ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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6 Resource Management 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport, communication or information systems).
6.4 Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. NOTE The term “work environment” relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather). |
ISO 9001 Training - Key Explanation Points and
Tips:
Planning for the types of infrastructure
resources needed for your
business may include - facility; production equipment; IT equipment, software and security; laboratory;
packaging; dies; molds; tooling; jigs; fixtures; storage; transportation; communication; office; materials; labor;
utilities and supplies, etc.
The key
strategic business factors to be considered for infrastructureplanning include: future needs; current
availability and capacity; cushion for growth; contingency planning; linkage to current and future product
programs. This planning may be done through business planning (clause 5.1); quality management planning (5.4) and
planning for QMS processes Clause 4.1). The actual deployment of such resources may be determined by each process
owner.
You are
required to maintain your
infrastructure. Your planned preventive maintenance program should include controls for - schedule and timing;
availability and training of personnel; types and scope of maintenance; maintenance and competency/training
records; tracking to maintenance objectives; use, storage and control of spare parts; control of any maintenance
outsourcing; etc. There are many software programs available to help do this.
Work
environment include controls for ergonomics; personnel safety and facility conditions that are conducive to
achieving product quality. Some of the factors to consider in determining and managing the
work environment include - ergonomics (worker movement; fatigue; manual effort and loads, etc);
workplace location; heat; light; humidity; airflow; noise; vibration; hygiene; cleanliness; pollution; adequate
facilities (lockers; lunchroom; cafeteria; washrooms; etc); health and safety regulations; cleanliness of premises;
etc.
The extent to
which the above environmental factors may apply to any organization will vary based on size, risk and other
considerations. The focus should be employee safety, welfare and product conformity.
Performance
indicators to measure the effectiveness of processes (see first paragraph above) that determine and control the
effective use of infrastructure may include - equipment maintenance - uptime/downtime; productivity - equipment and
workforce; accident and safety incidents; non-value added use of floor space; excessive handling and storage;
number of instances specific resources were not available or delayed;
etc.