This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
The Chief Executive Officer must deploy a clearly written policy statement on the objectives for, and commitment to, product and service quality.
Workers throughout the organization must understand the policy as it applies to their jobs. However, it is not required that each employee be able to recite the policy.
The Quality Policy is usually expressed as a short written statement in easy to understand language.
If a machine operator on the manufacturing floor were to be asked about the Quality Policy, the operator would not be expected to recite the policy, but would be expected to know where to obtain or see a copy of the policy. The machine operator would also be expected to know how the policy affected his or her work. This might include safety practices for using the equipment, how to maintain the equipment, clear understanding of how to fabricate the product to comply with the design specifications, how to obtain help in carrying out the work, how to identify nonconforming products, what to do with them and the like.
Executive Management must take a strong leadership role not only in creating the written Quality Policy, but in communicating it throughout the organization.
Maintain an authorized organization chart that defines clear responsibilities for all people whose work affects product quality. This includes people who:
a) take action to prevent product defects, or
b) identify and record any product quality problems, or
c) recommend or provide solutions to product quality problems, or
d) verify that quality problems have been solved, or
e) control further work on a product until quality problems are solved.
A job description, position description, or authority and responsibility statement is required.
The itemized clauses in this section broadly refer to people whose work affects product quality, and include most people in a typical company. Making responsibilities understood requires more than connecting boxes with lines on the traditional organization chart. It requires providing clear written descriptions of accountable roles and responsibilities in assuring product quality.
Inspections of products, reviews of procedure and design documents, and audits of work practices must be identified and carried out. People performing this work must have been trained to carry out these verifications (See 4.18, Training). Design reviews and audits must be conducted by people independent of (not directly responsible for) the work being verified.
Inspections may be replaced by verification activities that are designed to prevent problems rather than simply detect errors. Verification activities that require independent personnel include both quality systems audits, and product design reviews.
Name a person who has the responsibility and authority to oversee and assure compliance with the ISO 9001 Standard. This compliance is required throughout all organizations involved with design and development, production, installation, and servicing activities.
The Management Representative is generally a highranking individual, preferably reporting to the President. A written description, preferably in the Quality Manual, defines his responsibility and authority to carry out the requirements of the Standard. It is not required that the Management Representative devote full time to this position, as long as enough time is available to assure compliance with the Standard. The Management Representative typically carries out the following steps to gain and maintain compliance:
Internal audits must be conducted to assess the degree of compliance with the documented quality system. It is the responsibility of top management to review the results of these audits, their ensuing corrective actions and other pertinent quality related information to ensure the continuing effectiveness of the quality system. Historical records of the reviews must be kept.
Internal audits are typically done on a rotating schedule that covers each area at least once a year. The ISO 9001 Management Representative summarizes the results of these internal audits (see 4.17) and corrective actions (see 4.14) and reviews the results with top management. Management is also expected to review customer complaints and other pertinent quality related data such as product return rates, manufacturing yields, warranty repair data and direct measures of customer satisfaction. Management is expected to support follow-through on identified corrective actions. Records of these management reviews are kept.
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