ISO 9001 Implementation Guide

DEMO
	GAP ANALYSIS
	IMPLEMENTATION PROJECT
	GANTT CHART
	DOCUMENTATION
	TRAINING

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangement (see 7.3.1)

a) to evaluate the ability of the results of design and development to meet requirements, and

b) to identify any problems and propose necessary actions.

Participants in such review shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

(from BS EN ISO 9001:2000)

In short, at different stages of the design, you must review it. Think of it as a form of progress review. Are you on target? Are there problems, etc.? This review should be a part of planning as described in 7.3.1 and is crucial on a number of levels, including ensuring customer requirements are achieved and making sure the development process is on schedule and on budget.

Perhaps more important, however, is the data that is produced during a proper review. From the beginning stages of manufacturing the product to its delivery, a good review will uncover issues before they become a problem to the customer.

A good example of where a proper review can be crucial is with software design. Reviews can ensure that the product is working properly and won’t interfere with other software programs and systems. The same is true for any organization—at the end of the day, make sure that the design and the end product will do what you and the customer want it to do.

Chances are, the elements of this clause are already being performed in most organizations, so be careful not to over-document or stifle the design team’s creativity with a lot of paperwork. However, it is important that the records are no longer just the results of reviews but also include any necessary actions. Also, it is important that all departments are involved in the reviews and good records are kept of their findings and actions. Also, remember to make them appropriate to the organization as well as the product or service.

ISO 9000 | IMPLEMENTATION | ISO 9000 FAMILY | QUALITY | QUALITY ASSURANCE | QUALITY MANAGEMENT | TOTAL QUALITY MANAGEMENT | PDCA CYCLE | AUDIT | QUALITY CONTROL | QUALITY CONTROL MANAGEMENT | QUALITY CONTROL TESTING | DOCUMENT MANAGEMENT | ISO 9000 QUALITY MANUAL | ISO 9000 SOFTWARE | ISO 9000 FAQ | ISO 9000 GLOSSARY | LINKS

Legal Terms | Privacy Policy | Brand GuideLines | Common Criteria

QUALITY MANAGEMENT SYSTEMS, GENERAL REQUIREMENTS, DOCUMENTATION REQUIREMENTS, GENERAL, QUALITY MANUAL, CONTROL OF DOCUMENTS, CONTROL OF RECORDS, MANAGEMENT RESPONSIBILITY, MANAGEMENT COMMITMENT, CUSTOMER FOCUS, QUALITY POLICY, PLANNING, QUALITY OBJECTIVES, QUALITY MANAGEMENT SYSTEM PLANNING, RESPONSIBILITY, AUTHORITY AND COMMUNICATION, RESPONSIBILITY AND AUTHORITY, MANAGEMENT REPRESENTATIVE, INTERNAL COMMUNICATION, MANAGEMENT REVIEW, GENERAL MANAGEMENT REVIEW, REVIEW INPUT, REVIEW OUTPUT, RESOURCES MANAGEMENT, PROVISION OF RESOURCES, HUMAN RESOURCES, GENERAL, COMPETENCE, AWARENESS AND TRAINING, INFRASTRUCTURE, WORK ENVIRONMENT, PRODUCT REALIZATION, PLANNING OF PRODUCT REALIZATION, CUSTOMER-RELATED PROCESSES, DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT, REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT, CUSTOMER COMMUNICATION, DESIGN AND DEVELOPMENT, DESIGN AND DEVELOPMENT PLANNING, DESIGN AND DEVELOPMENT INPUTS, DESIGN AND DEVELOPMENT OUTPUTS, DESIGN AND DEVELOPMENT REVIEW, DESIGN AND DEVELOPMENT VERIFICATION, DESIGN AND DEVELOPMENT VALIDATION, CONTROL OF DESIGN AND DEVELOPMENT CHANGES, PURCHASING, PURCHASING PROCESS, PURCHASING INFORMATION, VERIFICATION OF PURCHASED PRODUCT, PRODUCT AND SERVICE PROVISION, CONTROL OF PRODUCTION AND SERVICE PROVISION, VALIDATION PROCESSES FOR PRODUCTION AND SERVICE PROVISION, IDENTIFICATION AND TRACEABILITY, CUSTOMER PROPERTY, PRESERVATION OF PRODUCT, CONTROL OF MONITORING AND MEASURING DEVICES, MEASUREMENT, ANALYSIS AND IMPROVEMENT, GENERAL MEASUREMENT, ANALYSIS AND IMPROVEMENT, MONITORING AND MEASUREMENT, CUSTOMER SATISFACTION, INTERNAL AUDITS, MONITORING AND MEASUREMENT OF PROCESSES, MONITORING AND MEASUREMENT OF PRODUCT, CONTROL OF NONCONFORMING PRODUCT, ANALYSIS OF DATA, IMPROVEMENT, CONTINUAL IMPROVEMENT, CORRECTIVE ACTION, PREVENTIVE ACTION,

ISO 9001 GUIDE

ISO 9001 guide

Quality Management system software