Iso 9001

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

• ISBN13: 9780873895088
• ISBN10: 0873895088
• Edition: 2nd
• Format: Hardcover
• Copyright: 2001-02-01
• Publisher: Asq Pr

Table of Contents

Preface	xiii
Introduction	1	(14)
Introduction	2	(7)
General	2	(1)
The Eight Quality Management Principles	3	(2)
Process approach	5	(2)
Relationship with ISO 9004	7	(1)
Compatibility with other management systems	8	(1)
Scope	9	(4)
General	9	(1)
Application	10	(3)
Normative reference	13	(1)
Terms and definitions	13	(2)
Quality Management System and General Documentation	15	(24)
Quality management system	16	(23)
General requirements	16	(2)
Definitions	18	(1)
Typical Audit Items for Compliance	19	(1)
Documentation requirements	20	(1)
General	20	(5)
Definitions	25	(1)
Typical Audit Items for Compliance	26	(1)
Quality manual	26	(1)
Definitions	27	(1)
Typical Audit Items for Compliance	28	(1)
Control of documents	28	(1)
Control of records	29	(6)
Definitions	35	(1)
Considerations for Documentation	36	(1)
Typical Audit Items for Compliance	37	(2)
Management Responsibility	39	(22)
Management responsibility	40	(21)
Management commitment	40	(1)
Customer focus	40	(1)
Definitions	41	(1)
Considerations for Documentation	42	(1)
Typical Audit Items for Compliance	42	(1)
Quality policy	43	(3)
Definitions	46	(1)
Typical Audit Items for Compliance	46	(1)
Planning	47	(1)
Quality objectives	47	(1)
Quality management system planning	47	(3)
Services	50	(1)
Hardware, Software and Processed Materials	50	(1)
Definitions	50	(1)
Considerations for Documentation	51	(1)
Typical Audit Items for Compliance	51	(1)
Responsibility, authority and communication	52	(1)
Responsibility and authority	52	(1)
Management representative	52	(1)
Internal communication	52	(2)
Definitions	54	(1)
Typical Audit Items for Compliance	54	(1)
Management review	55	(1)
General	55	(1)
Review input	55	(1)
Review output	56	(1)
Definitions	57	(2)
Typical Audit Items for Compliance	59	(2)
Human and Other Resources	61	(16)
Resource management	62	(15)
Provision of resources	62	(1)
Definitions	63	(1)
Considerations for Documentation	64	(1)
Typical Audit Items for Compliance	64	(1)
Human resources	65	(1)
General	65	(1)
Definitions	66	(1)
Considerations for Documentation	66	(1)
Typical Audit Items for Compliance	67	(1)
Competence, awareness and training	67	(2)
Definitions	69	(1)
Considerations for Documentation	69	(1)
Typical Audit Items for Compliance	69	(1)
Infrastructure	70	(1)
Services	71	(1)
Hardware, Processed Materials, and Software	72	(1)
Definitions	72	(1)
Considerations for Documentation	72	(1)
Typical Audit Items for Compliance	72	(1)
Work environment	73	(1)
Services	74	(1)
Hardware and Processed Materials	74	(1)
Definitions	75	(1)
Considerations for Documentation	75	(1)
Typical Audit Items for Compliance	75	(2)
Planning of Product Realization and Customer-Related Processes	77	(14)
Product realization	78	(13)
Planning of product realization	78	(2)
Definitions	80	(2)
Considerations for Documentation	82	(1)
Typical Audit Items for Compliance	82	(1)
Customer-related process	83	(1)
Determination of requirements related to the product	83	(1)
Definitions	84	(1)
Considerations for Documentation	85	(1)
Typical Audit Items for Compliance	85	(1)
Review of requirements related to the product	86	(2)
Considerations for Documentation	88	(1)
Typical Audit Items for Compliance	88	(1)
Customer communication	89	(1)
Considerations for Documentation	90	(1)
Typical Audit Items for Compliance	90	(1)
Design and Development	91	(22)
Design and development	92	(1)
Design and development planning	92	(1)
Definitions	93	(1)
Considerations for Documentation	94	(1)
Typical Audit Items for Compliance	94	(1)
Design and development inputs	95	(1)
Definitions	96	(1)
Considerations for Documentation	97	(1)
Typical Audit Items for Compliance	98	(1)
Design and development outputs	98	(2)
Definitions	100	(1)
Considerations for Documentation	100	(1)
Typical Audit Items for Compliance	101	(1)
Design and development review	101	(2)
Definitions	103	(1)
Considerations for Documentation	103	(1)
Typical Audit Items for Compliance	104	(1)
