ISO 9001:2015 Clause No.
Requirements of ISO 9001:2015
Guidance
CLAUSE 4 • The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall This new concept monitor and review information about these relates to the factors external and internal issues. and • NOTE 1 Issues can include positive and negative conditions affecting factors or conditions for consideration. organizational • NOTE 2 Understanding the external context can operation be facilitated by considering issues arising from E.g. regulation, legal, technological, competitive, market, cultural, governance and social and economic environments, whether stakeholders international, national, regional or local. • NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the 4.1 organization Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements
Consider who the interested parties might be and what their relevant interests might be, e.g. customers, shareholders, board members, competitors, regulators.
4.2
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Auditing Questions
How has the organization determined external and internal issues? How do you monitor and review information about this? Are these relevant to purpose and strategic direction?
How have you determined what interested parties are relevant to the QMS? How have you determined what requirements those parties have that are relevant to the QMS? How has impact or potential impact been determined? Is the organization reviewing and monitoring information about these interested parties and their relevant requirements?
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4.3
The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization. The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
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How have the boundaries and applicability of the QMS been used to establish the scope of the organization? How have: The external and internal issues; the requirements of relevant interested parties and; the products and services of the organization been considered when determining the scope of the organization? Where is the scope available? Where is it maintained as Elements which do not documented information? apply can and should Does it state what products and be services are covered by the justifiedunderClause4.3 QMS? of 9001:2015. Does it justify how instances of requirements of the QMS cannot be applied? Can the organization claim conformity to the ISO 9001:2015 International Standard by Ensuring that requirements determined as not applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products, services and enhancement of customer satisfaction?
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4.4
4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system. 4.4.2 To the extent necessary, the organization shall: a) maintain documented information to support the operation of its processes; b) retain documented information to have confidence that the processes are being carried out as planned.
An elevated focus on processes. Adoption of the process approach is now mandatory and will be audited accordingly
How has the QMS been established? Show me how this is implemented and how is it maintained and continually improved? How have the processes been determined and how do they interact? How have the processes been determined for the QMS? What are the inputs and outputs for those processes? What is the sequence and interaction of the processes? What are the criteria, methods, measurement and related performance indicators needed to operate and control those processes? What resources are needed and how are these made available? How are responsibilities and authorities assigned for those processes? How are risks and opportunities considered and what plans are made to implement actions to address them? What methods are used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve intended results? How are opportunities to improve the processes and the QMS determined?
CLAUSE 5
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Top management shall demonstrate leadership and commitment with respect to the quality management system by: a) taking accountability for the effectiveness of the quality management system; b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization; c) ensuring the integration of the quality management system requirements into the organization’s business processes; d) promoting the use of the process approach and risk-based thinking; e) ensuring that the resources needed for the quality management system are available; f) communicating the importance of effective quality management and of conforming to the quality management system requirements; g) ensuring that the quality management system achieves its intended results; h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; i) promoting improvement; j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit
Enhances 5.1, Management commitment, from the 2008 Standard. The 2015 repositions some requirements to “leadership”, not management. The emphasis has shifted from ensuring to “engaging”.
5.1.1
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• Show me how top management demonstrates leadership & commitment with respect to the QMS by taking accountability of the effectiveness of the QMS? • How is the quality policy & objectives established for the QMS and how they are compatible with the strategic direction & the organizational context? • How is the quality policy communicated within the organization? • How this is understood and applied? • How can the requirements of the QMS integrated into the business processes? • How do you promote awareness of the process approach and how do you ensure that resources needed for the QMS area available? • How do you communicate the importance of effective quality management and conforming to the QMS requirements? • How do you ensure that the QMS achieves its intended results? • How to engage, direct and support people to contribute to the effectiveness of the QMS? • How do you promote continual improvement and support other relevant management roles to demonstrate leadership in their areas of responsibility?
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Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met; b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; c) the focus on enhancing customer satisfaction is maintained
Enhances 5.1, Management commitment, from the 2008 Standard. The 2015 repositions some requirements to “leadership”, not management. The emphasis has shifted from ensuring to “engaging”.
Top management shall establish, implement and maintain a quality policy that: a) is appropriate to the purpose and context of the organization and supports its strategic direction; b) provides a framework for setting quality objectives; c) includes a commitment to satisfy applicable requirements; d) includes a commitment to continual improvement of the quality management system.
Enhanced requirements from the 2008 version: more attention to be paid to the application of the policy across the organization. There is a need for “documented information”, as opposed to a documented statement.
5.1.2
5.2.1
5.2.2
The quality policy shall: a) be available and be maintained as documented information; b) be communicated, understood and applied within the organization; c) be available to relevant interested parties, as appropriate.
