Implementation Guideline for clause 9 of ISO 9001 2015 standard

Clause 9 of ISO 9001 2015 standard servers purpose of Check requirement of PDCA cycle.

Clause 9 – Performance Evaluation

Clause 9.1 – Monitoring, Measurement, Analysis & Evaluation

Clause 9.1.1- General

This clause of ISO 9001 2015 standard requires that for evaluation of QMS effectiveness and performance, organization shall define performance indicators, method for getting data for identified performance indicators, frequency of monitoring and measurement, and Evaluation method of analysis of performance indicators.

This may include performance indicators like customer satisfaction, rework/rejection % , Defect/ Error %, Deviation in planned Vs Actual %, Customer complaint Ratio, Supplier performance, Equipment breakdown %, Sales growth etc. There could be many performance indicators which can be defined based on processes. Evaluation method would include statistical tools and techniques.

Clause 9.1.2- Customer Satisfaction

This clause of ISO 9001 2015 standard is similar to 8.2.1 clause requirement of previous version ISO 9001 2008 standard. Requirement requires to monitor customer’s perception about degree up to which customer needs and expectations have been fulfilled. It includes obtaining, monitoring and reviewing these information. This will be great input in improving QMS. Customer complaints and customer feedback analysis, evaluation and implementation of corrective and preventive actions will become key success factor for any organization.

Clause 9.1.3- Analysis and evaluation

This clause of ISO 9001 2015 standard specifies various parameters which shall be analysed and improvement opportunities shall be evaluated.

Such parameter & their evaluation includes

  • Extent up to which conformity to product and service requirements have been met.
  • Customer satisfaction %
  • Performance of external providers
  • Performance and effectiveness of quality management system.
  • Effectiveness of actions taken on risk and opportunities.
  • Extent up to which planning have been achieved.
  • Need for improvements in the quality management system.

Clause 9.2- Internal audit

This clause of ISO 9001 2015 standard is similar to clause 8.2.2 of previous version ISO 9001 2008 standard. This clause requires that internal audit shall be done at definedĀ  intervals for evaluation of effectiveness of quality management system. Auditor selection shall include objectivity and impartiality of process to be audited. Audit planning shall be done based on importance of processes, previous audit results and changes affecting organization. Record of audit result including corrective actions taken shall be maintained.

Clause 9.3- Management Review

This clause of ISO 9001 2015 standard has a change with respect to earlier standard. Management reviews are conducted to ensure continuing suitability, adequacy and effectiveness of quality management system and identification of improvement opportunities.

Input to management review shall include

  • Status of actions derived from previous management review
  • changes in internal and external issues
  • performance and effectiveness of quality management system that includes information related to customer satisfaction, quality objective results, process performance and product conformity, non conformities and corrective actions, monitoring and measurement results, audit results, and performance of suppliers/external providers
  • Adequacy of resources
  • efffectiveness of actions taken on risk and opportunities.
  • Opportunities for improvement.

Output of Management review shall include

  • Changes in the quality management system including change in resources, methods, objectives etc.
  • Resources required
  • Opportunities for improvement.