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Table of Content
1. Auditing the Design and Development Process 2. Auditing Customer Communication 3. Auditing Competence and Effectiveness of Actions Taken 4. Audit Finding Evaluation
Auditing the Design and Development Process ISO 9001:2008 clause 7.3
Meaning: • refers only to design and development of products and services. • not design and development of processes, although it can be beneficial to apply the methodology of clause 7.3 to the latter.
Note: Auditing Design and Development Process for Service organization may be different from “traditional” manufacturing organization. .Auditing the Design and Development Process Auditing Objective: Determine whether the process is managed and controlled to enable products to meet their intended use and specified requirements.
specifications.What is Product Design and Development? Product Requirement Transform into Specified Product Characteristics i.e. statutory requirements and specific or implied customer requirements distinguishing features of the product .
availability) Ergonomic (e. 4.4. 2. Physical (e. mechanical. physiological characteristic. electrical. 5. 3. punctuality. hearing) Behavioral (e. maximum speed of an aircraft) .g.g. chemical or biological characteristics) Sensory (e. related to smell. 6.g.g. sight. taste.1 1.Examples of product characteristics – ISO 9000:2005 clause 3. honesty. courtesy.g. reliability.g. touch. veracity) Temporal (e. or related to human safety) Functional (e.
How to evaluate if exclusion of 7. .3 is correct? Establish who is responsible for defining the characteristics of product or service together with how and when it is carried out. to provide product that meets customer and applicable statutory and regulatory requirements. and such exclusions do not affect the organization’s ability. or responsibility.2 Application … are not acceptable unless these exclusions are limited w/in Clause 7. ISO 9001:2008 Clause 1.
In some cases.Each stage has specific deliverables that cover both the commercial and technical aspects of design and development of a product. . organizations might be able to justify the exclusion of certain sub-clauses or individual requirements from their QMS without necessarily excluding the entire clause.
How to start? Establish what design and development projects have been. = select a sufficient number of projects to be able to audit all stages of the design process . and are currently being undertaken.
Customer feedback to find out whether any design-related comment has been received and auditee has taken appropriate action.How to evaluate if there is on-going D&D activity? Validate by: • Ensuring that no changes have been effected to the previous design • Reviewing relevant documents and records such as: 1. Nonconformity reports to find out whether any designrelated NCs have been recorded. 3. Relevant document to find out whether any amendment has been issued during the review period. 2. .
6 Results of design and development validation and any necessary actions 7.2 Design and development inputs relating to product requirements 7.4 Results of design and development reviews and any necessary actions 7.3.5 Results of design and development verification and any necessary actions 220.127.116.11.3.7 Results of the review of design and development changes and any necessary actions .Records that we can take a look at… 7.
– suppliers. new or changed statutory and regulatory requirements.Auditing the need for design & development Triggering factors: – – – – – the organization’s strategic planning. service reports. market intelligence and research. – process changes. . – new technology. customer feedback and demand.
verification and validation that are appropriate to each design and development stage. and The responsibilities and authorities for design and development.3. as the design and development progresses. The review.3. c. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated.1) Auditing design and development planning ISO 9001:2008 Clause 7. During the design and development planning. the organization shall determine a. The design and development stages. .1 The organization shall plan and control the design and development of product. as appropriate. b.(7.
validation and review points defined? are the main milestones and timelines identified? is the implementation and effectiveness of the plan monitored? is the plan updated and communicated to all relevant functions as necessary? .ISSUES to CONSIDER: • • • • • • • • • • what is the overall flow of the design planning process? how is it described? what resources and competencies are required? what part of the design will be outsourced? who is responsible and are the authorities defined? how are (internal and external) interfaces between various groups identified and managed? are the required verification.
