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
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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
- 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 188.8.131.52, 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 184.108.40.206, 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
- 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
- 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 220.127.116.11, 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
- 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