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ISO 9001 REQUIREMENTS CLAUSE 5.1.2 CUSTOMER FOCUS The ISO 9001 Requirements Clause 5.1.2 Customer focus is about understanding and taking care of customer’s specified needs and expectations by providing products and services that effectively address them. Organizations gain competitive advantage by increasing the value to customers in one or more activities, relative to what
competitors offer.
ISO 9001 REQUIREMENTS CLAUSE 9.1.2 CUSTOMER SATISFACTION ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction. Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization. ISO 9001 REQUIREMENTS-WHAT ARE OUTSOURCED PROCESSES? ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the managerial control of your facility and ISO 9001 REQUIREMENTS CLAUSE 5.3 ORGANIZATIONAL ROLES ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities. Role: is the defined or expected behavior associated with a particular position, function or status in an organization. Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. Authority : The ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS-CLAUSE 4.2 UNDERSTANDING INTERESTED ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs. Let’s start with paraphrasing what the standard (not just this clause) says and requires regarding RIP’s: 1. An RIP may affect your ability to consistently provide conforming products and servicesto customers. 2.
ISO 9001 REQUIREMENTS CLAUSE 7.1 RESOURCES ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources. Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. ISO 9001 REQUIREMENTS CLAUSE 5.1.2 CUSTOMER FOCUS The ISO 9001 Requirements Clause 5.1.2 Customer focus is about understanding and taking care of customer’s specified needs and expectations by providing products and services that effectively address them. Organizations gain competitive advantage by increasing the value to customers in one or more activities, relative to whatcompetitors offer.
ISO 9001 REQUIREMENTS CLAUSE 9.1.2 CUSTOMER SATISFACTION ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction. Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization. ISO 9001 REQUIREMENTS-WHAT ARE OUTSOURCED PROCESSES? ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the managerial control of your facility and ISO 9001 REQUIREMENTS CLAUSE 5.3 ORGANIZATIONAL ROLES ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities. Role: is the defined or expected behavior associated with a particular position, function or status in an organization. Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. Authority : The ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS-CLAUSE 4.2 UNDERSTANDING INTERESTED ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs. Let’s start with paraphrasing what the standard (not just this clause) says and requires regarding RIP’s: 1. An RIP may affect your ability to consistently provide conforming products and servicesto customers. 2.
ISO 9001 REQUIREMENTS CLAUSE 7.1 RESOURCES ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources. Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 8.2.2 DETERMINING ISO 9001 Requirements Clause 8.2.2 Determining requirements related to products and services. Organizations typically offer a range of products and services through their marketing materials, websites, etc. All such products and services must be clearly defined in terms of their various dimensional, functional and other performanceISO 9001 CONSULTING
Use the credentials from point 3 above, to evaluate the selected consultants. Make sure you check references and perhaps arrange for the consultant to visit your organization and meet with you and key personnel. This would be a good way to size up the consultant againstthe criteria. 5.
ISO 9001 REQUIREMENTS When you have answered all 728 questions you will know more than most QMS Consultants about this ISO 9001 Standard. Statement. True/. False. 1. Improvement in systems and processes so. that continual improvement of quality can be achieved is not a major purpose of ISO 9001. quality management systems. 2. ISO 9001 REQUIREMENTS CLAUSE 6.3 PLANNING FOR CHANGES Purpose of ISO 9001 Requirements Clause 6.3 Planning for changes. One of the goals of the ISO 9001:2015 is to enhance the requirements for addressing changes at system and operational levels. The ISO 9001:2015 requirements provide a strong basis for a management system for business that supports the strategic direction of the organization. ISO 9001 REQUIREMENTS CLAUSE 7.1.2 PEOPLE. The next sub-clause 7.1.2 under resources requires the organization to determine and provide the people (capacity – see definition under 7.2.1) necessary for the effective implementation of its QMS and for the operation and control of its processes. As indicated in the previous clause 7.1.1, human resources constitute a key component ofthe
ISO 9001 REQUIREMENTS CLAUSE 7.3 AWARENESS ISO 9001 Requirements Clause 7.3 Awareness. You would think that awareness requirements under this clause were well covered from our discussion of previous requirements namely: · In clause 5.1.1f we talked about the role of top management in communicating the importance of effective QMS and conforming to QMS requirements. ISO 9001 REQUIREMENTS ISO 9001 Requirements ISO 9001 Requirements – Clause 4.3 Determining the scope of your QMS. In clause 1 we discussed the scope of the ISO 9001 standard and the flexibility it provided in selecting those requirements that applied to your business and ISO 9001 REQUIREMENTS CLAUSE 6.1 ACTIONS TO ADDRESS RISKS ISO 9001 Requirements ISO 9001 Requirements Clause 6.1 Actions to address risks and opportunities. An organization’s external and internal environment is subject to constant change and change is characterized by uncertainty which in turn pose risks. ISO 9001 REQUIREMENTS CLAUSE 9.1.2 CUSTOMER SATISFACTION ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction. Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization. ISO 9001 REQUIREMENTS CLAUSE 5.1.2 CUSTOMER FOCUS The ISO 9001 Requirements Clause 5.1.2 Customer focus is about understanding and taking care of customer’s specified needs and expectations by providing products and services that effectively address them. Organizations gain competitive advantage by increasing the value to customers in one or more activities, relative to whatcompetitors offer.
ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS-WHAT ARE OUTSOURCED PROCESSES? ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the managerial control of your facility and ISO 9001 REQUIREMENTS CLAUSE 7.1 RESOURCES ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources. Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; ISO 9001 REQUIREMENTS-CLAUSE 4.2 UNDERSTANDING INTERESTED ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs. Let’s start with paraphrasing what the standard (not just this clause) says and requires regarding RIP’s: 1. An RIP may affect your ability to consistently provide conforming products and servicesto customers. 2.
ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. ISO 9001 REQUIREMENTS ISO 9001 Requirements ISO 9001 Requirements – Clause 4.3 Determining the scope of your QMS. In clause 1 we discussed the scope of the ISO 9001 standard and the flexibility it provided in selecting those requirements that applied to your business and ISO 9001 REQUIREMENTS CLAUSE 9.1.2 CUSTOMER SATISFACTION ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction. Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization. ISO 9001 REQUIREMENTS CLAUSE 5.1.2 CUSTOMER FOCUS The ISO 9001 Requirements Clause 5.1.2 Customer focus is about understanding and taking care of customer’s specified needs and expectations by providing products and services that effectively address them. Organizations gain competitive advantage by increasing the value to customers in one or more activities, relative to whatcompetitors offer.
ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS-WHAT ARE OUTSOURCED PROCESSES? ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the managerial control of your facility and ISO 9001 REQUIREMENTS CLAUSE 7.1 RESOURCES ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources. Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; ISO 9001 REQUIREMENTS-CLAUSE 4.2 UNDERSTANDING INTERESTED ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs. Let’s start with paraphrasing what the standard (not just this clause) says and requires regarding RIP’s: 1. An RIP may affect your ability to consistently provide conforming products and servicesto customers. 2.
ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. ISO 9001 REQUIREMENTS ISO 9001 Requirements ISO 9001 Requirements – Clause 4.3 Determining the scope of your QMS. In clause 1 we discussed the scope of the ISO 9001 standard and the flexibility it provided in selecting those requirements that applied to your business and UNDERSTANDING ISO 9001:2015 ECOURSE Online Help – Call (905-593-8867) or email me at artjlewis@gmail.com if you have questions on any of the course materials, test quizzes or need advice on QMS implementation issues. I want this eCourse to truly work for you in fulfilling your QMS and career objectives. “Understanding ISO 9001:2015 eCourse” is available for US$ 199.00.ISO 9001 CONSULTING
Use the credentials from point 3 above, to evaluate the selected consultants. Make sure you check references and perhaps arrange for the consultant to visit your organization and meet with you and key personnel. This would be a good way to size up the consultant againstthe criteria. 5.
ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 8.2.2 DETERMINING ISO 9001 Requirements Clause 8.2.2 Determining requirements related to products and services. Organizations typically offer a range of products and services through their marketing materials, websites, etc. All such products and services must be clearly defined in terms of their various dimensional, functional and other performance ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. ISO 9001 REQUIREMENTS CLAUSE 6.3 PLANNING FOR CHANGES Purpose of ISO 9001 Requirements Clause 6.3 Planning for changes. One of the goals of the ISO 9001:2015 is to enhance the requirements for addressing changes at system and operational levels. The ISO 9001:2015 requirements provide a strong basis for a management system for business that supports the strategic direction of the organization. ISO 9001 REQUIREMENTS CLAUSE 5.3 ORGANIZATIONAL ROLES ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities. Role: is the defined or expected behavior associated with a particular position, function or status in an organization. Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. Authority : The ISO 9001 REQUIREMENTS CLAUSE 5.2 QUALITY POLICY ISO 9001 Requirements Clause 5.2 Quality policy. Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, including establishing the quality policy and objectives. The quality policy is the organization’s expression of its strategic direction and commitmentto
ISO 9001 REQUIREMENTS CLAUSE 6.1 ACTIONS TO ADDRESS RISKS ISO 9001 Requirements ISO 9001 Requirements Clause 6.1 Actions to address risks and opportunities. An organization’s external and internal environment is subject to constant change and change is characterized by uncertainty which in turn pose risks. SAMPLE - ISO 9001:2015 QMS PROCESS MATRIX. SAMPLE - ISO 9001:2015 QMS Process Matrix. This QMS Process Matrix is an example of one of many ways to apply the process approach to implement your QMS processes. I have enjoyed great success with it for many of my clients It provides a simple but effective bird’s eye view of your QMS documentation & controls. ISO 9001 REQUIREMENTS CLAUSE 5.1.2 CUSTOMER FOCUSISO 9001 CLAUSE 8 1ISO 9001 CLAUSE 8 EXAMPLES The ISO 9001 Requirements Clause 5.1.2 Customer focus is about understanding and taking care of customer’s specified needs and expectations by providing products and services that effectively address them. Organizations gain competitive advantage by increasing the value to customers in one or more activities, relative to whatcompetitors offer.
ISO 9001 REQUIREMENTS CLAUSE 9.1.2 CUSTOMER SATISFACTION ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction. Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION5 8 2 5FRACTION ANSWER
ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization.ISO 9001 CONSULTING
Use the credentials from point 3 above, to evaluate the selected consultants. Make sure you check references and perhaps arrange for the consultant to visit your organization and meet with you and key personnel. This would be a good way to size up the consultant againstthe criteria. 5.
ISO 9001 REQUIREMENTS-WHAT ARE OUTSOURCED PROCESSES? ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the managerial control of your facility and ISO 9001 REQUIREMENTS CLAUSE 5.3 ORGANIZATIONAL ROLES ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities. Role: is the defined or expected behavior associated with a particular position, function or status in an organization. Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. Authority : The ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS CLAUSE 7.1 RESOURCES ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources. Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. CLAUSE 7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSESISO 9001 REQUIREMENTSISO 9001 PDFISO 9001 QUALITY MANAGEMENT ISO 9001 Requirements – Clause 7.1.4 Environment for the operation of processes. The term environment in this context refers to the work environment and is used to describe the set of conditions in which employees perform their work and under which products and services are produced. Conditions can include physical, social, psychological and ISO 9001 REQUIREMENTS CLAUSE 5.1.2 CUSTOMER FOCUSISO 9001 CLAUSE 8 1ISO 9001 CLAUSE 8 EXAMPLES The ISO 9001 Requirements Clause 5.1.2 Customer focus is about understanding and taking care of customer’s specified needs and expectations by providing products and services that effectively address them. Organizations gain competitive advantage by increasing the value to customers in one or more activities, relative to whatcompetitors offer.
ISO 9001 REQUIREMENTS CLAUSE 9.1.2 CUSTOMER SATISFACTION ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction. Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION5 8 2 5FRACTION ANSWER
ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization.ISO 9001 CONSULTING
Use the credentials from point 3 above, to evaluate the selected consultants. Make sure you check references and perhaps arrange for the consultant to visit your organization and meet with you and key personnel. This would be a good way to size up the consultant againstthe criteria. 5.
ISO 9001 REQUIREMENTS-WHAT ARE OUTSOURCED PROCESSES? ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the managerial control of your facility and ISO 9001 REQUIREMENTS CLAUSE 5.3 ORGANIZATIONAL ROLES ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities. Role: is the defined or expected behavior associated with a particular position, function or status in an organization. Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. Authority : The ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS CLAUSE 7.1 RESOURCES ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources. Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. CLAUSE 7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSESISO 9001 REQUIREMENTSISO 9001 PDFISO 9001 QUALITY MANAGEMENT ISO 9001 Requirements – Clause 7.1.4 Environment for the operation of processes. The term environment in this context refers to the work environment and is used to describe the set of conditions in which employees perform their work and under which products and services are produced. Conditions can include physical, social, psychological and ISO 9001 REQUIREMENTS CLAUSE 8.2.1 CUSTOMER COMMUNICATION ISO 9001 Requirements Clause 8.2.1 Customer communication. · Clause 7.4 communications which deals with general requirements for external and internal communications; and. · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization. ISO 9001 REQUIREMENTS-WHAT IS THE PROCESS APPROACH? The purpose of the process approach is to enhance an organization’s effectiveness and efficiency in achieving its defined objectives. Process effectiveness and efficiency can be assessed through internal or external review processes. All processes must also meet (customer, organizational and applicable regulatory) requirements. ISO 9001 REQUIREMENTS CLAUSE 7.2 COMPETENCE ISO 9001 Requirements Clause 7.2 Competence. You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. ISO 9001 REQUIREMENTS CLAUSE 7.1.6 ORGANIZATIONAL KNOWLEDGE ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. ISO 9001 REQUIREMENTS CLAUSE 5.2 QUALITY POLICY ISO 9001 Requirements Clause 5.2 Quality policy. Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, including establishing the quality policy and objectives. The quality policy is the organization’s expression of its strategic direction and commitmentto
ISO 9001 REQUIREMENTS CLAUSE 4.1 UNDERSTANDING THE ISO 9001 Requirements v2015 Clause 4.1 Understanding the organizational context In clause 0.1 Introduction and 1.0 Scope we talked about how this ISO standard provides a generic set of control requirements for all organizations and how these generic requirements must be tailored to fit the nature of each business and their productsand services.