2) Auditing design and development inputs ISO 9001:2008 Clause 7. unambiguous and not in conflict with each other. .3. information derived from previous similar designs. Requirements shall be complete. and Other requirements essential for design and development. The inputs shall be reviewed for adequacy.2 Inputs relating to product requirements shall be determined and records maintained.(7. These inputs shall include a) b) c) d) Functional and performance requirements Applicable statutory and regulatory requirements Where applicable.3.
auditors should develop an understanding of how the organization identifies its own inputs based on: – – – – – the organization’s products and processes.(7. organizational risks and impacts. .2) Auditing design and development inputs When auditing the design and development inputs. statutory and regulatory requirements applicable to the product . financial. environmental.3. health and safety issues. customer’s requirements and expectations.
(7.3. and • issues that the organization may encounter if some relevant inputs are not considered.2) Auditing design and development inputs Auditors should • evaluate the risks. . • the possible implications for customer satisfaction.
and Specify the characteristics of the product that are essential for its safe and proper use.(7. Contain or reference product acceptance criteria. Note: Information for production and service provision can include details for the preservation of products. production and service provision.3. .3) Auditing design and development outputs ISO 9001:2008 Clause 7.3 The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. Design and development outputs shall a) b) c) d) Meet the input requirements for design and development Provide appropriate information for purchasing.3.
Outputs can include information relevant to the following: – – – – marketing. . production.3) Auditing design and development outputs D&D outputs should comply with the identified needs in order to ensure that the resulting product can fulfil its intended use. information for service provision and maintenance of the product after delivery – and. should be provided in a form that enables verification and validation activities to be performed. quality assurance. sales and purchasing.3.(7.
(7.3.3) Auditing design and development outputs Auditors should obtain evidence from the projects selected to confirm that: – information regarding the completion of design and development stages is available. – design and development outputs have been confirmed . – the design and development process has been completed for the stage under review.
3.1) a) b) To evaluate the ability of the results of the design and development to meet requirements.3.4) Auditing the design and development process and design reviews ISO 9001:2008 Clause 7. systematic reviews of desig and development shall be performed in accordance with planned arrangement (see 7.4 At suitable stages.(7. .3. and To identify any problems and propose necessary actions. Records of the results of the reviews and any necessary actions shall be maintained. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed.
3.4) Auditing the design and development process and design reviews Auditors should •verify that the overall design and development process is controlled in accordance with the organization’s original plan being reviewed •the design and development reviews take place at appropriate planned stages •Participated by representatives from concerned/related functions .(7.
(7. adequacy and effectiveness of the designed product? – are the relevant design objectives being achieved? – are there adequate records of reviews? .3.4) Auditing the design and development process and design reviews The following issues should be considered by auditors when examining the review process: – do reviews occur at planned stages throughout the design process? – are the reviews carried out in a systematic way involving representatives of the functions concerned with the stage(s) being reviewed? – have all original and any new inputs been considered ? – are the original outputs still relevant or have revised outputs been identified? – have revised inputs and outputs been reviewed and approved by those with the relevant responsibility and authority (including the customer where appropriate)? – does the output demonstrate the suitability.
3.2.5 Verification shall be performed in accordance with planned arrangements (see 7.3.5) Auditing design and development verification ISO 9001:2008 clause 7.4) .(7.1)to ensure that the design and development outputs have met the design and development input requirements.3. Records of the results of the verification and any necessary actions shall be maintained (see 4.
3. .(7.5) Auditing design and development verification • Design and development verification is aimed at providing assurance that the outputs of a design and development activity have met the input requirements for this activity as shown in Figure 2 below.
3. • undertaking demonstrations including prototypes. • reviewing documents prior to issue. and.5) Auditing design and development verification Verification can comprise activities such as: • performing alternative calculations. • comparing a new design specification with a similar proven design specification. . simulations or tests.(7.
the completed design or development is acceptable and the results are consistent with and traceable to the initial requirements. security.3. logic flow. Auditors should determine that only verified design and development outputs have been submitted to the next stage. and compliance with other requirements and design inputs. evidence is available to demonstrate that the verification results and any further actions have been recorded and confirmed when actions are completed. inputs. interfaces. as appropriate. . outputs. etc. allocation of timing.(7. the design or development provides safety.5) Auditing design and development verification Auditors should determine that the design and development verification activities should provide confidence that: • • • • • required verifications are planned and that verification is performed as appropriate during the design and development process. the completed design or development is the result of implementation of a proper sequence of events.
