9.7 Mandated Standards and Codes Requirement


9.7 Mandated Standards and Codes Requirement

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.

Table 9.2: Typical Standards and Codes To Be Listed

Name of Standard and Code

Responsible Manager

Where Located

Currency Method

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




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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