ISO 9000 and the Small Company

ISO 9000 and the Small Company

The ISO 9000 is a "generic management system standard," which is primarily concerned with quality management:

The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organization can time and time again deliver the product or services that meet the client's quality requirements. These good practices have been distilled into a set of standardized requirements for a quality management system, regardless of what your organization does, its size, or whether it's in the private, or public sector." (ISO Web site)

Benefits: Any business across sectors, whether big or small in size, gains significantly by acquiring ISO certification. Since many countries have adopted the ISO 9000 series as a national standard, an ISO 9000 certified company improves its access to world markets. ISO 9000 certification also facilitates ease of trade since ISO standards serve as a quality assurance. On a local level, ISO 9000 certification reassures prospective customers about the quality of product manufactured and gives the ISO 9000 registered firm a competitive advantage. Implementing ISO 9000 standards leads to the firm enjoying several internal benefits as well, such as improvements in facility performance; product; employee productivity; reduced costs arising out of inefficiency; and scope for continuous improvement in quality (Standards Council of Canada Web site).

ISO has published a handbook for small businesses to dispel the myth that ISO 9000 is for big companies only. The handbook does not set change the requirements of the standards, and is intended only as an informative and comprehensive guide. In addition to basic explanations, it suggests first steps towards a quality system, whether to go it alone or use consultants, offers guidance in matters such as training and auditing, and gives a brief outline of the certification process. (ISO Web Site).

Management Role: Quality of product leading to customer satisfaction and success in business is the primary concern of top management. As such, the benefits from the ISO 9000 standards will accrue only if the top management is totally committed to its purpose, which means money, time and involvement. Small firms, with sales of less than $11 million, that have implemented ISO 9000 standards, report costs of $75,000 and an implementation time of 18 months (CIRAS Web site).

To start with, top management must play a pivotal role in defining the company's quality policy, which must meet ISO regulations, besides being relevant to the company's own field of business. Once the quality policy is in place, management has a continued role to play in conducting regular internal audits to ensure that standards are being met through adherence to defined processes and in order to evaluate policy impact with actual results (management effectiveness); results of statistical score-keeping tools; noted problems or defects (results of internal audits); customer complaints and resolutions; and the effectiveness of previous solutions in handling of non-conforming products (CIRAS Web site).

Development of Documentation: ISO 9001 requires a company to conform to 20 elements of the quality standard in design control, contract review and process control. Compliance is determined by an audit of the company's quality system against the standard by an independent auditing firm called a registrar. To achieve certification, a company must develop a documented quality system through a quality manual, procedures and work instructions that outline the way the company complies to the standard (CIRAS Web site).

A small manufacturing company would need to follow the ISO 9001 quality assurance model, since it outlines the requirements for business processes ranging from design and development, to production, installation and servicing. Of course, with the publishing of the new ISO 9001:2000, the standards as set out by the revised version will need to be taken into account.

The new version lays far more emphasis on continuous improvement, customer satisfaction, the importance of standards and processes being viewed as a business (not manufacturing) system and the need to harmonize ISO 14000 (environmental management) with ISO 9000. The new standard takes the process management approach of Plan-Do-Check-Act, which is widely followed in the business world. (Alamo Learning Systems Web site).

There are several key steps that must be taken prior to commencing work on the documentation required such as the creation of a core task force; communication of the importance of adhering to ISO 9000 standards across the company; assessment of current quality systems; drawing up of an implementation plan and schedule; training in ISO requirements of a lead coordinator; and training of appointed personnel in documentation and implementation (CIRAS Web site).

Post the preliminaries, work on developing the quality manual, quality procedures and work instructions can begin. The quality manual is a series of policy statements for each of the elements of the ISO 9000 quality standard, representing the quality of the product being manufactured, under a set of documented procedures and work instructions.

The main goal for a quality manual is to ensure that customers are satisfied with the product performance. A good quality manual should take into consideration all equipment, controls, manufacturing and other processes, resources and skills that will be needed for meeting customer needs and expectations as well as processes as per ISO 9000 standards; set specific goals for each product alongwith a provision for quality records and evaluation preparation methods; and consider equipment required to measure, test and control quality.

The quality manual must be accompanied by quality procedures that define the policy in terms of clear-cut responsibilities and action plans, as well as work instructions that define the specific steps to accomplish tasks.

The documentation must cover all aspects of business operations including customer contracts (assess and document all specifications, with provision for amendments); design control (documentation of processes used to confirm, control and verify product design to customer need, regulatory and environmental/safety standards); data and document creation, publication, distribution, use and revision; purchasing (technical requirements, records of past performance and methods of control/verification); product identification and traceability; production, installation and servicing processes; inspection and testing; equipment control; control of non-conforming products; corrective and preventive action; handling, storage, packaging, preservation and delivery; maintenance and control of quality records; and methods for conducting periodic internal audits of the quality system (CIRAS Web site).