3. validation shall be completed prior to the delivery or implementation of the product.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.6 Design and development validation shall be performed in accordance with planned arrangements (see 7. Records of the results of validation and any necessary actions shall be maintained (see 4.3.(7.4). .6) Auditing design and development validation ISO 9001:2008 Clause 7. where known.2.3. Wherever applicable.
that the particular requirements for specific intended use are fulfilled. • provision of evidence. .6) Auditing design and development validation • confirmation by examination.(7. • Is the validation process capable of checking that the final product and/or service will meet.3. although these could be modified during the realization of design and development. the customer’s needs when it is in use ? Validation methods should be specified as part of the design and development planning process. or does meet.
and approved before implementation.(7. as appropriate.3.7 Design and development changes shall be identified ad records maintained. The changes shall be reviewed.7) Auditing design and development changes ISO 9001:2008 Clause 7.2. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.4) . verified and validated.3. The review of design and development changes shall include the evaluation of the effect of the changes on constituent parts and product already delivered.
as appropriate Approved before implementation Records maintained .(7.7) Auditing design and development changes Changes to design and development shall be: • • • • • Identified Reviewed Verified and validated.3.
7) Auditing design and development changes Review of changes shall include: • Evaluation of the effect of the changes on constituent parts and product and products already delivered • Maintain records of the results of review and any necessary actions .3.(7.
Auditors should consider the following : • are the sources and requests for changes properly identified and communicated? • is the impact of any change evaluated? • is any additional design proving or testing undertaken where appropriate? • are the effects of the changes on constituent parts and product already delivered evaluated? • has appropriate approval been given before a change is implemented (this could include statutory or regulatory approval or approval by the client)? • are the changes fully documented and do records include information regarding any necessary additional actions? .3.(7.7) Auditing design and development changes Design and development changes made during the design process need to be controlled.
and 7) Get the customer to confirm it's what they wanted. 5) Change the design if you have to until you can confirm you met the requirements. .KEY POINTS… IN SUMMARY 1) Plan design activities. 4) Test the design to see if it met requirements. specs and changes. 2) Determine the requirements. 6) Document the process. 3) Execute the initial design.
End of Session 1 .
Auditing Customer Communication Learning Session 02 .
Importance of Customer Communication .
Requirements ISO 9001:2000 clause 7. including customer complaints. and c) customer feedback.2.3 : Customer communication The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information. b) enquiries. . including amendments. contracts or order handling.
• Clause 7. where applicable. acceptance of changes to contracts or orders).Other ISO 9001:2008 requirements regarding Customer Communication • Clause 5. submission of tenders.2. . by the customer.2 Where the customer provides no documented statement of requirement. acceptance of contracts or orders. • Clause 8. the customer requirements shall be confirmed by the organization before acceptance.3b Authorizing the use of non conforming product by release or acceptance under concession by a relevant authority and.2 The organization’s review of the requirements related to the product conducted prior to the organization's commitment to supply a product to the customer (e. the organization needs to have a system in place to obtain those requirements.g.2.2 Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction • Clause 7.
and for translation into requirements for the organization……” .Guidance from ISO 9004:2000 (clause 7. The organization should implement and maintain such processes to ensure adequate understanding of the needs and expectations of its interested parties.2) Processes related to interested parties Management should ensure that the organization has defined mutually acceptable processes for communicating effectively and efficiently with its customers and other interested parties.
