External documents

Are all internal and external documents that relate to the requirements of ISO 9001 controlled in accordance with documented procedures ... 

The requirements of clause 4.5 therefore apply to policies and practices, derived documents, and external documents that are prescriptive but not descriptive. The descriptive documents are covered by clause 4.16 on quality records. 

The control which you exercise over external documents is somewhat limited. You cannot for instance control the revision of such documents therefore all the requirements concerning document changes will not apply. You can, however, control the use and amendment of external documents. You can control use by specifying which versions of external documents are to be used and you can remove invalid or obsolete external documents from use or identify them in a way that users know that they are invalid or obsolete. You can control the amendment of external documents by controlled distribution of amendment instructions sent to you by the issuing agency. 

There are two types of external documents, those in the public domain and those produced by specific customers. In some cases the issues of both types of documents are stated in the contract and therefore it is important to ensure that you possess the correct version before you commence work. Where the customer specifies the issue status of public domain documents that apply you need a means of preventing their withdrawal from use in the event that they are revised during the term of the contract. Where the issue status of public domain documents is not specified you may either have a free choice as to the issue you use or, as is more likely, you may need to use the latest issue in force. Where this is the case you will need a means of being informed when such documents are revised to ensure that you can obtain the latest version. The ISO 9000 series for instance is reviewed every five years, so could well be revised at five-year intervals. With national and international legislation the situation is rather different as these can change at any time. You need some means of alerting yourself to changes that affect you and there are several methods from which to choose ... 

The method you choose will depend on the number and diversity of external documents... 

The requirements for document review and approval do not distinguish between internal and external documents. However, there is clearly a need to review external documents prior to their internal release in order to establish their impact on the organ-... 

The document availability requirement applies to both internal and external documents alike. Customer documents such as contracts, drawings, specifications, and standards need to be available to those who need them to execute their responsibilities. Often these documents are only held in paper form and therefore distribution lists will be needed to control their location. If documents in the public domain are required, they only need be available when required for use and need not be available from the moment they are specified in a specification or procedure. You should only have to produce such documents when they are needed for the work being undertaken at the time of the audit. However, you would need to demonstrate that you could obtain timely access when needed. If you provide a lending service to users of copyrighted documents, you would need a register indicating to whom they were loaned so that you can retrieve them when needed by others. 

Customer engineering standards and specifications are external documents. Therefore your procedure for controlling external documents should also cover these documents. Where ISO/TS 16949 differs from ISO 9001 on this topic is that ISO 9001 does not require external documents to be reviewed or implemented. However, any external document received or procured for the organization should be reviewed for its applicability before it is brought under control, otherwise resources could be wasted on controlling documents that have no practical use in the organization. This requirement could be placed under Contract rev/ew since any documents issued by customers form part of the contract and should go through contract review before acceptance and implementation. 

Ensure your quality system procedures identify all the types of document requiring control including external documents. 

External Documents e.g. Regulations, note document and version control ... 

A very good description of the accident, originating from internal as well as external documents. Always recommendations and lessons to be learned are available. The coding has been done in an extensive way and an extended abstract is available. 

SWISS-PROT [25, http //www.expasy.org/sprot/] is a curated protein sequence database which provides a high level of annotation, such as the description of a protein s function, its domain structure, PTMs, conflicts between literature references and variants. It also provides a minimal level of redundancy, a high level of integration with other biomolecular databases, and an extensive external documentation. Created in 1986, it now includes more than 100 000 entries from more than 7000 different species. SWISS-PROT is available from more than 100 WWW servers world-wide and its main host is the ExPASy server. 

Besides, complexity also is enhanced by the dependencies that must be covered during the product life. These dependencies may be existing between the components of the products as well as between these components and external actors such as project members, external documents and so on. 

Dependability cases are provided by manufacturers and operating companies. They usually comprise large, complex argument structures on the development process, on system properties and environmental assumptions, and on operating procedures with multiple interdependencies and references to external documents... 

The requirement does not contradict any other requirement and is fully consistent with all authoritative external documentation. 

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