QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES
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QUPAOLLITICYIEMSAANNADGPERMOECNETDSUYRSETSEM Abstract:
hts reserved worldwide. Origination Date: XXXX
C. All rig Document LL Identifier: , Date: lties Document JnF Specia Revision:
QMS-00 QMS Policies and Procedures Latest Revision Date
Orig
? This handbook documents (your Company's) quality management system policies and Copyright procedures.
Copyright ? JnF Specialties, LLC. All rights reserved worldwide.
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This document expires 30 days after printing unless marked "Released". Date Printed:
Form Rev: Orig
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Your Company Name
QMS-00 Policies and Procedures Rev: Orig
. REVISION LOG
ide Issue Date
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ts Issue Item
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cialties, LLC. All righ NOTE: Company policies herein are expressed from the perspective of "As-a-Matter-of-Fact". To apply this perspective, JnF Spe mentally add the phrase to the beginning of each paragraph herein. Delete this note prior to release of quality handbook.
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TABLE OF CONTENTS
e. Section 1:
Scope...................................................................................................................................................................................................... 5
id Section 2:
Normative references ............................................................................................................................................................................. 5
w Section 3:
Terms and Definitions............................................................................................................................................................................ 5
rld Section 4:
Context of the Organization ................................................................................................................................................................... 5
o 4.1 Understanding the organization and its context...................................................................................................................................................................................... 5
w 4.2 Understanding the needs and expectations of interested parties ............................................................................................................................................................ 5
d 4.3 Determining the scope of the quality management system .................................................................................................................................................................... 5
e Non-Applicable Provisions of the QMS ..................................................................................................................................................................................................................................... 5
rv 4.4 Quality management system and its processes ....................................................................................................................................................................................... 5
e Section 5:
Leadership.............................................................................................................................................................................................. 7
es 5.1 Leadership and commitment ................................................................................................................................................................................................................... 7
r 5.1.1
General.................................................................................................................................................................................................................................................................... 7
ts 5.1.2
Customer focus ....................................................................................................................................................................................................................................................... 7
5.2 Policy ....................................................................................................................................................................................................................................................... 7
h 5.2.1
Developing the quality policy ................................................................................................................................................................................................................................ 7
ig 5.2.2
Communicating the quality policy ......................................................................................................................................................................................................................... 7
ll r 5.3 Organizational roles, responsibilities and authorities ............................................................................................................................................................................. 7
Section 6:
Planning ................................................................................................................................................................................................. 7
. A 6.1 Actions to address risks and opportunities.............................................................................................................................................................................................. 7
C 6.1.1
Planning for the QMS............................................................................................................................................................................................................................................. 7
L 6.1.2
Planning requirements ............................................................................................................................................................................................................................................ 8
L 6.2 Quality objectives and planning to achieve them ................................................................................................................................................................................... 8
, 6.2.1
Establishing quality objectives ............................................................................................................................................................................................................................... 8
s 6.2.2
Achieving quality objectives .................................................................................................................................................................................................................................. 8
ltie 6.3 Planning of changes................................................................................................................................................................................................................................. 8
Section 7:
Support ................................................................................................................................................................................................... 8
ia 7.1 Resources................................................................................................................................................................................................................................................. 8
c 7.1.1
General.................................................................................................................................................................................................................................................................... 8
pe 7.1.2
People ..................................................................................................................................................................................................................................................................... 8
S 7.1.3
Infrastructure .......................................................................................................................................................................................................................................................... 9
7.1.4 7.1.5 7.1.5.1
JnF Environment for the operation of processes........................................................................................................................................................................................................... 9
Monitoring and measuring resources ..................................................................................................................................................................................................................... 9 General.................................................................................................................................................................................................................................................................... 9
7.1.5.2 Measurement traceability ....................................................................................................................................................................................................................................... 9
7.1.6
Organizational knowledge...................................................................................................................................................................................................................................... 9
t ? 7.2 Competence ............................................................................................................................................................................................................................................. 9
h 7.3 Awareness................................................................................................................................................................................................................................................ 9
ig 7.4 Communication ..................................................................................................................................................................................................................................... 10
r 7.5 Documented information....................................................................................................................................................................................................................... 10
y 7.5.1
General.................................................................................................................................................................................................................................................................. 10
p7.5.2
Creating and updating........................................................................................................................................................................................................................................... 10
Co7.5.3
Control of documented information ..................................................................................................................................................................................................................... 10
7.5.3.1 Documents required by QMS and International Standard ................................................................................................................................................................................... 10
7.5.3.2 Activities for control of documented information................................................................................................................................................................................................ 10
Section 8:
Operation.............................................................................................................................................................................................. 10
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8.1 Organizational planning and control..................................................................................................................................................................................................... 10
8.2 Requirements for products and services ............................................................................................................................................................................................... 11
8.2.1
Customer communication..................................................................................................................................................................................................................................... 11
. 8.2.2