It is important for the auditor to verify how the organization communicates about the quality of its product / service to the end users and also the mechanism for obtaining a feedback (besides complaints) from the end users. It should be recognized that the needs of the dealers / retailers may at times be different from those of the end users. Although there is no specific requirement in ISO 9001:2000 for a documented procedure.Verifying the effectiveness of customer communications • Verifying the effectiveness of customer communication is therefore a critical component for achieving customer satisfaction. It further gives examples of customers including the “end user”. ISO 9000 defines the term “customer” as the recipient of the product. complexity and culture of the organization it may be necessary to have one in order to ensure effective implementation of the customer communication process. depending on the size. • • . Many organizations sell their products / services through dealers and retailers and may not be receiving orders directly from the end users.
requirement or order.1 Customer communication falls in three general categories: • An organization’s general communication to existing or potential customers – such as advertisements or marketing information. • Specific information relating to a customer enquiry.The auditor’s approach . and • Communication in response on customer feedback and complaints .
which includes – advertising material – web sites – product catalogues Where the organization receives orders from dealers and not the end users. . The auditor should also try to establish how the customer needs have been identified and product specifications arrived at. the auditor should establish that the product information available to the end users (pamphlets.2 Some or all of the following means of an organization’s general customer communication may be observed by the auditor: Product information. brochures.The auditor’s approach . web sites etc) describes the product / service adequately and accurately.
discontinued or no longer available. . web sites and product catalogues are reviewed to reflect the organizations current product offerings and services and what measures are taken if a particular product is modified. • Query/take a look into. for example.The auditor’s approach .3 • Verify the product information to confirm that it is readily available to customers or potential customers and provides information that is up-to-date and accurate. how often advertising material.
4 Some or all of the following means of an organization’s specific customer communication may be observed by the auditor: Enquiries. contracts or order handling. including amendments – – – – – – – – – quotations order forms confirmation of order amendment to order delivery documentation invoices credit notes e-mail & general correspondence visit reports or notes to/from customer Customer feedback and complaints management process – Letters in response to complaints – Acknowledgments .The auditor’s approach .
the organization needs to have a system in place to obtain or confirm these customer requirements before the organization accepts the order. – During the design/development process there may be considerable communication between the organization and the customer.The auditor’s approach . by the customer . where applicable. – During the process of authorizing the use of non conforming product by release or acceptance under concession by a relevant authority and.5 There are also further instances where the auditor will experience the organization’s communication with the customer: – During the ordering process where the customer provides no documented statement of requirement.
The auditor’s approach . contract or order. .6 The auditor would use normal trace methods to verify compliance with the customer communications requirements of ISO 9001 and whether the organization communicated effectively with the customer in the execution of the enquiry.
Auditing Competence and Effectiveness of Actions Taken .
Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. provide training or take other actions to achieve the necessary competence.2 : Competence. skills and experience (see 4. and Maintain appropriate records of education.2.ISO 9001:2008 Clause 6.4).2. c) d) e) . training and awareness The organization shall: a) b) Determine the necessary competence for personnel performing work affecting conformity to product requirements. training. Evaluate the effectiveness of the actions taken. Where applicable.
How to start? . it is recognised that some organizations will have separate human resource processes. . where most of the evidence needed can be found.However.Usually audited as part of a product realization process audit and not in isolation. .
theoretical or practical training.Things an organization needs to do to satisfy the requirement • Identify what competencies are required by personnel performing work which affects quality • Identify which personnel already performing the work have the required competencies • Decide what additional competencies are required • Decide how these additional competencies are to be obtained – training of personnel (external or internal). hire or reassign personnel • Review the effectiveness of actions taken to satisfy competence needs • Periodically review competence of personnel . assignment of existing competent personnel to different work • Train. hiring of new competent personnel.
• Throughout the process. training.Other things to consider. . skills and experience. the organisation is required to maintain appropriate records of education. • However.. ISO 9001:2000 does not specify how the process will be established or the exact nature of the records to be maintained.
