Concept for Control of Documents
The QMS documentation is made up of the following main components:
•QMS Document Control Index
•EMS Document Control Index
•QMS & EMS Documents
•QMS & EMS Forms
•QMS & EMS Journals & Logs
•QMS & EMS Manuals
•QMS & EMS Procedures
•QMS & EMS Work Instructions
Document Naming Convention
The QMS & EMS documents are constructed as ‘electronic or paper sections’ with each having an electronic file name that matches the paper document title name. Example the QMS manual has an electronic file name of 422 Quality Manual v01 and a document title of Quality Management System Manual.
A working draft may be annotated with (draft #), e.g. 422 Quality Manual v01 (draft 1)
•### indicates a clause or element in the Standard that the document is directly related with;
•Descriptive name, indicates the intended purpose;
•V## indicates the revision (version number);
•(draft#) indicates a proposed draft under development or review;
An Optional trailing Date formatted as YRMONTHDAY, e.g. 130115 (January 15, 2013) may be used for the effective date, e.g. 422 Quality Manual v01 130115.
QMS Document Control Index is a comphrehensive report made possible by printing the QMSCAPA Document Report.
Other Document Conventions
QMS/EMS Manual (QM/EM):
The QM top-level document section defines the company's Quality policies and Quality objectives; defines the scope of the Quality system, including details and justification for any exclusion. The QM describes the overall QMS, its processes, and their sequence and interaction; and references applicable operational procedures.
QMS/EMS Procedures (QP/EP):
QP’s are second-level document section defining specific ISO 9001 & 14001 Quality system procedures. Quality procedures are code numbered QP-SSS. QP stands for Quality Procedure; SSS is the related section in the ISO 9001 & 14001 to which the procedure pertains.
QMS/EMS Documents (QD/ED)
QD’s are third-level reference documents intended to provide a more in-depth explanation of QMS related subjects and topics. Quality documents are code number as QD-SSS. QP standards for Quality Document; SSS (if used) is the related section in the ISO 9001 & 14001 Standard.
QMS/EMS Forms (QF/EF):
QF’s are fourth-level documents. These are usually one-page forms or matrices defining a "template" for establishing a record. Forms are code numbered USC-QF-SSS Long Name -v#, e.g. QF stands for Quality Form, SSS is the related ISO clause of the procedure to which the form pertains, and the long name is the common name of a form (document) pertaining to the same procedure. Forms are established as separate documents, but are associated with specific procedures, and work instructions through the numbering system.
QMS/EMS Journals or Logs (QJ,QL/EJ,EL)
Journals and Log are document names used interchangeably and considered to be fourth level forms and records. Journals and logs are intended to be perpetual or periodical records, which are usually in the form of a Microsoft Word or Excel document or another form of electronic data.
QMS/EMS Work Instructions (WI):
WI’s are third-level documents. The purpose of work instructions is to guide personnel in performing specific tasks, such as carrying out and controlling a production processes (process operator instructions), handling products, calibrating measuring equipment, conducting tests or inspections, etc.
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