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• How top management demonstrates leadership and commitment with respect to customer focus, ensuring statutory and regulatory requirements are determined and met? • How can risks & opportunities that can affect conformity of products & services determined? • How can the ability to enhance customer satisfaction determined and addressed? • How to maintain the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements? • How can customer satisfaction be maintained? • How top management establishes, reviews and maintains a quality policy? • How it is determined to be appropriate for the purpose and context of the organization? • If it provides a framework for setting and reviewing quality objectives? • If it contains any commitment to satisfy applicable requirements and for continual improvement of the QMS? • Whether the quality policy is available as documented information? • How can it be communicated? • How can it be understood and applied within the organization and how is it available to relevant interested parties?
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Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. Top management shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the requirements of this International Standard; b) ensuring that the processes are delivering their intended outputs; c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management; d) ensuring the promotion of customer focus throughout the organization; e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
The role of the Management Representative has disappeared; however the requirements of the 2008 clause 5.5.2 still need to be met. There is a new requirement that someone is tasked with preserving the integrity of the QMS while it is in the process of change.
5.3
• How will top management ensure that the responsibilities and authorities for relevant roles are communicated, understood and assigned within the organization? • How does top management assign the responsibility and authority for a)Ensuring that the QMS conforms with the requirements of the ISO9001:2015 International standard b) Ensuring that processes are delivering their intended outputs? • How will the performance of the QMS, opportunities for improvement and the needs for change or innovation will be reported to top management? • How will the customer focus be promoted within the organization? • How will the integrity of the QMS maintained when changes are planned and implemented?
CLAUSE 6
When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) enhance desirable effects; c) prevent, or reduce, undesired effects; d) achieve improvement
Organizations must determine its context, and the arising risks and opportunities. Actions to address risk must be proportional to the potential impact.
6.1.1
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• How are the internal & external issues plus the interested parties considered while planning for the QMS? • How can the risks and opportunities be determined and addressed so that the QMS can a) achieve its intended results; b) Prevent or reduce undesired effects; c) Achieve continual improvement? • Has the organization taken into consideration the issues referred in 4.1 and the requirements referred to in 4.2?
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The organization shall plan: a) actions to address these risks and opportunities; b) how to: 1) integrates and implements the actions into its quality management system processes (see 4.4); 2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
6.1.2
The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system. The quality objectives shall: a) be consistent with the quality policy; b) be measurable; c) take into account applicable requirements; d) be relevant to conformity of products and services and to enhancement of customer satisfaction; e) be monitored; f) be communicated; g) be updated as appropriate. The organization shall maintain documented information on the quality objectives
Extension of 2008 clauses, 5.4.1 and 5.4.2. Stronger emphasis on the importance of objectives, which should be set for processes. The organization must retain documented information on quality objectives.
6.2.1 When planning how to achieve its quality objectives, the organization shall determine: a) what will be done; b) what resources will be required; c) who will be responsible; d) when it will be completed; e) how the results will be evaluated. 6.2.2
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• Whether the organization has planned actions to address risks and opportunities? • How are they integrated and implemented into the QMS processes? • How to evaluate their effectiveness? • Whether the actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services? • Whether the organization has quality objectives, relevant functions, levels and processes? • Are these consistent with the quality policy? • Whether they are measureable and consider applicable requirements? • Whether they are relevant to the products and services and enhance customer satisfaction? • Are they being monitored? How? How often? • How will they be communicated? • How can they be updated? • Whether the documented information on the quality objectives is appropriate and maintained? • While planning how to achieve quality objectives, whether the organization has determined: a) What is to be done? b) What resources will be used? c) Who will be responsible? d) When it will be completed? e) How will the results be evaluated?
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6.3
When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4). The organization shall consider: a) the purpose of the changes and their potential consequences; b) the integrity of the quality management system; c) the availability of resources; d) the allocation or reallocation of responsibilities and authorities.
An extension of the existing requirement: organizations must identify the purpose and likely consequences of change, and the necessary resources and responsibilities.
CLAUSE 7 The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual Need to evidence improvement of the quality management system. external as well as The organization shall consider: internal resource a) the capabilities of, and constraints on, existing requirements. internal resources; b) what needs to be obtained from external 7.1.1 providers. The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
No significant change
7.1.2
7.1.3
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE Infrastructure can include: a) buildings and associated utilities; b) equipment, including hardware and software; c) transportation resources; d) information and communication technology.
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Enhanced reference to examples: hardware, software, transportation
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• Whether the changes to the QMS are planned systematically? • How to demonstrate the purpose and potential consequences of these changes and the integrity of the QMS? • How resources will be made available? • How responsibility and accountability is allocated or reallocated? • How resources are determined for the establishment, implementation, maintenance and continual improvement of the QMS? • How will the capabilities and constraints on internal resources and needs from external providers are to be considered? • How has the organization determined and provided the persons necessary for the effective implementation of its QMS and for the operation and control of its processes? • How has the organization determined, provided and maintained the infrastructure necessary for the operation of its processes and for achieving conformity of products and services?
