Document and data control ISO 9001

Clause 4.5 of ISO 9001 requires the supplier to establish and maintain documented procedures to control all documents and data pertinent to the quality system. The aim of this clause of the standard is to ensure that only authentic documents and data are used and that these are readily available to the personnel performing various tasks affecting the quality of the product. To comply with this requirement, one must clearly understanding what types of documents and data need to be controlled and how this control is to be exercised.

Categories of document or data

Most manufacturing companies use the following broad categories of documents :

Prescriptive or guidance documents developed internally

  • Quality manuals and procedures.
  • Design drawings, design data and specifications.
  • Purchase documents
  • Process schedules and instructions.
  • Quality plans and inspection procedures
  • Handling and packaging instructions

Reference documents of external origin

These might include such documents as :

  • Applicable national and international standards.
  • Statutory and regulatory instructions
  • Contracts or orders.
  • Design and technology documents

Records and data generated internally

  • Inspection reports and test data
  • Vendor evaluation reports
  • Records of design reviews
  • Audit reports
  • Data on process capability
  • Investigation reports
  • Minutes of management review meetings
Miscellaneous documents

These cover various kinds of documents which are used by the company for its operations,  such as :

  • Correspondence files
  • Administration instructions and records
  • Financial and accounts data and records
  • Internal notes and memoranda
  • Proposals
  • Brochures

Of the above-mentioned documents, only the first three categories need some kind of document control in terms of the ISO 9001 standard. The documents in the last category are to be treated as uncontrolled documents. Even in the first three categories, the extent of control varies considerably, as is explained in the paragraphs that follow.

Identification of documents

The first essential requirement for documents control is identification. A logical system needs to be devised and every document must be given a unique identity. Documents generated internally could be identified by assigning a code to indicate the issuing department (e.g. RD for Research and Development PUR for Purchasing Department). There could, in addition be a code for the type of document (e.g SP for specifications, DR for drawings, PI for process instructions and TR for test report).

Finally, each document within a given type could be given a serial number to establish its unique identity. A company manufacturing different products or undertaking jobs for different customers also needs to relate the documents to the different products or contracts.

Extent of document control

The extent of document control depends on the nature of the documents. Guidance documents developed internally would require the most comprehensive control, covering preparation, review, approval, distribution, revision and disposal when no longer required. Control of reference documents of external origin would cover distribution and maintenance of the currency of documents.

Document preparation and approval

The document-control procedure should clearly specify the departments responsible for preparing various types of document. The levels at which documents are to be approved should also be laid down for proper accountability. For certain documents, input from one or more departments may be required. In such cases, a department should be designated to take responsibility for interdepartmental contribution and for document preparation. The document would then need to be approved by all the parties concerned before release. Some documents may also need to be approved by clients before finalization. in these instances, care must be taken to ensure that the documents are sent to the customer, and his/her consent obtained in time to allow production to begin on schedule.

Distribution control

One of the criticisms of a quality system conforming to ISO 9000 standards is that it generates a lot of paper. The basic philosophy of a quality system is to plan every activity and to make all personnel aware of the standard procedures for carrying out their functions. The distribution of documents should be based on who needs to know what. Documents should be issued only to the personnel or groups who will have to act on the basis of the documents or for whose guidance the documents are intended. Originating departments must maintain a register of the groups or sections to whom documents are to be automatically issued.

They should have a record of actual distribution and the number of distributed copies. These records will provide accurate information on the holders of the documents and facilitate amendment and updating. Occasionally, certain groups or departments not covered by the automatic distribution system may require documents for specific jobs. A record of such issues should also be maintained.

Modification of documents

Changes in a products design or its manufacturing process are inevitable in any enterprise. Changes in design may be ordered by the customer or may become necessary to reduce safety hazards, to improve product reliability and performance, or to reduce manufacturing costs without sacrificing quality. Changes in process documents may be imposed by the introduction of an improved process or manufacturing equipment. An effective method for controlling document changes is essential because of the impact of engineering or design changes on production. Errors due to the use of incorrect engineering documents can have serious financial and marketing consequences.

Control of documents of external origin

The 1994 version of the ISO 9001 standard has extended the document control requirement to documents of external origin. As these documents are developed by external agencies, the requirement of review and approval cannot apply. The only document control measure that can be carried out in their case concerns use and amendment. Use can be controlled by specifying which versions of the external documents are to be employed and amendments by the regulated distribution of amendment instructions received from the issuing authority.

For documents such as contracts or design and technology instructions issued by the customer, it is the customers responsibility to intimate whenever any changes or amendments are to be effected in its documents. For documents in the public domain such as standards or regulations on the other hand, it is the responsibility of the supplier to keep them updated. Therefore, the supplier needs to adopt measures to ensure prompt information whenever any attachment takes place in documents in the public domain. The following are some of the methods by which one can be altered to changes in standards or legislation.

  • Subscribing to journals of standards bodies which provide information or changes in standards and the issue of new standards.
  • Obtaining membership of a trader or industry association which provides bulletins to its members about changes in the law and relevant standards.
  • Subscribing to general publications that provide news of changes in legislation.
  • Remaining in touch with the enforcement agencies that deal with the relevant products.
Controlling Forms

Documentation on the quality system comprises a number of forms on which specified information is entered by the groups concerned. The information in these forms is then used by other groups, as part of the overall quality-assurance function. These forms include inspection reports, process-control charts and calibration certificates, route cards and labels.

A suitable functional group, usually the quality-assurance department, is designated to coordinate the design and use of forms. Before a form is designed, the information to be obtained, its purpose, and potential use must be determined. Details of information required and the responsibility for filling it in should be clearly indicated. All forms must have a unique title and reference number in the procedural manuals, as well as for the maintenance of records. Effective control of forms not only ensures the proper functioning of a quality system but also prevents duplication of effort and uncontrolled proliferation of paperwork.

Master list of documents

For effective documents control, a master list of all documents in the quality system is required. This list should normally be updated by the quality-assurance department on the basis of information received from all issuing departments. Copies of the list should be supplied to the departments concerned. All modified documents must be assigned an identification number according to the procedure described earlier. The quality-assurance department should be informed immediately about any amendment so that this change can be reflected on the master list. Organizations with a large number of documents should computerize their master lists for ease of updating and reference.


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