Fortunately, bestselling author Craig Cochran has translated ISO into plain English that anyone can understand. Plus, Cochran shows what has changed between the and version.
This straightforward book is ideal for people who are new to ISO , experienced ISO coordinators who want to get more out of an established system as they transition to the new standard, and for employees who just need a basic understanding of what ISO is and how it applies to them.
This may seem. Why does ISO have to be so confusing? Implementing ISO is a comprehensive guide to making the necessary transition to the new standard.
The changes can also be used to stimulate transformation in organisations and their wider environments, coordinating processes to achieve both customer satisfaction and reduced operating costs.
What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization?
How do you. Small businesses face many challenges today, including the increasing demand by larger companies for ISO compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this.
ISO is here. A lot has changed. There's an entirely new structure. New requirements have been added. Old requirements have been updated and moved. Some requirements have been removed. To remain compliant, you've got to transition to the new standard. Fortunately, you've got access to inside information in this new. This handbook was developed to help small and medium-sized organizations better understand ISO It is intended to facilitate implementation and improvement.
This requires the organization to consider all the various elements of a process, not just the one or two pieces believed to be the most important. The result is an organization that truly knows itself and understands what it takes to be successful.
Is ISO asking for you to define all your processes this way? If your existing documentation works for you, then by all means keep it in place. This is exactly what it sounds like.
Inputs are usually received from other preceding processes, and could include physical or informational resources. The outputs are the products that result from the process or the services that are performed. These could be intermediate products or services, as opposed to something a customer would actually pay for.
If you think of a process model as flowing from left to right, then you can imagine the inputs on the left side and output on the right side. Even the simplest organizations have multiple processes.
ISO asks you to sequentially order these processes. So the design process would come before the purchasing process, the purchasing process would come before the production process, and so on. The criteria for the process is how it will be judged. This is basically the requirements that the process is attempting to meet. Methods are the procedures that must be used in the operation of the process. The measurements and performance indicators are what will tell you if the process is meeting the criteria you established or not.
These could include raw materials, supplies, specifications, utilities, or any number of things. The intent of this is to prevent this from happening. Resources are planned and acquired in advance, and they meet all the requirements of the process. Simply put, someone is responsible for each process. This is the primary responsibility and authority for the process, but there may be other responsibilities stated on the tasks level. For example, there might be a responsibility and authority for procuring materials, a responsibility and authority for inspecting the final product, and responsibility and authority for communicating with the customer.
At a minimum, you must state who is in charge of the overall process. This subclause specifically addresses the requirements of clause 6. You really have to address clause 6. Listing everything would make for a very cluttered process model. How will you know that the process is effective? The evaluation is nothing more than comparing actual results to intended results and identifying that gap.
Here, you might define potential categories of improvement for the process in question. These could include cost reductions, efficiency improvements, fewer nonconformities, higher customer satisfaction, or any number of other measures. When determining opportunities for improvement, think about the specific process in question, and especially consider the risks and opportunities that were determined in clause 6.
These should guide you to the most meaningful improvements. The output of this little exercise is a comprehensive understanding of what is needed to operate your processes. To be fully sustainable, this understanding should be maintained as documented information. This gives you a great deal of discretion in how you document your process and in what records you might keep.
Likewise, records may not be necessary if the process outputs are insignificant. The point is to gain a practical understanding of the management, control, and improvement of your processes. A process approach should always be considered when writing or revising documentation. We can talk about processes all day long, but it might be more helpful to actually see one. No, you can choose whatever format works best for you.
At a high level, you do have to define all the variables shown in subclause 4. An easy and visual way to do this is through a fishbone diagram. Does subclause 4. You have to determine where documentation is necessary.
This section provides an introduction to the topic of leadership within the context of the quality management system QMS and beyond. The version of ISO included just four items that top management was required to demonstrate commitment to, but the version asks leadership to commit to 11 different items. What does that tell you about the topic of leadership? It gains in importance every time ISO is revised. The current list of commitments in ISO is impressive in that it really puts leadership front and center in the QMS.