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The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE A suitable environment can be a combination of human and physical factors, such as: a) social (e.g. non-discriminatory, calm, nonconfrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ substantially depending on 7.1.4 the products and services provided.
The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a) are suitable for the specific type of monitoring and measurement activities being undertaken; b) are maintained to ensure their continuing fitness for their purpose. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
More prescriptive than before with a requirement to determine, provide and maintain a suitable environment. There is a note in the new clause that examples of “environment for the operation of processes” include social, psychological and environmental
• How has the organization determined, provided, and maintained the environment necessary for the operation of its processes and to achieve conformity of products and services?
Measuring “equipment” becomes measuring “resource”, acknowledging that professional judgment and human senses may also be a measuring resource, e.g. tea tasting.
• How has the organization determined and provided the resources needed to ensure valid and reliable results while monitoring and measuring is used to verify the conformity of products and services to requirements? • Whether the organization has ensured that the resources provided: a) Are suitable for the specific type of monitoring and measurement activities being undertaken? b) Are maintained to ensure their continuing fitness for their purpose? • Whether the organization retained documented information as evidence of fitness for purpose of the monitoring and measurement resources or not?
7.1.5.1
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When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; b) identified in order to determine their status; c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
7.1.5.2
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• Whether the organization has ensured that if measurement traceability is a requirement for providing confidence in the validity of measurement results, that measuring equipment is: a) Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards & when no such standards exist, the basis used for calibration or verification is retained as documented information? b) Identified in order to determine their status or not? c) Safeguarded from adjustments, damage or deterioration that would invalidate the subsequent measurement results? • How has the organization determined if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, &takes appropriate action?
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The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. NOTE 1 Organizational knowledge is knowledge specific to the organization; it is gained by experience. It is information that is used and shared to achieve the organization’s objectives. NOTE 2 Organizational knowledge can be based on: a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services); b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers 7.1.6 or external providers). The organization shall: a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system; b) ensure that these persons are competent on the basis of appropriate education, training, or experience; c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; d) retain appropriate documented information as evidence of competence. NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; 7.2 or the hiring or contracting of competent persons.
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Examples of such knowledge could be intellectual e.g. designer software and external sources of knowledge e.g. academia or conferences
• How has the organization determined necessary knowledge for the operation of processes? • How to determine necessary knowledge required for achieving conformity of products and services? • How will you maintain this knowledge and make it available to the extent necessary? • How to consider current knowledge and how to acquire additional knowledge when addressing changing needs and trends?
The requirement has been extended to include people performing work under the organization’s control, i.e. outsourced resource such as agencies.
• How do you determine the necessary competence of people doing work under your control that affects quality performance? • How to determine competence on the basis of appropriate education, training and experience? • How to take actions for acquiring necessary competence where applicable and to evaluate the effectiveness of those actions? • Whether the appropriate documented information as evidence of competence is retained or not?
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The organization shall ensure that persons doing work under the organization’s control are aware of: a) the quality policy; b) relevant quality objectives; c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance; d) the implications of not conforming with the quality management system requirements 7.3
7.4
7.5.1
7.5.2
The organization shall determine the internal and external communications relevant to the quality management system, including: a) on what it will communicate; b) when to communicate; c) with whom to communicate; d) how to communicate; e) who communicates. The organization’s quality management system shall include: a) documented information required by this International Standard; b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: — the size of organization and its type of activities, processes, products and services; — the complexity of processes and their interactions; — the competence of persons.
This is more expansive and now applies to all persons doing work under the organization’s control. People must be aware of policy, objectives, how they contribute and the implications of not conforming to the QMS. This is now much more prescriptive and includes external communications. Organizations must now determine what, when, with whom and how communications should take place.
• How are people in the organization aware of the quality policy and relevant quality objectives? • What is their contribution to the effectiveness of the QMS? • What will be the benefits of improved performance? • What will be the implications of not conforming to the QMS requirements? • How has the organization determined internal and external communications relevant to the QMS? • How to determine: What to communicate? When to communicate? With Whom to communicate? How to communicate?
The Documented information must be controlled but there is no longer a requirement to have a documented procedure for this process. Requirements now extend to access and usage, recognizing that electronic information can be accessed as read-only, without authority to change.
• Does the organization have the documented information as required by this standard? • Whether the documented information determined by the organization is necessary for the effectiveness of the quality management system?
When creating and updating documented information, the organization shall ensure appropriate: a) identification and description (e.g. a title, date, author, or reference number); b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); c) review and approval for suitability and adequacy
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• Whether the documented information contains identification, description and the appropriate format? • How the documented information is reviewed and approved for suitability and adequacy?
