Engineering Simulation – Quality Management Systems – Requirements
NAFEMS Quality Standard Supplement 001
This NAFEMS QSS 001 is a quality management system supplement for engineering simulation, which conforms to the internationally recognised quality standard ISO 9001:2000. Proper application of QSS 001 will ensure that quality principles are built into the simulation process at a fundamental level, facilitating evaluation and control of quality at every stage of the process and enabling engineering simulations to be consistently carried out to the required professional standards.
Widespread growth in the use of management systems has increased the need for organisations providing engineering simulation (see NOTE) to ensure they operate within a quality management framework compliant with NAFEMS QSS 001 and ISO 9001. NAFEMS QSS 001 contains requirements which organisations providing engineering simulation need to meet if they wish to demonstrate that they operate a recognised quality management system, are technically competent, and are able to generate technically valid results. QSS 001 can be used by internal and external parties, including certification bodies, to assess the organisation's ability to meet customer, regulatory and its own requirements. The decision on whether to adopt a quality management system for engineering simulation needs to be a strategic decision made by the top management of the organisation.
In developing QSS 001, care has been taken to interpret and incorporate all the requirements of ISO 9001 that are relevant to providing simulation work meeting professional standards. Section 7 specifies requirements for technical competence, while the remaining sections specify requirements for sound management. Conformance of the organisation’s quality management system to the requirements of ISO 9001 does not in itself demonstrate the competence of the organisation to produce technically valid simulations. Nor does demonstrated conformity to QSS 001 imply conformity to all the requirements of ISO 9001. Therefore, organisations which conform to QSS 001 also need to operate in accordance with ISO 9001. Certification bodies may use QSS 001 and ISO 9001 for joint assessment and certification to confirm the competence of organisations providing engineering simulation.
QSS 001 specifies requirements, supplementary to ISO 9001, for quality management in engineering simulation employing computational methods. It is intended for application where a simulation organisation needs to demonstrate its ability to consistently provide engineering simulation meeting customer and applicable regulatory requirements, and which aims to enhance customer satisfaction through the effective application of a quality management system, including processes for continual improvement.
All the requirements of QSS 001 are intended to be applicable to all organisations employing computational methods in engineering simulation, regardless of their type and size. Where any requirements of QSS 001 cannot be applied due to the nature or scope of the organisation, these can be considered for exclusion. Where exclusions are made, claims of conformity to QSS 001 are not acceptable unless these exclusions are limited to the requirements in section 7, and such exclusions do not affect the organisation's ability, or responsibility, to provide simulations that meet customer and applicable regulatory requirements.
0.2 Process approach
0.3 Relationship with ISO 9001
2 Normative reference
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.5 Responsibility, authority and communication
5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.4 Work environment
7 Product realisation
7.1 Planning of product realisation
7.2 Customer-related processes
7.3 Design and development
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
A Simulation categories of importance
B Personnel competence
C Correspondence between NAFEMS QSS 001 Rev. 1.0 and NAFEMS QSS Rev. 2.0