D 02 - Processes - Set of documents

Document set - 91 quality management system process sheets

$39.13

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Added the: 07/05/2008
Last update: 31/01/2023
Number of pages: 189

See other documents

See the set of documents D 15v15 ISO 9001 Readiness

See the set of documents D 35v15 ISO 9001 Internal audit

See the set of documents D 65v15 ISO 9001 package

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All of these documents are editable to suit your needs and context.

D 02 Process sheets for your management system
Codification	Title	Sub-clause	Pages
	Management
PQBD02M1	Develop strategy (example in pdf)	5.1.1	2
PQBD02M2	Satisfy requirements	4.2	2
PQBD02M3	Identify hazards and assess OH&S risks	***6.1.1	2
PQBD02M4	Establish process ownership	4.4	2
PQBD02M5	Establish policy	5.2	2
PQBD02M6	Address risks	6.1	2
PQBD02M7	Identify environmental aspects and impacts	*6.1.2	2
PQBD02M8	Implement preventive actions	**6.1.2.2	2
PQBD02M9	Plan the QMS (quality management system)	6.2	2
PQBD02M10	Deploy objectives	*6.2.1	2
PQBD02M11	Acquire resources	7.1	2
PQBD02M12	Communicate	7.4; **8.5.5.1	2
PQBD02M13	Negotiate the contract	8.2.1	2
PQBD02M14	Conduct second-party audit	**8.4.2.4.1	2
PQBD02M15	Measure the satisfaction	9.1.2	2
PQBD02M16	Analyse data	9.1.3	2
PQBD02M17	Audit	9.2	2
PQBD02M18	Carry out management review	9.3	2
PQBD02M19	Improve	10.3; **10.3.1	2
PQBD02M20	Consult workers	***5.4	2
PQBD02M21	Evaluate compliance	***9.1.2	2
PQBD02M22	Assess risks	¤¤¤6.1.2	2
PQBD02M23	Treat risks	¤¤¤6.1.3	2
	Realization
PQBD02R1	Guarantee product safety (example in pdf)	4.4.1.2; **8.1.3	2
PQBD02R2	Investigate incident	***10.2	2
PQBD02R3	Elaborate contingency plans	**6.1.2.3	2
PQBD02R4	Maintain equipment	7.1	2
PQBD02R5	Recall equipment	****7.1.5.2	2
PQBD02R6	Manage calibration/verification records	**7.1.5.2.1	2
PQBD02R7	Carry out FMEA	8.3; **7.3.1.1	2
PQBD02R8	Sterilize medical devices	¤¤7.5	2
PQBD02R9	Carry out process review	8.1	2
PQBD02R10	Manage waste	*8.1	2
PQBD02R11	Transfer of work	****8.1	2
PQBD02R12	Manage critical items	****8.1 f	2
PQBD02R13	Manage operational risk	****8.1.1	2
PQBD02R14	Struggle against counterfeit parts	****8.1.4	2
PQBD02R15	Prevent emergency situations	*8.2	2
PQBD02R16	Implement PRPs	¤8.2	2
PQBD02R17	Notify regulatory authorities	¤¤8.2	2
PQBD02R18	Design and development	8.3	2
PQBD02R19	Notify customers on changes	****8.3.6	2
PQBD02R20	Assess embedded software	**8.3.2.3	2
PQBD02R21	Manage special characteristics	**8.3.3.3	2
PQBD02R22	Approve product	**8.3.4.4	2
PQBD02R23	Purchase components	8.4	2
PQBD02R24	Control outsourced processes	8.4	2
PQBD02R25	Manage external providers	****8.4.1.1	2
PQBD02R26	Evaluate test reports	****8.4.2	2
PQBD02R27	Meet statutory and regulatory requirements	**8.4.2.2	2
PQBD02R28	Produce	8.5	2
PQBD02R29	Establish the HACCP plan	¤8.5	2
PQBD02R30	Receive, store and deliver	8.5.1	2
PQBD02R31	Implement control plan	**8.5.1.1	2
PQBD02R32	Inspect first article	****8.5.1.3	2
PQBD02R33	Implement traceability	8.5.2; **8.5.2.1	2
PQBD02R34	Manage changes	8.5.6; **8.5.6.1	2
PQBD02R35	Use alternate methods	****8.5.6.1.1	2
PQBD02R36	Sell products	8.6	2
PQBD02R37	Approve rework and repair	8.7.1.4; 8.7.1.5	2
PQBD02R38	Dispose of nonconforming products	**8.7.1.7	2
PQBD02R39	Inspect production	9.1	2
PQBD02R40	Control nonconformities	10.2	2
PQBD02R41	Implement corrective actions	10.2	2
PQBD02R42	Solve problems	**10.2.3	2
PQBD02R43	Use error-proofing devices	**10.2.4	2
PQBD02R44	Meet security requirements	¤¤¤8.1	2
PQBD02R45	Register and unsubscribe	¤¤¤8.1	2
PQBD02R46	Distribute access	¤¤¤8.1	2
PQBD02R47	Manage authentication	¤¤¤8.1	2
PQBD02R48	Develop and support security	¤¤¤8.1	2
PQBD02R49	Manage security continuity	¤¤¤8.1	2
PQBD02R50	Implement security	¤¤¤8.1	2
PQBD02R51	Manage networks	¤¤¤8.1	2
PQBD02R52	Monitor after marketing	¤¤8.2	2
PQBD02R53	Evaluate benefit/risk ratio	¤¤8.2	2
	Support
PQBD02S1	Maintain regulatory watch (example in pdf)	*6.1.3	2
PQBD02S2	Manage staff	7.1.2	2
PQBD02S3	Acquire and maintain infrastructure	7.1.3	2
PQBD02S4	Manage inspection means	7.1.5	2
PQBD02S5	Manage laboratory	**7.1.5.3	2
PQBD02S6	Provide training	7.2	2
PQBD02S7	Verify auditor competency	7.2.3; 7.2.4	2
PQBD02S8	Empower employees	**7.3.2	2
PQBD02S9	Provide information	7.5	2
PQBD02S10	Control documentation	7.5.3	2
PQBD02S11	Keep accountability	7.5.3	2
PQBD02S12	Manage configuration	****8.1.2	2
PQBD02S13	Manage IT	7.1.3	2
PQBD02S14	Apply discipline	¤¤¤7.2	2
PQBD02S15	Manage the employment contract	¤¤¤7.2	2
PQBD02A01	Processes and ISO 9001 sub-clauses		1
PQBD02A02	Process map	4.4	1
PQBD02A03	Processes and sub-clauses other standards		2
PQBD02List	List of processes		3
Total			189

* ISO 14001; ** IATF 16949; *** ISO 45001; ****AS9100D; ¤ISO 22000; ¤¤ISO 13485; ¤¤¤ISO 27001

M: management process

R: realization process

S: support process