ISO 9000 for injection molders.

What does it take to get ISO 9000 quality certification? Here are basic guidelines on how to get started, what to expect from an ISO audit, and how to select an ISO consultant and registrar.

ISO 9000 registration has become an accepted and effective tool to document quality-management practices in all types of industrial operations--including a growing number of injection molding firms.

Benefits of ISO registration include important marketing advantages and internal cost reductions. Even well-managed molders whose quality procedures already meet many ISO requirements have experienced such benefits as a result of formal certification. Both in North America and abroad, more and more buyers of molded parts are coming to demand ISO registration as a purchasing specification. This is particularly true in the automotive, medical, and defense industries (see PT, Jan. '91, p. 53; May '93, p. 54).

Applying ISO 9000 procedures in plastic molding operations poses some unusual problems because of the exceptional complexity of the molding process and the large number of variables that must be managed and controlled. This article is based on the experiences of molders that have obtained ISO 9000 registration. It identifies principal requirements, lists essential steps, and suggests how to estimate the cost and time frame to achieve ISO registration.

CATEGORIES OF ISO REGISTRATION

ISO 9000 registration certifies that a company applies modern quality management and that its quality-assurance practices meet the requirements of its customers. The ISO 9000 system provides three levels of certification according to the scope of services that a manufacturer provides. (ISO 9004 is not a certification level, but just guidelines that a firm may use in developing its own quality system if it doesn't already have one.)

ISO 9003 is the least comprehensive certification level. It is for firms that only perform final inspection and testing of products manufactured by others.

Injection molders generally seek registration either for ISO 9002 or 9001. ISO 9002 is defined as a "model for quality assurance in production, installation, and servicing." It's suited to custom molders--those who confine themselves to molding parts designed by others and take no responsibility for part or tool design or material selection.

The most comprehensive category is ISO 9001--termed a "model for quality assurance in design/development, production, installation, and servicing." It applies to what might be called "contract manufacturers"--those firms that accept responsibility for part and tool design along with molding. This article will focus on ISO 9001.

REQUIREMENTS OF ISO 9001

ISO registration involves a company being certified by an accredited registrar. Registrars are accredited to perform quality-systems audits by the Registrar Accreditation Board (RAB) in the U.S. or by one of several authorized European national accreditation bodies. There are over 20 registering bodies now in the U.S. The person who carries out the official assessment of a company's quality-management system on behalf of the registrar is an auditor or assessor. The auditor seeks to determine whether a company meets three requirements:

1) It has defined the procedures needed to ensure that its products and services consistently meet a specified quality standard.

2) It has documented these procedures in manuals that are available for use by the responsible employees.

3) It can prove that these quality procedures are being followed reliably.

While these points may appear simple and straightforward, it takes considerable managerial effort and a highly disciplined organization to provide the assurances demanded for ISO certification.

Quality-management requirements under ISO 9001 have been formally categorized into 20 elements that cover all aspects of an operation. The role of quality management within a company must be clearly defined. Thus, one of the first requirements for ISO registration is that the lines of responsibility and authority within the organization be clearly documented, typically on an organization chart. The chart should make it clear that the crucial quality-control function has sufficient autonomy to protect it from any interference.

Once the basic organization of a company has been established and areas of responsibility have been defined, the next step is to examine all major operating functions and verify that there are established procedures to ensure operational control and consistent quality in every phase. The procedures for each major operation and function must be documented and made available to the relevant personnel. Management must see to it that employees are trained in quality procedures and that these procedures are followed faithfully and without exception. It's also essential to provide the means for updating and revising procedures and for periodically verifying their adequacy and effectiveness.

When applied to an injection molding operation, quality management covers an especially wide spectrum of considerations. It encompasses every step, beginning with product design and resin selection to meet requirements for functionality. Subsequent steps include mold design, selection of the molding machine, purchase and quality assurance of incoming materials, determination of appropriate processing conditions, inspection of material in process and of final parts, specification of testing procedures and testing equipment, maintenance of processing and testing equipment, identification and disposal of non-conforming product, and identification of finished parts--to name the most important phases.

It's important to note that ISO registration requires that the technical resources for quality assurance must be adequate and the facilities appropriate in all phases of the operation. There is no single set of technical requirements that applies to all injection molders. What may be considered "adequate resources" and "appropriate facilities" will depend upon the quality requirements imposed by the molder's customers. In order to serve today's high-tech industries, for example, a molder may be required to use CAD/CAM, computerized mold-filling and Cooling simulation, advanced programmable machine controls, and real-time process and production monitoring. One may speculate that it may eventually become justifiable for ISO certification to include classifying molders according to levels of technological capability.

SHOULD YOU GET OUTSIDE HELP?

One of the first questions to consider is whether to manage the preparations for ISO registration on your own or engage an outside consultant.

The personnel who have created and implemented your current quality-management practices may find it difficult to evaluate them with the necessary detachment and objectivity. That calls for an independent outside expert.

An outside specialist may also find it easier than company insiders to implement some basic rethinking of company structure, processes, technology, and methods. If you decide to engage an outside consultant, it's important that he or she possess more than just expertise in the rules and regulations of ISO 9000. The consultant also must have in-depth knowledge of plastics processing in order to apply available technology effectively to reach your quality-control objectives.

The function of the outside consultant is to provide guidance, examples, and working tools--e.g., sample quality manuals that may serve as models or prototypes. But it is essential that the company's employees take prime responsibility for creating the new procedures and writing the necessary documentation. This is the only way to ensure that the new quality-management system will be practical, that it will be written using familiar terminology, and that employees will consider it their own creation and will thoroughly identify with it.

