ISO 9000 - Quality Systems Services

Quality Management Systems Implementation (ISO 9000)

W. Edwards Deming --

"Quality is everyone's responsibility."

Implementation Process Outline:

Phase I - Gap Analysis/Project Plan

Compliance to an ISO 9000 system helps ensure that:

You are defining and documenting your key production and activities

Workers are trained in job related skills

Management has established a system for control of documentation, materials, segregation of nonconforming items, and remedial action when defective items are found

Companies that comply with the requirements of ISO 9000 are more focused on meeting the needs of the customer. Quality Systems Services can assist you through all phases of the implementation plan

Determine the areas which are compliant
Identify what is required to bring the Registration into compliance
Develop a timeline and determine resources that are required for meeting the requirements of the standard

Phase II - Quality System Development

There are four levels of documentation required for ISO 9000. They are:

Quality Manual -- Defines approach and responsibility
Procedures -- Defines who, what, when
Work/Job Instructions (Functional, departmental) -- Answers how
Other Documenation (Forms, records, etc.) -- Provides a quality record

These four tiers of documentation are developed based on the needs identified from the gap analysis

Mr. Brad Ishler has played a key role in facilitating the gap analysis and to prepare an initial plan for implementation for our ISO 9000 project. As this project moves forward, we look to utilize their services even further.

M. Thomas Zubler, Director of Quality Assurance
Cannon Instrument Company

Phase III - Preparing for the Registration Process

Determine the roles and responsibilities of everyone in the organization
Select a registrar
Provide any necessary training
Conduct internal audits
Address any non-compliances

Phase IV - Surveillance Audits

Submit QA Manual to the Registrar
Schedule Surveillance Audits
Prepare organization for surveillance audits
Participate in surveillance audits
Address any non-compliances
Celebrate your success after receiving your certificate

Important Considerations:

Top management must be engaged in the process
Use a cross functional team approach for implementation
Communicate early and often with everyone
Develop a rapport with your registrar
Pay attention to details
Continually look for ways to improve your processes

With Quality Systems Services as our consultant, our ISO 9001 certification and our ISO/IEC 17025:2005 accreditation were achieved in an efficient and organized manner.

John A. Walls, III, President
Calyx Metrology Laboratory, Inc.

For more information about Quality Management Systems Implementation, contact our Sales Department: sales@qualitysystemsservices.net