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The Standard is somewhat nebulous with regard to required standards and codes. There are several statements in ISO 9001:2000 Clauses 7.2.1 and 7.3.2 that, taken together, give some indication of the intent (i.e., they address statutory and regulatory requirements). What is advisable and appears to be generally acceptable to registrars is to create a list of the product-/process-oriented standards and codes maintained by the organization, state who is responsible for them, show where they are kept, and explain how they are kept current.
Table 9.2 summarizes various standards and codes that might be listed by an organization. The list will vary significantly based on the organization's product lines and certifications, which could include environmental, medical, and telecommunications, as well as automotive and aerospace requirements. For example, customer standards are numerous in the automotive industry. Standards and codes are normally very clearly defined in marketing requirements, engineering specifications, technical files, test procedures, and product brochures.
Name of Standard and Code | Responsible Manager | Where Located | Currency Method |
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21 CFR, Part 210 | Regulatory affairs | Office files | U.S. government publications |
ISO 9000:2000; Q9001-2000; & Q9004-2000 | ISO 9000 management representative | Office files | Subscription to the ASQ |
AAALAC guidelines | Pathology | Laboratory files | AAALAC committee member |
NIH guidelines | Operations | On-site files | Subscription |
U.S. pharmacopoeia national formulary | Quality-assurance manager | Laboratory files | Subscription to USP-NF |
IPC-610 manufacturing codes | Quality-assurance manager | Design and manufacturing areas | IPC Membership |
CE Mark: EN60601-1-2 EN55011 Class B IEC 801-2 IEC 801-3 IEC 801-4 IEC 801-5 | Engineering-design administrator | Administrator's office files | Review annually and obtain latest revisions from test house |
UL 2601 | Design engineering | Design-engineering files | Subscription |
Big Three automotive standards | Design engineering | Design-engineering library | Supplied by Big Three |
Mechanical contractor standards | Senior engineer | Contractor's engineering library | Subscription |
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