FIVE STEPS TO REGISTRATION

Because every plant operation is different, it is not possible to specify in exact detail what your plant must do to prepare for ISO registration. But the following five steps are generic guideposts along the path to ISO 9001.

Step 1 Assess your current quality-management practices. The registration process begins with an examination of the company's prevailing quality-management practices and quality-control objectives in the context of the ISO framework. This often turns out to be the most critical phase of the entire project because it requires objectivity and a broad perspective. It must not be dominated by ingrained thinking or constrained by prevailing company practices. This is the area where outside consultants are likely to be best equipped to apply the necessary realism and objective judgment.

This assessment should conclude with the preparation of an initial outline of tasks to adapt and refine existing quality-control practices so that they conform to ISO requirements. This outline should lead to a preliminary estimate of the costs of the registration project and of the resources and time needed to carry it out.

Step 2 Select a registrar. Choose the ISO registrar that will carry out the final audit. One reason to select a registrar prior to making changes in your quality-management program is that the registrar may assist you in defining the standards to be met at the official audit. Also, many registrars are heavily booked and there may be a significant delay (up to six months) before they can schedule a registration audit.

When choosing a registrar, ask whether the organization has expertise in plastics molding to the quality level specified by your customers. The greatest differences in judgment among auditors are likely to occur in evaluating whether your quality-management technologies and practices meet the criteria specified in the contract agreements between you and your customers. A meaningful ISO certification--i.e., meaningful to your customers--therefore demands competent auditors with up-to-date industry experience.

Another important question is whether the registrar's accreditation is recognized in all countries where your company does business. And, in case the registrar later leaves the business--or ceases business altogether--does it have a memorandum of understanding with one or more other registrars to which the registration could be transferred? The registrar normally should not be a consultant to the company because of the potential for conflicts of interest.

The cost of the audit and registration should be established in advance through a fee schedule that identifies all charges, including those for reports and periodic reassessments.

Step 3 Define the changes needed to achieve ISO compliance. The initial outline of quality-management tasks defined in Step 1 now can be refined based on expectations and information obtained from the registrar in Step 2. A definite plan and firm estimates of the financial resources, manpower, and facilities needed to achieve certification can now be prepared. Needed funds must be committed.

Step 4 Implement the enhanced quality policies and practices. Implementation of the registration program defined in the previous steps generally begins with assignment of a company management representative as project leader. This project leader will be the principal contact for an outside consultant, if one is used.

One of the first tasks for the ISO project leader is to organize project teams to implement the program strategy. Common elements of such programs are the preparation of any missing procedures, documentation of existing procedures and preparation of a quality manual or manuals, writing detailed operating instructions, and training.

Step 4 may involve the introduction of new quality-management practices and new technologies. This could include adding machine calibration and maintenance schedules, process validation and optimization, q-c sampling plans, and modeling techniques for validating part or mold design.

Step 5 Undergo ISO 9001 registration audit. The actual ISO audit focuses on two major aspects of a company's operations. One is largely generic and quite straightforward. It deals with the administration of quality procedures--e.g., the adequacy of manuals, records, documentation of procedures, and systems for monitoring that those procedures are followed.

The second aspect is highly industry specific and deals with the adequacy of the resources and technology being employed. It comes down to a determination of whether the technologies applied to part design, process control, part-quality control, etc. meet the molder's customers' demands as specified in the manufacturing contract. This determination will be influenced by the quality demands for the product being produced, the standards of the particular industry being supplied, and the prevailing quality practices in that industry.

To maximize chances of obtaining ISO approval on the first audit, it pays to arrange for a preliminary audit. An independent consultant may be best suited to organize this trial run. Due to their familiarity with the operation, company personnel might overlook mistakes that would be readily apparent to an independent observer.

An official ISO 9001 audit of an injection molding operation by a registrar may take from one to three days. The time will depend on the size of the operation, complexity of the product line, quality level to be attained, and degree of preparation on the part of the molder.

CUSTOMER HAS THE LAST WORD

Even ISO-registered molders are likely to face additional demands for verification of their quality-assurance programs from key customers. Many automotive and aerospace firms may want to carry out their own quality audits of a molder's operations, despite an ISO certification. Such investigations may rival or exceed the standards of the most rigorous ISO audit. These customers normally want to know the name of the ISO registrar. The registrar's reputation is likely to influence the extent of their own verification of the molder's quality procedures.

The likelihood of facing some additional customer audits raises the question as to whether the cost and effort required to obtain ISO registration is warranted. In fact, customers are much less likely to audit molders who are ISO certified. And since ISO registration requires a molder to meet or exceed his customers' product-quality expectations, he can rest assured that he will pass any reasonable inspection by his customer with flying colors.

Also keep in mind that companies with the best quality-assurance practices also have the lowest overall manufacturing costs. Good quality management always pays for itself.

ISO 9001 Elements

Processors must document quality management for these 20 protocols to be certified under ISO 9001.

4.1 Management Responsibility 4.2 Quality System 4.3 Contract Review 4.4 Design Control 4.5 Document & Data Control 4.6 Purchasing 4.7 Control of Customer-Supplied Product 4.8 Product Identification & Traceability 4.9 Process Control 4.10 Inspection and Testing 4.11 Control of Inspection, Measuring & Test Equipment 4.12 Inspection and Test Status 4.13 Control of Non-Conforming Product 4.14 Corrective & Preventive Action 4.15 Handling, Storage, Packaging, Preservation & Delivery 4.16 Control of Quality Records 4.17 Internal Quality Audits 4.18 Training 4.19 Servicing 4.20 Statistical Techniques