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9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION - APB Consultant

ISO 9001:2015 CLAUSE 8 OPERATION

CLAUSE 8 OPERATION
The bulk of the management system requirements lies within this single clause. Clause 8 addresses
both in-house and outsourced processes, while the overall process management includes adequate
criteria to control these processes, as well as ways to manage planned and unintended
change.Whatever the organisation is in business to achieve, clause 8 is it. The overall process
management includes having process criteria, controlling the processes within the criteria, controlling
planned change and addressing unintended change as necessary. The organization shall plan,
implement and control the processes needed to meet their discipline-specific requirements. This also
relates to implementing the actions determined in 6.1 (actions to address risks and opportunities) and
6.2 (objectives and plans to achieve them). The organization is required to:

Establish criteria for the processes (possibly in work instructions)
Implement control of the processes, in accordance with the criteria (possibly through training and
awareness)
Keep documented information to the extent necessary to have confidence that the processes
have been carried out as planned (possibly within its QMS, or integrated MS)
Control planned changes and review the consequences of unintended changes, taking action to
mitigate any adverse effects (possibly through a management of change process)
Ensuring outsourced processes are controlled. This would include control and/or influence
(depending on its ability to do so — size of order, importance to external organization etc.).
Typical audit evidence would relate to: the type and extent of control/influence to be applied is
defined within its QMS, processes for assessing the importance/risk of the outsourced activity
and deriving suitable controls, and monitoring the effectiveness of the controls etc. This could involve
the purchasing, risk/compliance, and operations/production functions within the organization. The
context of the organization, and the relevant needs and expectations of interested parties, will clearly
have a bearing on the extent of control/Influence expected of its outsourced processes.

Clause 8, Operation, has seven sub-clauses:

8.1 Operational Planning and Control
8.2 Determination of Requirements for Products and Services
8.3 Design and Development of Products and Services
8.4 Control of Externally Provided Products and Services
8.5 Production and Service Provision
8.6 Release of Products and Services
8.7 Control of Nonconforming Process Outputs, Products, and Services

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9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION - APB Consultant

8.1 Operational Planning and Control
The Organization should plan, implement, and control the processes, as outlined in 4.4,
needed to meet requirements for the provision of products and services and to implement the
actions determined in 6.1 by determining product and services requirements; establishing
criteria for the processes and for the acceptance of products and services; determining the
resources needed to achieve conformity to product and service requirements; implement
control of the processes in accordance with the criteria; determining, maintaining and retain
documented information to the extent necessary to have confidence that the processes have
been carried out as planned and to demonstrate conformity of products and services to
requirements. The output of this planning should be suitable for the organization’s operations.
The organization should control planned changes and review consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary. The organization should
ensure outsourced processes are controlled in accordance with 8.4.

Clause 8.1 requires that operations be conducted through processes that are planned and controlled
regardless of whether the organization or an outside party performs the process. Requirements for
products and services are required to be determined and criteria established for
acceptance. Identification of resources needed to achieve conformity is required. Planned changes
are required to be controlled and action taken to mitigate the effects of unintended consequences of
changes. Documented information is required to be kept (retained) to demonstrate conformity
of product and service to requirements and that processes have been carried out as planned. The
individual planning step in the 2008 version focuses on determining how to verify conformity, the 2015
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record control.1 for documented information is to retain or maintain documented information as necessary to provide confidence that the processes have been carried out as required. implement and control the processes needed to meet the requirements for the provision of products and services. It also indicates a requirement to review consequences and mitigate adverse effects as necessary. This is a requirement in the automotive industry. On the other hand. human resources. production. measurement and monitoring of product and processes. Organizations should also consider maintaining documented information describing the operational processes and how they are to be carried out.1 makes the point that the organization “shall plan.com/iso-90012015-clause-8-operation/ 3/21 . even though ISO 9001:2015 may appear to some to have reduced the requirements for processes and controls. we believe clause 8.1 is on controls governing the making of product to meet customer requirements and all the QMS processes that. The only requirement in clause 8. The organization needs to incorporate any additions.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . and perhaps to an even greater level of comprehension. but ISO 9001:2015 requires that the organization understand the processes needed to deliver conforming products to customers. design and development. receiving. A lack of repetitious requirements in each clause does not mean processes and documented information are not required. purchasing and materials management. Note that the requirement for processes to accomplish all the operational activities is not repeated in each clause.4 and 6. shipping. business planning etc. document. It has become a best practice demonstrated in many organizations even though ISO 9001 does not explicitly require adherence to the design and development requirements for internal process designs. implement. whether performed onsite or off-site. some organizations may not have embraced the process approach to operational controls. as appropriate. but may sometimes include http://isoconsultantpune. deletions. Subtle “new” requirements related to control of changes and mitigating adverse effects should also be considered. make this happen. and thus may already be close to conforming. This enhances both the effectiveness and the efficiency of processes. Therefore. Identify key performance measures for both products and processes and align them with your quality and business objectives. The output of Operation planning may be implemented in many different ways. infrastructure provision and maintenance. It may be advisable to: Create a quality plan for a product or service to describe how the QMS will be modified and applied to all operations. etc.” It also reinforces the relationship between clauses 4. Many organizations long ago adopted the process approach to managing operations.APB Consultant version is oriented around the notion of managing and adequately resourcing a set of processes so that a state of control is achieved even when intended or unintended changes occur. or modifications that are perceived as necessary or desirable to conform with these more process—oriented requirements and possibly to improve process effectiveness. directly or indirectly. The clause also requires that the organization keep documented information to have confidence that these processes have been carried out as required. control. It does not necessarily have to be all in one document. Consider using the product design and development process approach for designing processes. The first sentence of clause 8. Operation processes may include customer related processes (sales and marketing). Less documentation may be required. requires an organization to define. and keep records at least at the same level as previously required.1. The requirement to plan. These processes must be understood not only with respect to the products themselves but also in the broader context of the objectives of the organization and any other requirements of the QMS (including interested parties and risks and opportunities).. Some of the support processes that come to bear on Operations include document control. coupled with clauses 4 and 6. They may review of the language in the new standard and tweaking processes and documented information. and control the processes needed to meet the requirements for the provision of products and services would be very difficult to achieve if documented information is not created and maintained for all processes of the QMS The focus of clause 8. laboratory services and control of monitoring and measuring devices. packaging. IT. Such a plan could include or reference procedures and records to be maintained and analyzed.

