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Applying the Principle of Factual Approach to Decision Making in ISO 9001

Effective decisions are based on the analysis of data and information. (ISO 9004:2009)

 

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1. Management Review

At the top management level, there must be evidence records of the review as specified in the review inputs and outputs under ISO 9001 Clause 5.6.2 “Review Input” and Clause 5.6.3 “Review Output”. Strategic and policy decisions are made based on reports from the review inputs. Management decisions are translated into improvement projects as part of continual improvement of QMS or the organization’s business strategy.

 

Top management must ensure that measurable quality objectives are established at relevant functions and levels within the organization as per ISO 9001 Clause 5.4.1 “Quality Objective”. At the process or functional level, the established quality objective must be monitored and there must be evidence records of correction and corrective action taken when the planned results is not achieved as per ISO 9001 Clause 8.2.3 “Monitoring and Measurement Processes”.

 

2. Quality Objectives

Data and statistical analysis must be evidence for all processes so that preventive action can be instituted to avoid potential nonconformity and for creating the opportunity for continual improvement projects. Customer feedback based on customer complaints, suggestions and perception surveys are also objective input for management decision and actions. This is defined in ISO 9001 Clause 8.4 “Analysis of Data”.

 

3. Use of Data Analysis

4. Monitoring and Measurement of Production

5. Maintaining and Improving QMS

The processes and product requirements have to be measured and monitored at appropriate stages of the production processes, from the purchase of key inputs until the final use, and even disposal of the product. Actions are required to be taken according to the acceptance criteria, and there must be evidence records on these activities defined in ISO 9001 Clause 8.2.4 “Monitoring and Measurement of Product” and 8.3 “Control of Nonconforming Product”.

 

The ISO 9001 Clause 8.2.2 “Internal Audit” is crucial for maintaining discipline in the implementation of QMS. Audits will raise non-conforming reports for corrective actions and observation for improving QMS and its processes. Audits results are objective evidence for decision and actions. Further evidence records come from corrective and preventive actions taken to address nonconformity and potential non-conformity respectively.

 

ISO 9001 8 Principle - Continual Improvement

Continual Improvement

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