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Documented information required by the quality management system and by this International Standard shall be controlled to ensure: a) it is available and suitable for use, where and when it is needed; b) it is adequately protected (e.g. from loss of 7.5.3.1 confidentiality, improper use, or loss of integrity). For the control of documented information, the organization shall address the following activities, as applicable: a) distribution, access, retrieval and use; b) storage and preservation, including preservation of legibility; c) control of changes (e.g. version control); d) retention and disposition. Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled. Documented information retained a evidence of conformity shall 7.5.3.2 be protected from unintended alterations. CLAUSE 8 The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6 by: a) determining the requirements for the products and services; b) establishing criteria for 1) the processes; This is a reworking and 2) the acceptance of products and services; reorganizing the 2008 c) determining the resources needed to achieve Clause 7.1 conformity to the product and service requirements. The requirements; requirement to plan d) implementing control of the processes in and develop processes accordance with the criteria; is not new, but has e) determining and keeping documented been extended to information to the extent necessary: include 1) to have confidence that the processes have implementation and been carried out as planned; control. 2) to demonstrate the conformity of products and services to their requirements. NOTE “Keeping” implies both the maintaining and the retaining of documented information. The output of this planning shall be suitable for the organization’s operations. The organization shall 8.1 control planned changes and review the
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• How will the documented information be controlled? • How to make it available and suitable for use? • How to protect it?
• When controlling documented information, how to address distribution, access, retrieval, use, storage and preservation, legibility, control of changes, its retention and disposition. • How to identify appropriate and controlled documented information of external origin which is necessary for the QMS.
• How processes will meet the requirements for provision of products and services planned, implemented and controlled? • How can the requirements for products and services be determined? • What is criteria for processes and acceptance for products and services? • How can the resources be determined? • How is control process implemented? • Determine the documented information that shows that the processes have been carried out as planned and conforms products and services to the requirements. • How can it be determined that the output from the planning process is suitable for your operations? • How to control planned
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consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization shall ensure that outsourced processes are controlled
Communication with customers shall include: a) providing information relating to products and services; b) handling enquiries, contracts or orders, including changes; c) obtaining customer feedback relating to products and services, including customer complaints; d) handling or controlling customer property; e) establishing specific requirements for contingency actions, when relevant.
8.2.1
changes? • How to review the consequences of unintended changes? • Action to be taken to mitigate any adverse effects? • How to control outsourced processes? A subtle change in the supplier customer relationship: the organization has already determined the products and services it intends to offer, reflecting a more common business environment for certification customers. Requirements should include those from interested parties and also include statutory and regulatory requirements relating to the product.
When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: a) the requirements for the products and services are defined, including: 1) any applicable statutory and regulatory requirements; 2) those considered necessary by the organization; b) the organization can meet the claims for the products and services it offers. 8.2.2
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• What is the process for communicating with customers? • How to communicate information relating to products; services; enquiries; contracts; order handling; customer views, perceptions and complaints; handling or treatment of customer property; specific requirements for contingency actions?
• What is the process for determining the requirements for products and services to be offered to potential customers? • How to establish, implement and maintain this process? • How to define product and service requirements including statutory and regulatory requirements? • How to ensure that we have the ability to meet the defined requirements and substantiate any claims for our products and services?
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The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include: a) requirements specified by the customer, including the requirements for delivery and postdelivery activities; b) requirements not stated by the customer, but necessary for the specified or intended use, when known; c) requirements specified by the organization; d) statutory and regulatory requirements applicable to the products and services; e) contract or order requirements differing from those previously expressed. T he organization shall ensure that contract or order requirements differing from those previously defined are resolved. The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.
• How has the organization determined that it has the ability to meet the requirements for products and services offered to customers? • If the organization has conducted a review before committing to supply products and services to a customer that includes: a) Requirements specified by the customer, inclusive of requirements for delivery and post delivery activities? b) Requirements not stated, but are necessary for the specified or intended use, when known? c) Requirements specified by the organization? d) Statutory and regulatory requirements applicable to the products and services? e) Contract or order requirements different from those previously expressed? • Whether the organization ensured that contract or order requirements differing from those previously defined are resolved or not? • How has the organization ensured that customer requirements are confirmed by the organization before acceptance, if the customer does not provide a documented statement of their requirements?
The organization shall retain documented information, as applicable: a) on the results of the review; b) on any new requirements for the products and services.
• Whether the organization has retained documented information as applicable: a) On the review’s results? b) On any new requirement for the products and services?
8.2.3.1
8.2.3.2 The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products 8.2.4 and services are changed.
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• How has the organization ensured that relevant documented information is amended, and that relevant persons are made aware of it.
