some hints for QMS audit -2[分享]

　


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4.2 Quality System

4.2.1 General

[]Does the company have a documented quality system[/]

Yes - This is defined in the company systems manual.

[]Is the quality system described comprehensively in the quality manual or in other documents[/]

Yes - In the company systems manual and in other systems documents.

[]Is the structure of the documentation outlined in the quality manual[/]

Most of the detail is in the system flow charts and related documentation.

[]Are all relevant quality system elements of this standard described[/]

They are defined as appropriate to Company X Chemicals.

[]Are all quality relevant system procedures included in the quality manual or does it reference the quality system procedures Based on results of internal quality audits and regarding the status of the achieved quality goals, for example, through customer surveys, personnel surveys, quality circle activities as well as by quality reports, customer complaint reports, etc.[/]

The systems manual contains mainly policy as is typical for 'quality systems' manuals. Within each company systems manual section related documentation is cited. Some detail exists (depending on section) as appropriate to this level of documentation.

[]Has the quality manual been enforced by the upper management[/]

Upper management monitors to ensure the company systems manual, as well as all other systems documentation, is followed.

4.2.2 Quality system procedures

[]Are the quality system procedures and the derived instructions binding and have they been enforced by the assigned organizational unit For example, work instructions, inspection instructions.[/]

All documentation within Company X Chemicals is followed and are binding from the date of origin (Company X Chemical's Effectivity Date) to when a procedural document is withdrawn from use in its entirety.

4.2.3 Quality planning

[]Does the company define how quality requirements for products will be met systematically (quality plans)[/]

A quality plan is, for example, work plan, inspection plan, development plan or upon customer request procedures regarding inspections (kind, scope).

Yes. Company X Chemicals utilizes Contract Review and Design Control as the basis of Quality Planning. Most of the items cited in this questions' qualifier extension are in Design Control as Design Outputs which are based upon Design Inputs.

[]Is the scope of the quality system defined regarding[/]

Plants

There is only one location

Products (Products can be: industrial product or process, service, hardware and software or a combination of both.

From the systems manual introduction, page 1 " Company X Chemicals, Incorporated is a small business supplying chemical products to automotive Tier 2 suppliers, to the industrial (metal cleaning and phosphating) sector, to institutional (USDA approvals and restaurant) businesses, and to the transportation (truck washing) industry."

Organizational units?

Organizational 'units' are defined in the organizational chart.