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ISO 9000 Solutions, Inc. SM 148 Timberlink Grand Island, New York 14072 Phone: 1-888-845-6514 E-mail: [email protected]

ISO 9000 Solutions, Inc. SM

Free Download -2000
Excerpted from the Complete Compliance Package 2000

Sample material extracted from our ISO9001:2000 based Quality Management System Templates. These pages are formatted as Adobe Acrobat .PDF files (read only). Purchased files are delivered via Internet Download only. All purchased files are provided in an editable Microsoft Word.doc format as well as the Adobe Acrobat .PDF.

ISO 9000 Solutions Complete Compliance Package -2000, Starterguide-2000, Quality Assurance Manual- 2000, Genesis Module-2000, Quality Procedures2000, and Internal Audit-2000 are all trademarks of ISO 9000 Solutions, Inc. SM

2001 ISO 9000 Solutions, Inc. SM Revision 3.0

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ISO 9000 Solutions Free Download 2000

Introduction
Unless otherwise specified, no part of this publication may be reproduced in any form or by any means, including electronic or mechanical, without the prior written consent of ISO 9000 Solutions, Inc. Limited exception is made in the instance of the sole or single client use of this publication as a documentation template. This publication may not be copied and/or redistributed to any third party. This publication has not been licensed for resale or multiple client use. Consultants should purchase this product on a per client basis. If you receive this publication from someone other than ISO 9000 Solutions Inc, you should be aware that the author/publisher may not have received payment.

Pages 1 2: Quality Manual Excerpt Pages 3 4: Quality Procedures Excerpt Pages 5 6: Internal Audit Checklist Excerpt Pages 7 9: Bonus: Corrective Action Procedure And CA Process Flowchart

2001 ISO 9000 Solutions, Inc. SM Revision 3.0

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Rev. 4R Date: 01/03/01

Quality Assurance Manual

Section 5 Page 1 of 3

Title: Management Responsibility

5.1 Management Commitment
ISCG has implemented a Quality Management System that is continuously maintained for effectiveness and process improvements in accordance with the requirements of ISO 9001:2000 and all other statutory or regulatory requirements as appropriate.

5.2 Customer Focus

ISCG establishes, implements and maintains documented procedures for contract review and for the coordination of related activities. It is the responsibility of the Order Service Department to review all tenders and contract offerings. Customer quotations, inquiries, orders and contracts are reviewed to ensure customer requirements are adequately defined and documented. Any changes or amendments to the contract are reviewed according to the procedures established by Sales, Marketing and Customer Service functions.

5.3 Quality Policy

ISCG defines and documents its Policy for Quality, which provides the overall objectives for an effective Quality Management System. The Quality Policy is relevant to the companys goals and the expectations of its customers. ISCG is a provider of professional services and products with sales in various world markets. Our Quality Policy is:

ISCG is committed to providing its customers with Quality products and services that continually meet and exceed customer expectations.

Approved: Executive Manager

Date:_______________

ISCGs employees and management are committed to assuring that this policy is implemented, understood and maintained at all levels of the organization.

2001 ISO 9000 Solutions, Inc. SM Revision 3.0

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Rev. 3R Date: 01/03/01

Quality Assurance Manual

Section 8 Page 3 of 5

Title: Measurement, Analysis and Improvement

8.5 Improvement 8.5.1 Continual Improvement
ISCG continually improves the effectiveness of its Quality Management System through the use of the Quality Policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.

8.5.2 Corrective Action

ISCG establishes, implements and maintains documented procedures to initiate corrective and preventive actions for conditions adverse to quality. Corrective Action Procedures define the requirements for: a) b) c) d) e) f) reviewing non-conformities (including customer complaints) determining causes of non-conformities evaluating the need for action to ensure that non-conformities do not recur determining and implementing the action needed records of the results of action implemented review of corrective action implemented

The Quality Assurance Manager is responsible for Corrective Actions and a feedback system is used to provide early warning of quality problems and for input into the corrective action system.

8.5.3 Preventive Action

ISCG establishes and maintains documented procedures to determine the appropriate preventive actions required to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive Action Procedures define the requirements for: a) b) c) d) e) determining potential non-conformities and their causes evaluating the need for action to prevent occurrence of non-conformities determining and implementing the action needed records of the results of action implemented reviewing preventive action implemented

The Quality Assurance Manager is responsible for Preventive Action at ISCG.

2001 ISO 9000 Solutions, Inc. SM Revision 3.0

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Quality Procedure # OPM 4.2 Origin Date: 04/27/98 Rev. Date: 01/03/01 Page: 1 of 3

Title: Quality Management System - Documentation

1.0 Purpose 1.1 This procedure defines the documentation structure of the Quality Management System documents at ISCG.

2.0 Responsibility 2.1 The Quality Assurance Manager is responsible for this procedure.

3.0 Requirements 3.1 The flowchart contained in 6.0 Method (Flowchart and/or Narrative) defines the structure of the Quality Management System documentation implemented at ISCG to maintain consistent product/service quality that conforms to specified requirements. Level I is maintained in the form of the Quality Policy Level II documentation is maintained in the form of the Quality Assurance Manual. Level III and IV documentation is reviewed in OPM 4.2A and OPM 4.2B, Procedures and Work Instructions, respectively. Level V documentation is maintained as records/reports.

3.2 3.3

3.4

3.5 4.0 Definitions N/A 5.0 Records 5.1

Their respective departments will handle the control of documents, records and procedures as defined in the Master Documents List, Master Records List and Master Forms List.

6.0 Method 6.1

The following flowchart defines the structure and numbering of the quality system documentation at ISCG.