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The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. 8.3.1 In determining the stages and controls for design and development, the organization shall consider: a) the nature, duration and complexity of the design and development activities; b) the required process stages, including applicable design and development reviews; c) the required design and development verification and validation activities; d) the responsibilities and authorities involved in the design and development process; e) the internal and external resource needs for the design and development of products and services; f) the need to control interfaces between persons involved in the design and development process; g) the need for involvement of customers and users in the design and development process; h) the requirements for subsequent provision of products and services; i) the level of control expected for the design and development process by customers and other relevant interested parties; j) the documented information needed to demonstrate that design and development 8.3.2 requirements have been met.
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This new clause mandates the introduction of a design and development process where this activity is required
• How to establish, implement and maintain a design and development process to ensure subsequent provision of products and services.
Builds on existing 2008 clauses 7.3.1- 7.3.6. Design and development needs to be approached as a process.
• While determining the stages and control for design and development, how to consider the nature, duration and complexity of the activities; requirements that specify particular process stages including applicable reviews; required verification and validation; responsibilities and authorities? • How are interfaces controlled between individuals and parties? • What is the need for involvement of customer and user groups? • Has the documented information that confirms design and development requirements have been met, are maintained.
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The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: a) functional and performance requirements; b) information derived from previous similar design and development activities; c) statutory and regulatory requirements; d) standards or codes of practice that the organization has committed to implement; e) potential consequences of failure due to the nature of the products and services. Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs shall be resolved. The organization shall retain documented information on design and development inputs.
Builds on existing 2008 clauses 7.3.1- 7.3.6. Design and development needs to be approached as a process.
The organization shall apply controls to the design and development process to ensure that: a) the results to be achieved are defined; b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements; c) verification activities are conducted to ensure that the design and development outputs meet the input requirements; d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use; e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities; f) documented information of these activities is retained
Builds on existing 2008 clauses 7.3.1- 7.3.6. Design and development needs to be approached as a process.
8.3.3
8.3.4
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• How do you determine requirements essential for the type of products and services being designed and developed, including: Functional & performance requirements; Statutory and regulatory requirements; Information from previous similar development and designed activities; Standards or codes of practice which the organization is a committed to implement; Potential consequences of failure; • Whether the inputs are adequate for design and development purposes, complete and unambiguous? • Whether the organization has resolved conflicting design and development inputs? • If the documented information on design and development inputs has been retained? • How will the controls that are applied to the design and development process ensure that the results achieved by design and development activities are clearly defined? • Whether the design and development reviews are conducted as planned? • If the outputs meet the input requirements by verifying that the resulting products and services are capable of meeting the requirements for the specified application or intended use? • Whether any necessary action has been taken on problems determined during the reviews, or verification and validation activities? • Whether the documented
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The organization shall ensure that design and development outputs: a) meet the input requirements; b) are adequate for the subsequent processes for the provision of products and services; c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria; d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision. The organization shall retain documented information on design and development outputs.
Builds on existing 2008 clauses 7.3.1- 7.3.6. Design and development needs to be approached as a process.
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The organization shall retain documented information on: a) design and development changes; b) the results of reviews; c) the authorization of the changes; d) the actions taken to prevent adverse impacts.
Builds on existing 2008 clauses 7.3.1- 7.3.6. Design and development needs to be approached as a process.
8.3.5
8.3.6
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information of the activities is retained? • How to ensure whether the design and development outputs meet the input requirements for design and development or not? • If they are adequate for the subsequent processes for the provision of products and services? • Whether they include or refer monitoring and measuring requirements, and acceptance criteria, as applicable? • How do they ensure that the products to be produced, or services to be provided, are fit for intended purpose and are safe and proper for use? • Whether the documented information which results from the design and development process is maintained? • How to review, control and identify changes made in the design inputs and outputs during design and development of products and services, ensuring there is no impact on conformity to requirements? • How does the organization retain documented information on: a) The design and development changes? b) The results of reviews? c) The authorization of the changes? d) The actions taken to prevent adverse impacts?
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The organization shall ensure that externally provided processes, products and services conform to requirements. The organization shall determine the controls to be applied to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization’s own products and services; b) products and services are provided directly to the customer(s) by external providers on behalf of the organization; c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization. The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and reevaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations
Enhanced emphasis on external providers and the extent of employment of contractors in current commercial practice. Extent of controls needs to take account of the potential impact on the organization’s ability to consistently meet requirements. Risk assessment will be applicable here
8.4.1
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• How to ensure that externally provided processes, products and services conform to specified requirements? • How to apply specified requirements for the control of externally provided products and services when: Products and services are provided by external providers for incorporation in your products and services; Products and services are provided directly to customers by external providers on your behalf; A process or part-process is provided by an external provider as a result of the decision to outsource a process or function. • How to establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers. • How to assess their ability to provide processes or products and services in accordance with requirements specified? • If the documented information of the results of evaluations, monitoring of performance and reevaluations of external providers is maintained?
