A procedural instruction (abk. VA ) is a document that is required by various standards . With a VA, the implementation of normative requirements in a company is determined and - in the sense of a binding regulation - documented in a comprehensible manner.
The respective procedures must be defined, documented, implemented and maintained. This entitlement entails the activities of release , training and testing or auditing , the implementation of which must be clearly documented.
Procedural instructions are one way of implementing the documented procedures required for a quality management system. Current standards (e.g. IATF 16949 , DIN EN ISO 9001: 2015 ) allow some degrees of freedom with regard to the depth of documentation, type and scope as well as the choice of media (paper, electronic data, etc.) depending on the organizational structure and size.
Discussion and criticism
The classic subdivision into a "document pyramid" made up of the QM manual, procedural instructions, work instructions and project procedures derived therefrom is e.g. This is described, for example, in ISO 10013 "Guidelines for the creation of quality management manuals".
In practice, this procedure easily leads to a large number of documents that can only be understood by quality experts. Those who should perform these procedures often oppose such a system because, e.g. B. complicated, outdated or in practice can only be complied with with considerable effort. This tendency was already described in 1996 in the field of software.
In the meantime, the ISO has made it clear that a "documented QM system" does not necessarily mean a "system of documents" ( ISO 9001 requires (and always has required) a "Documented quality management system", and not a "system of documents" ) . Accordingly, the word "procedural instruction" no longer appears in many current ISO standards.
An alternative is the consistent use of the process-oriented approach . Only a few core documents are required, while the operational processes are graphical, e.g. B. are shown as flow charts in a process folder.
- ISO / TS 16949: 2000 (D) page 9 Note 1-3.
- DIN EN ISO 9001: 2008 , Section 4.2.3 Control of documents.
- DIN EN ISO 9001: 2008 , Section 8.2.2 Internal Audit.
- DIN EN ISO 9001: 2008 , Section 4.2.4 Control of records.
- DIN EN ISO 9001: 2008 , Section 4.2 Documentation requirements.
- DIN EN ISO 9001: 2008 , Section 4.2.2 Quality Management Manual.
- ISO / TR 10013: 2001-07 Guide for the documentation of the quality management system.
- John Favaro, When the Pursuit of Quality Destroys Value (PDF; 138 kB), IEEE Software, vol. 13, no. 3, pp. 93-95, May 1996, doi : 10.1109 / 52.493026 .
- Guidance on the documentation requirements of ISO 9001: 2008 (pdf, English; 54 kB)
- Guidance on the concept and use of the process approach for management systems (pdf, English; 231 kB).