Iso 9001

by Tsiakals, Joseph J.; Cianfrani, Charles A.; West, Jack E.

• ISBN13: 9780873894814
• ISBN10: 0873894812
• Format: Hardcover
• Copyright: 2000-05-01
• Publisher: Asq Pr

Table of Contents

Preface	xi
Introduction	1	(14)
General	2	(1)
Process approach	3	(2)
Relationship with ISO 9004	5	(1)
Compatibility with other management systems	6	(2)
General	8	(2)
Permissible exclusions	10	(2)
Normative reference and Definitions	12	(1)
product	13	(2)
Quality Management System and General Documentation	15	(12)
General requirements	16	(3)
Definitions	17	(1)
Typical Audit Items for Compliance	18	(1)
General documentation requirements	19	(8)
Definitions	25	(1)
Typical Audit Items for Compliance	25	(2)
Management Responsibility	27	(34)
Management commitment and Customer focus	28	(3)
Definitions	29	(1)
Considerations for Documentation	30	(1)
Typical Audit Items for Compliance	30	(1)
Quality policy	31	(11)
Definitions	34	(1)
Typical Audit Items for Compliance	35	(1)
Quality objectives and Quality planning	36	(3)
Services	39	(1)
Hardware, Software and Processed Materials	39	(1)
Definitions	40	(1)
Considerations for Documentation	40	(1)
Typical Audit Items for Compliance	41	(1)
Administration	42	(15)
General	42	(1)
Responsibility and authority	42	(1)
Management Representative	42	(1)
Internal communication	42	(2)
Definitions	44	(1)
Typical Audit Items for Compliance	45	(1)
Quality manual	46	(1)
Definitions	47	(1)
Typical Audit Items for Compliance	47	(1)
Control of documents and control of quality records	48	(6)
Definitions	54	(1)
Considerations for Documentation	55	(1)
Typical Audit Items for Compliance	56	(1)
Management review	57	(4)
General	57	(1)
Review input	57	(1)
Review output	57	(2)
Definitions	59	(1)
Typical Audit Items for Compliance	60	(1)
Human and Other Resources	61	(14)
Provision of resources	62	(7)
Definitions	63	(1)
Considerations for Documentation	64	(1)
Typical Audit Items for Compliance	64	(1)
Assignment of personnel	65	(1)
Definitions	66	(1)
Considerations for Documentation	66	(1)
Typical Audit Items for Compliance	66	(1)
Training, awareness and competency	67	(1)
Definitions	68	(1)
Considerations for Documentation	69	(1)
Typical Audit Items for Compliance	69	(1)
Facilities	69	(3)
Services	71	(1)
Hardware, Processed Materials, and Software	71	(1)
Definitions	71	(1)
Considerations for Documentation	72	(1)
Typical Audit Items for Compliance	72	(1)
Work environment	72	(3)
Service	73	(1)
Hardware and Processed Materials	74	(1)
Definitions	74	(1)
Considerations for Documentation	74	(1)
Typical Audit Items for Compliance	74	(1)
Planning of Realization Processes and Customer Related Processes	75	(14)
Planning of realization processes	76	(4)
Definitions	78	(1)
Considerations for Documentation	79	(1)
Typical Audit Items for Compliance	79	(1)
Customer-related processes	80	(9)
Identification of customer requirements	80	(1)
Definitions	81	(1)
Considerations for Documentation	82	(1)
Typical Audit Items for Compliance	82	(1)
Review of product requirements	83	(2)
Considerations for Documentation	85	(1)
Typical Audit Items for Compliance	85	(1)
Customer communication	86	(1)
Considerations for Documentation	87	(1)
Typical Audit Items for Compliance	87	(2)
Design and/or Development	89	(20)
Design and/or development planning	90	(1)
Definitions	91	(1)
Considerations for Documentation	92	(1)
Typical Audit Items for Compliance	92	(1)
Design and/or development inputs	93	(1)
Definitions	94	(1)
Considerations for Documentation	95	(1)
Typical Audit Items for Compliance	95	(1)
Design and/or development outputs	96	(2)
Definitions	98	(1)
Considerations for Documentation	98	(1)
Typical Audit Items for Compliance	98	(1)
Design and/or development review	99	(1)
Definitions	100	(1)
Considerations for Documentation	101	(1)
Typical Audit Items for Compliance	101	(1)
Design and/or development verification	102	(1)
Definitions	103	(1)
