Iso 9001:2015 in plain english pdf download

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DRH et manager, levez-vous! Fallstudien zum Produktionsmanagement:. Grundlagen und Instrumente des Produktionscontrollings. Il forex trading reso semplice. Il Social Trading. Industrie 4. You simply make a commitment to satisfy applicable requirements. The proof of meeting the requirements is embodied within the remainder of the QMS. Commits to continually improving the QMS. This means exactly what it says. The organization must commit to continual improvement.

The easiest and most obvious way to do this is to use these exact words in your policy, although you could certainly paraphrase the commitment or put your own spin on it. As with the previous commitment, the true evidence of improvement will be woven throughout the system.

The current version must always be available and employees must comprehend it. Treat your quality policy like the uppermost document in your QMS, not just some random one-page missive.

Make sure to address the following points with the implementation of your policy: The quality policy must be accessible and documented.

It will have a revision level and be approved by top management. Some organizations even go as far as putting document numbers on their quality policies, though a title is usually adequate. The quality policy must be shared openly, comprehended by employees, and utilized within the organization. ISO has always required that the quality policy be available to and understood by employees. ISO adds an additional requirement that the policy be applied or utilized.

First, the policy is communicated. That means exactly what it says. Most quality policies fit on a single screen or sheet of paper, so this could be covered during a company meeting or some other forum. If an auditor were to ask an employee what the quality policy means to him or her, the employee should be able to say a few words about it and how he or she supports it in day-to-day activities.

We apply the quality policy by reminding ourselves that it exists and making sure that our actions support its intent and commitments. Be accessible to interested parties. This is the new requirement related to the quality policy. You could decide, for instance, to make your quality policy available if somebody enters your lobby or visits your website. This would be a very simple and unobtrusive way to meet the requirement. The whole point is to allow interested parties to understand what your organization is committing itself to.

Nothing lasts forever, not even a quality policy. The passage of time can render any policy obsolete. A typical approach is that top management review the quality policy at least once a year, although organizations could certainly review it more often. The management review function is the most common forum for reviewing the quality policy.

Ecolink Inc. Located in Tucker, Georgia, Ecolink www. Maybe not a glamorous business, but Ecolink long ago saw an opportunity to leverage its environmental stewardship and help customers make smart choices. When the company implemented ISO , it wanted a quality policy that really set the tone for its business practices and strategy. Environmentalism was one of the key principles that was stressed. As Roudebush led the company through the development of the quality policy, other important themes emerged.

These included work-life balance, positive karma, and high integrity and ethics. The final result was a wide-ranging and unique quality policy that truly fit the organization it was written for. Roudebush decided that he wanted to go one step further than the quality policy. What sort of employee behaviors would reinforce the principles the company was founded on? They represent a natural extension of the quality policy, but define actions and behaviors that could be put into practice every minute of the day.

The employees bring the concepts to life through practical examples of how the norms guide their actions. It might take a while. Defined responsibilities and authorities are one of the hallmarks of a QMS. Responsibility is what personnel must do, and authority is what they are empowered to do. When roles, responsibilities, and authorities are clear there is less confusion and more efficiency. How many times have you heard the following statements?

We have some confusion around who does what. I have a lot of responsibility but no authority. The ball gets dropped a lot around here. We have too many chiefs and no Indians. These are all symptoms that responsibilities and authorities may not be clearly defined and communicated.

Only the smallest organizations could effectively communicate responsibilities and authorities without some sort of documentation.

Job descriptions are a common way of meeting this requirement, though they are certainly not required. Procedures can also effectively communicate responsibilities and authorities. A lot of responsibilities in this clause of ISO were formally responsibilities of the entity known as the management representative. That role is no longer mentioned in the standard, but obviously it still has relevance and its responsibilities remain.

However, each of the responsibilities and authorities required in clause 5. Anybody with an understanding of ISO and its application could fill the role. Some of the specific ways this is done include: Using ISO as a model for establishing the system. Conducting internal audits to ensure that processes meet the standard. Receiving training on the practical application of ISO and passing this knowledge along to others within the organization.