ISO 9001 REQUIREMENTS V2015 CLAUSE 0.1 ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard. The major purpose of the ISO 9001 requirements for an organization is to identify and meet the needs and expectations of its customers and other stakeholders and to gain competitive advantage.One of the strategies it might use to achieve these goals is to employ universally recognized business tools to improve the effectiveness ISO 9001 REQUIREMENTS CLAUSE 7.1.5 MEASURING AND ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.. Measurement process – is a set of operations to determine the value of a quantity. ISO 9001 REQUIREMENTS CLAUSE 6.1 ACTIONS TO ADDRESS RISKS ISO 9001 Requirements ISO 9001 Requirements Clause 6.1 Actions to address risks and opportunities. An organization’s external and internal environment is subject to constant change and change is characterized by uncertainty which in turn pose risks. ISO 9001 REQUIREMENTS-CLAUSE 4.2 UNDERSTANDING INTERESTED ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs. Let’s start with paraphrasing what the standard (not just this clause) says and requires regarding RIP’s: 1. An RIP may affect your ability to consistently provide conforming products and servicesto customers. 2.
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ISO 9001:2015 REQUIREMENTS TRAINING LEARN HOW TO BECOME AN EXPERT IN THIS ISO 9001 QMS STANDARD Do you face one or more of the following problems? * You struggle to understand the ISO 9001 requirements because they are vague and ambiguous. * You’re looking for a clear explanation of exactly what each requirement means and how to correctly apply it. * Your organization has difficulty transitioning the QMS from the 2008 version to the 2015 version because it is not clear on what has changed and how to apply the new requirements. * You are implementing ISO 9001 for the first time and would like to set up an effective QMS and get certified without any problems. * You want to become a QMS consultant and would like a good reference manual and mentor to help you become an expert in quality management and the ISO 9001 standard. * As an QMS auditor you have difficulty figuring out how to audit the new requirements such as organizational context, risk based thinking and requirements of interested parties. * As a member of top management, you are interested in using the ISO 9001 standard as a strategic management tool and need guidance. IF YOU RUN INTO THESE PROBLEMS, YOU HAVE THE FOLLOWING OPTIONS TOOVERCOME THEM:
* TAKE A CONVENTIONAL CLASSROOM TRAINING COURSE. These courses can take one to three days and cost $1,200 – $2,000 (with travel and other expenses). The problem with such courses is that you get too much information to absorb in too short a time. You are likely to forget 90% or more of the information when you get back to work and get caught up in your daily routine. * BROWSE THE INTERNET. Spend endless hours scouring the internet for expert information explaining the requirements of this Standard. Yes, you may find some tidbits here and there, but the trouble is no expert worth their salt will want to provide their “bread and butter”knowledge for free.
* ENGAGE A QMS EXPERT. I have recently retired and have written a comprehensive course titled “Understanding ISO 9001:2015”. This course has over 330 pages explaining every requirement in fine detail with lots of implementation examples. I share over 45 years of business experience including 25 years in the quality management field. You can check out my ‘bio’ in more detail on the About Uspage.
INTRODUCING ……… ISO 9001:2015 eCourse THIS “ISO 9001:2015 ECOURSE” WILL HELP: * BEGINNERS – to understand and apply ISO 9001 requirements. * QMS MANAGERS– to develop a more effective QMS for yourorganization.
