, implemented and maintained.  In other words, this person keeps the QMS from simply being a book on the shelf.

The person must report the performance of the QMS to top management and ensure the promotion of the awareness of customer requirements.

 

3.       Ensure the existence and use of appropriate communication processes to broadcast the effectiveness of the QMS.

 

To go back to the engine analogy….

The definition of an engine is a machine with moving parts that converts power into motion.

Your company has many moving parts: people, information, infrastructure, machinery.  To convert these into the “motion” of profit requires good planning, good assessment, and good execution.  In short, it requires good management.

As always, please contact us for any of your Quality Management needs. We are ready to assist!

Regards,

DonnaLynn