9.1.3 Analysis & Evaluation [ISO 9001, with Procedure]

What is the Analysis & Evalution Procedure?

The purpose of the Analysis and Evalution Procedure is to establish and define the roles and responsibilities for collecting and analyzing data.

Contents

You must be able to show, through meaningful and relevant data, that your quality management system is effective. This will allow you to determine where targeted improvements can be made. Data used for this purpose should be gathered from within your organization and from any relevant external sources. Since each company is different, the data you gather will be unique.

Analysis of Data

What should ISO 9001 Analysis & Evaluation Include?

Where the analysis shows unacceptable performance then those items should become Quality objectives 6.2 and where appropriate, become subject to preventive or corrective action.

Why Should I Analyze Data?

The purpose of analyzing data is to:

  • Assess organizational performance against established plans and stated quality objectives
  • Identify areas for improvement
  • Help determine the cause of problems
  • Provide guidance for determining the most appropriate corrective or preventive action to take

Methods of Data Collection

Data collected for analysis includes:

  • Results from customer surveys
  • Results from employee surveys
  • Customer, supplier and employee feedback
  • Results from internal audits
  • Results from process monitoring and measurements
  • Results from product monitoring and measurements
  • Non-conformance reports
  • Warranty claims and returned products

Calibrated Equipment Analog Computing Machine

How Do I Analyze Data?

Effective data analysis is an essential part of any quality management system:

  • Use statistical techniques where appropriate (e.g. Statistical Process Control)
  • Data should be analyzed by designated, competent personnel
  • Use data feedback for continuous product and process improvement

Should I Document Our Analysis & Evaluation Process?

It is not a mandatory requirement to document your analysis & evaluation process. However, you should always look to adequately define and control any operational processes that generate information on the performance of your quality management system. Therefore, the implementation of an analysis of data procedure will be appropriate to many businesses.

How's Best to Document the Process?

Develop and implement a procedure that defines the roles and responsibilities for analyzing quality management system data in order to drive continual improvement and to facilitate a factual approach to decision making:

  • Data collection
  • Data analysis
  • Information output
  • Reporting

Measuring Analysis of Data Process Effectiveness

The effectiveness of the analysis of data process is often determined by looking for evidence that the organization has sufficiently utilized data from the outputs of its activities and has used that data to drive continual improvement and enhance customer satisfaction.

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Updated: 4th September 2021
Author: Richard Keen

Richard Keen

Richard Keen

Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
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Analysis & Evaluation Procedure

The purpose of this procedure is to establish and define the roles and responsibilities for collecting and analyzing data.

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