2001 ISO 9000 Solutions, Inc. SM Revision 3.0

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Quality Procedure # OPM 4.2 Origin Date: 04/27/98 Rev. Date: 01/03/01 Page: 2 of 3

Title:

Quality Management System - Documentation

LEVEL I
QUALITY POLICY

LEVEL II
QUALITY ASSURANCE MANUAL

LEVEL III
QUALITY PROCEDURES

Numbering: QA - 1

LEVEL IV
WORK INSTRUCTIONS Numbering: WI 4.1(A) WI 8.5 (Z)

LEVEL V
RECORDS/REPORTS FORMS
Numbering: relative alphanumeric identifiers (i.e. audit checklist.06)

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Internal Audit Checklist Sample

4 Quality Management System ISO ELEMENT General Requirements OVERALL EFFECTIVENSS Page 1 / 1 RESULTS PASS FAIL

QUESTION AUDITOR NOTES OBJECTIVE EVIDENCE Has a formal Quality Management System been established with appropriate documentation? 2 Does the documentation identify operations? 3 Does the documentation determine the sequence and interaction of operations to ensure control? 4 Is there an Organizational Chart of the company defining the interrelation of personnel effecting Quality? 5 Are all the departments or functions responsible for Quality clearly identified? 6 Do personnel responsible for Quality decisions have organizational authority? 7 Do departments or functions responsible for Quality have the necessary resources? 8 Has executive management determined the resources needed and information necessary for operations? 9 Is monitoring, measuring and analysis of operations performed? 10 Are necessary actions implemented to achieve planned results and continual improvements? 11 Are outsourced operations identified and controlled to ensure conformity with specified requirements? ADDITIONAL COMMENTS AND SUGGESTIONS 1

PASS

FAIL

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4 Quality Management System

Page 1 / 1

ISO ELEMENT
Documentation Requirements

OVERALL EFFECTIVENESS

RESULTS
PASS FAIL

QUESTION AUDITOR NOTES OBJECTIVE EVIDENCE Does a Quality Policy exist and is it posted or available for review? 2 Does the Quality Manual describe Quality objectives and outline the scope of the Quality System? 3 Does the Quality Manual define any exclusions? 4 Does the Quality Manual make reference to Quality Procedures where applicable? 5 Have all the appropriate Quality Procedures been documented and implemented? (ref. ISO 9001) 6 Does executive management define and ensure the compatibility of interaction between all operations? 7 Is there a formal written procedure to control all Quality documents by revision status? 8 Are Quality Plans available and documented for use in all phases of operations? 9 Are records controlled to ensure objective evidence of conformity and effective operations? (ref. ISO 9001, 4.2.4) ADDITIONAL COMMENTS AND SUGGESTIONS 1

PASS

FAIL

2001 ISO 9000 Solutions, Inc. All rights reserved.

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Quality Procedure # OPM 8.5A Origin Date: 05/15/98 Rev. Date: 01/16/01 Page: 1 of 3

Title: Improvement Corrective Action

1.0 Purpose 1.1 This procedure defines the system used for corrective action and continual improvements at ISCG.

2.0 Responsibility 2.1 The Quality Assurance Department is responsible for this procedure.

3.0 Requirements 3.1 The Quality Management System is continuously improved through the use of the Quality Policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews. The Flowchart contained in 6.0 Method (Flowchart and/or Narrative) defines the method(s) used at ISCG for corrective actions.

3.1

4.0 Definitions 4.1 5.0 Records Record corrective action report (CAR) Description Record of corrective action Location Retention quality assurance 5 years minimum office Corrective Action is the action taken to correct the occurrence of non-compliance and conditions adverse to quality.

6.0 Method 6.1 The following Flowchart defines the corrective action process.

2001 ISO 9000 Solutions, Inc. All rights reserved.

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Quality Procedure # OPM 8.5A Origin Date: 05/15/98 Rev. Date: 01/16/01 Page: 2 of 3

Title: Improvement Corrective Action Corrective Action

Identification of Non-conformities Individuals within the organization identify any non-conformance. Nonconformities are formally identified through internal audits, customer complaints, observations, and all other applicable means of analysis.

Corrective Action Report [CAR] Contains the non-conformance identification, implementation responsibility, and monitoring of implementation. The CAR is submitted to Quality Assurance then entered into the CAR LOG and assigned a number by Quality Assurance.

Non-conformities Reporting When a non-compliance is identified it must be documented on a Corrective Action Report [CAR]. The individual(s) identifying the nonconformity completes the first section of the [CAR], with as much detail as possible. The Corrective Action Report is then submitted to Quality Assurance.

Implementation The department and/or individual(s) that are noted as responsible on the CAR are required to identify the root cause and implement the corrective action in a timely manner.

Corrective Action Approval The implemented Corrective Action is reviewed and approved by the originator if it is found effective.

NO
Implementation Satisfactory?

YES
Corrective Action Review Corrective Action and its effectiveness are reviewed according to OPM 8.5B, (Preventive Action).

2001 ISO 9000 Solutions, Inc. All rights reserved.

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CONTROLLED DOCUMENT (IF THIS MARK IS IN RED)

Quality Procedure # OPM 8.5A Origin Date: 05/15/98 Rev. Date: 01/16/01 Page: 3 of 3

Title: Improvement Corrective Action

7.0 References 7.1 Corrective Action Report [CAR]

Revision History: Revision 1 2 3 4 5 6 7 Date 05/15/98 06/15/98 07/16/98 12/09/98 01/18/99 07/29/99 01/16/01 Description original revised procedure flowchart format revised procedure to define who initiates CAR revised procedure to detail the process linked the CAR to the CAR LOG changed non-conformance to noncompliance align with ISO 9001:2000 requirements

Originator:

Date:

Approval:

Date:

2001 ISO 9000 Solutions, Inc. All rights reserved.

Rev. 3.0 01/31/01