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The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers. The organization shall: a) ensure that externally provided processes remain within the control of its quality management system; b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output; c) take into consideration: 1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements; 2) the effectiveness of the controls applied by the external provider; d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.
8.4.2 The organization shall ensure the adequacy of requirements prior to their communication to the external provider. The organization shall communicate to external providers its requirements for: a) the processes, products and services to be provided; b) the approval of: 1) products and services; 2) methods, processes and equipment; 3) the release of products and services; c) competence, including any required qualification of persons; d) the external providers’ interactions with the organization; e) control and monitoring of the external providers’ 8.4.3 performance to be applied by the organization;
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• How to determine whether the controls applied to the external provision of processes, products and services, take into consideration: a) The potential impact of the externally provided processes, products and services on the ability to continuously meet customer and applicable statutory and regulatory requirements? b) The perceived effectiveness of the controls applied by the external provider? • What verification or other activities have to be done to ensure externally provided processes, products and services do not adversely affect your ability to deliver conforming products and services to your customers? • How does the organization: a) Ensure that externally provided processes remain within the control of its QMS? b) Ensure if it has defined both the controls it intends to apply to an external provider and those it intends to apply to the resulting output? • How to communicate to external providers, the applicable requirements for products and services to be provided or the processes to be performed on behalf of the organization? • How to communicate approval or release of products and services, methods, processes or equipment; competence of personnel, including necessary qualification; their interactions with the organization's QMS? • How to control and monitor the external provider’s performance; verification activities that the organization, or its customer,
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f) verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.
The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable: a) the availability of documented information that defines: 1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed; 2) the results to be achieved; b) the availability and use of suitable monitoring and measuring resources; c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; d) the use of suitable infrastructure and environment for the operation of processes; e) the appointment of competent persons, including any required qualification; f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement; g) the implementation of actions to prevent human error; h) the implementation of release, delivery and post-delivery activities.
No significant changes.
8.5.1
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intends to perform at the external provider’s premises? • How to ensure the adequacy of specified requirements? • What are the controlled conditions for production and service provision, including delivery and post-delivery activities? • What are the controlled conditions for: a) Documented information defining the characteristics of the products and services? b) Documented information defining the activities to be performed and the results to be achieved? c) Monitoring and measuring activities at appropriate stages to ensure that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met? d) Use and control of suitable infrastructure and process environment? e) The availability and use of monitoring and measuring resources? f) The competence and required qualification of persons? g) Validation and periodic revalidation, of the ability to achieve planned results where the resulting output cannot be verified by subsequent monitoring or measurement? h) The implementation of products and services release, delivery and post-delivery activities?
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8.5.2
8.5.3
8.5.4
8.5.5
8.5.6
The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services. The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision. The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability The organization shall exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services. When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred. The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. The organization shall meet requirements for postdelivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, the organization shall consider: a) statutory and regulatory requirements; b) the potential undesired consequences associated with its products and services; c) the nature, use and intended lifetime of its products and services; d) customer requirements; e) customer feedback The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. The organization shall retain documented information describing the results of the review of
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• How to identify process outputs for ensuring conformity of products and services? • How to identify the status of process outputs? • How has the organization controlled the unique identification of process outputs, where applicable? • What documented information is to be retained? • How has the organization cared for customer or external provider’s property while under its control? • How to identify, verify, protect and safeguard that property? • How to report to the customer or external provider if their property is incorrectly used, lost, damaged or found to be unsuitable for use?
• How preservation of process outputs during production and service provision to maintain conformity to product requirements is maintained?
• How to fulfill requirements for post delivery activities related with products and services? • How to determine risk; nature, use and intended lifetime; customer feedback; statutory and regulatory requirements, while determining the extent of post delivery activities? • How are unplanned changes reviewed and controlled to ensure continuous conformity with specified requirements? • Has the organization retained documented information
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changes, the person(s) authorizing the change, and any necessary actions arising from the review.
The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. The organization shall retain documented information on the release of products and services. The documented information shall include: a) evidence of conformity with the acceptance criteria; b) traceability to the person(s) authorizing the release.
No substantive change needed. Note refreshed terminology referring to services in addition to product.
The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery. The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services. The organization shall deal with nonconforming outputs in one or more of the following ways: a) correction; b) segregation, containment, return or suspension of provision of products and services; c) informing the customer; d) obtaining authorization for acceptance under concession. Conformity to the requirements shall be verified when nonconforming outputs are corrected.
Some minor changes; There is no longer a requirement for a documented procedure, but there is a requirement to maintain documented information on actions taken, including concessions and authorizations.