errors. The organization must also ensure that it has the ability to meet the defined requirements and substantiate the claims for the products and services it offers. orders. etc. product and process monitoring and measurement controls. scrap rates. functional. plans to control and correct any product or process nonconformities. dimensional . The expectation is to flow down to the off-site facility. etc. omissions and failures etc. product acceptance criteria and quality objectives. These documents may include contracts. while determining the requirements for the products and services to be offered to customers that the product and service requirements (including those considered necessary by the organization). specific resources needed to make. work instructions. Your quality plans should include the processes needed. 8. etc. PPM’s (defective parts per million). or order handling. the relevant ISO 9001 requirements that you would have to implement. had you carried out the process at your own facility. combined with unwritten practices. product quality plans. and details of records to be kept.2. handling or controlling customer property. processes and resources in determining the nature and extent of documented controls you need to have.2 Determination of Requirements for Products and Services 8. contract or project quality plans to accomplish this. Quality objectives may include defect rates. and establishing specific requirements for contingency actions. These must be readily available to those performing these processes.. tolerances and acceptance levels. verify and deliver product. you must also identify what specific documents are needed for effective planning.g. scrap rates. You may also consider using specific product. contracts. Objectives may be used to monitor and improve process productivity. including changes.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . are defined. procedures and methods. Look at the risks related to your product. specifications. improvement in on time delivery. Performance indicators to measure the effectiveness of product realization in meeting requirements and achieving quality objectives will be specific to each realization process and focus on reducing variation and waste in realization processes and related use of resources. The organization shall conduct a review before committing to supply products and services to a customer.3 Review of Requirements for Product and services 8. product returns from customers etc. obtaining customer feedback relating to product and services including customer complaints.2. the customer may specify objectives and requirements and criteria for the product realization processes as well. You must also consider indicators to measure product performance such as – reduction in defect rates. inquiries.APB Consultant several documents such drawings. waste and rework.1 Customer Communication The organization must establish the processes for communicating with customers to provide information relating to products and services. documents needed such as work instructions or engineering specifications. machine set-up. The review should include http://isoconsultantpune. inspection criteria. and their related measurements. and applicable legal requirements. reference to support processes. Focus on defect prevention in planning the controls for product realization.2. You must identify and document all processes addressing this clause as part of your QMS . For these processes. when relevant. Where any of the product realization processes are done off-site (e. your QMS must include the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements.com/iso-90012015-clause-8-operation/ 4/21 . 8. depending on the nature of the product. Requirements or criteria for the product may include physical properties. 8.2. In many instances. process sheets etc.3. process sequence and control parameters. a documented procedure etc. operation and control of production processes.1 The organization must ensure that it has the ability to meet the requirements for products and services to be offered to customers. reduction of cycle time.2 Determination of Requirements related to Products and Services The organization must ensure. at head-office).

Clause 8. 8. contract or order requirements differing from those previously expressed.2. when the requirements for products and services are changed. shouldn’t we concentrate some key planning effort on the processes used to communicate with them? It is generally necessary that a careful record be maintained of the requirements. consider the information in clause 7.3 of ISO 9001:2008. changes. This includes: http://isoconsultantpune.APB Consultant the requirements specified by the customer. The point of grouping these items under customer communications is to emphasize that these communications need to be systematically planned like all other processes. statutory and regulatory requirements applicable to the products and services.2 requires the organization to determine the requirements related to its products and services. including the requirements for delivery and post- delivery activities.1 requires processes to accomplish specific types of information exchange. the organization must confirm them before accepting them.4. and that relevant persons are made aware of the changed requirements. Clause 8. Any contingency actions that are relevant.3).5. including customer requirements Documented agreements with the customer. Often the process involves multiple discussions. The specific requirements of the 2008 version have been significantly simplified. reviews (clause 8. the review can cover relevant product information.4 on communication and the requirements related to process management in clause 4. Clause 8. and other information needed to meet customer requirements Customer feedback including complaints The handling and treatment of customer-owned items was covered in great detail in clause 7.and service-related information Handling customer orders of all types and changes thereto Getting customer feedback including complaints Exercising appropriate controls for any customer-owned property Establishing requirements for contingency actions Clause 8.2. and even early design and development work (clause 8. The organization must ensure that contract or order requirements differing from those previously defined are resolved. requirements specified by the organization.2).9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION .com/iso-90012015-clause-8-operation/ 5/21 .2.1 requires the organization to conduct communications with customers. It require five specific types of communication with customers to be included in the organization’s processes: Product and service information. Carefully thought-out methods are needed to efficiently retain this input information for later use in the design process and as input to resolution of disputes that may arise.4 Changes to requirements for products and services The organization should ensure that relevant documented information is amended.2.2.1 is similar to clause 7.2. requirements not stated by the customer. In doing so. In some situations. If the customer is the organization’s most import contact. such as contracts. when a formal review is impractical for each order. when known. orders.2.4 in ISO 9001:2008. When the customer does not provide a documented statement of their requirements. such as catalogues.3.2 The organization should retain documented information on the results of the review and on any new requirements for the products and services. but necessary for the specified or intended use. The detail requirements for communications with customers include: Providing product. such as internet sales. 8.2.

Full determination of customer requirements can be an iterative process. Often the organization has learned key things that must be done a certain way for the product or service to meet customer requirements. However. It is also the organization’s responsibility to determine whether it can successfully deliver conforming product or service to the customer. documentation of the open issues and providing for the attendant business risk may prove to be an acceptable approach to meeting the requirements of this clause.. To avoid customer complaints or dissatisfaction. it is essential to obtain a clear understanding of customer requirements by whatever means possible. Often with advanced products there is a need to advance the state of the art as product development progresses. In such cases. unique regulatory and statutory requirements should be considered as well as commercial terms and conditions. regulatory requirements or marketplace norms). Since the review process required in clause 8.2b requires that the organization have the ability to meet requirements. the defined requirements could be the development of the needed technological advance. retention of documented information of review results (eg.2. including activities such as holding face-to-face meetings and attending pre.bid meetings.22 does not require retention of any documented information on these determinations. Many products are regulated and customers may have no knowledge of the regulatory or statutory details. Clause 8. when. it is recommended to have such records. even for “requirements” that are not clearly stated (e. The documented information should include both product requirements specified by the customer and product requirements not specified by the customer but necessary for intended or specified use.2. It is the organization’s responsibility to understand all these requirements and their specific application. and using what method) can be a practical necessity.3 states the obligation of the organization to review the requirements of products and services. if customers are purchasing complex systems with custom engineering and software according to a complex set of commercial terms. It is recommended that you maintain documented information to describe the process for determination of all aspects of product and service requirements. The determination of customer requirements is a critical activity and generally involves several functions and levels in an organization. Clause 8. including any requirements for delivery or post-delivery actions Requirements known to be needed by the organization even though not specified by the customer Applicable statutory and regulatory requirements applying to the product or service http://isoconsultantpune. But communication and understanding of customer requirements is only one piece of the requirements puzzle. Often there are known issues that may evolve into real requirements at a later stage. who reviewed what. While clause 8.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION .2. perhaps even performing a failure modes and effects analysis (FMEA) on the processes as a form of risk assessment. Also. In such cases.g. Such situations should be clearly identified and the business risks understood.com/iso-90012015-clause-8-operation/ 6/21 . which includes: Customer-specified requirements for the product or service. Customers cannot be expected to know about many of these things. the organization should consider a comprehensive understanding of customer requirements.2 is often iterative.APB Consultant Establishing a process for determining the requirements for the products offered to potential customers Determining requirements of the customer Determining requirements for the organization Determining requirements from applicable statutes and regulations Determining that the organization has the ability to meet the requirements and substantiate claims related to its products and services One of the key things that the communication with customers needs to ensure is that customer requirements and other requirements for the product or service are clearly understood. Conformity is not difficult for organizations providing off-the-shelf catalog products manufactured to published specifications or standardized services with normal delivery requirements.

