Practical advice on ISO 9001:2015 Clause 6.2 Quality Objectives
ISO 9001 Implementation Projects frequently run into difficulties when addressing the requirements of ISO 9001:2015 Clause 6.2 Here's how you can avoid such difficulties.
Table of Contents
- What are Quality Objectives?
- Who sets Quality Objectives?
- Example of Quality Objectives as Documented in a Management Review
- Do's and Don'ts When Setting Quality Objectives
- Achieving Quality Objectives
- How to Achieve Measurable Benefits When Dealing with Quality Objectives
- The Virtuous Circle - A Rational Approach to Fulfilling Quality Objectives
- Applying the Virtuous Circle Approach When Setting Quality Objectives
- Management System Fundamentals - Policy and Objectives
- Relationship Between Risk Management and Quality Objectives
What are Quality Objectives?
The term Quality Objectives is defined in ISO 9000:2015 as an objective related to quality. Not very helpful.
ISO/TS 9002 defines quality objectives better. It says: ‘Quality objectives should be established at relevant functions, levels and processes, as appropriate, to ensure the effective deployment of the organization’s strategic direction and its quality policy.
For example, quality objectives might be set at an operational level, for the procurement function or the design process.’
Quality Policy and Quality Objectives together are believed to be the foundation of every effective quality management system.
Who sets Quality Objectives?
Top management may establish quality objectives at the strategic level, the tactical level or the operational level. The strategic level includes the highest levels of the organization and the quality objectives can be applicable to the whole organization.
The tactical and operational levels can include quality objectives for specific products, processes, units or functions within the organization and should be compatible with its strategic direction.
Example of Quality Objectives as Documented in a Management Review
Continual Improvement & Quality Objectives
The Quality Management System continues to work satisfactorily.
Current Quality Objectives:
- Establish a system to record Staff performance measurement and versatility. A trial will be carried out for the production area.
Action By: M Cahill & Donald Smyth
Due Date: May 2017 (carried forward)
New Quality Objectives:
- Develop top-level Flow Charts for both
- SAP System – Purchasing Process
- SAP System – Sales Process
This is primarily for training purposes.
Action By: M Cahill
Due Date: May 2017 (carried forward)
- The new Packing System has been introduced. New packing procedures are now required (see CAR 10/15)
Action By: M Cahill
- Remove reference to Process Description Master Table from QMS as no longer used.
Action By: M Cahill
Due Date: May 2016 (carried forward)
- Five corporate KPIs (mandatory reporting) are adopted as Quality Objectives. These are:
- Loss time injury rate (LTIR)
- On-time delivery (OTD)
- Days Inventory Outstanding (DIO)
- Customer Complaint Rate (CCR)
- Productivity (value-added)
In due course, targets will be assigned to each.
Reference to these KPIs as Quality Objectives will be added to the Quality Manual.
Action by: Omar Ahmed
Due Date: May 2016
Note that the Objectives are not just set when implementing ISO 9001, They are not ‘set in stone’ and will change in time in line with changes to customer and other business requirements.
Do's and Don'ts When Setting Quality Objectives
- Do Choose Quality Objectives within the scope of the Quality Management System (QMS). Communicate these to the persons working under the organization’s control who have the ability to influence the achievement of quality objectives.
- Do remember that Quality Objectives do not have to be quality assurance related. Although if this were a problem area, top priority should be given to it in choosing objectives. Objectives such as increasing sales while maintaining the QMS or the introduction of automation to reduce costs would be acceptable.
- Do make sure that the chosen objectives must be measurable and stated clearly. Aspirational statements are not acceptable.
Here we address the commonly-made errors that lead to non-compliances being found during ISO 9001 Audits. Some typical errors include:
- Don't forget to set measurable objectives.
- Don't forget to make a credible plan to achieve the objectives
- Don't make Objectives too narrowly focused. Quality objectives must be set across many functions and levels within the organization
- Don't make Objectives that do not relate to the organization (as documented in fulfillment of ISO 9001:2015 Clause 4.1 requirements).