This is a new and powerful requirement. It tells leadership that they are ultimately responsibility for the outcome of the QMS. All roads lead back to leadership.
The intent is that top management take an active role in the functioning of the QMS. Management review will be one of the key tools for making this happen.
Top management should be able to talk intimately about all these topics and explain how their leadership and commitment drove the processes forward. This sentence contains multiple requirements. First, top management ensures that there is a quality policy and quality objectives. Second, the policy and objectives must agree with the strategic direction of the organization.
That requires, of course, that there be a strategic direction, which is usually defined in a business plan, strategic plan, budget, or some other executive planning tool.
If the strategic plan includes big actions, then it would be appropriate for the quality policy and objectives to mirror those actions in some way, possibly by mentioning them or providing metrics that lead in the same direction. The policy and objectives also need to be congruent with the context of the organization that was determined in clause 4. If the environmental scanning required in clause 4. Top management should be comfortable explaining and illustrating this. Make sure that the QMS is used to help manage the business.
This is a new requirement in ISO The QMS processes are the way that we should holistically manage our organizations, and they must be fully incorporated into our business processes. For instance, the corrective action required by ISO is how we solve problems within the organization. Management review is how top management reviews data and information and makes decisions.
Internal auditing is how we ensure process discipline. Get the idea? Top management should be able to demonstrate how ISO processes are the true business processes within the organization, not puppet processes to impress an auditor. Advocate the process approach and how risk affects the business. This is a completely new requirement in ISO First, it requires that top management be advocates for the process approach. Recall clause 4. Risk-based thinking is the second part of the requirement.
Risks and opportunities are addressed in clause 6. The philosophy behind risk-based thinking is that we apply our resources in a proactive manner and as efficiently as possible. It follows these steps: 1. Scan the environment and objectively look inward at the organization. Determine which risks and opportunities are the most significant. Determine actions to proactively manage the risks and opportunities.
Continually evaluate the effectiveness of the actions to address risks and opportunities. Make sure that resources are available for the functioning of the QMS. Through existing processes like strategic planning and management review, the need for resources is identified and a plan is developed for their provision.
Top management should address how resources have been determined and provided, giving specific examples as they relate to the QMS.
This is a communication requirement that is directly fulfilled by top management. You should believe in it, too. Besides just talking the talk, actually demonstrating involvement in the QMS goes even further.
A QMS consumes considerable resources to implement and maintain, so there should be some payback. This payback is in the form of planned results, such as less waste, higher customer satisfaction, and higher profits. The most obvious way for top management to monitor intended results would be through tracking the progress of quality objectives.
Participating in management review and reviewing QMS data streams would be two other ways. Show leadership in getting employees involved in the QMS. This is another requirement that asks top management to get engaged in an area in which it might not have previously been involved. Top management must have direct oversight with the people involved with the ISO effort. The most obvious way to satisfy this requirement would be through vigorous participation during management review and in carefully analyzing all its inputs.
Encourage improvement activities. This is a completely new requirement. It actually includes a couple of different requirements. Top managers must be aware of the improvement efforts within the organization. Then they must communicate their support and promotion of the improvement efforts.
Participation on at least a periodic basis is well worth the time and effort. Assist other managers in showing QMS leadership. They are much more likely to support the QMS, though, if top management emphasizes that their support is needed and they must participate in a positive way. Achieving one of them is likely to actually achieve two or three. In the absence of records, ask a variety of personnel how the commitments were met and how top management demonstrated leadership. And, of course, ask top management how they demonstrated leadership and commitment over the QMS.
Their own words will reveal a lot. Top management of our organization is the vice president of operations, but she has designated that the plant manager act as top management for ISO purposes. Is this OK? Top management is whoever leads your organization at the highest levels within the defined QMS scope. Customer focus is the awareness of who the customers are, their strategic importance, and their needs and expectations.
When everybody in the organization shares a customer focus, they have unity of purpose and all work in the same direction. Customer focus was required in ISO , but it was just a single sentence of not much consequence. In ISO , the requirement has been expanded considerably. Top management must now show leadership in four points of customer focus.