The review process must also accommodate. Such a plan can be generated as the unique occasion arises.g. a simple order-entry process can have a very simple.3 is to balance the risks to the organization with the effort expended in a review of customer requirements. A formal process should be deployed that indicates who will do what and how often.com/iso-90012015-clause-8-operation/ 7/21 . adherence to referenced external standards. If. This simple and fundamental requirements are often much harder to meet. legal. A process for reviewing oral orders for off-the-shelf products with 24 hour delivery (e. Thus. Cell phones are used to relate the latest changes to schedules and requirements. what is an organization expected to do to conform to the requirements? The first step should be to develop a clear understanding of the nature of the various kinds of customer requirements and fully understand each communication channel involved. electronic orders. Changes tend to come from all sorts of sources. for example. brief. an organization publishes a catalog and accepts only written orders for catalog—listed items to standard delivery times. or tender as well as applicable statutory and regulatory requirements. and an almost infinite combination of these and other possibilities. the organization could simply note in documented information (i.g. creative thinking will be required to efficiently review customer requirements. initiating. The complexity of the order/quote review process depends on the products and services of the organization. so design the system in such a way that you can deliver just http://isoconsultantpune.. complex contracts or quotations. as appropriate. or quotations occur.. For the large. software packages) will differ considerably from a process for reviewing a large order for a one-of-a-kind product with a two-year delivery (e. a procedure) that any circumstances different from standard terms and conditions will be addressed by a specific quality plan. contract. The obligation assumed by the organization includes not only the products defined but also ancillary items such as conformance to stated delivery dates.. Accordingly. the organization is required to ensure that relevant documented information is amended and communicated. This simple process can be used as valid evidence that requirements can be met. If an organization must address possibilities that occur only rarely. manufacturing. unsolicited orders.e. contracts. and compliance with the commercial terms and conditions applicable to the order. faxed orders. finance. the procedures governing such reviews can be complex and lengthy.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . then the order or contract. orders through distributors or representatives.. and effective contract-review process.g. blanket orders with periodic releases. orders. These considerations should be a key part of considering process interactions. control rules are needed so that decisions related to changes are made by the appropriate people with the relevant and up-to-date information. Clause 8. and quality assurance. If the organization is involved in internet sales. the review process may involve many organizational entities such as engineering. With such a spectrum of possibilities.4 states that changes are required to be controlled and documented information updated to ensure that changes are properly included in documented information. Thus.2.review procedure can be simple. When changes to product requirements. Customer floor-level workers in today’s environment often talk directly to factory workers in customers’ plants. a clerk) reviewing. within the organization. as applicable. The process could be a designated individual (e. The situation can turn into chaos.2. an order for a control system for an electric power-generating station). and dating the written order. a manager.APB Consultant Requirements of the final contract or order differing from those previously provided by or discussed with the customer The review is required to: Be performed prior to the organization’s commitment to produce the product or service Ensure resolution of all order requirements that may differ from those previously defined Include confirmation of the requirements in cases where the customer does not provide documented requirements o Retain documented information on the results of the review The acceptance of an order or the submission of a quote or tender by an organization obliges the organization to meet the conditions stated in the order or to provide the goods and services included in the scope of the quotation or tender. keeping in mind that the purpose of the review is to add value and not to create a bureaucratic morass. quote. A good guideline to keep in mind when developing a process to address the specific requirements of clause 8. Often rapid response is critical for the customer.

4 Design and development controls 8.. Many of these requirements may also come from regulatory. packaging. etc. resources. a review of such requirements. Your review process must ensure that you compare the customer’s order or contract with your latest quotation. combined with unwritten practices. because they did not assess all the risks. Indicators may include reduction in quote cycle time.3 Design and Development of Products and Services Clause 8. Customer requirements extend beyond product specifications and may include on-time delivery. after you have sent them your quotation. functionality. for contract review and customer communication. industry or from within your own organization. Performance indicators to measure the effectiveness of customer-related processes in meeting requirements and achieving quality objectives should focus on reducing variation in and improving these processes and related use of resources. product quality plans. etc. etc. Sometimes it may take a few months to receive an order or contract from the customer. you must also identify what specific documents are needed for effective planning. Your customer relations management process must include a sub-process for change control and must include – a review of the change either from customer or internal from organization and its impact on fit. You must consider all laws and regulatory requirements that may affect your product. development costs and investments.APB Consultant that. financial. Your review records must show the basis of review.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . Where some or all of the processes – for determining customer requirements.. other processes. possible failures in processes. You must identify and document all processes addressing this clause as part of your QMS . Customer related processes must include controls for determining customer and regulatory requirements. ratio of contracts/orders awarded to quotes). then you must show the linkages and interaction of these offsite activities with your on-site QMS processes. Have a process for change control. on design and development controls. order-entry errors and omissions etc. documentation. labeling. Make sure you do your due diligence and risk analysis before you commit to contractual arrangements.3. Depending on the product or service. production processes.3. potential for. you must determine if any industry or regulatory requirement is applicable on product characteristics or process parameters that affect the product’s safety or compliance with regulatory requirements.1 General 8.2 Design and development planning 8. You should also consider financial and profitability risk. form. For these processes. processes and resources in determining the nature and extent of documented controls you need to have. Customer communications may take many forms such as software and interfaces for design and development.com/iso-90012015-clause-8-operation/ 8/21 . For significant issues or changes. procedures and methods.5 Design and development outputs http://isoconsultantpune. delivery.3. Considerations for Documented Information to Be Maintained and/or Retained. and improvement in conversion ratio (i. a documented procedure etc.. customer satisfaction feedback. specifications. logistics. Keeping good records of changes is both a challenge and a practical necessity. obtain customer approval in writing for any waivers or changes of contractual or QMS requirements. and resolve any differences (accept or re-negotiate). I have seen many companies get into serious financial trouble.3. work instruction. orders. including suppliers.3. and effects of. are done offsite.3 Design and development inputs 8. pre and post-award review cycle time. These documents may include – contracts. communications. The nature of requirements review may be different for different types of product or services. Look at the risks related to your product. etc. after sales servicing. before you accept the order or contract. operation and control of production activities. Manufacturing risk analysis is an assessment of your organization’s capacity and capability to effectively and efficiently provide the customer specified deliverables.e. your facility and work environment.3. 8. etc. You must ensure that personnel at all levels have the competency and training to use these communications media and tools. mode of delivery. and communication with the customer. QMS requirements. for taking on products transferred from another supplier. Risk analysis should include timing. materials. labor. has six subclauses: 8.