8.6
8.7.1
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showing the results of reviews of changes, the personnel authorizing change and any necessary actions? • How has the planned arrangement been implemented at appropriate stages to verify product and service requirements have been met? • What evidence has been retained? • How is the release of products and services held until planned arrangements for verification of conformity have been satisfactorily completed, unless approved by a relevant authority, or the customer if applicable? • Whether the documented information which shows traceability to the person authorizing release of products and services is maintained? • How has the organization ensured that outputs that do not conform to their requirements are identified and controlled? • Whether the organization has taken appropriate action on outputs based on the nature of the nonconformity and its effect on the conformity of products and services? • How has the organization applied action on nonconforming products and services, detected after the delivery of products and during or after the provision of services? • Whether the organization has used one or more of the following ways to deal with nonconforming outputs a) Correction? b) Segregation, containment, return or suspension or provision of products and services? c) Information to the customer? d) Authorization for acceptance
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under concession? • Whether the organization has retained documented information describing: a) The nonconformity? b) The actions taken? c) Any concessions obtained? d) Identification of the authority deciding the action in respect of the nonconformity?
The organization shall retain documented information that: a) describes the nonconformity; b) describes the actions taken; c) describes any concessions obtained; d) identifies the authority deciding the action in respect of the nonconformity. 8.7.2 CLAUSE 9
The organization shall determine: a) what needs to be monitored and measured; b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; c) when the monitoring and measuring shall be performed; d) when the results from monitoring and measurement shall be analyzed and evaluated. The organization shall evaluate the performance and the effectiveness of the quality management system. The organization shall retain appropriate documented information as evidence of the results.
An enhanced emphasis on evaluation of results, in addition to measurement and analysis. Monitoring should be based on risk. Customer perception now includes soliciting perceptions about the organization and its products and services. Preventive action and statistical techniques are no longer referenced.
9.1.1 The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information. NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer 9.1.2 reports.
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• How to determine: What needs to be monitored and measured? What are the methods for monitoring, measuring, analyzing and evaluating? When monitoring and measuring are to be performed? When are the results to be analyzed and evaluated? • Is there a documented information showing that monitoring and measurement activities have been implemented in accordance with determined requirements? • How to evaluate the quality performance and the effectiveness of the QMS? • How to monitor customer perception of the degree to which requirements have been met? • How can the information be obtained relating to customer views and opinions of your products and services? • What are the methods for obtaining and using this information?
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The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement. The results of analysis shall be used to evaluate: a) Conformity of products and services; b) The degree of customer satisfaction; c) The performance and effectiveness of the quality management system; d) If planning has been implemented effectively; e) The effectiveness of actions taken to address risks and opportunities; f) The performance of external providers; g) The need for improvements to the quality management system.
9.1.3 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system: a) conforms to: 1) the organization’s own requirements for its quality management system; 2) the requirements of this International Standard; b) is effectively implemented and maintained.
There is no longer a need for a documented procedure. Internal audit programme shall take into consideration changes to the organizations.
9.2.1
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• How does the organization analyze and evaluate data and information arising from monitoring, measurement and other sources? • How the output of analysis and evaluation is used to: Demonstrate conformity of products and services to requirements? Assess and enhance customer satisfaction? Ensure conformity and effectiveness of the QMS? Demonstrate that planning has been successfully implemented? Assess the process performance? Assess the performance of external providers? Determine the need or opportunities for improvements in the QMS? • Where are the results of analysis and evaluation used to provide inputs to management review? • Whether the internal audits are being conducted at planned intervals? • Whether they determine if the QMS conforms to the requirements of ISO 9001:2015 standard and to the other requirements established by Organization or not? • How do they determine if the QMS is effectively implemented and maintained or not?
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The organization shall: a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits; b) Define the audit criteria and scope for each audit; c) Select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; d) Ensure that the results of the audits are reported to relevant management; e) Take appropriate correction and corrective actions without undue delay; f) Retain documented information as evidence of the implementation of the audit program and the audit results. 9.2.2
Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.
Overall purpose remains the same; however inputs should now include strategic items relating to context, risk and opportunities. Trends and indicators should be used to monitor quality performance.
9.3.1
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• Whether the audit programme(s) take into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization and the results of previous audits? • What is the audit criteria and scope for each audit? • Is selection of auditors and the conduct of audits are objective and impartial? • Do they audit their own work? • How are results reported to management? • Whether all necessary corrections and corrective actions are taken without any delay? • Whether the documented information of the audit program and the audit results is maintained? • With what frequency the top management reviews the organization's QMS? • How can the QMS be deemed suitable, adequate and effective? • What types of information are reviewed in management reviews? • Do these include actions; status of previous reviews; changes to internal and external issues; relevant to the QMS; issues that affect strategy; KPIs for nonconformities and corrective actions; monitoring and measurement of results; audit results; customer satisfaction; issues concerning external providers; issues concerning other relevant parties; adequacy of resources and effectiveness of QMS; process performance; conformity of products and services; actions taken to address risks and opportunities and their
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effectiveness; new potential opportunities for continual improvement.
