Access QMS - Service Offerings

Total <QMS or EMS> Development Programs - Process and Flow

Prior To Start Of Project:
On receipt of a contract, order or tender, the client should be requested to fill out the questionnaire and supply a hard copy of their current QMS, including:

All policies, procedures, work instructions (excluding work instructions developed for the performance of manufacturing specific tasks), and samples of forms (quality records).

The organization chart and quality policy should also be provided.

For clients where inspection, testing or calibrations take place, a sample of the records for each and the scope of inspections, tests and calibrations performed.

For an ISO/TS 16949 program: a sample of a recent PPAP package, including APQP documentation (client to obliterate customer identifications and part names and numbers).

Obtain translation of QMS into English as applicable.

Perform Documentation Audit:
On receipt of the questionnaire and QMS, a documentation audit will be performed to the relevant standard (ISO 9001:1996, ISO 9002:1996, QS-9000:1996, etc.). This audit will determine: the viability of the current system, the works required to develop or update/upgrade the system, and provide specific pointers for review at on-site visitations. Based on the complexity of the system, this audit should take between 2 and 10 business days.

Documentation Audit Report and Timeline Development:
After the documentation audit is performed, the following will be developed:

A report on the results of the documentation audit, including the ability of the QMS to fulfill the intent of the relevant standard and any perceived gaps. Additionally, any recommendations for the company to implement as an aid to registration.

An approximate project timeline, including the consultant(s) assigned to the project (based on project schedule and QMS complexity).

A list of specific questions and/or clarifications to be asked and discussed upon the on-site visitation including specific areas/elements to be reviewed.

On-Site Visitation:
Schedule the on-site visitation. The on-site visitation will accomplish the following:

Meet the management staff and gage the level of knowledge and commitment to the project.

Allow the management staff to meet the consultant(s)

Obtain the specific information/clarifications from the documentation review.

Review of the specific areas/elements from the documentation review and gage the client's current status of the QMS.

Present the timeline and documentation audit report, with any recommendations.

Present hard copy of the Quality Policies for review, if available.

If elements of the current QMS can be incorporated or salvaged for use in the new QMS, obtain electronic copies.

Visitation Report:
On return from the client visitation:

Write visitation report (a general overview of the visit with general observations). Include names and titles of all personnel contacted during the visit.

Document any gaps found during the visitation.

Document the specific answers and clarification to questions from the specific list developed prior to the visitation.

Document the objective evidence found during the review of the specific areas/elements developed prior to the visitation.

Consultancy Start:
Forward copies of the following to the consultant(s):



INTRODUCTION <QMS OR EMS> Total Development Programs <QMS OR EMS> Development/Process & Flow	Total <QMS or EMS> Development Programs - Process and Flow Prior To Start Of Project: On receipt of a contract, order or tender, the client should be requested to fill out the questionnaire and supply a hard copy of their current QMS, including: All policies, procedures, work instructions (excluding work instructions developed for the performance of manufacturing specific tasks), and samples of forms (quality records). The organization chart and quality policy should also be provided. For clients where inspection, testing or calibrations take place, a sample of the records for each and the scope of inspections, tests and calibrations performed. For an ISO/TS 16949 program: a sample of a recent PPAP package, including APQP documentation (client to obliterate customer identifications and part names and numbers). Obtain translation of QMS into English as applicable. Perform Documentation Audit: On receipt of the questionnaire and QMS, a documentation audit will be performed to the relevant standard (ISO 9001:1996, ISO 9002:1996, QS-9000:1996, etc.). This audit will determine: the viability of the current system, the works required to develop or update/upgrade the system, and provide specific pointers for review at on-site visitations. Based on the complexity of the system, this audit should take between 2 and 10 business days. Documentation Audit Report and Timeline Development: After the documentation audit is performed, the following will be developed: A report on the results of the documentation audit, including the ability of the QMS to fulfill the intent of the relevant standard and any perceived gaps. Additionally, any recommendations for the company to implement as an aid to registration. An approximate project timeline, including the consultant(s) assigned to the project (based on project schedule and QMS complexity). A list of specific questions and/or clarifications to be asked and discussed upon the on-site visitation including specific areas/elements to be reviewed. On-Site Visitation: Schedule the on-site visitation. The on-site visitation will accomplish the following: Meet the management staff and gage the level of knowledge and commitment to the project. Allow the management staff to meet the consultant(s) Obtain the specific information/clarifications from the documentation review. Review of the specific areas/elements from the documentation review and gage the client's current status of the QMS. Present the timeline and documentation audit report, with any recommendations. Present hard copy of the Quality Policies for review, if available. If elements of the current QMS can be incorporated or salvaged for use in the new QMS, obtain electronic copies. Visitation Report: On return from the client visitation: Write visitation report (a general overview of the visit with general observations). Include names and titles of all personnel contacted during the visit. Document any gaps found during the visitation. Document the specific answers and clarification to questions from the specific list developed prior to the visitation. Document the objective evidence found during the review of the specific areas/elements developed prior to the visitation. Consultancy Start: Forward copies of the following to the consultant(s): The documentation audit report The visitation report Electronic copies of the current QMS The applicable new standard The timeline