ISO 9001:2015, 10, Improvement

ISO/FDIS 9001:2015, clause 10, Improvement, has three sub-clauses:

10.1 General
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement

This article provides a summary of the Improvement requirements and identifies the changes from ISO 9001:2008.

10.1 General

The organization must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

These actions must include:

a) improving products and services to meet requirements, as well as, address future needs and expectations;

b) correcting, preventing, or reducing undesired effects;

c) improving the performance and effectiveness of the quality management system.

NOTE: Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation, and reorganization.

Changes from ISO 9001:2008

Opportunities for Improvement

The phrase “opportunities for improvement” is only mentioned in ISO 9001:2008 at clause 5.6.1 (Management Review – General). The phrase has been repeated in ISO/FDIS 9001:2015 at clause 9.3.2.f (Management Review Inputs) and added to clause 5.3.c (Organizational Roles, Responsibilities, and Authorities) and clause 10.1 (Improvement – General).

Customer Requirements and Customer Satisfaction

Although “meet customer requirements” and “enhance customer satisfaction” are expressed several places in ISO 9001:2008, they aren’t mentioned in the old clause 8.5 under Improvement. Clause 10.1 in ISO/FDIS 9001:2015 adds that improvement actions are taken to meet customer requirements and enhance customer satisfaction.

Future Needs and Expectations

ISO/FDIS 9001:2015 adds that organizations are to not only improve products and services to meet known requirements, but also to address “future” needs and expectations.

Changes from Annex SL Common Text

Annex SL has clause 10 as “Improvement”, clause 10.1 as “Nonconformity and Corrective Action” and clause 10.2 as “Continual Improvement”.

Since ISO/FDIS 9001:2015 has added a new Clause 10.1, General, the “Nonconformity and Corrective Action” clause has been bumped to clause 10.2 and the “Continual Improvement” clause to clause 10.3.

10.2 Nonconformity and Corrective Action

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization must:

a) react to the nonconformity and, as applicable:

1) take action to control and correct it;

2) deal with the consequences.

b) evaluate the need for action to eliminate the causes of the nonconformity so it does not recur or occur elsewhere, by:

1) reviewing and analyzing the nonconformity;

2) determining the causes of the nonconformity;

3) determining if similar nonconformities exist, or could potentially occur.

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to the quality management system, if necessary.

The corrective actions must be appropriate to the effects of the nonconformities encountered.

10.2.2 The organization must “retain” documented information as evidence of the:

a) nature of the nonconformities and any subsequent actions taken;

b) results of any corrective action.

Use of “retain” indicates the documented information refers to “records” kept as evidence.

Changes from ISO 9001:2008

Clause Numbers

The corrective action requirements in clause 8.5.2 of ISO 9001:2008 are now stated in clause 10.2 of ISO/FDIS 9001:2015.

Corrective Action

The requirements in clause 10.2 of the draft ISO 9001:2015 are very similar to the requirements stated in ISO 9001:2008, clause 8.5.2.

The draft standard adds that the organization must react to a nonconformity by first controlling and correcting it, as well as, dealing with its consequences. It also adds a requirement to determine if similar nonconformities exist, or could potentially occur.

A new requirement is to update the risks and opportunities determined during planning, if necessary. Another new requirement is to make changes to the quality management system, if necessary.

Clause 10.2.2 adds that the documented information retained as evidence must now indicate the nature of the nonconformity and any subsequent actions taken.

Documented Information

Clause 8.5.2 of ISO 9001:2008 requires a documented procedure for the corrective action process. Clause 10.2 of ISO/FDIS 9001:2015 does not require a documented procedure.

Clause 8.5.2 refers to keeping records of the results of action taken. Clause 10.2.2 changes the requirement from keeping “records” to retaining “documented information” as evidence.

Preventive Action

ISO/FDIS 9001:2015 has dropped the concept of preventive action that is currently conveyed in clause 8.5.3 of ISO 9001:2008. It has been replaced by risk-based thinking, which is described in ISO/FDIS 9001:2015, clause 0.1 (introduction – General), 0.3.3 (Risk -Based Thinking), 5.1.1.d (Leadership and Commitment – General), and Annex A.4 (Risk0Based Thinking).

Changes from Annex SL Common Text

ISO/FDIS 9001:2015 uses the common text of Annex SL for this clause almost without change. The new standard adds two sub-clause numbers to separate out the requirements for documented information. It also adds to update risks and opportunities determined during planning, if necessary. And, it clarifies that a nonconformity may arise from a complaint.

10.3 Continual Improvement

The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system.

The organization must consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that must be addressed as part of continual improvement.

Changes from ISO 9001:2008

Clause Numbers

The continual improvement requirements in clause 8.5.1 of ISO 9001:2008 are now stated in clause 10.3 of ISO/FDIS 9001:2015.

Needs and Opportunities

ISO/FDIS 9001:2015 adds that the results of analysis and evaluation (clause 9.1.3) and the outputs of management review (clause 9.3) are to be considered for needs or opportunities that must be addressed as part of continual improvement.

Effectiveness of Quality Management System

Improving the “effectiveness” of the quality management system is a requirement of ISO 9001:2008, clause 8.5.1. The ISO/FDIS 9001:2015 standard adds in clause 10.3 that the organization is to also improve the “suitability” and “adequacy” of the quality management system.

Clause 8.5.1 states that the quality management system is to be improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. This statement is not carried over to clause 10.3 of ISO/FDIS 9001:2015.

Changes from Annex SL Common Text

The requirement to continually improve the suitability, adequacy, and effectiveness of the quality management system is part of the common Annex SL text. The other requirements in clause 10.3 have been added for ISO/FDIS 9001:2015.