ISO, Quality Assurance & Requirements

ISO 9000

Quality Assurance

Requirements

As we move into the next century, the terms quality assurance, quality management, and total quality control are becoming the new buzz words. Actually they are more than buzz words; they are reality for many American companies as well as foreign ones. The concept of total quality control (TQC) has been widely practiced in Japan for over a decade and is a way of life for Korean companies as well. With the collapse of the Berlin Wall, the unification of Germany, the European Common Market, the dismantling of the Communist party, and Asian communities beginning to band together, one international quality assurance standard for all nations seems to be most practical.
This chapter will discuss the latest requirements for these international
standards.

Introduction to ISO 9000 Standards

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies (ISO member bodies) that is headquartered in Geneva, Switzerland. The American National Standards Institute (ANSI) is the representative organization for the United States within the International Organization for Standardization federation. The purpose of the International Organization for Standardization is to develop internationally recognized standards to facilitate commerce worldwide and to enhance product safety.
The work of preparing international standards is normally carried out through ISO technical committees. Each member body or country interested in a subject for which a technical committee has been established has the right to be represented on the committee. In 1979, Technical Committee 176, Quality Assurance, was formed and in 1985 the ISO 9000 Series of Standards was circulated in draft form to the member bodies for approval. In 1987, following approval by a majority of the member bodies, the ISO 9000 Series of Standards became an international standard recognized worldwide.
Since the United States is a member of the International Organization for Standardization, the ISO 9000 series was concurrently adopted as an ANSI standard, the Q90 Series of Standards. ISO 9000
series standards and the ANSI Q90 series are identical in content. The ISO 9000–Q90 series consists of five standards:



The first document is ISO 9000, which is essentially an overview and guide for the series. This standard is entitled “Quality Management and Quality Assurance Standards—Guidelines for Selection and Use.”This document lists the reference standards applicable to the other standards, definitions useful for the establishment of an ISO quality assurance system, and characteristics of quality systems and gives generic quality assurance and control requirements regarding quality management, quality assurance, and quality control.
The next three documents (9001, 9002, 9003) provide three levels of generic quality system requirements that must be addressed within an ISO 9000 quality assurance program. The most stringent, ISO 9001, entitled “Quality Systems—Model for Quality Assurance in Design/ Development; Production, Installation, and Servicing,” establishes a model or guide for the manufacturer of pressure vessels to use in establishing a quality assurance program for design and/or development of their product. This ISO 9001 program includes 20 different quality
 points. Table 12.1 lists the 20 attributes and compares the requirements of ISO 9001 quality assurance requirements with those of ASME Code Section III, Nuclear Quality Assurance, requirements. There are close similarities. Note that the nuclear quality assurance program does not list statistical process control (SPC) nor does it address service (after service). Generally speaking, a holder of an ASME Code Section III Code symbol stamp already has many facets of an ISO 9001 program in place

Table. Comparison of Quality Assurance Requirements between ISO 9001

and ASME NQA-1

Many pressure vessel manufacturers in the United States are under the impression that if they perform any design functions for pressure vessels, then they must obtain ISO 9001 certification. This is not the case. If a pressure vessel manufacturer is manufacturing vessels under known, existing nationally recognized standards such as TEMA or ASME, where the design formula and function are known and accepted, that manufacturer may certify under the ISO 9002 model. If the owner is designing vessels or entire systems where no known standards exist, ISO 9001 is appropriate.
The ISO 9002 model is for an organization in which design is not a significant function in its operation; however, some design does take place. The ISO 9002 is entitled “Quality Systems—Model for Quality Assurance in Production and Installation.” Note that design, development, and servicing have been deleted. This model has only 18 attributes which must be described in the quality assurance program.
The ISO 9003 is a model for an organization primarily concerned with final inspection or testing of a product. This standard is entitled “Quality Systems—Model for Quality Assurance in Final Inspection and Test.” This is the lowest level of an ISO 9000 quality assurance system with only 12 attributes. Very few companies hold or will hold an ISO 9003 certification.
It is important that a company must select the model, ISO 9001, ISO 9002, or ISO 9003, that is most appropriate for the product or service they are providing. It would not make sense for a company only engaged in final testing of products such as a weld testing laboratory to seek certification for ISO 9001 if very few of the quality functions required by an ISO 9001 quality system are performed by the company.
The last and final ISO 9000 standard, ISO 9004, is a guide to quality management planning and implementation for a producer of products or services. It attempts to specify what types of controls and information should be provided to meet the various requirements of the particularmodel the company has selected. Some manufacturers may find ISO 9004 an excellent guide for the preparation of checklists for auditing ISO 9001, ISO 9002, and ISO 9003 quality assurance programs.