applicable legal requirements. The organization must take any necessary actions on the problems determined during the reviews. 8. the documented information needed to demonstrate that design and development requirements have been met 8. 5. implement. as is suitable for the products and services of the organization. 8. the need for involvement of customers and users in the design and development process.3. the level of control expected for the design and development process by customers and other relevant interested parties. potential consequences of failure due to the nature of products and services.APB Consultant 8. the required design and development verification and validation activities. and maintain a design and development process. 2. 8. including. 10. 3. 4. Design and development reviews.3.3 Design and Development Inputs The organization must determine the requirements essential for the specific type of products and services being designed and developed. The organization must maintain any documented information of these activities. They can be conducted separately or in any combination. 7. Design and development reviews are conducted as planned. the required process stages.3.3. 9. Ensure inputs are adequate for design and development purpose. 6.5 Design and Development Outputs http://isoconsultantpune. verification and validation have distinct purposes. the responsibilities and authorities involved in the design and development process. information derived from previous similar design and development activities. including applicable design and development reviews.com/iso-90012015-clause-8-operation/ 9/21 . standards or codes of practice the organization has committed to implement. 8. the need to control interfaces between persons involved in the design and development process. the organization must consider the following in determining the stages and controls for design and development: 1.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION .3.4 Design and Development Controls The organization should apply controls to the design and development process to ensure that results to be achieved by the design and development activities are clearly defined.3. functional and performance requirements. or verification and validation activities. complete.6 Design and development changes 8. Validation activities are conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known). duration and complexity of the design and development activities. Verification activities are conducted to ensure that the design and development outputs have met the design and development input requirements.2 Design and Development Planning While planning for design and development. and unambiguous. the nature. such that they are adequate for subsequent production or service provision. the requirements for subsequent provision of products and services.1 General The organization should establish. as applicable. Resolve conflicts among Design and Development inputs. the internal and external resource needs for the design and development of products and services.

http://isoconsultantpune. and the documented information needed to confirm that input requirements are met. The key reason for this emphasis on planning is to maximize the probability that the project will meet defined requirements. It is required to include the following: Planning to determine design stages considering activities such as verification and validation. or subsequently) to design inputs and design outputs to the extent that there is no adverse impact on conformity to requirements. information from earlier projects. 8. and the success of the design and development project often rests heavily on proper identification. and validation into the design and development project. regulatory and statutory requirements. In many cases a number of organizations are involved in this process.. Requirements need to be established for the incorporation of review. and potential consequences of failure. Design and development controls. Design and development outputs are required to meet input requirements. including such things as functional requirements. to be adequate for subsequent processes in the provision of the product or service. The intent is to ensure that the organization plans and controls design and development projects. They must include or have a reference of monitoring and measuring requirements. understanding. implemented. and control of design interfaces. review and control changes made (during the design and development of products and services.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . applicable standards or codes. The organization needs to determine how communications will be structured (e. Controls are required to ensure that changes do not have an impact on the products and service conformity. as applicable. verification. This process may be used for both products and services and for associated processes. The organization is required to retain documented information resulting from the design and development process. authority.6 Design and Development Changes The organization should identify. Stages of the project need to be determined. an additional benefit should be that projects are completed on time and within budget Planning is required at the level of detail needed to achieve the design and development objectives—not to generate an excessive amount of paperwork. Conflicting requirements are required to be resolved. They should be adequate for the subsequent processes for the provision of products and services. and responsibilities. and acceptance criteria. control of design interfaces. and interfaces need to be defined. This includes changes to design inputs or outputs. including clear delineation of the results to be achieved.3. and to ensure the products and services are fit for their intended purpose.com/iso-90012015-clause-8-operation/ 10/21 . planning and conducting design and development reviews and verification activities to ensure design outputs meet input requirements. including design and development changes. Design and development activities needed for products and services are required to be planned and controlled through an established. Determination of the design and development inputs required. resources needed for design and development. and maintained process. weekly meetings. design review.g. periodic reports.APB Consultant The organization must ensure that design and development outputs meet the input requirements for design and development. the result of review. the authorization of changes and action taken to prevent adverse impact. or other methods). are fit for intended purpose and their safe and proper use. and controlled. and validation to ensure the products and services meet the requirement for the application intended. or services to be provided. The organization must retain documented information on design and development changes. customer involvement. The organization must retain the documented information resulting from the design and development process. They must ensure products to be produced. Design and development changes are required to be identified. If the design and development processes are well planned and controlled. reviewed.

The degree and details of planning may vary according to size and length of contract or project. operation and control of production activities These documents may include contracts. Product design and development planning must focus on error prevention rather than detection in product quality as well as product realization processes. durability. reliability. responsibilities. Your design and development plan must include methods to communicate information. tooling. review . You must identify. Consider including customer and supplier personnel at appropriate stages to do work and review results or progress. handling.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . reviews and resources. You must track progress against your plan at regular intervals or project milestones and update the plan as activity progresses. etc. processes and resources in determining the nature and extent of documented controls you need to have . as well as measurable improvements in products developed. sales. responsibilities. Many organizations use various software tools to document their product or process design and development plans. packaging. You must identify and document all processes addressing this clause as part of your. Indicators may include reduction in design cycle time. validations. maintainability. life. product http://isoconsultantpune. drawings and specifications. Performance indicators (to measure the effectiveness of design and development processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving these processes and related use of resources. Your plan must be dynamic and updated as requirements and circumstances change. field data. specification errors. changes. timeline and resources. A multi-disciplinary approach applies collective and relevant knowledge and skills of these different functions to carry out or review design and development activities. your own organization’s database of previous design and development projects. then you must show the linkages and interaction of these offsite activities with your on-site QMS processes. purchasing. engineering. The design and development project plan serves as both a document and a record as it is updated for completion for various activities. design and development costs etc. Your plan must specify the design and development stages. technical drawings and specifications. past experience with similar product. You must have a process that should be part of your design and development plan to identify. You must take a multi-disciplinary approach that includes as needed. deploy and use design input information such as documents coming from various sources such as customer contracts. risk. outsource or actually do design and development. Where some or all of clause 8. development cycle time. timing. packaging. competitor analysis. other functions (besides design) such as quality. document. and other requirements essential to the product. procedures and methods. There are many tools available for planning ranging from a simple checklist to complex software. Design and Development usually requires the input and involvement of many other functions and processes such as contract review. The scope of your design and development activity must consider all aspects of the product and product realization processes to ensure its conformity to requirements. You have flexibility in determining the scope of the stages. and outcomes.APB Consultant You must include product design and development in your QMS scope if you contract or convey the perception that you design product. feedback from suppliers.com/iso-90012015-clause-8-operation/ 11/21 . and reviews. specific tests. work instructions. regulatory. industry standards. omissions. results. combined with unwritten practices. For these processes. This clause is equally applicable for designing and developing manufacturing processes. If the nature of your business does not require you to design and develop product (e. performance. review.. document and review design inputs requirements for function. activities and tasks. product life. This includes product identification..3 design and development activities are done off site. cost. Your plan must clearly identify these other functions and their specific role and responsibilities regarding the project. a documented plan for design and development. etc. traceability. You must have an overall plan for your design project. production. a documented procedure etc.g. discussions. Look at the risks related to your product. storage and protection during internal processing and delivery to the customer. customer and regulatory requirements. quality. safety. you must also identify what specific documents are needed for effective planning. regardless whether you buy. special or safety characteristics from the customer or regulatory body. in your quality manual. complexity. identification. you manufacture strictly from customer provided engineering drawings and specifications). verification and validation required for your product design and development projects. Product design and development sometimes results in new manufacturing processes or changes to existing manufacturing processes. then you must clearly state this exclusion to your QMS scope.

