WHAT CHANGES WERE MADE IN THE 1994 VERSION OF ISO 9001?

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.

ARE THE ISO 9000 STANDARDS SUBJECT TO CHANGE?

According to ISO procedures, all ISO standards, including those in the ISO 9000 series, must be reviewed and revised or reaffirmed at least once every five years. ISO has already begun to revise and supplement the ISO 9000 series. Some of these standards/guidelines will supplement ISO 9000 and ISO 9004, while others will be included in the new ISO 10000 series. Both series have been reserved for use by ISO TC 176.

Recently released ISO standards and guidelines in the quality area include: ISO 9000-3, Guidelines for the Application of ISO 9001 to the Development, Supply and Maintenance of Software ; ISO 9004-2, Quality Management and Quality System Elements -- Part 2: Guidelines for Services ; ISO 10011 Part 1, Guidelines for Auditing Quality Systems -- Auditing ; ISO 10011 Part 2, Guidelines for Auditing Quality Systems -- Qualification Criteria for Auditors ; ISO 10011 Part 3, Guidelines for Auditing Quality Systems -- Managing Audit Programs ; and ISO 10012-1, Quality Assurance Requirements for Measuring Equipment -- Part 1: Management of Measuring Equipment .

In addition, ISO/DIS (Draft International Standard) 8402-1 Quality Systems Terminology ; and DIS 9000-2 Addendum to 9000 on Guidelines for Implementing 9001-2-3 ; DIS 9004-3 Addendum to 9004 on Processed Materials are under review by ISO TC 176. ISO TC 176 is also considering committee draft (CD) 9004-4 Addendum to 9004 on Quality Improvement ; guidance documents on project management, quality plans, quality manuals, the economics of quality, and configuration management; documents covering revisions to ISO 9000, 9001-2-3; and 9004; and a working draft (WD) 10012-2: Quality Assurance Requirements for Measuring Equipment -- Part 2: Measuring Equipment .

Some national and regional standards bodies are developing supplemental guidance for the application of the ISO 9000 series to specific industries. CEN and CENELEC, for example, are developing more specific requirements for the application of the ISO 9001 to the medical device industry. The U.S. Food and Drug Administration (FDA) is planning to revise its Good Manufacturing Practice (GMP) regulations for medical devices to follow ISO 9001 with appropriate additional requirements. Draft GMP regulations are expected to be issued by the end of 1992. The International Organization for Legal Metrology (OIML) is developing a document entitled: "Quality Assurance as Applied for Initial Verification of Measuring Instruments, " which provides guidance on the applicability and use of the ISO 9000 Standard Series in the manufacture of measuring instruments.

DOES TC 176 HAVE A PLAN FOR REVISING AND SUPPLEMENTING THE ISO 9000 STANDARDS?

Vision 2000 - A Strategy for International Standards' Implementation in the Quality Arena During the 1990s is a long range plan through the year 2000 developed by an Ad Hoc Task Force of ISO TC 176. The plan includes providing additional guidance on how to apply the ISO 9000 series standards to four generic product categories (hardware, software, processed materials, and services), as well as providing guidance on related issues, such as quality system auditing. As noted above, these documents are in various stages of development. Minor modifications in the original ISO 9000 series are expected in 1993, with major revisions in 1997. The long range goal, according to Vision 2000, is to have a single Total Quality Management Standard by the year 2000.

HAVE ANY ISO 9000 OR RELATED STANDARDS BEEN PUBLISHED SINCE 1987?

ISO has continued to supplement the ISO 9000 Series. Some of these standards have been included as parts under ISO 9000 and ISO 9004, while others have been included in the new ISO 10000 Series. Both the ISO 9000 and 10000 Standards Series have been reserved for use by ISO TC 176.

Recently released ISO standards and guidelines in the quality area include:

ISO 9000-3, GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE (1991).

ISO 9004-2, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART 2: GUIDELINES FOR SERVICES (1991).

ISO 10011 PART 1, GUIDELINES FOR AUDITING QUALITY SYSTEMS - AUDITING (1990).

ISO 10011 PART 2, GUIDELINES FOR AUDITING QUALITY SYSTEMS - QUALIFICATION CRITERIA FOR AUDITORS (1991).

ISO 10011 PART 3, GUIDELINES FOR AUDITING QUALITY SYSTEMS - MANAGING AUDIT PROGRAMS (1991).

ISO 10012-1, QUALITY ASSURANCE REQUIREMENTS FOR MEASURING EQUIPMENT - PART 1: MANAGEMENT OF MEASURING EQUIPMENT (1992).