Assessment of the Quality Assurance Program

As a part of establishing an ISO 9000 type quality assurance (QA) program, the company must pass a conformity assessment by a recognized third-party agency. This is where things get complicated. This is the area which causes the most confusion within the industry. In the United States, compliance with ISO 9000 is nonmandatory. Consequently, there is currently no governmental or local jurisdictional requirements for conformance. Current market forces, primarily foreign, are dictating the need for establishing an ISO 9000 type quality assurance program. The American Society for Quality Control has formed a subsidiary corporation called the Registrar Accreditation Board (RAB) to accredit companies that will then register suppliers under the appropriate Q90–ISO 9000 series standard. An accredited company could then perform the conformity assessment and, if acceptable, issue a Certification of Compliance.
Worldwide, the situation is decidedly different. Increasingly, nations around the globe are adopting the ISO 9000 Series of Standards as the acceptable model for a QA program and some have made conformity to ISO 9000 a condition for doing business. Most prominent among these foreign markets is the European Community. As a member of the International Organization for Standardization, the European Community also adopted the ISO 9000 series as a Community standard in 1987. In the European Community (EC) it is known as the EN 29000 Series of Standards. Once again, EN 29000, ISO 9000, and Q90 are identical.
In 1957 the European Economic Community was established by the Treaty of Rome. Its objective was to create a union of European nations with common economic ideas and goals. Although noble in thought, in practice it met with only limited success due to the insistence by the member countries of retaining national standards and economic laws. In 1979, however, the European Court of Justice ruled that one member state could not block the import of a product sold in another member state except for health or safety reasons. This established the principal of mutual recognition of national regulations and industrial standards. As a result, the necessity for developing standards and directives to this end became apparent. Thus, the requirement in the European community revolves around product conformance.

The European Economic Community has technical committees working to develop industry-specific directives. These industry specific directives describe the requirements that must be met for a particular type of product as well as how the company may prove conformance to such industry specific requirements. As part of the framework for this, the company must have a quality assurance program that meets one of the models of the ISO 9000 series discussed above. Conformance is accomplished in accordance with options provided for the type of product. A Large Pressure Vessel Directive is in the final stages of approval and draft copies have been distributed to interested parties. In Annex II of the Large Pressure Vessel Directive is a list of the classifications and the required ISO 9000 quality assurance modules to be used by manufacturers of different classes of pressure vessels. For example, in the case of large pressure vessels, the specific directive offers several choices for manufacturers to demonstrate conformance and gives information to assist manufacturers in the proper selection of the ISO 9000 model for establishing the quality assurance program.

For class A vessels, manufacturers may wish to be assessed by a combination of modules B and F or modules B and D or module H plus design examination. Details the global chart used to assist manufacturers in selecting the correct quality assurance program for their products and companies. Is important to note that pressure vessel manufacturers must know their clients and products when establishing their quality systems. By choosing modules B and F, manufacturers submit prototypes of their finished products to a Notified Body for type examination and statistic clarification. By choosing modules B and D, they undergo a quality



Assurance program assessment by a Notified Body with respect to the requirements of ISO 9002 and also type testing by the Notified Body. By choosing module H plus design examination, manufacturers are assessed by a Notified Body with respect to the requirements of ISO 9001, plus the design documents for the vessel are checked for adequacy.

TABLE  Modules for Certification and Testing—Global Approach

Notified Bodies and the CE Mark

Only companies that are certified as third-party accreditation bodies and that are registered firms within their respective countries and within the EC may audit, certify, and register firms for application of the CE mark. On the national level, each European country has its own standardization organization. Regardless of which option, either product verification or complete ISO 9000 certification, manufacturers choose, successful assessment by a Notified Body will result in manufacturers being registered with that Notified Body and will allow them to place the CE mark on their products. This mark is the European Economic Community symbol for compliance to the directive of that particular product. Each member state establishes recognized Notified Bodies. Mutual recognition of each members’ Notified Body is mandatory.
It is important to realize that Notified Bodies can only exist within a member state of the European Community. It is also important to verify when selecting a Notified Body that it is a recognized agency for the type of product being manufactured. Not all Notified Bodies are qualified to certify pressure vessels. There is currently no provision for mutual recognition of Notified Bodies outside of the EC. Consequently, assessment by an agency outside the European Community will not guarantee that a Certificate of Compliance will be recognized by a member state. Once again, this is still market-driven. If a customer within the European Community will accept a pressure vessel built to the ASME Code, there is no requirement that manufacturers meet the requirements of the European directive. Compliance to the directive would, however, guarantee universal acceptance of the product throughout the EC.

As a direct result of the EC 1992 initiative, and the increasing acceptance of ISO 9000 as an internationally recognized model for a quality assurance system, the ASME has indicated a need to evaluate ISO 9000 criteria with the possibility of bringing ASME’s quality control requirements closer to those of ISO 9000.

Source : Digital Engineering Library @ McGraw-Hill