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CRS-02-02R AS9120-2002 Audit Checklist.doc

CRS-02-02R AS9120-2002 Audit Checklist.doc

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CRS-02-02R AS9120-2002 Audit Checklist.doc
CRS-02-02R AS9120-2002 Audit Checklist.doc

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Published by: Johan Hunter on Jan 02, 2013
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12/11/2013

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AS9120-2002 AUDIT CHECKLIST
 
AUDIT NO.:ORGANIZATION:
 
DocumentRequirement Audit Point ReferenceAssessor Notes*S/U/OFI
4 Quality management system4.1 General Requirements
The organization shall establish, document,implement and maintain a quality managementsystem and continually improve its effectiveness inaccordance with the requirements of thisInternational Standard.The organization shalla)identify the process needed for the qualitymanagement system and their applicationthroughout the organization, b)determine the sequence and interaction of these processes,c)determine criteria and methods needed toensure that both the operation and controlof these processes are effective,d)ensure the availability of resources andinformation necessary to support theoperation and monitoring of these processes,e)monitor, measure and analyses these processes, andf)implement actions necessary to achieve planned in accordance with therequirements of this InternationalStandard.Where an organization chooses to outsource any process that affects product conformity withrequirements, the organization shall ensurecontrol over such processes. Control of suchoutsourced process shall be identified within thequality management system.
 NOTE: Processes needed for the quality managementsystem referred to above should include processes for management, provision, product realization andmeasurement.
1)Has the organization established andmaintained an quality management system, therequirements of which are described in thewhole of clause 4?
Note:
 
The organization is requested to submit documentation to support compliance with thecriteria identified in a) and b) with the quality policy manual to SAI for review. Examples of acceptable documentation are:1)Process map(s)2)Procedures Flow Chart(s)
CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Improvement07/12/2005Page 1 of 43
 
AS9120-2002 AUDIT CHECKLIST
 
AUDIT NO.:ORGANIZATION:
 
DocumentRequirement Audit Point ReferenceAssessor Notes*S/U/OFI
4.2 Documentation requirements4.2.1 General
The quality management system documentationshall includea)documented statements of a quality policyand quality objectives, b)a quality manual,c)documented procedures required by thisInternational Standard,d)documents needed by the organization toensure the effective planning, operationand control of its processes, ande)records required by the InternationalStandard.f)quality system requirements imposed bythe applicable regulatory authorities.The organization shall ensure that personnel haveaccess to quality management systemdocumentation and are aware of relevant procedures. Customer and/or regulatory authoritiesrepresentatives shall have access to qualitymanagement system documentation.
 NOTE 1 Where the term “documented procedure”appears within this International Standard, this meansthat the procedure established, documented,implemented, and maintained. NOTE 2 The extent of the quality management systemdocumentation can differ from one organization toanother due toa)the size of organization and type of activities, b)the complexity of process and their interactions, andc)the competence of personal. NOTE 3 The documentation can be in any form or typeof medium.
1) Does the quality management systemdocumentation includea)documented statements of a quality policyand quality objectives, b)a quality manual,c)documented procedures required by thisInternational Standard,d)documents needed by the organization toensure the effective planning, operationand control of its processes,e)records required by the InternationalStandard, andf)quality system requirements imposed bythe applicable regulatory authorities?2) Does the organization ensure that personnel haveaccess to quality management systemdocumentation and are aware of relevant procedures, and that customer and/or regulatoryauthorities representatives shall have access toquality management system documentation?CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Improvement07/12/2005Page 2 of 43
 
AS9120-2002 AUDIT CHECKLIST
 
AUDIT NO.:ORGANIZATION:
 
DocumentRequirement Audit Point ReferenceAssessor Notes*S/U/OFI
4.2.2 Quality manual
The organization shall establish and maintain aquality manual that includesa)the scope of the quality managementsystem, including details of and justification for any exclusions b)the documented procedures establishedfor the quality management system, or reference to them, andwhen referencing the documented procedures, therelationship between the requirements of thisInternational Standard and the documented procedures shall be clearly shown.c)a description of the interaction betweenthe processes of the quality managementsystem.1)Has the organization established andmaintained a quality manual that includesa)the scope of the quality managementsystem, including details of and justification for any exclusions b)the documented procedures established for the quality management system, or reference to them, andIs the relationship between the requirements of thisInternational Standard and the documented procedures clearly shown?c)a description of the interaction between the processes of the quality managementsystem.
 
CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Improvement07/12/2005Page 3 of 43

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