WHAT IS ISO TC 176 WORKING ON?

The following standards are under development in TC 176's subcommittees (SC):

SC 1 - TERMINOLOGY

o DRAFT INTERNATIONAL STANDARD (DIS) 8402-1 QUALITY SYSTEMS TERMINOLOGY

SC 2 -QUALITY SYSTEMS

o DRAFT INTERNATIONAL STANDARD (DIS) 9004-3, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART 3: GUIDELINES FOR PROCESSED MATERIALS (Will be published mid to late 1993.)

o DRAFT INTERNATIONAL STANDARD (DIS) 9000-2, QUALITY MANAGEMENT AND QUALITY SYSTEM STANDARDS - PART 2: GENERIC GUIDELINES FOR THE APPLICATION OF ISO 9001, ISO 9002, AND ISO 9003 (Will be published mid to late 1993.)

o DRAFT INTERNATIONAL STANDARD (DIS) 9004-4, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART 4: GUIDELINES FOR QUALITY IMPROVEMENT (Will be published mid to late 1993.)

o COMMITTEE DRAFTS (CD) 9000-1, 9002, 9003, AND 9004-1, REVISIONS TO ISO 9000, 9001, 9002, 9003, AND 9004 (Expected to be out for DIS ballot shortly.)

o COMMITTEE DRAFT (CD) 9004-6, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART 6: GUIDELINES QUALITY PLANS

o WORKING DRAFT (WD) 9004-5, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART 5: GUIDE TO QUALITY ASSURANCE FOR PROJECT MANAGEMENT

o COMMITTEE DRAFT (CD) 9004-7, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART 7: GUIDELINES FOR CONFIGURATION MANAGEMENT

SC 3 - QUALITY TECHNOLOGIES

o WORKING DRAFT (WD) 10012-2: QUALITY ASSURANCE REQUIREMENTS FOR MEASURING EQUIPMENT - PART 2: MEASURING ASSURANCE

o COMMITTEE DRAFT (CD) 10013: GUIDELINES FOR DEVELOPING QUALITY MANUALS (Expected to be out for DIS ballot shortly.)

o WORKING DRAFT (WD) 10014: GUIDE TO THE ECONOMIC EFFECTS OF QUALITY

o WORKING DRAFT (WD) 10015: CONTINUING EDUCATION AND TRAINING GUIDELINES

WHAT COUNTRIES HAVE ADOPTED THE ISO 9000 STANDARD SERIES?

According to information collected by ISO (as of October 20, 1991) and updated as of September, 1992, the EC and fifty-six countries have or are expected to soon adopt the ISO 9000 Standard Series as voluntary national standards. The list includes:

WHAT ARE THE NUMBERING SYSTEMS USED BY COUNTRIES TO DESIGNATE THE ISO STANDARD SERIES?

Countries adopting the ISO 9000 standards assign numbers to the standards based on their own national standards numbering systems. As noted in the following examples, these numbers may be very different from those numbers assigned by ISO to the Series, even though the standards are identical.

In the United States, the ISO 9000 Standard Series has been adopted as the ANSI/ASQC Q90 Series (soon to be changed to the ANSI/ASQC Q9000 Series). In Europe, it has been adopted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) as the European Norm (EN) 29000 Series. In the U.K., it is BS 5750 Parts 0 to 3. In Pakistan, it is the PS 3000-3004 Series. In Tanzania, they are TZS 500-504; while in China, they are GB/T 10300.1 - 10300.5.

WILL QUALITY SYSTEM APPROVALS BE MANDATORY IN THE EC?

Having an approved quality system will not be a blanket requirement for all products. However, for suppliers of construction products, certain classes of medical devices and personal protective equipment, telecommunications terminal equipment, gas appliances, commercial scales, and possibly other products (such as pressure equipment, recreational craft, cable ways, and lifting equipment for people), approval of a supplier's quality system will be a key component of the EC's legal requirement for certification. For most of these products, ISO 9000 registration in one alternative to proving compliance, not an absolute requirement.

In other directives, such as the Council Directive dated June 14, 1989 on machinery (89/392/EEC), manufactures of some products will be permitted to self declare that their product conforms to the requirements of the directive and to place the European Community (CE) mark on the product. However, such machinery manufacturers must maintain a file on the manufacture of those products, including information on "the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive" -- in other words, on the manufacturer's quality system. It is possible that the ISO 9000 (EN 29000) Series Standard could be used within the European Community to evaluate the adequacy of such quality systems.

Manufactures need to review all relevant EC directives for specific requirements applicable to their products.