They might not actually perform these tasks, but rather perform an oversight or communications role. All the requirements of this section can be met by effectively addressing other parts of the standard.
Top management will make sure that customer requirements and applicable statutory and regulatory requirements are determined and met. In small organizations, top management is personally involved in determining and meeting customer requirements.
However, in most organizations top management empowers others to determine and meet customer requirements. As long as top management has ensured that this happens, the spirit of the requirement has been met. Top management achieves this primarily through ensuring resources are provided for the following activities: Staffing positions that determine customer requirements Clearly defining responsibilities and authorities for customer service and sales Training personnel in customer communications Developing procedures for taking orders and product realization Ensuring the customer requirements are reviewed for accuracy and completeness The second part of this requirement concerns statutory and regulatory requirements.
These types of specialized requirements are most often determined by a technical or legal function, as they are beyond the grasp of most laymen. As long as top management makes sure that these requirements are met and that roles have been assigned for the tasks, then the requirement is met.
Top management will make sure that risks and opportunities affecting products, services, and customer satisfaction are determined and acted upon.
It stems from the risk-based nature of ISO , specifically the risks and opportunities related to products and customer satisfaction. The very survival of the organization requires that we address these in a meaningful and effective way. Top management can ensure this by reviewing the action plans that address risks and making sure that adequate resources are available for their implementation.
Actions to address risks and opportunities are a required input to management review, so if top management is participating and leading management review, this should happen automatically.
Top management will ensure that the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained. This can be accomplished by ensuring that effective inspection and verification processors are in place. Support of the internal audit process will also reinforce this focus.
Top management will make sure that the organization focuses on creating customer satisfaction. A focus on customer satisfaction is usually accomplished through communicating about customer perceptions. This means opening up direct communication lines with the customer and asking hard questions. What have we done well lately? What have we not done well? What could make you want to seek a different supplier? These questions and answers should be regular discussion points led by top management.
Nearly all the requirements of this section can be met through simple oversight and communication. These requirements also connect to stronger requirements in other parts of the standard.
As long as top management is involved in a two-way conversation on these topics—receiving and analyzing information, and then sharing information with other parts of the organization—they will have met the requirement. It seems like we would satisfy 5. This section of ISO is often met through achievement of other requirements. We would like to introduce the concept of internal customers to our employees. Can we do this as part of ISO ? Yes, of course. The policy is often structured as a series of bulleted commitments, though you could adapt whatever format is appropriate.
It could just as well be called a mission statement, vision, charter, statement of excellence, or any number of other names. Some organizations expand the use of the quality policy by covering such items as culture, values, ethics, and other attributes. As long as you address the minimum requirements, you can add whatever else you feel is appropriate. Here are some questions you can ask top management to establish the quality policy: As an organization, what do we really believe in?
What are we striving for? What role does the customer play in our success formula? What makes our products better than similar products? What words would you use to summarize our organizational culture? Take these themes, temper them with a healthy dose of realism, and you probably have some themes that can be included in your quality policy. The policy is the uppermost document in your QMS, and it influences other high- level documents. For example, if you have a strategy to design certain products, the quality policy might state that innovation is a key principle.
The quality policy provides a stepping stone to strategic direction and quality objectives. Do we need to actually say in our quality policy that it will be communicated, understood, applied, and available to interested parties? Not unless you want to. Those are requirements related to implementing the policy, not commitments that must be stated within the policy.
Does the quality policy have to be signed by top management? Top management should be able to talk about the policy and give examples of how its actions model commitments. The standard also says that the policy must be reviewed. This is typically done at least once a year during management review or some other high-level leadership forum.
Finally, the first sentence says that the quality policy must be maintained, and this is accomplished by communicating it to employees and using it as a guide for action. This means that the quality policy relates to the core purpose and activities of the organization. In fact, it may briefly describe what the organization does.
