DBSQMI Products and Services provide for a full turn-key approach to achieve your certification goals, through the implementation of segments I, II, and III services as indicated below. Or you can select specific areas of concentration to support your self directed program. Products and Services are offered in the following areas: 

• ISO 9000 - Programs for Manufacturing & Service/Contract Businesses 
• QS-9000 - For Automotive Suppliers 
• EN-46000 - Medical Devices & Packaging Businesses 
• CE Mark - Meeting the European Medical Device Directive 
• TE-9000 - Tooling and Equipment 
• AS-9000 - Aerospace Companies 
• ISO/TS 16949 - International Automotive Suppliers

Specific Programs and Services 

• Assessments - Gap Assessment (segment I) of your Quality System, or selected assessments 
• Pre-certification Assessments - Practice Audit of your Quality System prior to certification 
• Training Programs - Complete on-site or off-site courses for company personnel 
• Documentation Development - Quality Manual, Procedures, and Work Instructions 
• Implementation Management - Implementation Plan & Schedule (segment II) to certification 
• Consulting - On-site Quality System implementation development support, and Segment III 
• Internal Audits - Conduct internal audits for your company to meet the ISO requirements 
• Registrar Selection - Assist in selection of a registrar that is right for your company 
• ISO Certification -Affiliated with a European based registrar to conduct certification audits 
• Conformance Audits - Compliance assessment and report without the cost of certification 
• Supplier/Subcontractor Audits- Low cost alternative for auditing of your Suppliers 
• Industries Served

TWO DAY CONSULTATION ASSESSMENT

Two (2) days of consultation evaluation of your company's quality management system, with no formal report. The objectives would be to provide an overview assessment of company activities through a general walk through (or targeted areas as directed by the company), various interviews, and documentation sampling to provide the company with verbal direction as to what areas should be developed and what areas look to be in position for a certification audit. Company personnel participate and take notes throughout the two days.

 (a) This module is designed for company's who feel that their quality system is in place and for final preparation prior to the certification audit.

(b) This module can also be used for companies that are in the beginning stages of development of their quality management system (and not interested in a full gap assessment), and are looking for an overview direction as to what the requirements are in areas that are sampled so they have some starting points to work with. 

Two (2) days of on-site evaluation of your company's quality management system, with formal report provided (third day, report development). The objectives would be to provide an overview assessment of company activities through a general walk through (or targeted areas as directed by the company), various interviews, and documentation sampling to provide the company with a documented formal report as to what areas should be developed and what areas look to be in position for a certification audit. 

(a) This module is designed with the same intent as indicated in items a and b in the 2 day program (section I above), except with the additional deliverable of a documented formal report with recommendations to be used as a basis for final certification preparation or starting points to work with.

Two days of assessment of the company's documented quality system and some sample department audits (third day for report development). The objective of this module would be to provide the company with a comprehensive assessment of their documented quality system. The program would take place at the company's facility through a desk top review (audit) of the company's quality manual and procedures to assess the current state of these documents in meeting the ISO requirements. The audit is conducted in the same fashion as would be conducted by a Registrar. Those two days on-site allow for about 1/2 day to perform some actual departmental audits. The deliverables of this module include a comprehensive report on the state of the documented quality system that includes what is in place, what is not, and recommendations as to what is needed. Any departmental audits are also included in the report. 

a) This module is designed for companies who have a documented quality system in-place and are seeking a 3rd party assessment as to its conformance level to the ISO standards. The intent is also to provide a final clearing house of the quality manual prior to submission for Registrar review. The audit sampling provides some insight as to whether the documented quality system is being implemented. 