Responsibility for making sure that processes produce effective outputs In other words, are we getting the right results? The first step toward this is defining the processes in the first place. Once we have defined processes, we can establish performance indicators or objectives that will tell us if the process is delivering the intended results.

This role is really one of measurement and reporting. It can be done by one person or multiple people, but the evidence of it happening is usually some kind of data that top management can examine and draw conclusions from. Sound like an important responsibility? It is. Responsibility for reporting on the QMS and improvement opportunities to top management This is another role that can be summarized by one word: reporting.

The person performing this role is a conduit through which data flows. The person assigned this responsibility should be good at summarizing information, facilitating its analysis, and driving toward specific improvement actions. In fact, the last few words of this requirement allude to the fact that somebody must be responsible for leading the management review. Responsibility for driving a customer focus throughout the company Customer focus should be a natural thing.

However, the larger and more complex organizations become, the more hidden the customer becomes. Gradually, people begin to forget that customers even exist. The purpose of this role is to not let that happen. The person assigned this responsibility can perform a number of specific tasks to create this awareness: Ensure that customer feedback is being collected and analyzed. Communicate the results of customer feedback. Ensure that the organization records, acts on, and learns from customer complaints.

Facilitate process improvements that aid customers. Drive an awareness of internal customer relationships. Encourage and facilitate product innovation. Many of the previous roles were reporting responsibilities, but this role is definitely an enforcing responsibility.

This role ensures that we consider the QMS any time we make changes by asking some of these questions: Should we write a new document? Should we revise an existing document? Should training take place? Should top management communicate something? Should we begin measuring something, or perhaps even stop measuring something? This role asks these questions, and many others, and then makes sure that we have reasonable answers for each of them. Probably not.

An organizational chart usually shows reporting relationships and organizational structure, not responsibilities and authorities. Is it OK if we continue to have one?

Risk management could be the single most significant addition to ISO It requires a complete change of focus in implementing a quality management system QMS. Most organizations do this anyway, at least unconsciously. ISO requires a fully conscious and planned approach to risk management. If implemented correctly, it will become one of the most powerful processes in the organization. Risk management sounds intimidating.

The alternative to risk management is far worse. What is it? Crisis management, of course. The investment you make in risk management is going to be much less than the cost and time necessary to handle full-blown problems. Employees at all levels begin thinking about risk in their day-to-day activities. It focuses our effort on the things that matter most. A good risk management system reveals significant risks and opportunities.

We can then apply a proportionate amount of control to the risks that are most threatening. It helps create a culture of prevention and risk management. A risk management process will gradually affect the way everybody thinks. All decisions are made with an understanding of the inherent risk and potential benefits. It helps make us more successful. The ultimate result of a risk management system is more success and less failure.

Before we go much further, we should define risk. Risks can be good or bad, but uncertainty is always involved. We can never know for sure if a risk is going to occur or how it will affect us. Where do the risks and opportunities come from? They originate from brainstorming. You already have some very good raw material for this examination of risks.

Our raw material are clauses 4. You certainly remember clause 4. This was framed in the context of strengths, weaknesses, opportunities, and threats.

The weaknesses and threats we identified obviously equate to risks. The remainder of the internal and external issues comprise the opportunities category. The other raw material for our analysis of risk and opportunities is interested parties. Specifically, what do these interested parties require of us? This was identified in clause 4. Each requirement may constitute a risk, an opportunity, or a combination of both. There is a third input to your risks and opportunities: corrective actions.

Corrective actions are aimed at removing causes of nonconformity and ultimately removing risk. If you do a good job of corrective actions, your overall risk will be reduced.

It might be helpful now to divide the output of clauses 4. Our challenge now is to evaluate the significance of the risks and opportunities. They are not all created equal. Some risks can kill people or put us out of business, while others may be nothing more than a nuisance.

