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ISO 9001:2015 Clause 8: Operation

31 March, 2015Liibaan Cali Afrax &Mohamed Hashi Mohamed##: 1Operation includes planning & control, determine market needs, interaction with customers, planning process, control of external provisions of products/services, production of product, provision of services, release of products/services, control of non-conforming products/servicesISO 9001:2008 ISO 9001:2015 Clause 7: Product realizationClause 8: Operation

ISO 9001:2015 clause 8 #: Emphasize that the information presented today is based on current work of WG24 and should not be used to make any changes to an organizations quality management system since it could change.28.1 operational planning and controlThe organization shall plan, implement and control those processes that it has previously identified in clause 4.4 to meet product or service requirements.Planning process Establishing products and service requirementsOrganization must consider its processes For each process must establish Criterial How it control the process The acceptance criteria output for each process Recourse necessary to support each process Create and keep documented information It must additionally plan how to address any risks and opportunities

ISO 9001:2008 ISO 9001:2015 7.1 Planning of product realization 8.1 Operational Planning and control ISO 9001:2015 clause 8 #: 8.2 Determination of requirements for products and servicesISO 9001:2008 ISO 9001:2015 7.2 Customer-related processes

7.2.3 Customer communication 8.2 Determination of requirements for products and services8.2.1 Customer communication8.2.1 Customer communicationThe organization is requires to ensure that it has processes in place for effective customer communications channels, to allow dialogue regarding:

product and service information,enquiries, contracts, order handling, changes, andreceiving customer views and perceptions, including complaints.Handling or treatment of customer property if applicable Specific requirement for contingency action when relevant

ISO 9001:2015 clause 8 #: 8.2.2 Determination of requirements related to the products and servicesThe Standard requires the organization to stablish implement and maintain process to ensure product and service requirements have been defined. These requirements can come from the customer, may be mandated by laws or regulations, and include generally accepted standards within industry or market. The organization must then ensure that it has the ability to meet the defined requirements.ISO 9001:2008 ISO 9001:2015 7.2.1 Determination of requirements related to the products 8.2.2 Determination of requirements related to the products and servicesISO 9001:2015 clause 8 #: 8.2.3 Review of requirements related to the products and servicesThe organization is required to review requirements relating to its products and services. This review needs to consider:That requirements set by the customer including once relating to delivery and post-delivery.The requirements not stated by the customer but that are known to be necessary for the product or service to be suitable for the customers intended use,The review also must consider any statutory or regulatory requirement, and any new or changed requirements.Documented information describing the results of the review shall be retained.ISO 9001:2008 ISO 9001:2015 7.2.2 Review of requirements related to the products 8.2.3 Review of requirements related to the products and servicesISO 9001:2015 clause 8 #: 8.3 Design and Development of products and services8.3.1 GeneralBefore the organization establish a detailed requirements for the products and services the organization must implement and maintain a design and development process. ISO 9001:2008 ISO 9001:2015 7.3 Design and Development8.3 Design and Development of products and servicesISO 9001:2015 clause 8 #: 8.3.2 Design and Development planning To effectively plan the design and development process, the organization must:Clearly define the stages involved in the design and development process.Identify the design and development verification and validation that is required for each stage.Describe clear responsibility and authority for the people doing this work.See that design information flows effectively among the various groups having a role in designing, selling, managing, manufacturing, and servicing the products.Keep design and development plans up to date.ISO 9001:2008 ISO 9001:2015 7.3.1 Design and Development planning8.3.2 Design and Development planning ISO 9001:2015 clause 8 #: 8.3.3 Design and Development inputsThe organization is required to determine product and service input requirements, including:what it does and how well it must perform,legal and regulatory requirements,internal and external resources needs,Potential consequences of design and development failure,The customers and other interested parties expected level of control of the design and development process

ISO 9001:2008 ISO 9001:2015 7.3.2 Design and Development inputs8.3.3 Design and Development inputsISO 9001:2015 clause 8 #: 8.3.4 Design and Development controls The organization is required to apply controls to its design and development process in order to ensure that:The results from undertaking the design and development process are clearly defined;Design and development reviews take place in accordance with planned arrangements;The design and development outputs meet the design and development inputs (verification);The resulting products and services are fit for their intended use or specified application where this is known to the organization (validation).

ISO 9001:2008 ISO 9001:2015 7.3.4, 7.3.5, 7.3.6 Design and Development review, verification and validation 8.3.4 Design and Development controlsISO 9001:2015 clause 8 #: 8.3.5 Design and Development outputThe output of design and development must include sufficient information to verify that design output meets design input requirements.

Design outputs must include or reference any related monitoring or measuring requirements and acceptance criteria.