A review of competencies might also be needed when a new tender or contract is being considered. An organisation needs to identify what competencies are required by personnel performing work that affects quality. competencies development plan. database. register. • • • Discussions could initially be held with top management to ensure they understand the importance of identifying the competencies required. Competence requirements may be included in contract documents where the activities of subcontractors can have an impact on processes and/or product quality characteristics.The objective of the auditor should be to determine whether there is a systematic approach in place to identify these competencies and to verify that the approach is effective. which may lead to different competency requirements in the organization. etc. contract. Evidence of this could be found in related records. These may also be a potential source of information regarding new or changed activities or processes. Auditors need to determine whether the organisation has identified new or changed competence needs during surveillance audits. Guidance . project or product plan. The outcome of the process may be a list. .Issues that would be looked into… 1. human resources plan.
Evidence may be obtained throughout the audit with an emphasis on those processes.Issues that would be looked into… 2. task and products where human intervention may have the greatest impact. customer complaints. Also. monitoring activities. nonconformity records.Verify that some form of evaluation process is in place to ensure that the competencies are appropriate to the organization's activities. The auditor may review job descriptions. records of management reviews. activities. testing or inspection activities. . the process should ensure that any deficiencies are being acted upon and the effectiveness of personnel is being measured. Are competent people assigned to those work place activities necessary to control the quality characteristics of its processes and products? Guidance . definition of responsibilities and authorities. and that the personnel selected as competent are demonstrating these competencies. audit reports. processes validation records etc. Verify that the activities that affect quality are performed by persons selected as competent.
peer review. for further examples). etc. The organization may need to demonstrate the attainment of competence of its personnel through a combination of education. reviews of training and employment records and/or interviews (see ISO 19011.The organization may use a number of techniques including role-play. peer review. this same method would not be acceptable to evaluate whether an auditor performed satisfactorily during an audit. this alone would not provide evidence that the trainee is competent). observation. training records could be viewed to verify that a training course had been successfully completed (but note. Table 2. – For example. training and/or work experience. • .. – However. this may require observation. interviews.Issues that would be looked into… 3. The organization needs to evaluate the effectiveness of the actions taken to satisfy the competence needs • Guidance . The appropriateness of a particular evaluation method will depend on many factors. – Instead.
• Guidance – The auditor needs to verify that some form of effective monitoring process is in place and being acted upon. or – the regular inspection. – regular appraisals of personnel and their performance. Ways of doing this include a – continuing professional development process (such as the one described in ISO 19011). Maintenance of competence. • • Ongoing changes in competence requirements may indicate that an organization is proactive in maintaining personnel performance levels. testing or auditing of product for which individuals or groups are responsible.Issues that would be looked into… 4. .
Consideration of the need for competence includes sources as .Statutory and regulatory requirements. Management should consider analysis of both the present and expected competence needs as compared to the competence already existing in the organization. .Guidance from ISO 9004:2000 6.Evaluation of the competence of individual people to perform defined activities.Changes to the organization’s processes. and .Future demands related to strategic and operational plans and objectives . .1 Competence Management should ensure that the necessary competence is available for the effective and efficient operation of the organization. ad standards.Anticipated management and workforce succession needs .2. affecting the organization and its interested parties. tools and equipment.2.
the stages of development of people and the culture of the organization.Guidance from ISO 9004:2000 6. It should also include awareness of the consequences to the organization and its people of failing to meet the requirements. together with experience.2 Awareness and Training Planning for education and training needs should take account of change caused by the nature of the organization’s processes.2. . Education and training should emphasize the importance of meeting requirements and the needs and expectations of the customers and other interested parties.2. improve their competence. The objective is to provide people with knowledge and skills which.
Culture and social behavior .Communication skills .Tacit and explicit knowledge .Leadership and management skills .Creativity and innovation.Knowledge of markets and the needs and expectations of customers and other interested parties. planning for education and training should consider: . and .Guidance from ISO 9004:2000 To support the achievement of the organization’s objectives and the development of its people.Teambuilding . .Experience of people .Problem solving .Planning and improvement tools .