had it been done internally. performing tests and simulations. review design and development progress. concentrations. Provide appropriate design and development output information to: Purchasing material or service specifications Production output such as product specifications.If you outsource any part of your design and development activity. Note that special requirements can also include process parameters such as temperature. performing tests and trials.APB Consultant realization.3 such as approval. whereas validation is checking product or process is suitable for its intended use does it perform/function in the way intended by your customer or your organization. Such a multi- disciplinary approach has the benefit of applying the collective and relevant knowledge and skills of these different functions to carry out or review design and development activities. responsibilities and timeline for completion.3. etc. Any problem you have encountered during the verification and validation or identified during review must be resolved. performing alternate calculations.Product design Verification includes design reviews. etc. testing various process parameters. Verification is checking product or process to input requirements.3 on the outsourced work and the organization doing the work. You must review all input requirements.5. comparison between customer requirements and internal development plans. Where any sophisticated design and development tools such as AutoCAD are used requiring specific competency or training. drawings. then you must exercise the same controls required by clause 8. Manufacturing process design verification include design review . The purpose of these reviews is to evaluate results to requirements. had it been done internally. etc.3. special characteristics. frequency and scope of these controls must be defined in your design and development plan or other document. before being firmed up. purchasing. If you outsource any part of your design and development activity. etc. performance reliability and maintenance criteria. Product may be prototype or finished product and documentation could be a computerized or hard copy drawing or specification. work instructions.com/iso-90012015-clause-8-operation/ 12/21 . Many documents are created from the design and development output stage such as drawings. All design and development reviews must be included in your design and development plan. timing. complexity and risks involved. actions to be taken. then you must exercise the same controls required by clause 8. operator instructions and other documents used to make or verify product. Inclusion of these controls in your design and development plan is one of many effective ways to achieve this. comparing the new design to a similar proven design if available. Do design reviews at one or more milestones of the design and development project. reviewing the design documents before release. etc. You must identify and include any special and safety characteristics in your process control documents such as quality plans.3 on the outsourced work and the organization doing the work. this information may be used for trials and validation. diagnostics. You must take a multi-disciplinary approach for doing these reviews and keep appropriate records of issues discussed.Product and manufacturing process validation includes – design reviews. before you use it any further. distribution. quality plans. depending on customer requirements. verify product design and validate developed product at various stages of your design and development process. Check design and development output against the input requirements specified in 8. ensure you provide and keep appropriate records of competency and training of personnel performing design and development activities and use of these tools. etc. You must carry out these controls according to your plan and keep appropriate records . These documents must be controlled as per clause 7. design and development validation against customer requirements and design and development input requirements. product drawings. the size. corrective action and lessons learned from documented process failures and product nonconformities. http://isoconsultantpune.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . Design and development output may be product or documentation or both. The nature. revision control. Initially. process capability studies. reviewing the manufacturing process design documents before release. within the organization and your process must manage this interaction by defining responsibilities and means of communications. check project progress and costs to plan and take actions on any problems encountered. top management etc. Service output such as product specifications.

cost etc. the authorization of changes and action taken to prevent adverse impact must be maintained.1. including necessary qualification. products and services to be provided or the processes to be performed on behalf of the organization. their interactions with the organization’s quality management system. The organization must apply the specified requirements for control of externally provided products and services when products and services are provided by external providers for incorporation into organization’s own products and services. It should define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output. products and services are provided directly to the customer by external providers on behalf of the organization. quality and business risks. The organization must establish and implement verification or other activities necessary to ensure the externally provided processes. The organization should communicate to external providers applicable requirements for the following: 1. Changes may come from internal. a process or part of a process is provided by an external provider as a result of a decision by organization to outsource a process or function.3 ie define plan. manufacturing process.4 Control of Externally Provided Products and Services 8. and services meet the requirements. The organization should ensure that externally provided processes remain within the control of its quality management system. 8. methods. Impact of the change must be evaluated on materials used.com/iso-90012015-clause-8-operation/ 13/21 .4.1 General The organization must ensure that externally provided processes. products. regulatory compliance. and services on the organization’s ability to consistently meet customer and applicable legal requirements and effectiveness of the controls applied by the external provider. verify and validate to the extent necessary to meet customer requirements and control product. the result of review. monitoring of performance.4. 4. 8. organization must consider the potential impact of the externally provided processes.3 planning for change and must also determine all risk and opportunities as given in clause 6. 8. and re- evaluation of external providers based on their ability to provide processes or products and services in accordance with specified requirements. Documented information on design and development changes. products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers. 3. While planning for change the organization must follow all the requirements as given in clause 6. products. products and services. The organization must retain appropriate documented information of the above mentioned activities and any necessary action arising out of evaluation.4. 2. products. processes or equipment.3 Information on External Providers The organization must ensure the adequacy of specified requirements prior to their communication to external providers. approval or release of products and services.2 Type and Extent of Control The organization should ensure that externally provided processes.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . selection. In determining type and extent of controls to be applied to external provision of processes. and services conform to specified requirements. competence of personnel. Get all requests for product or manufacturing process design changes in writing from your customer. The organization must determine and apply criteria for evaluation. http://isoconsultantpune. characteristics and use of developed product. design process. customer or regulatory sources. have inputs and outputs.APB Consultant Make sure your process for design and development changes follow appropriate steps of clause 8.

You must control both. maintainability. your criteria for supplier selection and evaluation may include the potential supplier’s financial capability. sequencing. intends to perform at the external provider’s premises. It might be useful to maintain a list of all qualified suppliers. Then determine what controls you need to ensure consistent purchased product quality and consistent supplier performance. You must also show the linkage and interaction of purchasing processes with other processes such as design. rework. The onus is still on you to ensure that purchased product from customer-designated sources meets all requirements. Many times the customer may require the use of pre-approved purchased products and suppliers. The importance of these criteria will vary according to the items materials or services you purchase.APB Consultant 5. life. Where any of your controlled suppliers have gone through a significant organizational change you must verify the continuity and effectiveness of their QMS. supplier or industry. You must have specifications/criteria for purchased product. you must document the controls for purchased product and suppliers. There are several ways to evaluate your suppliers. You must identify your purchasing processes whether on site or off site. manufacturing.5. cost etc. technical and manufacturing capability and capacity. specifications or proprietary information). purchasing from a supplier 2.com/iso-90012015-clause-8-operation/ 14/21 . returnable packaging. whether paid for or customer provided. calibration. These may include materials. 6. reliability. Use supplier monitoring indicators to evaluate the consistency. These specifications may come from your organization. you might consider requiring some of your key suppliers to comply with some or all of ISO 9001 requirements and perhaps even certification. maintenance. etc. intellectual property (drawings. regulatory bodies. Categorize your purchased products and services accordingly. verification activities that the organization. product sent for outsourced work etc. products and services. you are required to carry out ongoing monitoring and measurement of their performance. Externally provided processes. manufacture. calibration. For each process. and requirements to control your buying process. as well as the supplier you buy from. You can categorize your suppliers accordingly based on these criteria. reliability. components. support.4 requirements apply to items that go into the product. and cost must be applied to purchased product going into your end product. tooling. subassemblies. On-time delivery is very important and disruptions (due to waiting for materials) at your customers or even your own facility must be avoided. tooling. assemble and maintain your end product. Besides product quality. measuring and test equipment. customer. production equipment. check the product or deliver the product. outsourcing processes to an external provider. Purchased product includes raw materials. supplies.3. product returned for servicing under warranty. You can then apply different controls for different purchased products. facilities. reputation. sorting. products and services. service. transport vehicles. including any http://isoconsultantpune. durability. these specifications must be controlled as per clause 7.4 covers the requirements to control purchased product including your outsourced process. Clause 8. manufacture the product. and so you can apply different criteria to different suppliers. Factors such as targets for product quality. Your controls must primarily be based on prevention of nonconformities in both product and supplier performance. Depending on the risks related to materials supplied and supplier performance. an arrangement with an associate company 3. Determine how important the purchased product is to design. As documents.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . the product you buy. In addition to the initial evaluation and approval of suppliers. products and services includes 1. control and monitoring of the external provider’s performance to be applied by the organization. machinery and equipment. testing. The controls required for external provision can vary widely depending on the nature of the processes. etc. You must keep records of all supplier evaluations (whether initial or periodic). capability and reliability of their performance for quality. or its customer. support. control suppliers you buy from. delivery. Note that clause 8. flexibility to handle changes. tooling maintenance. The organization can apply risk-based thinking to determine the type and extent of controls appropriate to particular external providers and externally provided processes.

