Changes Made in the 1994 Version of ISO 9001

The following list of significant changes in the 1994 version of the Standard has been assembled from sources thought to be accurate. Simply Quality cannot be held responsible for any damages that result for inaccuracies in this list. For more information on ISO 9001 contact: Simply Quality, PO Box 21 Middletown, NJ 07748. E-mail comments to info@simplyquality.org

Directives of the International Organization for Standardization require that all standards be reviewed every five years. The purpose of this review is to ensure that:

• The standards reflect experience gained from its practical application.
• The standards remain stable to facilitate ongoing training and use.
• The standards are usable by companies regardless of size, industry or product offering.

As a result, the ISO 9000 series of standards has been revised and officially adopted in July 1994. The most significant changes from the 1987 version of ISO 9001 are as follows:

• The importance of using third-party registration agencies is now recognized by the language of the Standard.
• The term "customer" replaces the term "purchaser".
• The introduction mentions the assessment of quality capabilities by external parties (i.e., third party registration agencies).
• Subclause 4.1.1, Quality policy, includes reference to customers' expectations and needs, and the supplier's internal organizational goals. The quality policy must be defined by "management with executive responsibility".
• Subclause 4.1.2.2, Resources, is now broader than"verification resources and personnel" was. It now includes reference to management, trained personnel, work performance, and verification activities. The requirement for independent personnel carrying out design reviews has been removed. The requirement for independence of audit personnel has been moved to 4.17.
• Subclause 4.1.2.3, Management representative, must now be appointed by "management with executive responsibility." The Management Representative is now explicitly required to report on the Quality System for the purpose of management review and improvement.
• Subclause 4.2.1, Quality system-General, now includes an explicit requirement for a quality manual that defines the documentation structure of the Quality System, including "reference to the quality system procedures and outline [of] the structure of the documentation used in the quality system."
• Subclause 4.2.2, Quality system procedures, now clarifies the degree of documentation required for the Quality System. It states that the extent of documented procedures required for work activities shall depend upon "the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity."
• Subclause 4.2.3, Quality planning is entirely new. It covers Quality System planning and product quality plans. It states that the quality plan for a product, project, or contract may be in the form of a detailed reference to those documented procedures of the Quality System that are appropriate to providing complete assurance of product quality. Most of the information to be considered was in the "Note" in the 1987 version of the Standard.
• Subclause 4.3, Contract review, now includes pre-contract tender arrangements as well as contracts and ordering requirements within its scope. It also includes provisions for orders received by verbal means and requires identifying how amendments to a contract will be handled.
• Subclause 4.4, Design control, has been expanded to include design validation, and separate requirements for design review and design verification.
• Subclause 4.4.4, Design input, must include applicable statutory and regulatory requirements.
• Subclause 4.4.5, Design output, specifically states that documents shall be reviewed before release.
• Subclause 4.4.6, Design Reviews, is a new section stating that design reviews are mandatory and must be planned, conducted and documented.
• Subclause 4.4.7, Design Verification, states that design verification must be carried out at appropriate stages of design and must ensure that "design stage output meets the design stage input requirements."
• Subclause 4.4.8, Design Validation, is new and is in addition to "design verification." Design validation must ensure that the product conforms to defined user needs or requirements. This is in addition to design verification which must ensure that design stage output meets design stage input requirements. Design validation follows successful design verification and is normally performed on the final product.
• Subclause 4.4.9, Design changes, still requires controls, but no longer requires design control "procedures", since this control naturally falls within the requirement for document and data control.
• Subclause 4.5, Document and data control, is expanded to include "data" and "documents of external origin such as standards and customer drawings." The use of electronic media is recognized in a note. Fortunately, "obsolete documents" may be "retained for legal or knowledge-preservation purposes" if they are "suitably identified."
• Subclause 4.6.1, Purchasing, General, now requires documented procedures to "ensure that purchased product (see 3.1) conforms to specified requirements."
• Subclause 4.6.4.1, Supplier verification at subcontractor's premises, is new. It requires that if source inspection is to be used, it must be specified in the purchasing documents.
• Subclause 4.8, Product identification and traceability, requires traceability, where applicable, to begin at receipt rather than during production.
• Subclause 4.9, Process control, now includes servicing and has added requirements for maintaining process equipment to ensure continuing process capability. The previous section 4.9.2 on "special processes" has been incorporated into the text of section 4.9. The requirements for qualification of equipment and personnel to carry out process operations shall be specified.
• Subclause 4.10.1, Inspection and testing, General, requires the quality plan or documented procedures to specify the required inspection, testing, and quality records.
• Subclause 4.12, Inspection and test status, specifies that status "shall be maintained , as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product."
• Subclause 4.14, Corrective and preventive action, now includes separate requirements for corrective and preventive action. Corrective action refers to eliminating the causes of actual nonconformities, and preventive action refers to eliminating the causes of potential nonconformities. Requirements to implement and record changes in documented procedures and the use of formal procedures for handling customer complaints have been clarified and strengthened.
• Subclause 4.14.3, Preventive action, now requires that "relevant information on actions taken is submitted for management review."
• Subclause 4.16, Control of quality records, allows for storage on electronic or other media. Procedures must address access to quality records. Records no longer have to be "identifiable to the product involved."
• Subclause 4.18, Training, now requires documented procedures.
• Subclause 4.20 Statistical techniques, requires statistical techniques to be identified.