When you use the requirements of ISO 9001: 2015 as the basis for your quality management system (QMS), you will realize that risk-based thinking is an important and new concept that has been introduced in the first step of quality planning. In addition to the idea that it is important to think about risk, there are requirements in the quality management system to identify and address risks and opportunities. But how is this done? Here we will explain a little more about what the standard needs and how you can meet these needs in your QMS.
What do the requirements of ISO 9001: 2015 actually specify?
There are requirements to address the risks and opportunities throughout the ISO 9001: 2015 certification . It starts from the beginning in section 4.4.1. Where the organization is required to determine the necessary processes to address the identified risks and opportunities. This issue is reinforced in Section 5.1.2. Where top management must ensure that the risks and opportunities that affect product / service compatibility are identified and addressed.
Risk and Opportunity Needs There is a section 6.1 on risk and opportunity measures. This section discusses the need for planning to address risks and opportunities, integrate these measures into the content management system, and evaluate its effectiveness. These measures must be commensurate with the potential impact on product and service compliance, and there are many ways to deal with risk.
The last mention of risk and opportunity is in Section 9.1.3, which discusses the analysis of information needed to determine the effectiveness of actions. Section 9.3.2 examines the effectiveness of management of measures taken to deal with risks and risks. Risks and opportunities must be updated when non-compliance occurs. (Section 10.2)
How can you meet these requirements?
It is important to note that there is no need for a formal process to monitor and control the risks and opportunities in the quality management system. Just like risk-based thinking, there is no need for complete risk management, you just need to identify the risks and opportunities and make decisions about what needs to be made.
As with any new requirements for ISO 9001: 2015, look at what you have already done in your organization to see if it addresses your current business practices. For example, many companies have business planning processes that examine business risks and opportunities that may exist, such as using SWOT analysis (strengths, weaknesses, opportunities and threats). کردن.
SWOT analysis is a strategic planning method used to help an individual or organization identify strengths, weaknesses, opportunities, and threats related to business competition or project planning.
The use of SWOT analysis in business planning also includes plans to address identified risks and opportunities, which are required by the ISO 9001: 2015 standard. For example, if you identify a risk that a key component of your product or service will become obsolete in the future, you can try to find an alternative before your customers are affected by your product.
If you have already done this as part of your recruitment strategy, you have already met the requirements of the ISO 9001: 2015 standard. Otherwise, this is definitely the best way you can use it. Remember, the format of this identification is not mandatory. So you can look at these risks and opportunities in any way you want.
Why pay attention to risks and opportunities?
As mentioned earlier, obtaining ISO 9001 represents a set of requirements that reflects the good practices that underpin the quality management system, and companies that want to stay sustainable, evaluate and address the risks and opportunities for their business. To grow your business, you need to figure out what the risks are and how they can affect you.
However, as always, it is important that you find the best way in your organization to do this activity to address your risks and opportunities. This can be as simple as brainstorming for SWOT analysis and then deciding whether to do anything about the identified hazards. This process benefits your business.
Always remember, there is a quality management system for the profitability of your business. Note that this does not cost you much. Therefore, always do your best for your business.
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