The management review shall be planned and carried out taking into consideration: a) the status of actions from previous management reviews; b) changes in external and internal issues that are relevant to the quality management system; c) information on the performance and effectiveness of the quality management system, including trends in: 1) customer satisfaction and feedback from relevant interested parties; 2) the extent to which quality objectives have been met; 3) process performance and conformity of products and services; 4) nonconformities and corrective actions; 5) monitoring and measurement results; 6) audit results; 7) the performance of external providers; d) the adequacy of resources; e) the effectiveness of actions taken to address risks and opportunities for improvement.
9.3.2
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• Do the management reviews include decisions and actions relating to: Continuous improvement opportunities? The need for changes in the QMS, including resource needs? • What documented information does the organization has as evidence of management reviews? • Whether the organization has planned and carried out taking into consideration: a) The status of actions from previous reviews? b) Change in external and internal issues that are relevant to the QMS? c) Information on the effectiveness and performance of the QMS which includes trends in: 1. Customer satisfaction and feedback from interested parties? 2. Extent to which quality objectives have been met? 3. Process performance and conformity of products and services? 4. Nonconformities and corrective actions? 5. Monitoring and measuring results? 6. Results of Audit? 7. Performance of external providers? d) The adequacy of resources? e) Effectiveness of actions taken to address risks and opportunities? f) Opportunities for improvement?
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• Whether the organization has ensured that the outputs of the management review includes decisions and actions related to: a) Opportunities for improvement? b) Need for changes to the QMS? c) Resource needs? • Whether the organization is retaining documented information as evidence of the results of the management reviews?
Opportunities for improvement; b) Any need for changes to the quality management system; c) Resource needs. The organization shall retain documented information as evidence of the results of management reviews.
9.3.3 CLAUSE 10 The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These shall include: a) Improving products and services to meet requirements as well as to address future needs and expectations; b) Correcting, preventing or reducing undesired effects; c) Improving the performance and effectiveness of the quality management system
The requirement for a documented preventive action procedure has gone.
10.1
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• How to determine and select opportunities for improvement? • What necessary actions have been implemented to meet customer requirements and enhanced customer satisfaction? • How to: Improve processes to prevent nonconformities? Improve products and services to meet known and predicted requirements? Correct, prevent or reduce undesired effects? Improve QMS results?
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When nonconformity occurs, including any arising from complaints, the organization shall: a) React to the nonconformity and, as applicable: 1) Take action to control and correct it; 2) deal with the consequences; b) Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: 1) Reviewing and analyzing the nonconformity; 2) Determining the causes of the nonconformity; 3) Determining if similar nonconformities exist, or could potentially occur; c) Implement any action needed; d) Review the effectiveness of any corrective action taken; e) Update risks and opportunities determined during planning, if necessary; f) Make changes to the quality management system, if necessary. Corrective actions shall be appropriate to the effects of the nonconformities encountered. 10.2.1
When corrective action has been completed, the organization can move on to consider whether any further action is required to prevent a similar nonconformity occurring in future. This requires the organization to determine what caused the nonconformities and then to consider whether the potential for a similar problem remains. The organization is then required to implement any actions identified as needed, review their effectiveness and make changes to the quality management system if necessary.
The organization shall retain documented information as evidence of: a) The nature of the nonconformities and any subsequent actions taken; b) The results of any corrective action. 10.2.2
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system. The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.
10.3
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Organizations will now need to demonstrate that they are using the outputs from their analysis and evaluation processes to identify areas of underperformance and opportunities for improvement. Appropriate tools and methodologies should be employed by the organization to support this activity.
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• In case of non conformities, how do you; React? Take action to control and correct it? Deal with the consequences? • Does the organization evaluate the need for action to eliminate the cause so that it does not reoccur or occur elsewhere by: Reviewing the nonconformity? Determining the cause of the nonconformity? Determining if similar nonconformities exist or could potentially occur? Actions needed are implemented? Review the effectiveness of corrective actions taken, if any? Make necessary changes to the QMS? • How corrective actions are appropriate to the effects of the nonconformities encountered? • What documented information is there as evidence of: The nature of the nonconformities and subsequent actions taken? The results of any corrective action? • How do you continually improve the suitability, adequacy and effectiveness of the QMS? • How are outputs of analysis and evaluation, and the outputs from management reviews are considered to confirm, if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement? • Which applicable tools and methodologies for investigation of causes of underperformance and for supporting continual improvement are used?
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Mail: trg@eurotechworld.net