Where has "statistics" gone with ISO 9001:2000?
ISO 9001:2008 for the benefit of readers
is construe with less manufacturing orientation and can its understanding in the language as well understood within the software and service industry sectors. ISO 9001 requires that "statistics" be address or its application.
Year 1994 ISO 9001 and ISO 9002, Element 4.20, addressed Statistics, namely Statistical Techniques. In Year 2000 of ISO 9001 statistics is addressed in clause 8.1. Clause 8.1 reference statistics as a method to apply for the monitoring
of processes, measurement, analysis and thus to improve. Based on information we receive and experience, clarify and confirm with your registrar on the interpretation of clause 8.1 and the applicability of statistics, as ISO 9001:2000
requires the use of statistics. Relevant also is clause 4.1 (c), which requires determining the criteria and methods for effectively operating and controlling the organisation's processes. Further, 4.1 (e) requires monitoring of
processes, measure and analysis. Linking to 4.1 (c) and (e), clause 7.1 (c) requires determining the product's acceptance criteria from planning aspects relevant to verification, validation, and inspection / test activities. Then going
back to clause 8.1 we can see the relation of applying methods, (that may include applied statistics) as a vehicle demonstrating conformity and to continually improve the effectiveness of the management system. In addition, others linking,
clause 8.2.3 requires process monitoring and clause 8.2.4 requires monitoring and measurement of the product's characteristics.
If beneficial, look into Guide ISO 11462-1:20001, "Guidelines for Implementation of Statistical Process Control (SPC)" -- [Part 1: Elements of SPC], which can be utilized for the implementation of statistics. We finalize this
informative session with "Plan-Do-Check-Act" as it can be applied within ISO 11462-1 section 7 or clauses of ISO 9001 noted elsewhere in this page. The explanation that follows relate to the applicability of ISO Guide 11462
(referencing specific clauses):
Plan: (7.1) process documented control plans; (7.2) process targets and (control) limits; (7.3) measurement system and evaluation; Do:
(7.6) records (data) and collection/compilation; (7.12) monitoring of the process output; (7.13) process control system; Check:
Assessments of short (7.14) and long term (7.15) variability; (7.16) communicating the resultant outcome from process analysis; and Act:
(7.20) leading to process improvement through optimization and troubleshooting techniques.
Consideration must be given to other support activities; (7.4) specific or work instructions; (7.9) process interrelations and sequencing; (7.10) records; (7.5) training; and (7.19) work teams.
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