Considerations and Documentation	103	(1)
Typical Audit Items for Compliance	104	(1)
Design and/or development validation	104	(2)
Definitions	106	(1)
Considerations for Documentation	106	(1)
Typical Audit Items for Compliance	106	(1)
Control of design and/or development changes	107	(1)
Considerations for Documentation	108	(1)
Typical Audit Items for Compliance	108	(1)
Purchasing	109	(8)
Purchasing control	110	(1)
Definitions	111	(1)
Considerations for Documentation	111	(1)
Typical Audit Items for Compliance	112	(1)
Purchasing information	112	(1)
Definitions	113	(1)
Considerations for Documentation	113	(1)
Typical Audit Items for Compliance	113	(1)
Verification of purchased product	114	(1)
Definitions	115	(1)
Considerations for Documentation	115	(1)
Typical Audit Items for Compliance	116	(1)
Production and Service Operations	117	(26)
Production and service operations	118	(20)
Operations control	118	(2)
Services	120	(1)
Hardware and Processed Material	121	(1)
Software	121	(1)
Definitions	122	(2)
Considerations for Documentation	124	(1)
Typical Audit Items for Compliance	124	(1)
Identification and traceability	125	(1)
Services	126	(1)
Hardware and Processed Materials	126	(1)
Software	127	(1)
Definitions	127	(1)
Considerations for Documentation	127	(1)
Typical Audit Items for Compliance	128	(1)
Customer property	128	(1)
Services	129	(1)
Hardware and Processed Materials	129	(1)
Software	130	(1)
Definitions	130	(1)
Considerations for Documentation	130	(1)
Typical Audit Items for Compliance	131	(1)
Preservation of product	131	(1)
Services	132	(1)
Definitions	133	(1)
Considerations for Documentation	133	(1)
Typical Audit Items for Compliance	133	(1)
Validation of processes	134	(1)
Services	135	(1)
Hardware and Processed Materials	136	(1)
Software	136	(1)
Definitions	136	(1)
Considerations for Documentation	137	(1)
Typical Audit Items for Compliance	137	(1)
Control of measuring and monitoring devices	138	(5)
Software	140	(1)
Definitions	140	(1)
Considerations for Documentation	140	(1)
Typical Audit Items for Compliance	141	(2)
Measurement	143	(22)
Planning	144	(21)
Definitions	145	(1)
Considerations for Documentation	145	(1)
Typical Audit Items for Compliance	145	(1)
Customer satisfaction	146	(2)
Definitions	148	(1)
Considerations for Documentation	148	(1)
Typical Audit Items for Compliance	148	(1)
Internal audit	149	(4)
Definitions	153	(2)
Consideration for Documentation	155	(1)
Typical Audit Items for Compliance	155	(1)
Measurement and monitoring of processes	156	(2)
Definitions	158	(1)
Considerations for Documentation	158	(1)
Typical Audit Items for Compliance	159	(1)
Measurement and monitoring of product	159	(2)
Definitions	161	(1)
Considerations for Documentation	162	(1)
Typical Audit Items for Compliance	163	(2)
Control of Nonconformity	165	(6)
Control of nonconformity	166	(5)
Definitions	167	(2)
Considerations for Documentation	169	(1)
Typical Audit Items for Compliance	169	(2)
Analysis of Data	171	(8)
Analysis of data	172	(7)
Hardware and Processed Materials	175	(1)
Services	175	(1)
Software	176	(1)
Definitions	176	(2)
Typical Audit Items for Compliance	178	(1)
Improvement	179	(12)
Planning for continual improvement	180	(1)
Services, Hardware, Processed Materials, and Software	181	(1)
Definitions	181	(1)
Typical Audit Items for Compliance	182	(1)
Corrective action	183	(2)
Services, Hardware, Processed Materials, and Software	185	(1)
Definitions	185	(1)
Considerations for Documentation	186	(1)
Typical Audit Items for Compliance	187	(1)
Preventive action	187	(2)
Services, Hardware, Processed Materials, and Software	189	(1)
Definitions	189	(1)
Considerations for Documentation	189	(1)
Typical Audit Items for Compliance	190	(1)
Annex	191	(6)
Table B.1 Correspondence between ISO 9001:1994 and ISO/DIS 9001:2000	192	(1)
Table B.2 Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994	193	(4)
Index	197