CONSULTING
ISO 9000
PRE-REGISTRATION
AUDIT CHECKLIST
In this section are some of the many questions which
the inspectors will be asking when you come to register for ISO 9002. The
inspectors may have a system ranging from A to E, covering their
assessments, from very good to unacceptable. A simple version
of this is a straightforward yes or no. Read them, you will
see they are the sort of questions every organisation should be asking
of itself:
Management Policy and Organisation - Applicable
to ISO 9001, 9002 and 9003
| • |
Is there a clear written policy on quality published
throughout the organisation? |
| • |
Is there an organisation for executing this? |
| • |
Are there defined procedures? |
| • |
Is there a clearly defined organisation with responsibilities
stated? |
| • |
Are the verification steps and responsibilities defined? |
| • |
Is there assigned authority? |
| • |
Is there a training programme? |
Design and design change control - Not
Applicable to ISO 9002
Design and design change control is not applicable to ISO 9002
Procurement - Applicable to ISO 9000, and 9002
| • |
Is there a supplier assessment system? |
| • |
A supplier register? |
| • |
Have specifications and standards been identified for all incoming
materials? |
| • |
Is there agreement with suppliers on Quality Management procedures? |
| • |
Are there performance records? |
| • |
Are suppliers expected to conform to ISO 9000? |
| • |
Is there EDI with suppliers or other formal documentation system? |
| • |
Is there traceability and identification? |
Control Review - Applicable to ISO 9001, and 9002
| • |
Is contract formally reviewed with the customer? |
| • |
Or customer brief? |
| • |
Do advertising promises constitute contract or brief? |
| • |
Are promises being met? |
| • |
Are capacity and equipment capable of meeting contract requirements? |
The Quality System - Applicable to ISO 9001, 9002,
and 9003
| • |
Does the system conform with the relevant standard? |
| • |
- Written procedures |
| • |
- Controls |
| • |
- Audit |
Documentation Control - Applicable to ISO 9001, 9002,
and 9003
| • |
Is the Quality manual controlled including all issues and page
updates? |
| • |
Are all documents including procedural manuals and work instructions
controlled? |
| • |
Is all documentation available where needed? |
Inspection and test - Applicable to ISO 9001, 9002,
9003
| • |
Is there a procedure for inspection of incoming
material? |
| • |
Is non-conforming material controlled? |
| • |
Where traceability is required is this clear at the inspection
stage? |
| • |
Have inspection staff authority to release and prevent release? |
| • |
Is there an in-process inspection in accordance with the quality
plan and documented procedures? |
| • |
Does corrective action halt faulty trends? |
| • |
Is non-conforming material identified, segregated and disposed
of? |
| • |
Are the holding, quarantine areas properly controlled? |
| • |
Are there final inspection, dock inspection or patrol inspections? |
| • |
Is there a specification or standard against which final inspection
is made? |
| • |
Have inspectors authority to refuse release of non-conforming
products? |
| • |
Is there a system for segregation, return, re-work, scrap of
non-conforming product? |
| • |
Are reworked items inspected? |
Inspection, measuring and test equipment - Applicable
to ISO 9001, 9002, 9003
| • |
Is there an inventory of all equipment? |
| • |
Is there a system of calibration against documented procedures? |
| • |
Are reference standards traceable to external standards and
external calibration, which are in turn approved? |
| • |
Is there a maintenance system and plan for equipment? |
| • |
Is equipment labelled for frequency of check and calibration? |
| • |
Are non-conforming pieces of equipment controlled? |
Handling, storage and delivery - Applicable to ISO
9001, 9002, 9003
| • |
Are all areas - stores, production, non-conforming
items, finished goods - clearly segregated and controlled? |
| • |
Are all items marked in accordance with the above status? |
| • |
Can handling methods damage the product? |
| • |
Are items exposed to theft or malicious damage? |
| • |
Is an item controlled from final inspection to acceptance by
the customer? |
| • |
Is there a feedback mechanism? |
Audits - Applicable to ISO 9001, 9002, 9003
| • |
Are there internal audits? |
| • |
Are there (optional) external audits by consultants? |
| • |
Is the audit covered by a plan and procedure? |
| • |
Do, or can, corrective actions arise from the audits? |
| • |
Does management review the audit results? |
Training - Applicable to ISO 9001, 9002, 9003
| • |
Is there a regular training programme? |
| • |
Are all training courses fully documented? |
| • |
Is responsibility for training closely defined? |
| • |
Are the instructors trained? |
| • |
Do you look at outside material - magazines, books,
videos, courses? |
Housekeeping - Applicable to ISO 9001, 9002, 9003
| • |
How does your lobby / reception look? |
| • |
Are your receptionists friendly and available (this includes
telephone operators)? |
| • |
Is the plant and equipment maintained? |
| • |
Is your place clean? |
| • |
How do your toilets look? |
| • |
Are your walls, floors, roofs clean? |
| • |
Is there scrap lying around? |
| • |
Is your canteen clean and pleasant? |
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