.The initiation and implementation of improvement processes .The organization’s impact on society . and .Periodic refresher programmes for people already trained.Benefits from creativity and innovation .Introductory programs for new people.The organization’s policies and objectives .Organizational change and development .The vision for the future of the organization .Guidance from ISO 9004:2000 To facilitate the involvement of people. education and training should also include .
Objectives. . .Evaluation in terms of enhanced competence of people. and . . The education and training provided should be evaluated in terms of expectations and impact on the effectiveness and efficiency of the organization as a means of improving the future training plans.Measurement of the effectiveness and the impact on the organization. .Identification of necessary internal support.Resources needed.Guidance from ISO 9004:2000 Training plans should include: .Programmes and methods. .
• How do you determine the necessary competence of our staff? • How do you handle new staff? Introduction plans? • In what areas do you need to elevate competence? In what way? • How do you evaluate the effectiveness of the actions taken? • Are your staff aware of the intent of your quality policy. quality objectives and how they contribute to fulfilling them? • Do you have the infrastructure you need? • Is the work environment good enough? How about the mood among the staff? .
Audit Finding Evaluation .
The bank applies all the requirements of ISO 9001:2008 for the realization of its Internet banking services. but chooses to implement a QMS only for its Internet banking services. For this service the bank has claimed conformity to ISO 9001:2008.4 Customer property from its QMS and claim conformity to ISO 9001:2008? .Scenario 1 : Customer property (intellectual property) controlled by a bank Situation: A bank provides a variety of services to its customers (i.5. with the exception of sub-clause 7. The bank clearly states in its Quality Manual which services are covered by the QMS. The bank does not feel that it has possession of any customer property as part of its Internet banking services and has stated this in the justification for the exclusion of sub-clause 7. personal and company bank accounts).5. Issue(s): Can the bank exclude sub-clause 7.e.4 Customer property from its QMS.5.4 Customer property.
Scenario 2 :
Exclusion of design and development by a contract manufacturer
XYZ Electronics is building a new factory to perform manufacturing of mobile phones, as a subcontractor. It has only one customer and this customer maintains responsibility and authority for product design. XYZ Electronics is responsible for purchasing of all components and for performing the manufacturing activities. The customer provides XYZ with the manufacturing and parts specifications, and is also responsible for notifying XYZ of any design changes and providing the appropriate change information.
XYZ Electronics, in the development of its QMS, has excluded the requirements of ISO 9001:2008 sub-clause 7.3 Design and development. XYZ Electronics considers the customer specifications as a customer supplied product and therefore controls this according to ISO 9001:2008 sub-clause 7.5.4 Customer property.
Can the XYZ Electronics exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?
Scenario 3 :
Regulators permit the exclusion of design development
KML designs and fabricates pressure vessels for electricity generating stations, in accordance with various mandatory pressure vessel regulations. The regulatory authority has not yet revised its requirements to take ISO 9001:2008 into account, but has confirmed that it will continue not to require manufacturer’s QMSs to include design. On this basis KML decides to exclude sub-clause 7.3 Design and development from its QMS and to claim conformity to ISO 9001:2008.
Can KML exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?
Scenario 4 : Outsourced design and development activities
CDH Construction Ltd. provides engineering and construction services for various developers, but does not have in-house design capabilities. The company employs a project manager who is responsible for the management of design activities. These activities are outsourced to TPL Engineering Ltd, an engineering consulting company.
The activities of TPL Engineering Ltd. are managed through the application of the requirements of sub-clause 7.4 Purchasing. The project manager of CDH Construction Ltd. oversees the design activities and is involved in design review meetings and design verification and validation activities. In addition, the project manager is responsible for ensuring that the design activities are carried out in accordance with the requirements of ISO 9001:2008 sub-clause 7.3 Design and development. However, CDH Construction Ltd. has excluded subclause 7.3 Design and development from its QMS, since the design activities have been outsourced.