Determining the requirements related to products and services .......................................................................................................................................................................... 11
e 8.2.3
Review of requirements related to products and services .................................................................................................................................................................................... 11
id 8.2.3.1 Ability to meet requirements ................................................................................................................................................................................................................................ 11
w 8.2.3.2 Retain documented information of review........................................................................................................................................................................................................... 11
ld 8.2.4
Changes to requirements for products and services ............................................................................................................................................................................................. 11
r 8.3 Design and development of products and services ............................................................................................................................................................................... 11
o 8.3.1
General through 8.3.6 Design and development changes .................................................................................................................................................................................... 11
w 8.4 Control of externally provided processes, products and services......................................................................................................................................................... 12
8.4.1
General.................................................................................................................................................................................................................................................................. 12
d 8.4.2
Type and extent of control.................................................................................................................................................................................................................................... 12
ve 8.4.3
Information for external providers ....................................................................................................................................................................................................................... 12
r 8.5 Production and service provision .......................................................................................................................................................................................................... 12
e 8.5.1
Control of production and service provision........................................................................................................................................................................................................ 12
s 8.5.2
Identification and traceability............................................................................................................................................................................................................................... 12
re 8.5.3
Property belonging to Customers or external providers....................................................................................................................................................................................... 12
ts 8.5.4
Preservation .......................................................................................................................................................................................................................................................... 12
8.5.5
Post-delivery activities ......................................................................................................................................................................................................................................... 13
h 8.5.6
Control of changes................................................................................................................................................................................................................................................ 13
ig 8.6 Release of products and services........................................................................................................................................................................................................... 13
ll r 8.7 Control of nonconforming outputs........................................................................................................................................................................................................ 13
8.7.1
Identify and control nonconforming outputs........................................................................................................................................................................................................ 13
A 8.7.2
Retain documented information for nonconformities .......................................................................................................................................................................................... 13
. Section 9:
Performance evaluation........................................................................................................................................................................ 13
LC 9.1 Monitoring, measurement, analysis and evaluation.............................................................................................................................................................................. 13
L 9.1.1
General.................................................................................................................................................................................................................................................................. 13
, 9.1.2
Customer satisfaction ........................................................................................................................................................................................................................................... 14
s 9.1.3
Analysis and evaluation........................................................................................................................................................................................................................................ 14
ltie 9.2 Internal audit.......................................................................................................................................................................................................................................... 14
9.2.1
Conduct internal audits at planned intervals ........................................................................................................................................................................................................ 14
ia 9.2.2
Audit requirements ............................................................................................................................................................................................................................................... 14
c 9.3 Management review .............................................................................................................................................................................................................................. 14
e 9.3.1
General.................................................................................................................................................................................................................................................................. 14
p 9.3.2
Management review inputs................................................................................................................................................................................................................................... 14
S 9.3.3
Management review outputs................................................................................................................................................................................................................................. 15
Section 10: Improvement ........................................................................................................................................................................................ 15
JnF 10.1
General ............................................................................................................................................................................................................................................ 15
10.2
Nonconformity and corrective action ............................................................................................................................................................................................. 15
10.2.1
Required actions for nonconformities .................................................................................................................................................................................................................. 15
? 10.2.2
Required records for nonconformities.................................................................................................................................................................................................................. 15
ht 10.3
Continual improvement................................................................................................................................................................................................................... 15
ig Appendix A: Company Processes and Applicable ISO 9001 Clauses ............................................................................................................................ 16
yr Appendix B: Company Processes and Applicable Documents....................................................................................................................................... 17
p Appendix C: Outsourced Processes................................................................................................................................................................................ 18
Co Appendix D: Quality Objectives..................................................................................................................................................................................... 18
Appendix E: Identification of Key Realization Processes .............................................................................................................................................. 19
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Section 1: Scope
(Your Company's) quality management system (QMS) policies and procedures summarize top management's stategic
e. view to improve the QMS, enhance Customer satisfaction and assure consistent delivery of products and services that id achieve conformance with Customer and applicable statutory and regulatory requirements. ldw Section 2: Normative references r Documents that are referenced herein are indispensable and their title's are displayed in Bold Italics. d wo Section 3: Terms and Definitions e Unless otherwise noted, the Company applies the definitions of key terms according to ISO 9001 and the QMS-16 rv Definitions and Abbreviations Procedure. ese Section 4: Context of the Organization ts r 4.1 Understanding the organization and its context igh The Company considers, monitors and reviews internal and external issues that affect its ability to achieve intended r results according to the QMS-04 Management Process Procedure. All 4.2 Understanding the needs and expectations of interested parties . The Company considers the needs and expectations of interested parties that affect its ability to achieve intended results C according to the QMS-04 Management Process Procedure. , LL 4.3 Determining the scope of the quality management system lties The Company's quality management system applies to all employees within all functional areas of the business operation.
The Company provides the following products and/or services:
ia Producer/Provider of [Your text] c NAICS code: [Your code(s)] pe SIC code: [Your code(s)] S QMS policies and/or procedures outline responsibilities, methods, measurements and related performance indicators to F ensure effective operation and control of the quality management system. Jn Non-Applicable Provisions of the QMS ? The Company cites no exclusions to the ISO 9001 standard. (list your exclusions to ISO 9001) ight 4.4 Quality management system and its processes r The Company's quality management system is fully documented and implemented and is maintained as needed to meet y the requirements of the Company's vision and governing policies. op The Company uses a process-oriented method of management, which emphasizes the importance of: C
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