asking for inspection and test results or certificates of compliance. etc. your supplier quality manual that they must meet.5 Production and Service Provision http://isoconsultantpune.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION .quote review cycle time. In any case these controls must be included or referenced in your quality or inspection plans. A review of adequacy of purchasing documents may include their completeness. by one or more functions. waste and rework.3 does not specify keeping of records. To the extent that you decide to do verification of purchased product. This may include identification and storage to prevent unintended use. improvement in on-time delivery. correctness. this may be a separate process on-site or off-site. etc.You could use a documented procedure or other combination of specific practices. service. As indicated earlier. e. accuracy. processes and resources in determining the extent of documented controls you need to have. that is performed by an external organization such as a subcontractor. Indicators for supplier performance may include reduction of defects in supplied product. A manufacturing company may outsource welding. controls and resources are needed . etc. had you performed the process at your own facility.4. Performance indicators to measure the effectiveness of purchasing processes in meeting requirements and achieving quality objectives should focus on measuring supplier performance and reducing variation in and improving purchasing processes and related use of resources. You must be able to demonstrate sufficient controls over outsourced processes to ensure that such processes are performed according to the relevant requirements of ISO 9001:2008. A software company may outsource software development. sister facility. must specify your requirements for the purchased product. you must also identify what specific documents. etc.. validation of outsourced process. Make sure you appropriately control un-inspected product. documents and methods. conducting product and QMS audits of your vendor. inspection plans. the suppliers QMS and any other initial or on-going controls you deem necessary for ensuring consistent supplier performance.com/iso-90012015-clause-8-operation/ 15/21 . blanket order. it must be identified and controlled.. purchase order-entry errors and omissions. You must define how you ensure the adequacy of these documents before you communicate them to your supplier. cost. In either case. the relevant ISO 9001 requirements that you would have to implement. procedures. For these processes. CLAUSE 8. etc. A bank may outsource check clearing services. You must identify and document all processes addressing this clause as part of your QMS. contract. you can apply different controls for different suppliers and products depending on your initial supplier evaluation and their ongoing product quality and delivery performance. etc. You can do it on receipt or at any time prior to use in production. etc.g. Consider using supplier quality plans. providing the vendor with product specifications. cost. The expectation here is that you flow down to your vendor. you must show evidence of carrying out (issue purchase documents) and review of these documents An outsourced process is any value-adding or conversion activity related to your product or service. you also have flexibility in when you do the verification. scrap. You have flexibility in determining the scope of purchased product verification. receiving errors & omissions etc. quantity. Indicators for purchasing process may include reduction in supplier. Your purchase documents such as purchase order. Outsourced processes may be controlled in any number of ways. Your inspection process must define and document the acceptance criteria and sampling plan for product conformity and what measurement tools needed and records needed to show effective control of purchased product quality and supplier performance. contract award cycle time.APB Consultant corrective actions placed on them for any nonconformities. heat treatment or painting of product. Note that the external organization may perform the outsourced activity at their facility or yours. Look at the risks related to your product.. your organization’s supplier quality manual. approval. timing. The nature and scope of such control will depend on the nature of the outsourced or subcontracted process and the risk involved. While clause 8. In larger organizations. computerized controls. Verification of purchased product can range from doing no verification to 100% verification. to verify that purchased product meets specified purchase (product and QMS) requirements.

it will be very useful to draw a flow chart to link the flow and interaction of the activities and sub-processes covered by these clauses. video. sales and billing. implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs. Use your product. procedures and methods. To improve your QMS. 5. delivery. if applicable to your business. when it has to be made. and post-delivery activities. graphical. 6. where applicable. etc. resources used. required qualification of persons.g. what measurement and monitoring tools to use. Quality plans address what has to be made. production capacity and capability. Carefully define and document the interaction of your operation scheduling process with your logistics processes such as inventory management. current or right version. These documents may include – a product quality plan. then they must be readily available and relevant i. processes and resources in determining the nature and extent of documented controls you need to http://isoconsultantpune. by whom. Schedule your operations taking into consideration customer delivery requirements. Look at the risks related to your product. Note that work instructions may exist in may forms such as narrative. If you determine that work instructions are needed at specific points in your process. availability of documented information that defines activities to be performed and results to be achieved. validation. how much has to be made. 7.Your quality plan must cover all operation process steps from receipt of materials.5. monitoring or measurement requirements. storage. Work instructions may be viewed as a subset of your quality plan and may relate to a specific task or activity of your overall product realization process for e. etc. project or contract quality plan to control your operation activities. 3. delivery and even post-delivery activities such as installation or training. material availability and usage. This clause provides a list of control requirements that you may use. what to inspect. of ability to achieve planned results of any process for production and service provision where resulting output cannot be verified by subsequent monitoring or measurement. customer communication.. packaging and labeling.1 Control of Production and Service The organization should implement production and service provision under controlled conditions. work instructions. packaging. personnel availability and usage. what to do if problems arise. audio. etc. e. what equipment to use. how it has to be made.APB Consultant 8.g. setting up a machine. combined with unwritten practices. packaging a product. etc. There may be serious risk to production flow. have been met. 8. physical display etc. as applicable: 1. Identify and control all operation process. 2. Show the interaction of these processes with other processes. how much to inspect. Include these controlled conditions. storage. Operational personnel must have timely access to all information relevant to their activities including specific work instructions if necessary. if such information is unavailable or untimely.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . availability of documented information that defines characteristics of products and services. appointment of competent person and. traffic and shipping control.com/iso-90012015-clause-8-operation/ 16/21 . Your quality plans are dynamic and must be updated for the changes in product specifications or process parameters. documented procedure. availability and use of suitable monitoring and measuring resources 4. production. and acceptance criteria for products and services. performing an inspection. use and control of suitable infrastructure and process environment for operation of process. many organizations overlook reviewing and updating their quality plans for corrective action taken to address a manufacturing process problem. and periodic revalidation. implementation of products and services release.e. operation and control of production activities. Use quality plans to control your operation processes. you must also identify what specific documents are needed for effective planning. in what sequence. Your quality plans should reference any work instructions specified for the process steps. when to inspect. You must identify and document all processes addressing this clause as part of your QMS For these processes.