Keep in mind that most quality policies are fewer than words, so this description will be very brief. If there are special concerns such as safety for an organization that manufactures dynamite, or confidentiality for an organization that performs mental health services , then these concerns must also be addressed in the policy. The final few words of this section really emphasize the need for a highly customized and specific quality policy.
Gives direction for determining quality objectives. The quality policy, either directly or indirectly, must provide guidance for setting objectives. Objectives are subject to change on a regular basis, and the policy is more of a thematic document that will change less frequently.
Commits to meeting applicable requirements. This is interpreted to mean requirements that exist within the scope of ISO 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. Explain why these objectives matter and why achieving them will make a difference to the organization. Be very specific. Provide guides to action to get employees thinking. Be revised as often as needed. Nothing remains static in business. Objectives must change to reflect new realities.
Achieving objectives should become a companywide goal, but the objectives themselves must be adaptable. Document your quality objectives.
This means your objectives must be written down in a document. Like all documents, it will be approved and be controlled for revision. Some organizations elect to combine their quality objectives with other documents. I have even seen the quality objectives and quality policy combined on more than one occasion. Do it in whatever way makes sense, just make sure that your objectives are documented. Each objective must be matched to an improvement plan. Because every objective is different, it stands to reason that every plan will be different.
Your plans should answer each of the following questions: What actions will be taken on objectives? You must be specific. What processes will be changed? How are they going to be changed? What intermediate steps will be taken? Lay out the actions in a logical manner so they can be implemented.
What resources will be needed to carry out actions? Change requires resources. Who will take the actions? Clearly designate and communicate responsibilities and hold people accountable.
When will actions be finished? Plans for establishing objectives take time to implement. Your time frames must be documented, especially when multiple steps are linked. How will you determine the effectiveness of the actions? The most logical place to evaluate results is within management review. You already have top management, data inputs, and momentum for analysis. ISO does not specifically say that plans for achieving objectives are maintained within documented information. How else could you communicate and implement your plans, though?
Document your plans for achieving objectives and make sure the information is shared widely. Yes, I would interpret the documentation requirement as applying to the quality objectives and to the plans for achieving them. Document both. Everyone in our organization has his or her own personal objectives. Does this satisfy ISO requirements? The intent of this requirement is to determine organizational objectives, not personal objectives.
Make sure that you have established objectives on a broader scale organizational, functional, or departmental. Can we include our quality objectives in our quality policy?
You can if you want, but it makes more sense to maintain them as separate documents. The objectives are likely to change much more often than the policy. Can we use profit as a quality objective? Yes, you can use profit as a quality objective.
Quality is a very broad topic and can encompass nearly anything the organization does. Profit certainly reflects on the quality of your processes and products. Change will happen to you and your organization. The question is this: Are you going to manage the change or allow yourself to be overwhelmed by it?
The only path to survival is to get ahead of the curve and address change systematically: Define the change, study the effects, and identify the interactions. There was a subclause that flirted with change management in ISO 5. Change management is a fully realized concept in ISO This clause specifically addresses planned changes.
Examples of these sorts of events could include: Purchase of new equipment Hiring of additional employees Adoption of new methods or tools Significant change in raw materials or supplies Application of new regulatory rules Although any change you make should be planned and deliberate, ISO focuses on significant changes.
Minor tweaks to your operation will happen all the time. This is really a judgment call on the part of your leadership team to decide what changes must go through a change management process. Just be able to rationally explain why certain changes did or did not go through change management.
These two pieces of information are usually well understood. What is not as well understood is the third element required by ISO the potential consequences or ramifications of the change. Consequences can be positive or negative. Consider how the QMS will be maintained during change. Despite all the work that people put into implementing the QMS, the system gets forgotten regularly. ISO tells you not to forget your system when making changes. What parts of the system will be affected by the change?
Do we need to write a procedure that describes the change or revise an existing procedure? Do we need to establish any new recordkeeping as a result of the change?
Do our employees need training to understand the change? Should we revisit our goals and objectives as a result of the change?
Do we need to institute maintenance as a result of the change, or revise existing maintenance schedules? Will the change require new inspection processes?
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