This is a 40 hour pre-assessment audit (48 hours for QS-9000, TE-9000, AS-9000 or EN46000 gap assessments) of your present Quality Management System to the ISO 9001/9002 requirements performed in similar fashion as a registrar audit. This would be about 2 days of on-site audits of your documented quality system and sample department audits, with the remaining time off-site for report development. Audits will be conducted in most all of your operating segments which include interviews with appropriate employees. The output of the gap analysis will be in the form of 2 summary reports (the gap reports) focused on percent of conformance and percent readiness, and a detailed report as to what is in place, what is in nonconformance, and recommendations for corrective actions. 

(a) This module is designed for those companies that seek a complete comprehensive assessment of their quality management system in both documented and performance categories in all segments of the company. It provides for a complete road map as to where your current quality system stands against the standard, and what you must do to bridge the gap to achieve certification.

Computerized Implementation Plan Development is an off-site development activity with review of the plan on-site with staff management. This plan is developed using the data from the Gap Assessment (segment I). It reflects a Mechanized Computer Project Management scheme which will be the key control/tracking tool through to certification. The output of the plan will be procedures and training requirements configured in a Main Gantt Chart of project activities, Sub-project Gantt Chart of activities, Critical Path definition, details of activities, accountability for activities, hours required per day, manpower forecast and histogram report, and project budget report (if requested).

The project management plan is updated as the implementation evolves and is used as the principle management tool for reporting to the management staff the progress, issues, and concerns of the various activities. This tool is a forecast device allowing management to keep the project on track before dates are missed. It provides a view of manpower requirements to assist management in its decision on implementation of resources. 

Implementation Consulting services are on an as-needed basis through to certification. This includes project management of activities, on-going assessments, review of work, procedures and quality manual development, training, internal audits, and participation in management reviews. As part of the consulting services, we assist in selection of a registrar that fits your needs. 

As part of the full implementation program the segment III portion would be approximately 1 to 2 days a month of on-site consulting services for documentation development and review, supporting the internal audit activity, implementing the required training of company employees (Management Training, Internal Auditing, & Employee Training), and a company wide final readiness assessment prior to the Registrar audit. 

Our documentation development services include quality manual development, procedure development, and work instruction development. We can supply temporary on-site technical writers who will assist in the configuration and drafting of company documentation through to word processing for final release. All documentation developed is reviewed by an RAB/IRCA auditor to ensure conformance to the applicable standards. 

Benefits

1. These services are available for those companies who do not have the internal resources to develop the required documentation on their own. 
2. For those companies who want to accelerate the documentation phase to shorten the time to certification. 

If your interest is in scheduling a certification audit, we are contract auditors for a major international registrar accredited to perform ISO 9000, QS-9000, EN46000 and ISO 14000 audits. 

Registrar Accreditation includes: 

•      Registrar Accreditation Board (RAB) - United States 
•      Raad Voor Accreditatie (RvA) - the Netherlands 
•      Automotive Industry Action Group (AIAG) - Southfield, MI 
•      Notified Body for CE MARK MEDICAL 
•      Notified Body for CE MARK MACHINERY & EMC 
•      Notified Body for CE MARK TELECOMMUNICATIONS Annex 3 & 4 

We provide Quality System Internal Auditing Services in accordance with the following standards:

• ISO 9000 Quality System Requirements
• QS-9000 3rd Edition Automotive Sector Quality Systems Requirements
• TE-9000 Automotive Tooling and Equipment Requirements
• AS-9000 Aerospace Sector Quality Systems Requirements
• EN46000/ISO 13485 Medical Device Sector Quality Systems Requirements

• Conducted in accordance with your internal procedures to meet your registrar's requirements.
• Audit finding reports written, on your company's prescribed format.
• Provide recommendations and assistance for continuing development of your quality system and/or your supplier's quality system.
• Audits lead and conducted by RAB/IRCA/AIAG certified auditors.

• Streamlined and effective auditing process using certified professionals for achieving or maintaining your certification and/or assessing your suppliers.
• Continued assistance to your internal audit teams to optimize your resources.
• Allows your internal resources to focus on your business rather than auditing.
• Your resource for implementing the internal audit requirement.