Can CDH Construction Ltd. exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?
exclude the traceability requirement of sub-clause 7. Traceability of the component parts of the product is not an internal or external requirement of this company. is a company that manufactures electric motors for sale by licensed distributors.5.Scenario 5 : Traceability Situation: AKP Corp. while claiming conformity to ISO 9001:2008. Issue(s): Can AKP Corp. The organization has excluded the traceability requirement of subclause 7.5.3 Identification and traceability from its QMS and claim conformity to ISO 9001:2008? .3 Identification and traceability from its QMS.
JWB developed its methodology and tools for performing customer’s internal audits based on the guidance of ISO 19011:2002.3 Design and development from its QMS and claim conformity to ISO 9001:2008? . Issue(s): Can JWB exclude sub-clause 7.Scenario 6 : Design of services Situation: JWB is a consulting firm that performs internal audits for small organizations that have implemented quality management systems that conform to ISO 9001:2008. it cannot have any design and development activities. The organization wishes to exclude clause 7. as a service provider.3 Design and development with the justification that. It delivers a customized service that has as its output a written internal audit report and all the supporting data from the audit.
any activity beyond that the sign-off would be subject to a supplementary contract.Control of production and service provision from its QMS and claim conformity to ISO 9001:2008? .Control of production and service provision. The consulting firm claims its QMS conforms to ISO 9001:2008 with the exclusion of post-delivery requirement (f) of sub-clause 7. The product delivered to its customers is an internal financial audit report.1.5. and that the customer has finally signed-off the report as being fully agreed.Scenario 7 : Post delivery activities Situation: The ABC consultancy organization provides financial auditing services to large manufacturing organizations.1. Issue(s): Can the ABC consultancy organization exclude the post-delivery requirement in bullet (f) of sub-clause 7. Contracts for internal financial audit services state that a contract is completed when ABC has issued. clarified and reviewed its report with the customer.5.
2 Validation of processes for production and service provision.5.5. with the exclusion of sub-clause 7. Issue(s): Can the small garment manufacturer exclude sub-clause 7.Scenario 8 : Validation of processes Situation: A small garment manufacturer carries out cutting work on textiles that are delivered to an internal sewing department for the next phase of the process.2 Validation processes for production and service provision from its QMS and claim conformity to ISO 9001:2008? . The quality of the output of the cutting work can be checked after finalization of the work. It has implemented a QMS and claims conformity to ISO 9001:2008 .
In this process the participants practice the use of simple measuring equipment such as rulers.6 Control of monitoring and measuring devices. Issue(s): Can the small training organization exclude sub-clause 7. . and not the crafted items produced by the participants. The organization carries out practical skills training.6 Control of monitoring and measuring devices from its QMS and claim conformity to ISO 9001:2008. The training organization has implemented ISO 9001: 2000 QMS and claims conformity to the standard with the exclusion of sub-clause 7. The organization’s product is the skills development.Scenario 9 : Monitoring and measuring devices Situation: A small training organization provides training to people who are not currently working and would like to upgrade their skills. spirit levels and plumb lines.
all facilities have to comply with the contents of the corporate quality policy. not all facilities are required to obtain certification. all purchasing functions and sales and distribution contracts for its operations worldwide. Headquarters provides global support for quality management. manufactures. In addition. all of which are wholly owned by GTV. Global TV (GTV) is an organization that designs. and to continually improve the QMS”. GTV management has decided to implement ISO 9001:2008 in all its facilities worldwide. sells.Scenario 10 : Complex Organization (Global TV) 10. GTV sells its product to retail outlets. and expects all facilities of GTV to have their own quality management system (QMS). GTV consists of a design centre. a manufacturing centre and a distribution centre. which in-turn sell the TVs to end-user customers. However. . a sub-assembly plant. distributes and services televisions (TVs) worldwide.1 Introduction This example illustrates some of the key issues a multinational organization with multiple work centres faces when implementing ISO 9001:2008 throughout the entire organization. which is “To provide customers of GTV with products and services that meet their needs and expectations.
sub-assembly plant.. the design centre’s customers are the subassembly plant and the manufacturing centre). the number of centres and plants has been reduced to one of each (design centre.e. • • .2 Application to a complex organization (Global TV) we have to take into consideration the organization’s customer. ISO 9001:2008 allows for the exclusion of any requirement(s) within clause 7. The customer of the individual centres and plants is the centre or plant that receives its product (i. manufacturing centre and distribution centre). Global TV’s ultimate customer is the end user who purchases the product from a retail distributor. When applying clause 1. where such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.Scenario 10 : Complex Organization (Global TV) NOTE: • For the purpose of simplifying the example for a complex organization.