* QMS AUDITORS – to conduct more effective QMS audits. * TOP MANAGEMENT – to understand and use ISO 9001:2015 as a strategic business tool. * CONSULTANTS – gain the expertise to provide value-added serviceto your clients.
* ORGANIZATIONS – looking to smoothly transition from ISO 9001:2008 to ISO 9001:2015. This eCourse will significantly fast-track your learning curve. The in-depth explanation of the requirements, plenty of implementation examples and vast scope of the test questions will help you easily and quickly achieve the objectives listed above. BENEFITS FROM USING THIS ISO 9001:2015 ECOURSE: * Learn at your own pace; * Over 600 test questions and another 700+ true/false questions to master and retain the knowledge; * Shows you how to apply the knowledge as you learn; * Learn to consult, train or audit to this standard faster than other learning methods. * Online consulting – The best benefit of all! You can call or email me for help with any questions on the course materials or with QMS implementation. Compare this to paying a consultant over $100 anhour
* Gain hands-on expertise better and cheaper than any other courseor training method.
HERE’S WHAT YOU GET WITH THE “ISO 9001:2015 ECOURSE”: * A 336 page PDF DOCUMENT explaining every requirement of the ISO 9001:2015 standard in detail with plenty of examples on implementing an effective QMS. See the side bar menu for extracts of the eCourse. * A comprehensive Business & QMS RISK & OPPORTUNITIES EVALUATION CHECKLIST that will help you tremendously in implementing & getting your QMS certified to ISO 9001:2015. * QMS PROCESS MATRIX – Use this simple yet powerful way to document your QMS using the process approach to pass your transition, initial certification or surveillance audit with flying colors. * AN ISO 9001:2015 QUALITY MANUAL in MS word that you can customize for your organization. Although not mandatory, it is still a very useful document to have. * 600+ TEST QUESTIONS to deepen and consolidate your knowledge. Check out these SAMPLE TEST QUESTIONS. * 728 TRUE/FALSE QUESTIONS. Do all 728 questions as instructed and you will know more about ISO 9001:2015 than most QMS consultants. Test yourself on these SAMPLE TRUE/FALSE QUESTIONS.
* Send me your completed 728 True/False quiz and I will issue you a “CERTIFICATE OF ACHIEVEMENT FOR SUCCESSFUL COMPLETION OF THE UNDERSTANDING ISO 9001:2015 ECOURSE“. See SAMPLE CERTIFICATE * ONLINE HELP – Call (905-593-8867) or email me at artjlewis@gmail.com if you have questions on any of the course materials, test quizzes or need advice on QMS implementation issues. I want this eCourse to truly work for you in fulfilling your QMS andcareer objectives.
“UNDERSTANDING ISO 9001:2015 ECOURSE” IS AVAILABLE FOR US$ 199.00 If you don’t have a PayPal account, you can still purchase through PayPal using your credit or debit card, with full security and no service charge. Click the Buy Now button above; this will take you to the PayPal page; then click Continue at the bottom of the PayPal page and follow the instructions to make your purchase through PayPal using your credit card. Call or email me if you have any downloading issues.Z35W7Z4V9Z8W
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* ISO 9001 Requirements ISO 9001 Requirements Explained * ISO 9001:2015 Requirements FAQ – Everything you want to know about the new ISO 9001:2015 QMS standard * ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard * ISO 9001 Requirements v2015 QMS – Clause 1.0 Scope * ISO 9001 Requirements QMS v2015 Clause 2&3 Normative references,terms & definitions
* ISO 9001 Requirements clause 4.1- Context of the organization * ISO 9001 Requirements-Clause 4.2 Understanding interested partiesneeds
* ISO 9001 Requirements Clause 4.3 Determining the scope of your QMS * ISO 9001 Requirements Clause 4.4 QMS and its processes * ISO 9001 Requirements Clause 5.1 Leadership and commitment * ISO 9001 Requirements Clause 5.1.2 Customer focus * ISO 9001 Requirements Clause 5.2 Quality policy * ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities * ISO 9001 Requirements Clause 6.1 Actions to address risks andopportunities
* ISO 9001 Requirements Clause 6.2 Quality Objectives * ISO 9001 Requirements Clause 6.3 Planning for changes * ISO 9001 Requirements Clause 7.1 Resources * ISO 9001 Requirements Clause 7.1.2 People * ISO 9001 Requirements Clause 7.1.3 Infrastructure * ISO 9001 Requirements – Clause 7.1.4 Environment for the operation of processes * ISO 9001 Requirements Clause 7.1.5 Measuring and monitoringresources
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