Design and development verification	104	(1)
Definitions	105	(1)
Considerations for Documentation	105	(1)
Typical Audit Items for Compliance	106	(1)
Design and development validation	106	(2)
Definitions	108	(1)
Considerations for Documentation	108	(1)
Typical Audit Items for Compliance	109	(1)
Control of design and development changes	109	(1)
Considerations for Documentation	110	(1)
Typical Audit Items for Compliance	110	(3)
Purchasing	113	(8)
Purchasing	114	(1)
Purchasing process	114	(1)
Definitions	115	(1)
Considerations for Documentation	115	(1)
Typical Audit Items for Compliance	116	(1)
Purchasing information	116	(1)
Definitions	117	(1)
Considerations for Documentation	117	(1)
Typical Audit Items for Compliance	118	(1)
Verifications of purchased product	118	(1)
Definitions	119	(1)
Considerations for Documentation	120	(1)
Typical Audit Items for Compliance	120	(1)
Production and Service Provision	121	(26)
Production and service provision	122	(1)
Control of production and service provision	122	(2)
Services	124	(1)
Hardware and Processed Materials	125	(1)
Software	125	(1)
Definitions	126	(2)
Considerations for Documentation	128	(1)
Typical Audit Items for Compliance	128	(1)
Validation of processes for production and service provision	129	(2)
Services	131	(1)
Hardware and Processed Materials	131	(1)
Software	131	(1)
Definitions	132	(1)
Considerations for Documentation	132	(1)
Typical Audit Items for Compliance	132	(1)
Identification and traceability	133	(1)
Services	134	(1)
Hardware and Processed Materials	135	(1)
Software	135	(1)
Definitions	135	(1)
Considerations for Documentation	136	(1)
Typical Audit Items for Compliance	136	(1)
Customer property	136	(1)
Services	137	(1)
Hardware and processed materials	138	(1)
Software	138	(1)
Definitions	138	(1)
Considerations for Documentation	139	(1)
Typical Audit Items for Compliance	139	(1)
Preservation of product	140	(1)
Services	141	(1)
Definitions	141	(1)
Considerations for Documentation	141	(1)
Typical Audit Items for Compliance	141	(1)
Control of monitoring and measuring devices	142	(2)
Software	144	(1)
Definitions	144	(1)
Considerations for Documentation	145	(1)
Typical Audit Items for Compliance	145	(2)
Measurement	147	(24)
Measurement, analysis and improvement	148	(23)
General	148	(1)
Definitions	149	(1)
Considerations for Documentation	149	(1)
Typical Audit Items for Compliance	149	(1)
Monitoring and measurement	150	(1)
Customer satisfaction	150	(3)
Definitions	153	(1)
Considerations for Documentation	153	(1)
Typical Audit Items for Compliance	153	(1)
Internal audit	154	(4)
Definitions	158	(3)
Considerations for Documentation	161	(1)
Typical Audit Items for Compliance	161	(1)
Monitoring and measurement of processes	162	(1)
Definitions	163	(1)
Considerations for Documentation	164	(1)
Typical Audit Items for Compliance	164	(1)
Monitoring and measurement of product	165	(2)
Definitions	167	(1)
Considerations for Documentation	168	(1)
Typical Audit Items for Compliance	169	(2)
Control of Nonconforming Product	171	(6)
Control of nonconforming product	172	(2)
Definitions	174	(1)
Considerations for Documentation	175	(1)
Typical Audit Items for Compliance	175	(2)
Analysis of Data	177	(10)
Analysis of data	178	(3)
Hardware and Processed Materials	181	(1)
Services	181	(1)
Software	182	(1)
Definitions	182	(2)
Typical Audit Items for Compliance	184	(3)
Improvement	187	(12)
Improvement	188	(1)
Continual improvement	188	(1)
Services, Hardware, Processed Materials, and Software	189	(1)
Definitions	189	(1)
Typical Audit Items for Compliance	190	(1)
Corrective action	191	(2)
Services, Hardware, Processed Materials, and Software	193	(1)
Definitions	193	(1)
Considerations for Documentation	194	(1)
Typical Audit Items for Compliance	194	(1)
Preventive action	195	(2)
Services, Hardware, Processed Materials, and Software	197	(1)
Definitions	197	(1)
Considerations for Documentation	198	(1)
Typical Audit Items for Compliance	198	(1)
Annex	199	(10)
Correspondence between ISO 9001:1994 and ISO 9001:2000	200	(4)
Correspondence between ISO 9001:2000 and ISO 9001:1994	204	(5)
Index	209