Scenario 10 : Complex Organization (Global TV) .
2: Manufacturing Centre (MC) Situation: MC receives orders from headquarters and delivers products to the distribution centre. It has established its QMS guided by. and b) Global TV headquarters is responsible for ensuring the Design Centre conforms to ISO 9001:2008.3 Design and development from its QMS and claim conformity with ISO 9001:2008? .3 Design and development from the scope of its QMS since it performs no design activities. and in conformity with.Scenario 10. All aspects of quality management required by ISO 9001:2008 are performed within the MC. with the sole exception of product design and development. the quality policy of GTV. The MC does include a statement and justification in its quality manual that it is excluding the product design and development process and further indicates that a) its customer is Global TV headquarters who provide orders to the manufacturing plant. Issue(s): Can the MC exclude Sub-Clause 7. The MC decided to exclude Sub-Clause 7.
Scenario 10. To date the only facility that has not implemented a quality management system is the Design Centre.3 : Global TV Situation: Global TV Headquarters distributes its products through retail outlets to the end user customer. The organization has implemented ISO 9001:2008 at it headquarters and has requested that all its facilities implement a quality management system conforming to ISO 9001:2008. Issue(s): Can Global TV claim conformity with ISO 9001:2008? . In its quality management system manual Global TV headquarters states that all of its facilities conform to ISO 9001:2008 and the organization has not taken any exceptions.
and not the end-user. The organization has responsibility for all ISO 9001:2008 requirements that can affect the organization’s ability to provide products that meet its customer and statutory and regulatory requirements.10. it has to ensure that all its relevant facilities are conforming to ISO 9001:2008. The organization’s individual facilities may exclude requirements within Clause 7 based on a justification making it clear that their customer is another division of the corporation. in order to claim conformity to ISO 9001:2008 at the corporate level.4 Summary Any complex organization (such as Global TV) has to be careful of its claim that its quality management system conforms to ISO 9001:2008. . The certificates of conformity referencing internal customers are of no direct value to the external customers of the organization. Therefore.
6 Records of assessment of product when calibration is out of tolerance 8.5 Records of design verification actions 7.1 Records determined by the organization to be necessary to ensure effective planning.3.3 Records of the nature of nonconformities and subsequent actions 8.5.g. damaged or unsuitable customer property 7.2.2 Records of design and development input 7.3.2 Records of review of customer requirements and follow-up actions 7.1 Records of the evaluation of suppliers 7.5.3. and experience 7.3 Records of the unique identification of product (traceability) • • • • • • • 7. skills.2.2 Records of education.18.104.22.168.6 Records of the results of calibration 7.6 Records of the basis of calibration used when no traceable standards exist 7. delivery notes and copies of purchase orders are not mentioned in that list but most organizations would want to keep them.5.4 Records of design and development review 7.1 Records of evidence that realization processes and product meet requirements 7.3.4 Records of lost.Mandatory records required by ISO 9001:2008 standard • • • • • • • • • • • • • 22.214.171.124 Records of person(s) authorizing release of product to the customer 8. .6 Records of design validation actions 7. operation and control of processes 5.2 Records of internal audits 8.5.2 Records of the results of corrective action taken 8.1 Records of management review 6.3 Records of the results of preventive action taken • PLUS… records the organization may choose to keep e.5.7 Records of design changes and results 7.2 Records of special process validations 7. training.
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