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ASA-100 Distributor Quality Manual

Table of Contents - click here for PDF demo - opens in new tab/page

1.0 Quality System and Quality Manual
2.0 Self-Audit/Evaluation
2.1 Internal audit
2.2 Audit requirements
3.0 Facilities
4.0 Training and Authorized Personnel
4.1 People
4.2 Competence
5.0 Procurement
5.1 General
5.2 Type and extent of control
5.3 Information for external providers
6.0 Receiving Inspection
7.0 Measuring and Test Equipment
8.0 Material Control
9.0 Shelf Life Control
10.0 Certification and Release of Materials
11.0 Shipping
12.0 Records
13.0 Technical Data Control
14.0 Corrective Action Process
14.1 Required records for nonconformities
Appendix A: Responsible Authorities

1.0    Quality System and Quality Manual

(Your Company's) quality management system's (QMS) quality manual summarizes top management's stategic view to enhance Customer satisfaction, improve the QMS and assure consistent delivery of products that achieve conformance with Customer and applicable statutory and regulatory requirements. The Company ensures that it can meet the claims for products and services it offers and ensures requirements for products and services are defined according to the Proposal Development and Contract Review Procedure.

2.0    Self-Audit/Evaluation

2.1 Internal audit

The Company conducts internal audits at least once each calendar year to provide information on whether the quality management system conforms to requirements and is effectively implemented, maintained and continuously improved according to the following procedures: Internal Auditing Procedure, Management Process Procedure, Control of Nonconformities Procedure and Corrective Action Procedure.

2.2 Audit requirements

The Company assigns Responsible Authorities to perform internal audits and report audit results to management according to the Internal Auditing Procedure.

3.0    Facilities

The Company determines and provides the resources needed to prevent damage to inventory in storage areas and to... The Company determines, provides and maintains the environment necessary for the operation of its processes according to the Management Process Procedure.

4.0    Training and Authorized Personnel

4.1 People

The Company determines and provides the people necessary for the effective operation and control of its processes and quality management system according to the Management Process Procedure, Responsibilities and Authorities Procedure and Training Procedure. See Appendix A for Responsible Authority Chart.

4.2 Competence

The Company ensures Employee competence according to..., which includes... The Company evaluates the effectiveness of training and maintains records... according to the Management Process Procedure, Training Procedure and Control of Documented Information Procedure. The Company maintains...

5.0    Procurement

5.1 General

The Company ensures that externally provided products are traceable to a prior source and conform to requirements according to the Purchasing Procedure and Receiving Procedure. The Company determines and applies criteria for... according to requirements and the Purchasing Procedure...

5.2 Type and extent of control

The Company ensures that externally provided products do not adversely affect the Company's ability to consistently deliver conforming products to its Customers according to the Purchasing Procedure and Receiving Procedure.

5.3 Information for external providers

The Company ensures that requirements are adequately documented prior to communicating with Suppliers according to the Purchasing Procedure.

6.0    Receiving Inspection

Incoming supplies are inspected to ensure..., which is defined in the Receiving Procedure.

7.0    Measuring and Test Equipment

Measuring equipment is identified for traceability then calibrated and/or verified prior to use and safeguarded from... according to the Calibration Procedure.

8.0    Material Control

The Company uses original/special packaging and suitable means to protect supplies from...

9.0    Shelf Life Control

The Company reviews purchase orders for life limited items according to Purchase Order Review Procedure then identifies and controls... items according to Receiving Procedure.

10.0    Certification and Release of Materials

The Company prepares a documentation package for shipments according to the Shipping Procedure, which includes... according to the Production Procedure.

11.0    Shipping

Products are released for delivery to Customers only after... Deliverable supplies are preserved, packaged, packed and marked according to the Shipping Procedure.

12.0    Records

The Company controls records to ensure they are available for each Customer purchase (fasteners, life limited items, raw materials, etc). Records are suitable for use when and where needed and are... according to the Control of Documented Information Procedure.

13.0    Technical Data Control

Documents required for production of deliverable items are readily available to all Employees and interested parties on the Company's internal server. The Company controls... according to the Control of Documented Information Procedure. Internal and external documents used for planning and operation of the QMS are...

14.0    Corrective Action Process

When a nonconformance occurs, including complaints, the Company reacts to the nonconformance and, as applicable,... according to the Corrective Action Procedure and Control of Nonconformities Procedure. The Company evaluates the need for action to eliminate the cause of each nonconformance... using the Request for Support Form (RFS) and... using the Investigation and Corrective Action Request Form (ICAR)...

14.1 Required records for nonconformities

The Company retains and maintains records regarding the nature of nonconformances, subsequent actions and results of corrective actions according to the Control of Documented Information Procedure.

Appendix A

...

REVISION HISTORY AND APPROVAL RECORD

Quality System Policy
ASA-100 QUALITY MANUAL
Rev: Orig (EO #1) (Release Date is Mandatory)

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