ISO 9001 QMS

Quality objectives are important for any organization that seeks to improve quality management system (QMS) & maintain its ISO 9001 certification. In this guide we will discuss –

🔘 What are ISO 9001 quality objectives?

🔘 Does ISO 9001 require quality objectives?

🔘 How to make the quality objectives work for you?

🔘 How many quality objectives should an organisation have?

What are ISO 9001 Quality Objectives & Why are they required?

Quality objectives are the standards used by the companies to transform the goal from the quality policy into an actionable plan for improvement. These quality policies are created keeping in mind the customer requirements and are linked to their requirements through the Quality Policy.

In short, Quality objectives of ISO 9001 are goals that are tied to the quality policy of a company. These objectives often measure items that are being identified as most important to the business.

In general these quality objectives include items like delivery, quality, and/or safety.

Does ISO 9001 require quality objectives?

According to the ISO 9001:2015, it is necessary for a company to have well structured quality objectives. Section 6.2 of the ISO 9001 standard elaborates on all the requirements. As per the ISO standard the quality objectives created by an organisation must coincide with the quality policy.

By this, we mean a company needs to pick a criterion, set a goal, and measure it over different timeframe & communicate the results.

Different requirements here include items like – state and federal regulations, ITAR, OSHA, and other industry relevant requirement. These requirements also ensure that the quality policy is well-documented, communicated, and understood within the organisation.

How to make the quality objectives work for you?

Now that we have discussed what are quality objectives as per ISO 9001, let’s understand how companies can make these objectives work for them.

Once you have finalised what things you need to monitor, measure and improves, the next thing to do is make the quality objectives effective in addressing what companies should focus on improving.

Companies should design the quality objectives around the concept – S.M.A.R.T (specific, measurable, achievable, realistic, and time-based). They should also make sure that their quality objectives are relevant to all the levels of company which means that each employee must understand how their job supports meeting the quality objectives.

Formulate Your Quality Objectives Around The S.M.A.R.T !

☑️ Specific: When creating a quality objective, a company must remain very clear and specific. For example: Instead of setting quality objective – “to improve non-conforming product”, you should set a clear and specific objective as – “to reduce non-conformances on the third widget line.”

☑️ Measurable: Remember one thing – if you cannot measure an objective, it is nearly impossible to see if the objective is met or not. Therefore, when you are creating a quality objective, make sure that it has to be measurable. For example: If your quality objective is “to improve quality of the products on the third widget line”, it is not as measurable as an objective “to reduce non-conformances on the third widget line from 15% to 5%”.

☑️ Agreed: If you wish to create a strong quality objective, it is important that it goes through all levels approvals from the top-management of the company. Once the objective is approved by the top management, it must be communicated to all different levels of organisation before implementing the plans to achieve the objective.

☑️ Realistic: Another important aspect that companies should consider while creating a quality objective is that it should be realistic. Being realistic can give you better space to plan for achieving them. For example: If you tell your employees that you want to reduce defects from 50% to 2%, they will not be able to see how this is possible.

☑️ Time-Based: Creating a quality objective needs to be time-bound so that it can be clear in heads of the entire organisation to achieve it. For example: Saying “reduce non-conformances on the third widget line from 15% to 5% in the next year” allows team for better planning.

You can also learn how to write good quality objective in our article: Quality Objectives – Driving Improvements.

How many quality objectives should an organisation have?

Every organisation has different answers for this question. However, in general, we would say five quality objectives are enough.

General Quality Objective Example For an Organisation

How often should you review the quality objectives?

Every organisation handles their management review in different ways – some weekly, some quarterly, and some yearly. Depending on the review process of your company, you must include quality objective review in the meeting agenda. We, however, will recommend you do this review every quarter.

If you are working on creating a quality objective for your organisation and are stuck with some complicated questions, luckily, at Elexes, we have experts who can help you create a good quality objective file for your product.

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

Post a comment

Your email address will not be published.