Likewise, some opportunities will ensure long-term success, while others just provide a temporary positive bump. ISO gives us that leeway. Figure 4. Obviously, you might need to customize it for your own unique circumstances.

The two rating factors shown in figure 4. Once you have rated the risks and opportunities and calculated the RPN for each one, select a threshold for action. For example, it might be all risks and opportunities whose RPNs are 10 or higher. All risks that fall into that category will be addressed through actions you determine.

These leaves a lot to your discretion. Your actions can be simple or elaborate, short term or long term, costly or cheap.

How you address the risks and opportunities is up to you. There are three requirements: They are planned. You plan them. You carefully define what will happen, who will be involved, when it will be done, and what resources will be needed, as applicable. They are integrated into QMS processes.

All the controls of the QMS will be applied to the actions. For instance, if they are maintained as documented information, then document control will apply. If measuring instruments are used, then calibration requirements will most likely apply. They must be proportional. The most significant risks will be matched with the most significant actions. Opportunities with the biggest payback will be matched with robust plans.

They are checked for effectiveness. You must determine if they achieved their objectives. Be as objective as possible when evaluating effectiveness. Are you going to leave something like this to tribal knowledge? Of course not. Smart organizations will document their process for determining and rating risks and opportunities, and they will keep records of what they learn.

Risks and opportunities has the most interactions of any section of ISO To properly implement this section, you need to clearly understand how it connects to other parts of the standard. This is possibly the single biggest input to your risks and opportunities. Much of what you learn in clause 4. Another key input to risks and opportunities are what your customers, suppliers, employees, regulators, and other interested parties require of you. When you fix something through corrective action, you have reduced risk.

This makes it a periodic input to your risks and opportunities. This is both an input and an output of risk. You must evaluate the effectiveness of actions taken to address risks and opportunities, and what you learn from this evaluation will be reflected back as possible changes to your actions. Also an input and an output of risk. An input to management review is an evaluation of the effectiveness of actions taken to address risks and opportunities. This is almost an exact repeat of the requirement we just discussed in subclause 9.

This is an output of risks and opportunity. Top management will promote risk-based thinking, and this will certainly involve a discussion of what the organization has identified as its risks. Another output of risks and opportunities. When you determine your QMS processes in 4. We chose to identify risks and opportunities directly related to our QMS.

Is that OK? ISO states that the risks and opportunities you identify are those needed to give assurance that the QMS can achieve intended results. I believe there are benefits to addressing risks in a universal manner, but that decision is yours. The risk matrix shown in figure 4. The example was developed for an organization that teaches onsite professional courses.

Quality objectives have long been a part of ISO The organization must lay out a path for how it hopes to achieve the objectives. These plans must describe what actions will be performed, what resources will be required, who will be involved, the time frames for completion, and metrics for success. This is a much more meaningful approach to implementing objectives, but it will require a bit more proactivity on the part of the organization.

Quality is a very broad topic. As a result, objectives can address a wide range of topics: product conformance, process performance, customer satisfaction, workplace safety, financial results, market share, cost reduction, and many others. As long as quality objectives measure the degree to which characteristics conform to requirements, they are fine. Good alternatives include business objectives, scorecard goals, key measures, and performance targets.

There is nothing in ISO that says you must use the same terminology as the standard. In fact, ISO is full of terminology that could be better understood by using more straightforward language.

Organizations have a bad habit of trying to reinvent the wheel when it comes to objectives. Top management should be fully engaged in the choice. Their involvement will help reinforce true drivers of success.

That means there must be more than one. But how many should an organization shoot for? Objectives keep people focused. They should separate the message from the noise. By understanding the quality objectives, employees know which direction the organization is headed and how they contribute to that direction. Four to eight objectives are usually adequate. This number enables the organization to address a variety of important concerns, yet keep the list nice and tight.