these validation controls in your quality plans. There are three distinct control requirements specified here. services.g. weld) or aesthetic (evidence of rust or dullness of chrome) reasons.2 Identification and Traceability The organization should use suitable means to identify “process outputs” where necessary to ensure conformity of products and services. electroplating. call center) have some form of monitoring during service execution to ensure service quality. equipment. scrap rates.e re-prove the changed process. etc. equipment. and production and testing methods that consistently result in a quality product or service. painting. materials. intermediate parts. Production process related indicators may include reduction in set-up time. In such instances. If you change any part of the proven process capability for e. etc. some types of welding. However. rust-proofing. Validation may also require customer or regulatory approval of the process. unique product identification is mandatory for safety.g. You must keep appropriate records of process validation showing both the achievement of planned results as well as the ongoing maintenance of such capability. 8. Product related indicators may include reduction in defect rates. processes. It is up to each organization to determine what combination of resources and methods will provide the required consistent process capability and quality of product or service. personnel. use in production.APB Consultant have. and delivery of product to the customer.5. Product status can be controlled using physical and electronic methods. production scheduling and operator errors and omissions etc. It should retain any documented information necessary to maintain traceability. Validation involves conducting capability studies using a combination of resources technology. heat-treatment. These records help to trouble-shoot product and process problems. you must revalidate i. Product status: It means knowing the quality status (good or bad) of materials and product through each of the above stages. run rates. process cycle time. THe organization should identify status of “process outputs” with respect to monitoring and measurement requirements throughout production and service provision. “Process outputs” can include products.g.. regulatory and risk management reasons. The organization should control unique identification of “process outputs” where traceability is a requirement. “Process outputs” are results of any activities which are ready for delivery to customer or to an internal customer (e. unless contractually required by customers or regulatory bodies. inspection and test details. resolve customer complaints. delivery.com/iso-90012015-clause-8-operation/ 17/21 . materials.g. then validation would be required. waste and rework. raw material storage.g. improvement in on time delivery. This usually involves keeping detailed records of product manufacturer such as material. for individual products or production batches. Product identification can be controlled using physical and electronic methods.. etc. Validation is usually required where product cannot be verified without damaging or destroying the product. PPM’s (defective parts per million). production. Performance indicators to measure the effectiveness of operation processes in meeting requirements and achieving quality objectives should focus on reducing variation in and improving production processes and related use of resources. equipment or personnel.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . and enables http://isoconsultantpune. if the timeliness of delivery is not verifiable. Product identification: It means knowing the identity of yours or customer supplied product from incoming receipt of materials. This would generally not be acceptable due to safety (e. environment. most service-oriented businesses (e.. receiver of inputs to next process). competent personnel. the quality of these activities may only be discovered after use. e. In certain industry sectors such as the automotive or aerospace or pharmaceutical industry. In the case of a service such as pizza delivery within 30 minutes of order placement. Unique Product Identification: It is not a mandatory requirement under ISO 9001. components. Include as appropriate. finished product storage. work in progress. etc.

are subject to risk of being damaged. In many instances.5. stolen. While this clause does not call for a specific documented information. storage. as well as increased customer property turnover rates. tools and equipment. authorized use. tooling. misplaced.4 Preservation apply to customer property. scrap. damaged. intellectual property. controls and documentation for these other clauses could be expanded to include customer property. Performance indicators to measure the effectiveness of processes that control identification and traceability may include reduction in identification errors and omissions.e. product returned for servicing under warranty. 8. use in production.5. stolen. components. transmission or transportation. work instructions and other specific documentation. MRP systems tracking specific production runs/lots. specifications or proprietary information.com/iso-90012015-clause-8-operation/ 18/21 . these controls may be included in your Operation processes through your product quality plans. identification. etc.5. traffic flow. All customer property is exposed to the risk of being damaged. Depending on the product. returnable packaging. measuring and test equipment. product sent for outsourced work. or otherwise found to be unsuitable for use. lost. status and traceability indicators. protect. customer provided materials or product. product quality status errors and omissions. The processes. Preservation can include identification. risk and use of resources by narrowing the problem down to a specific cause or instance. it also reduces cost. bar code labels linked to computer records. automated production transfer processes. You must establish controls for each of these risks. notification. Control to minimize the risks to customer/External provider property include inventory management. restricted access.perishable or obsolete i. These could be http://isoconsultantpune. misused. etc. Many of the controls needed for clause 8. production equipment.APB Consultant continual improvement of product and process. these controls may be included in your product realization processes through your product quality plans. lost. While this clause does not call for a specific documented information. past shelf life for use. preservation and storage. Performance indicators to measure the effectiveness of processes that control customer property may include reduction in identification errors and omissions. customer premises. verify. It should report to the customer or external provider when their property is incorrectly used. All raw materials. This could occur during receipt..2 Identification and traceability and clause 8. etc. facilities. Customer property can include material. supplies. and transportation to the customer.3 Property Belonging to Customers or External Providers The organization should exercise care with property belonging to customers or external providers while under the organization’s control or being used by organization. the OEM may specify the degree of unique identification and traceability required. product sent for outsourced work. damaged or otherwise found to be unsuitable such as perishable past its shelf life for use.5. intellectual property such as drawings. packaging. Examples of product identification and test status include physical tags. rejects. and personal data. The organization should identify. work instructions and other specific documentation. maintenance. work in progress. handling. misused. become unsuitable .4 Preservation The organization should ensure the preservation of “process outputs” during production and service provision.. handling. finished product. Marking customer/External provider property with a unique identification number that can be traced to a record that provides details of ownership is one of many acceptable controls. 8. lost. Customer or External provider property may include material. to the extent necessary to maintain conformity to requirements. Notify the customer/ External provider in writing if their property is lost. etc. etc. and safeguard the customer’s or external provider’s property provided for use or incorporation into products and services. and protection. etc. become unsuitable or obsolete for use. transport vehicles. storage. loss due to damage or unsuitability.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . and traceability errors and omissions. misplaced.

