The ISO9001:2015 Revision – Your understanding starts here!

The changes are being labelled as significant and having a big impact on companies existing quality management system but I say don’t panic.

Overview

The intention of ISO9001 remains the same; to demonstrate a company’s ability to consistently provide goods and services that meet customer and legal requirements & enhance customer satisfaction. This is done by installing and maintaining an effective system with processes that embrace continuous improvement. The standard has a greater focus on the process approach and introduces us to addressing risk in our business for planning. I have listed what I consider some of the biggest issues but please bear in mind these conditions I see as essentials to every successful business. My thoughts are that you will probably be doing them already, if not why not? What you may need help with is knowing how to easily demonstrate evidence of this to an auditor.

Understanding Leadership roles

The standard emphasises the role of high level management in the creation, execution and support of the company’s quality management system. The role is clearly defined in terms of customer expectation and the quality management systes. You may always delegate but you are ultimately accountable for the effectiveness of the system.

What does this mean for you?

Your top management need to be actively promoting the awareness of the process approach and Quality Management System. They need to ensure that policies are understood, followed and your objectives are met. They should be engaging, directing & supporting staff that have a direct impact on the effectiveness of the system and promoting improvement and innovation.

This also includes their commitment to understanding and meeting customer needs. Management should understand the risks which affect the company’s ability to deliver a consistent service and focus on enhancing the customer experience.

RESULT = Competent people managers, who believe in the system and understand their customers.

Understanding the context of your company

When looking at the context of the organisation, this directly relates to your business strategy and position in society. It is done to ensure that you fully understand the risks internal and external that are relevant to the company’s strategic direction and ability to achieve the outcome set by your Quality Management System.

What does this mean for you?

In brief you need to understand the vision / bigger picture with an awareness of all of the interested parties, e.g. shareholders, government, customers, supplier chain etc.. Think about your relationships with these people, their perceptions and values. Look at your policies and priorities and know what changes and trends will impact your business, for example, economic and natural environment, technology, competitors. Everything addressed in defining the context of the company is then used to determine the scope of the standard = the boundaries of the applicability of the Quality management system.

Result = A thorough and relevant business plan that addresses SWOT (Strengths, Weaknesses, Opportunities and threats). This vision (plan) needs to drive the reason for existence and in turn define the processes and objectives of the Quality Management System.

Planning

When planning for your Quality management system you need to ensure that all we have discussed so far is used to determine the risks and opportunities that are to be addressed, you can then be reassured that your system will be designed to achieve its desired outcomes. You will be preventing or reducing undesired effects, firefighting and unpredictable cost. Be consistent and relevant to your core values and vision and make sure your actions are SMART (Specific, Measurable, assignable, relevant & time bound).

What does this mean for you?

Your business plan is not just a paperwork exercise you have to take action on your findings. You must prioritise and plan your actions and integrate them into your quality management system. Any changes have to take place in a systematic manner, ensuring you identify risks and document evidence.

Result = Addressing your current and anticipated  future needs can lead to the identification of improvement and innovation opportunities. Better for you, your staff, your customers and your bottom line. Documenting progress means you can easily identify factors that have affected changes in performance.

Knowledge & Competence

There is a greater emphasis on the competency of staff, particularly those having a direct impact on the effectiveness of your quality management system.

What does the change mean for you?

You need to be aware and maintain the knowledge and training necessary to assure your processes are effective, efficient and meet customer expectations. This needs to be assessed and recorded for evidence. This also I feel links to the awareness and communication requirements as management determine the need for internal and external communications relevant to the Quality Management System. Staff carrying out operations need to know and understand the objectives, know what they contribute and the implications of not conforming.

Result = You will be addressing the changing needs of the company and interested parties, as a result you will be aware of your current knowledge and skill base. This way you will be able to determine whether you need to acquire more and take action appropriately

Operations and Processes

You should be familiar with the process approach if not please message me and I will provide further info on defining processes. You must review the requirements related to goods and services prior to commitment to provide them – Contract review; this must be recorded. Processes must be clearly defined in terms of input, output, resources and controls. Changes to your processes must be controlled and reviewed to mitigate any adverse effects. For example when a change occurs, only when all actions arising from development have been completed and there is no adverse impact on the ability to meet customer and all regulatory needs can the change be put into production. Anything you outsource must also be controlled and the new revision of the standard goes into much clearer requirements for this.

What does this mean for you?

You must plan and develop your processes with clear criteria (input/output) and control. Implement and control your processes to ensure that you meet objectives and customer needs. Included in the objectives should be the actions you have highlighted that are required to mitigate risks, everything should be interrelated. You need appropriate evidence that provides confidence that these actions have been carried out as planned.

Result = Your processes are designed, maintained and controlled well to ensure your customer’s needs (internal or external) are met. Your ability to achieve, maintain and demonstrate your objectives becomes easier and more predictable along with predictable costs.

Performance evaluation and Improvement

The standard says that you must monitor, analyse and evaluate your performance. Determine what needs to be monitored, ensuring that you include any external providers as well and look at what the performance indicators are of the quality management system itself. The standard requires that you improve on the suitability, adequacy and effectiveness of your Quality Management System; it must also be audited and reported to management / management review.

There is no longer reference to continuous in the draft (this has been removed due to Annex SL terms), the term preventative action has also been removed as it is are covered by the assessment of  risk.

What does this mean for you?

Due to the approach of this new standard make sure you consider the risks and opportunities that your core business plan identifies. Define, establish and monitor your core processes and performance indicators, ensuring you act on your findings and report them back at management reviews. Continually assess via audits and KPI (key performance indicators) the adequacy and effectiveness of your Quality Management System to identify improvements. Ensure actions are appropriate to any nonconformity found and document actions taken for evidence.

Result = Changes / improvements in your system can come from many sources, internal suggestions, audits, analysis of data, changes in the context of the company, changes in the risks and new opportunities. When you evaluate these things for improvement you will always be moving forward. Just remember to prioritise these needs, engage your people and most importantly take action.