To meet the requirements for this clause, evidence should demonstrate that your organization is reviewing both internal and external problems (context) at periodic intervals that might affect your business.
Well, it should be obvious that the subject of leadership is becoming increasingly important whenever ISO 9001 is updated. The most recent list of ISO 9001:2015 requirements for leadership and commitment are admirable in that they are genuine and the standard puts leadership at the forefront of the QMS. By doing this the management system is strongly encouraging you to run your business from the ‘top-down’. This means that top management are expected to be the driving force behind the management system and how it applies to the business.
The quality policy is the general promise and commitment to quality control and customer focus of top management when it comes to quality. It’s usually a brief paper with less than 100 words. The policy is frequently left to gather dust sitting on a reception wall and never even communicated out.
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importantly, is everyone in the organisation aware of how important your customers are to your business? If the answer to this question is no, then you have something seriously wrong. It seems pretty obvious that any and all businesses would cease to exist without their customers, right?
Responsibility for the quality management system, surely that lies with the quality manager, doesn’t it? Sadly, this is a common situation and misunderstanding within businesses across the globe. You’ll no longer find the term “management representative” that might be familiar to users of ISO 9001:20
What risks and opportunities I hear you ask? Well, do you remember those risks and opportunities that came from performing a PESTLE analysis at clause 4.1? This clause is asking you now to make plans to address those risks and opportunities. By doing this you are adopting a proactive approach to managing ri
As with most management systems, ISO 9001:2015 has always contained a requirement for setting and maintaining quality objectives but, it now has a clause requirements for you to establish plans that explain how you are going to achieve the
What is meant by changes?
Planning for changes; “what changes?” I hear you ask. Well thankfully, ISO 9001:2015 does not insist that you plan for all changes, only significant changes. How do you decide on what is a significant change?, that is entirely for you to decide. You might begin by asking yourself “what would happen if the change that we are about to implement goes wrong, and causes a negative impact?”. Let’s not forget, in quality management we are always trying to protect the customer from the effects of negative impact.
The general statement at clause 7.1 is a high-level requirement that sets the stage for the more detailed requirements of clauses 7.1.1 to 7.1.6 that follow. This requirement establishes the context and the need for resources that enable the management system to function effectively.
In my experience as an auditor and trainer, I’ve found that Clause 7.2 ‘Competence’ seems to be every internal auditor’s favourite clause to audit. However, I’ve also determined it is one of the most common clauses that internal auditors misinterpret.
Are you confused about the requirements of clause 7.3 awareness? If so, then continue reading the secrets to this requirement.
Are you confused about the ISO 9001:2015 Clause 7.4 Communication Requirements? If so, then all will be revealed in this detailed article
The terms “document” and “record” are frequently used interchangeably however, they refer to two distinct concepts. Not only are they distinct, but so are the controls used to manage them
Measurement, monitoring, analysis, and evaluation is the process used to critically evaluate the effectiveness of the management system. A management system is designed to promote continual improvement, and the process that you use to gauge if this is happening is by monitoring, measuring and analysing the results.
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