What exactly does it mean when ISO says that quality objectives must be established at relevant functions and levels? What, no hands? The answer is yes. All organizations are composed of a supply chain of internal functions, all working together. Thus, all functions and levels are relevant. That said, everyone within the scope of the management system will have quality objectives. These will either be organizationwide objectives that apply to everyone or functional objectives that specifically address departmental responsibilities and output.

Objectives can even be a mix of both. Your quality objectives will touch everybody in the organization in some manner, and everybody will have the ability to contribute to their achievement. It means that unless you want a hundred objectives, some of them should be fairly broad and universal. Supporting the quality policy. The quality policy is the uppermost document within your QMS.

It sets the tone for everything else that comes underneath it. You might even call it the mother document. Quality objectives must be aligned with its themes. Any special claims or commitments the organization includes in its quality policy must be backed up by objectives. Carefully examine your quality policy and make sure that anything above and beyond the minimum commitments required by ISO is supported by an objective. Nobody had interpreted the requirement literally, which is exactly the way it should be interpreted.

Objectives must be quantifiable. This point is very simple, but it bears explanation. General themes, philosophies, and aspirations rarely constitute measurable objectives. However, they could serve as possible first steps toward measurable objectives. The main reason for setting measurable objectives has nothing to do with ISO and everything to do with becoming more successful.

People have trouble contributing to fuzzy, undefined objectives. As a consequence, the organization begins to drift like a rudderless boat. Combined with leadership and an empowered work force, measurable objectives pave the way to success.

Consider applicable requirements. This is an extremely broad requirement that requires some clarification. Who provides the clarification? You do. Examine what you learned in clause 4. Be appropriate for effective products and services and customer satisfaction. This means that your objectives have to have an effect on two important concepts: product and service conformity, and customer satisfaction. Demonstration of this would be especially easy if you simply included at least one objective that related to your product.

Be checked on a routine basis. Believe it or not, this is a new requirement in ISO Top management should be a leader in monitoring and analyzing objectives. Management review is the perfect forum. Be shared and discussed. At their heart, quality objectives are nothing more than communication tools. Their purpose is to tell employees what measures are most important to your success.

So make sure to share the message as often as possible. Any gathering of employees, whether actual or virtual, is a good time to remind employees about the objectives. All organizational communications are fair game, also. These include leadership emails, newsletters, bulletin board postings, intranet updates, and any other transmission of information. Keep in mind that some employees may not be in the habit of thinking about corporate goals.

Get them in the habit! Yes, remind them for the hundredth time. Specifically, those that are critical to delivering a product that meets specified customer requirements and and expectations. This means that we must be sure to have a systematic way in which we can consistently deliver high quality service to our clients. This is done by:.

This clause also includes an element of performance evaluation. Here we are encouraged to obtain the customer views and perceptions to clearly understand what what the people who have used our product have to say. This clause encourages us to think of ways in which will be measuring what we have defined in our goals. In that case, we need to have a way in which that information can be made available. Moreover the standard goes on on to make it a requirement to have a standard to process this information.

We need to define how we will identify, collect and analyse the data relating to information we get from both internal and external sources. Is explained that are two types of people who would want to get ISO certified. Those who want to improve and those who are in it simply for the certificate. For those who simply want the certificate this clause is simply redundant. On the other hand, those who have a will to improve will clearly understand the benefit of the clause.

Here we are encouraged to not be passive about improvement, but rather to take a systematic approach towards the collecting of our ideas for improvement, and to find a way in which we can implement those ideas. Achieving ISO certification through the help of a consultant, or through internal work as a matter of fact, is useless if considered as a one-time project.

ISO certification should be seen as the Foundation of improvement, it is is like you have just graduated. Right after you finish your thesis and you get the certification in your hand you feel like you have mastered the topic that you have studied.

As an employer you know that that is very far from the truth. They need to work hard to learn from others and they need to do their best to deliver results. The same goes with your company. Once you get ISO certification, you still need to work hard to actually improve your company has a continuous journey that will never end as long as the business is still running.

As a final note the iso standard closes off with an important section, probably the most important.