ISO 9001:2008 ISO 9001:2015 7.3.3 Design and Development outputs 8.3.5 Design and Development outputsISO 9001:2015 clause 8 #: 8.3.6 Design and Development changes If change are made to either design input or design output the organization must Identify, review and control to ensure that conformity to requirements is maintained.Documented information is required.ISO 9001:2008 ISO 9001:2015 7.3.7 Control of Design and Development changes8.3.6 Design and Development changesISO 9001:2015 clause 8 #: 8.4 Control of externally provided products and services8.4.1 GeneralThe organization must ensure that externally provided processes, products or services meet the organizations specified requirements. When:products and services are provided by the external providers for incorporation into the organizations own products and services;products and services are provided directly to the customer by the external provider on behalf of the organization.The organization must establish criteria for how they evaluate and choose external providers. These criteria must be based on the external providers ability to provide products and services that meet product and service quality requirements. Finally,the organizationmust retain appropriate documented information of the result of the evaluations.ISO 9001:2008 ISO 9001:2015 7.4 Purchasing8.4 Control of externally provided products and servicesISO 9001:2015 clause 8 #: 8.4.2 Type and extent of control of external provision The organization is required to determine the type and extent of controls to apply to external providers

The extent of the controls depend on the importance of the externally provided processes, products and services.ISO 9001:2008 ISO 9001:2015 7.4.3 Verification of purchased product.8.4.2 Type and extent of control of external provisionISO 9001:2015 clause 8 #: 8.4.3 Information for external providersThe organization is required to communicate to external providers of processes, products and services. This information must include how products, services and processes are approved for external provision,required competencies for contracted personnel,Requirements for the external providers quality management system.ISO 9001:2008 ISO 9001:2015 7.4.2 Verification of purchased product.. 8.4.3 Information for external providers

ISO 9001:2015 clause 8 #: 8.5 Production and service provision8.5.1 Control of production and service provisionOrganizations are required to control the way in which they provide their products and services. These controlled conditions may include:Documented information regarding product and service specifications,written instructions for carrying out the work,suitable equipment,adequate tools for monitoring and measuring process and product characteristics,activities for monitoring and measuring process and product characteristics,criteria for product release,delivery and post-delivery servicing activities.

ISO 9001:2008 ISO 9001:2015 7.5 Production and service provision. 8.5 Production and service provision

ISO 9001:2015 clause 8 #: 8.5.2 Identification and traceabilityTo ensure conformity product and service, the organization must establish procedures to identify process output pertain throughout production and service provision.

Individual process outputs must have unique identification, and retain any documented information necessary to maintain traceability.

ISO 9001:2008 ISO 9001:2015 7.5.3 Identification and traceability. 8.5.2 Identification and traceabilityISO 9001:2015 clause 8 #: 8.5.3 Property belonging to customers or external providersSpecial care must be taken when a customer provides their property for use or incorporation into the product or service. Identify, verify, and protect customer property provided and maintainrecordsof lost, damaged or unsuitable customer property. ISO 9001:2008 ISO 9001:2015 7.5.4 Customer property . 8.5.3 Property belonging to customers or external providersISO 9001:2015 clause 8 #: 8.5.4 PreservationThe organization is required to take appropriate measures during production and service provision to safeguard process outputs, in order to maintain their conformity to requirements.

Preservation include identification, handling, storage, packaging, protection, and delivery of products or service provision throughout all processes.ISO 9001:2008 ISO 9001:2015 7.5.5 Preservation of product. 8.5.4 PreservationISO 9001:2015 clause 8 #: 8.5.5 Post-delivery activitiesThe organization shall determine the nature and extent of any post-delivery activities it needs to undertake.

When making this decision, the organization must consider the risks associated with the particular product or service, the nature of the product or service, how the product or service will be used and what the product or services intended lifetime is.ISO 9001:2008 ISO 9001:2015 -----------------------------. 8.5.5 Post-delivery activitiesISO 9001:2015 clause 8 #: 8.5.6 Control of changesThe organization is required to control any unplanned changes that are considered essential in order to ensure that products or services continue to meet their specified requirements.

The organization must retain documented information describing the results of the review of the changes, the person(s) authorizing the changes and any necessary actions.ISO 9001:2008 ISO 9001:2015 -----------------------------. 8.5.6 Control of changes ISO 9001:2015 clause 8 #: 8.6 Release of products and servicesThe organization must verify that products and services requirements have been met. Evidence that the product or service meets the acceptance criteria needs to be retained. The release of product and delivery of service to the customer shall not proceed until the planned tests and checks have been satisfactorily completed, unless otherwise approved by a relevant authority.Documented information that allows the individual authorizing any early releases to be identified must be retained.ISO 9001:2008 ISO 9001:2015 8.2.4 Monitoring and measurement of product. 8.6 Release of products and services ISO 9001:2015 clause 8 #: 8.7 Control of nonconforming process outputs, products and services The organization is required to identify any process outputs, products or services that do not conform to their intended requirements. Controls need to be established and implemented to ensure that these nonconforming process outputs, products or services are not delivered to the customer or used unintentionally.Where nonconforming process outputs, products or services are identified, the organization is required to take action to correct the fault. This corrective action must be proportionate, reflecting both the nature of the nonconformity and its ability to impact the organizations intended product or service. This requirement also applies to nonconforming products or services that are identified after delivery to the customer.ISO 9001:2008 ISO 9001:2015 8.3 Control of nonconforming product. 8.7 Control of nonconforming process outputs, products and services ISO 9001:2015 clause 8 #: The End!

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