- Don't make Objectives that do not relate to the needs and expectations of interested parties (as documented in fulfillment of ISO 9001:2015 Clause 4.4.1 requirements).
- Don't forget to monitor and/or review the progress being made in achieving the quality objectives. This is usually documented in a management review report.
Achieving Quality Objectives
In addition to setting Quality Objectives, you must also have a plan for achieving them. This must include:
- what will be done;
- what resources will be required;
- who will be responsible;
- when it will be completed;
- how the results will be evaluated.
A set of Quality Objectives chosen by top management. Also the documentation of the actions that have to be taken within the QMS to achieve the chosen Quality Objectives, and these documented in a series of Improvement Projects or similar.
How to Achieve Measurable Benefits When Dealing with Quality Objectives
Requirements for setting Objectives in a management system are a common feature of ISO Standards such as ISO 9001, ISO 14001, ISO 13485 and so on. They're sometimes called Quality Objectives or more often, simply Objectives.
Almost always the requirements are poorly addressed and the benefits that should accrue to the organization are rarely achieved. Add to this the requirements for planning, monitoring and measurement and for analysis and review, and external auditors are frequently presented with a confusing mess.
With the Virtuous Circle Approach, you can readily resolve matters.
The Virtuous Circle - A Rational Approach to Fulfilling Quality Objectives
Scattered throughout the various ISO Management System Standards we find references, with some variation in titles, to the following:
- Objectives and associated Targets,
- Improvement Projects, Programs and Plans to achieve those objectives and plans,
- Monitoring and Measurement of performance against the objectives and targets,
- Analysis and Reporting of results to top management and other relevant functions, and
- Management Review by top management of progress to amend or set new Objectives and Targets.
The fact that these are closely related to each other is hardly mentioned. And yet if we combine them into a simple cyclical process we make these requirements much easier to manage and much more capable of achieving tangible results of value to the organization.
Top management can see more easily how the resources consumed by management systems are yielding practical results. And this is not by accident but by deliberately managing the issues at hand. These include quality of product or service, protection of the environment, patient safety, food safety, information security, and so on.
The Virtuous Circle Flowchart
The Virtuous Circle flowchart shown here organizes these requirements into a single process.
Applying the Virtuous Circle Approach When Setting Quality Objectives
In applying the Virtuous Circle Approach When Setting Quality Objectives, we recommend that you combine all stages, except the Management Review, into a single Procedure and facilitate the management of all five related activities together.
Take a look at your Quality Manual, your Environmental Management Manual, your Information Security, and so on. See if the systems they are intended to manage wouldn't benefit significantly from applying the Virtuous Circle Approach.
And if you are currently involved in an ISO 9001 Migration, an ISO 14001 Migration, or an ISO 13485 Migration Project, you have an ideal opportunity to seamlessly introduce the Virtuous Circle approach.
Management System Fundamentals - Policy and Objectives
Implementing ISO 9001 can be described as establishing a Quality Policy, and setting and achieving Quality Objectives. This pairing of policy and objectives appear also throughout the ISO 9001 family of Standards.
The related requirements for targets, improvement, monitoring, and measuring, analysing data and review are never presented as a whole and are usually scattered throughout these Standards.
The result is frequently confused with no payback to the organization for the effort and resources applied. With the Virtual Circle Approach, you can end all that waste.
Relationship Between Risk Management and Quality Objectives
Whether you have formal risk management or use the less formal risk-based thinking approach, you will have improvement targets. These fit easily into the Quality Objectives and Targets box illustration.
Quality objectives are a very sensible requirement of ISO 9001. They keep the QMS grounded in reality. The need to ensure the effective deployment of the organization’s strategic direction and its quality policy is the foundation of this reality.
Whatever you do, do not choose objectives just to meet the standard’s requirement – choose relevant quality objectives that are meaningful for the organization and aid it in achieving its strategic objectives. Be sure that this will be checked during your ISO 9001 Certification Audit.
Note: First published in Nov 2020; revised and updated in Apr2021.