Generally, when something changes, that will be what the auditor is going to focus on; the vindictive auditor will try and catch you out, to show they know more than you, and make themselves look good. The professional auditor will focus on the continual improvement approach and appreciate that management systems change and improve over time.
Either way, to avoid non-conformities, you still need to be prepared. We’ve put together five key questions we think auditors will be asking, and we’ve also suggested how your quality management system could address it. …and for you technical “quality types” we’ve added some useful tips to make sure you are fully up to speed.
Understanding the organization and its context – clause 4.1
How have you determined the external and internal issues that are relevant to your business and its strategic direction?
If you are a big business – you will have a strategic business plan, now you may not need to show the auditor all of the plan, but you could highlight the parts where it mentions the external forces that are impacting on it as well as its internal strengths and weaknesses.
If you are a small business then having Vision and Mission statements should demonstrate where the business is heading – its strategic direction. To show the external and internal issues, then a SWOT analysis is a simple and effective tool to use. Where SWOT stand for Strengths, Weakness, Opportunities, and Threats. With Strengths and Weakness being internal issues and Opportunities and Threats being external issues.
Useful tip: ISO 9001:2015 does not require any of this to be documented the term it uses is determined, but there won’t be many auditors that will be happy if you just explain this to them without showing them anything written down.
Actions to address risks and opportunities – clause 6.1
How have you determined the quality risks and opportunities that need to be addressed?
If you are a big business – you will most probably already have a risk manager or risk department, and they will be looking at the big picture risks to the business. They may not however be quite so clear on the opportunities for the business – where it could be growing. This is more likely in the business plan. Also, because quality is about the customer, some of these risks and opportunities will need to be related to the customer. The QMS should be integrated with these identified risks and opportunities, so any actions and quality objectives should be aligned and able to be related back. If you are a small business then you may well have a risk register, if you have a safety system you almost certainly will have one. If you don’t have one – create one. They are normally a spreadsheet or table. To show that you have identified quality risks and opportunities, look at your business through the eyes of your customer or a potential customer, what you would not like if you were a customer (risk), and what would you like the business to be doing if you were a customer (opportunity). Once you have a list of customer risks and opportunities, identify how you can reduce the negative risks and build on the opportunities.
Useful tip: ISO 9001:2015 does not require any of this to be documented the term used is determined, it also does not require a risk register, risk manager or risk department but most auditors will want to see something written down.
Useful tip: ISO 9001:2015 requires the actions taken to be proportionate to the risk and opportunity, so BIG risk = BIG action. Small risk = small action.
Useful tip: There is no requirement for an organization to adopt ISO 31000 Risk management – Principles and guidelines. However for organizations who want a more formal approach to managing risk it may be useful.
Useful tip: ISO 9001:2015 does require documented information as evidence of management reviews and these reviews have to include the effectiveness of actions taken to address risks and opportunities.
Planning of changes – clause 6.3
How have you considered the purpose of any changes to the QMS and their potential consequences?
If you are a big business – there will most probably be changes occurring at many different levels. Some of the high-level changes may already look at the possible consequences of the change, although nearly always they will focus heavily on the benefits of the change rather than identify any of the negatives that may result. The more lower level, day to day changes will most probably be captured in such things as improvement registers, non-conformance reports, corrective action requests, and these changes will often not be identifying the possible consequences. In these cases additional fields could be added to identify the consequences of the change. If you are a small business then you most probably do not identify the consequence of any change before it is implemented, but you most probably do have non-conformance reports and some form of improvement or corrective action register. If that is the case just add a column or two to show what you expect to happen as a result of any change, and don’t forget to include the negative as well as the positive. That is also true for any changes that result from meetings – just include the possible consequences along with the actions and responsibilities.
Useful tip: ISO 9001:2015 does not require these possible consequences to be documented the term it uses is considered. However, in other areas of ISO 9001 and generally because of something going wrong documented information is required;
- That describes the nonconformity, the actions taken, any concessions obtained, and identifies the authority deciding the action. Clause 8.7.2
- As evidence of the nature of the nonconformity and any actions taken, and the results of any corrective action. Clause 10.2.2
- When the requirements for products and services are changed. Clause 8.2.4
- On design and development changes. Clause 8.3.6
- Any need for changes to the QMS. Clause 9.3.3
Quality management system and its processes – clause 4.4.1
How have you determined the inputs required and outputs expected from your QMS processes?
Any organization that is already certified against ISO 9001:2008 should have some form of document that describes the sequence and interaction of their processes, in fact the interaction between these processes should already be described in their quality manual (it was a requirement in ISO 9001:2008). But in ISO 9001:2015 you are now required to not only determine the processes needed for the QMS but also determine the inputs required and the outputs expected from these processes. If you are a big multifaceted organization managing a number of different projects within a matrix structure with many complex process maps, this could be an arduous task identifying the inputs and outputs of each of these individual processes. Auditors could have a field day here. Simplify and streamline your processes to make identifying inputs and outputs easier and your QMS more effective. If you are a small business then you most probably have a relatively straightforward end to end process map, so the identification of the inputs and outputs should be reasonably easy.
Useful tip: Managing interrelated processes is one of the keys to a good QMS and the output from one process is most likely the input to another process.
Useful tip: There is a lot of talk about the process approach in this version of ISO 9001:2015 however, it was very clearly spelled out as a requirement in ISO 9001:2000 so it’s been around for at least 15 years. If your consultant, quality person or auditor doesn’t know this – get a new one!
Useful tip: ISO 9001:2015 does not require a quality manual. This is a good thing. In most cases it was a poorly written copy of ISO 9001 interspersed with bits from the businesses’ procedures…and nobody reads a quality manual apart from the auditor.
Organizational knowledge – clause 7.1.6
How have you determined the knowledge necessary for the operation of your processes?
Firstly, there is a difference between knowledge and competence. Competence is the ability to apply knowledge and skills to achieve intended results. Competence is often demonstrated through a qualification. Knowledge is part of competence and it is gained by experience, and it is used and shared. Knowledge is based on,
- Internal sources – knowledge that is learned within the business; successes, failures, experiences etc.
- External sources – knowledge that is gained from; customers, standards, conferences, and even the internet etc.
ISO 9001 requires this knowledge to be maintained, made available, and also the business has to consider its current knowledge and how to acquire any additional knowledge it needs. In most organizations whether large or small there will be such things as; skills matrices, job or position descriptions, and performance review records. Normally these focus purely on a person’s competence or qualification, so these could be adjusted to include any knowledge requirements along with any actions to gain the knowledge where gaps appear.
Useful tip: Documented evidence of competence needs to be kept (clause 7.2) but not of knowledge.
Useful tip: Be aware there are two types of knowledge.
- Explicit knowledge – which is knowledge that can be written down; books, manuals, websites, papers.
- Tacit knowledge – is knowledge that’s difficult to write down, visualize or transfer from one person to another; sales, innovation, entrepreneurship, how to speak a language, riding a bike.