8.com/iso-90012015-clause-8-operation/ 19/21 . rejects. routine maintenance or total recall. The organization is required to review and control changes for all of the previously discussed “production and service provision” topics including 8. this section can be addressed simply by acknowledging that there are no post-delivery activities.5 Post-Delivery Activities The organization should meet requirements.5. fruits.5 Post-delivery activities. use and intended lifetime of its products and services: This is very commonly stated in the organization’s return policy or statement of liability. This could include technical support.. etc. the scope of their reaction plan. Many of the controls needed for clause 7. 8.5. contractual obligations (such as maintenance services) and supplementary services (such as recycling or final disposal) Post Delivery activities means based on customer agreement or other agreement. reusable packaging.3 Property belonging to customers or external providers. for post-delivery activities associated with products and services.5. Customer feedback: Customer feedback should be considered when determining the scope of post-delivery activities. condition reports.2 Identification and traceability. expressed or implied. climate and environment. they must be addressed the potential undesired consequences associated with its products and services: The organization must consider potential consequences. use..9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION . use of special equipment for handling. Some organizations clearly state that there are no warranties (or post-delivery activities) offered. If this is the case (and in the absence of any other requirements in this list). support. and any necessary actions arising from review. The extent of post delivery activity will depend on: Statutory and regulatory requirements: If statutory or regulatory requirements dictate post- delivery activities or warranties. waste. inventory cycle counts and condition evaluation.5. the organization may be responsible for providing support for their product or services after delivery. the post-delivery activities should be clearly described.g.APB Consultant Controlled using identification. tracking shelf life. controls for restricted access. protection through delivery and receipt. warranty.5. personnel authorizing change. Customer feedback. etc . handling and storage of hazardous materials. etc. 8. or frozen foods).4 Preservation and 8.6 Control of Changes The organization should review and control changes for production or service provision to extent necessary to ensure continuing conformity with requirements. status and traceability indicators. and intended lifetime of products and services. 8. customer requirements: If the customer requires post-delivery. and increase in inventory turnover and material/product availability. legal requirements. 8. training. scrap. etc the nature. stock rotation methods such as FIFO. and product safety. recycling. In determining the extent of post-delivery activities that are required the organization should consider risks associated with products and services. Post-delivery activities can include actions under warranty provisions. maintenance procedures. just in time. as applicable. special.1 Control of production and service provision (all of the controls established in the first place). returnable containers. nature. fresh produce.5. So. This also implies that the scope of those post delivery activities may change over time in response to customer feedback.3 Identification and traceability apply to preservation of product. The organization should retain documented information describing results of review of changes.5. bar codes. just as the QMS must have defined each of these items. any changes to them must be http://isoconsultantpune. etc. Performance indicators to measure the effectiveness of processes that control preservation of product may include reduction in obsolete and spoils materials an product (e. These controls may be included in your product realization processes through your product quality plans. and how they intend to respond.5. work instructions and other specific documentation. identification errors and omissions.

Records describing results of review of changes. Performance indicators to measure the effectiveness of product realization processes in achieving product conformity include productivity. You must identify and document all product realization processes that may address this clause. Where practical. Performance indicators to measure product conformity may include reduction in defect rates. consider completing all missed planned inspections and measurements before product delivery. and services that do not conform to requirements are identified and controlled to prevent unintended use or delivery. packaging. your own organization. processes and resources in determining the extent of documented controls you need to have. production. The organization should retain documented information for traceability to the person(s) authorizing release of products and services for delivery to the customer. You could use a product quality plan. etc. For such processes. Look at the risks related to your product. reduction of cycle time. operation and control. rework.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION .com/iso-90012015-clause-8-operation/ 20/21 . understood and validated when they are implemented. e. any documented information or other combination of specific practices. by customer. If you plan on releasing during any stage of production or shipping finished product. 8. The organization should also retain documented information for evidence of conformity with the acceptance criteria.g. monitor and measure product/service characteristics to verify conformity to requirements. omissions and failures. Product characteristics may be dimensional. products. and post installation. 8. you must also identify what specific documents are needed for effective planning. etc. what measurement device to use. as applicable. etc. Changes which are not clearly communicated create confusion. and any necessary actions arising from review has to be maintained. errors. waste. regulatory and industry sources. Products. You must ensure that all personnel performing monitoring and measurement are trained and competent. You must identify. reliability. performance. You must plan what characteristic(s) to measure. communicated. how often to measure.7 Control of Nonconforming Process Outputs. Requirements may come from your customer. finished product. as part of your QMS. Monitoring and measurement may be done by your personnel. subcontracted or outsourced labor or by the customer. at time of shipping. scrap rates. The organization should take appropriate action based on nature of nonconformity and its impact http://isoconsultantpune. in general. where all planned inspections and measurements to that stage have not been completed. Changes which have not been adequately reviewed and vetted may be implemented and result in an undesired outcome. shipping. The release products and services to the customer should not proceed until the planned arrangements for verification of conformity have been satisfactorily completed unless otherwise approved by a relevant authority and.APB Consultant controlled. approved. PPM’s (defective parts per million). acceptance criteria. durability. create instability and a robust change management process is critical to ensure changes are fully reviewed. project or contract quality plan must define the stages at which various monitoring and measurement will be carried out at incoming receipt of materials from suppliers or outsourced work. receiving. storage. improvement in on time delivery. life. personnel authorizing change. procedures and methods. Changes. product returns from customer. ensure that you obtain prior written approval/waiver from a relevant internal authority or the customer. functional. type of measurements. internal production processes. Use your quality plan to document these controls. and records needed for each product or product type. Retain evidence of conformity with acceptance criteria.7. cost. sample size.6 Release of Products and Services The organization should implement planned arrangements at appropriate stages to verify product and service requirements have been met. maintainability. etc. and Service 8.1 The organization should ensure process outputs. Your product.

e. obtaining authorization for acceptance under concession. All product realization processes must show the interaction with your process for nonconforming product. establish performance indicators to measure the effectiveness of the control of nonconformance process. you might consider taking action to eliminate the nonconformity as well as corrective action to eliminate the root causes of the nonconformity. If you find that nonconforming product has been shipped. and services are corrected. concessions obtained. ISO 9001:2015-Clause 8. http://isoconsultantpune. your own organizational activities or product shipped to customers. Depending upon the seriousness and scope of the nonconformity. should be treated as nonconforming product and controlled as mentioned above. you must take appropriate action to reduce the immediate and consequential effect of the nonconformity. notify appropriate personnel and customer. etc. Nonconformities may relate to suppliers and outsourced work. where appropriate.2 The organization should retain documented information that describes the nonconformity. products and services that does not conform to customer requirements. under controlled conditions.9/23/2017 ISO 9001:2015 CLAUSE 8 OPERATION .7. You need to be aware of any reporting requirements imposed by regulatory bodies and comply with them.com/iso-90012015-clause-8-operation/ 21/21 .7 applies to processes. without a customer concession. contain i. In both these situations. prevent further processing or use. you might consider taking action to eliminate the nonconformity as well as corrective action to eliminate the root causes of the nonconformity. improved alternate use of nonconforming product and cost recovery. A deviation authorization allows you to manufacture product different from the original specification. obtain customer concessions. The organization should verify conformity to requirements when nonconforming process outputs.APB Consultant on conformity of products and services. make sure that you obtain these authorizations in writing prior to shipping or manufacturing nonconforming product. Product or material found with no identification or its quality status is not known. determine policies for release for further processing or shipment to the customer. Depending upon the seriousness and scope of the nonconformity. applicable regulatory requirements or your own organization requirements. products. containment. segregation. evaluate what disposition action needs to be taken. under controlled conditions. Your organization must have controls and responsibilities to identify. keep records of the nature and other details of the nonconformity. action taken. return. or suspension of provision of products and services. This is applicable also to nonconforming products and services detected after delivery of products during or after provision of service.The organization should deal with nonconforming outputs in one or more of these ways: correction. identifies the person or authority that made decision regarding dealing with nonconformity. 8. Performance indicators to measure the effectiveness of control of nonconforming product may include reduction in cycle time to evaluate and dispose of nonconforming product. rework and re- verification. reduced errors in preventing unintended use or delivery. A similar rationale may be applied where product has been shipped that does not meet regulatory requirements. A concession authorization allows you to ship nonconforming product.It might be appropriate in specific circumstances to notify the customer and resolve the situation to your customer’s satisfaction. etc. informing the customer. carry out timely disposition.