12 key questions to ask as you transition to the new quality management standard ISO 9001:2015.

The introduction of the new quality management standard ISO 9001:2015 has arrived. The deadline for making the transition to the new standard was September 2018.  Many organisations are in the process of transition.

Previous changes in quality management standards have found some organisations unprepared, with the associated risk of a temporary loss of certification. This, of course, means more than just an embarrassment or an administrative headache; for many businesses, quality certification is critical to their tendering process and may also be essential for retaining certain important clients.

The loss of certification could therefore result in lost business, damaged trust and strained customer relationships – none of which any competitive modern business would wish to suffer. It could also mean incurring additional staff and supplier costs in an effort to undo the damage of an over-hurried transition.

Stay focused during transition

I have provided below a brief commentary on the most important changes that will be coming into effect.

For those that have their quality management system embedded into their work flow, the change should be relatively straight forward. However, those that use the certification merely as ‘a badge of honour’ – one that has limited real influence upon their daily business processes – will certainly find the transition more difficult.

One of the most positive aspects of this standard is that it is based on a generic management system, and all new ISO management system structures will be based on the same framework. The implementation of the new standard will allow you to concentrate on specific operational processes, not the duplication of the underlying management system. This should help minimise disruption and keep the changes focused tightly on the aspects that are most relevant to your operations.

Twelve key questions 

So these are some of the important things I believe you should be looking at as you transition to the new standard:

• Leadership
• Organisational Context
• Risk Approach
• Process Thinking

Leadership:

Leaders will be required to demonstrate that they have significant input into the quality management system. This should include policies, plans, and the strategic alignment of quality objectives, effectiveness and communication.  In the past, many leaders would just sign the quality policy and periodically attend management reviews; they saw that as the entirety of their role and obligations with respect to the Quality Management System (QMS).  However, the new standard will present more challenges to top management in terms of their involvement in the system.

These are some basic questions you should be asking yourself in relation to leadership:

• How involved are the leaders with regard to the QMS development, operation and objective setting?
• How does leadership promote, direct, and monitor the QMS within the organisation?
• Does leadership see QMS as a bolt-on activity, or an intrinsic part of daily management and operations?

Context:

An organisation will be assessed on its ability to determine internal and external issues that could potentially impact the ability of the QMS to deliver its intended results. Also, the QMS must demonstrate that it has identified ‘relevant interested parties’  and their requirements in relation to the QMS.

The Chartered Quality Institute defines relevant interested parties as “groups or individuals who have the ability to impact (or potentially impact) the organization’s ability to consistently supply products and services that meet customer and applicable statutory and regulatory requirements. Customers, shareholders, board members, staff and competitors would all fit into this classification.”

Questions that one should be asking yourself in terms of Context is:

• How do you determine which internal and external issues are relevant to your company’s strategy? And what influence would they have on your QMS?
• Who do you consider to be ‘relevant interested parties’, and do you know what their requirements are?
• Do you regularly review interested parties as well as internal and external issues?

Risk Approach:

In ISO9001:2015, the ability to identify issues before they occur is now referred to as ‘risk and opportunity’. As the term suggests, risk and opportunity can potentially result in either positive or negative impacts.  Consequently, an organisation must demonstrate that it has identified, reviewed and – where necessary – mitigated risk or exploited opportunities.

The sorts of questions you should be asking of your department might include:

• How do we go about assessing risk?
• Do we have a risk register?
• Do we have an effective review and resolution approach to our risk and opportunities?

Process Thinking:

This is seen as a specific requirement when designing and developing operations to achieve your QMS objectives. Models such as S-I-P-O-C or PDCA (Plan-Do-Check-Act) can be used together to help you map out and understand what critical issues impact your workflows. They can also be used to understand how workflows can be created and changed, and how they interact with other processes.

The sorts of questions you should be asking yourself include:

• Are our processes easily understandable? Do we know their critical components?
• Can we highlight value-added and non-valued-added steps in our processes?
• When evaluating, changing or creating a new processes, do we use a documented systematic approach?

Next steps…

There’s still time to do things right and ensure you create a smooth roadmap to the new standard.

I’m not saying these are the only questions you need to ask of your organisation, but by answering these questions honestly, you should gain a better understanding of your preparedness and what you still need to do. If there still seems a lot of work ahead, break it up into chunks and start with the easy parts.

The change has arrived, if you haven’t already done it, make your preparations now and get yourself into the strongest possible position. The new standard will mark the start of new opportunities in organisational quality management.

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If you need help with your own transition journey, please contact us via email or set up a 15 minute free consultation.  I’ll be releasing a review of different tools that can be used for ISO9001:2015 so why not follow me and keep yourself updated by subscribing to our newsletter.