An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The QualityManager wants the ISO 9001 certificate to cover the new contract.During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which three of the following options would represent acceptable opportunities for improvement in the report?
Answer(s): A,C,E
According to the ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities1, an improvement opportunity is a suggestion made by the auditor for the auditee to consider that, if implemented, may enhance the performance of the QMS. Improvement opportunities are not mandatory, but they should be based on objective evidence and aligned with the audit criteria and objectives. Improvement opportunities should also be realistic, feasible, and beneficial for the auditee. In this case, the evidence statements that represent acceptable improvement opportunities in the report are A, C, and E, because they address the potential causes and effects of the spelling errors in the print run, and propose possible actions that may improve the quality of the products and services, and the effectiveness of the QMS. These options are consistent with the requirements and principles of ISO 9001, such as clause 6.1 on actions to address risks and opportunities, clause 8.1 on operational planning and control, clause 8.5.1 on control of production and service provision, and clause 10.2 on nonconformity and corrective action. The other options are not appropriate improvement opportunities, because they are either irrelevant, unrealistic, or unhelpful for the auditee. For example, option B may contradict the audit objective and scope, option D may imply a lack of auditor competence or impartiality, option F may not address the root cause of the problem, option G may not be applicable or effective, and option H may not be feasible or justified.
ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities, ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.
Answer(s): D,E,G
You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.You: "How do you tell when the billet is ready for the rolling stage?"Operator: "I've done this job for 20 years. I can tell by the bright red colour."You: "What happens if the colour is wrong?"Operator: "The billet goes back into the furnace."You: "Is the pyrometer ever used?"Operator: "Only in borderline cases."You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.
Answer(s): A,E,F
According to ISO 9001:2015, clause 9.1.1, the organization is required to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results, and when the monitoring and measuring shall be performed. The organization is also required to retain appropriate documented information as evidence of the results.Therefore, in the scenario given, the organization should have planned for monitoring and measuring the billet temperature, as it is a critical factor for the quality of the product and the process. The organization should also have established a procedure that provides instruction in taking billet temperature, using the pyrometer or other suitable methods, to ensure consistency and accuracy. The organization should also have performed periodic analysis of the results of temperature checks, to identify trends, problems, and opportunities for improvement. Hence, the options that would provide evidence of conformance with clause 9.1.1 of ISO 9001 are A, E, and F, as they are aligned with the requirements of the clause. The other options are either irrelevant or not directly related to clause 9.1.1, as they do not pertain to the monitoring and measurement of the billet temperature.
ISO 9001:2015(en), Quality management systems -- Requirements, clause 9.1.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
DRAG DROPYou are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer(s): A
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.TableAudit evidenceISO 9001 Clause 8 extractFour of the 10 pallets of stock sampled in the warehouse were not labelled. "8.5.2 ... shall use suitable means to identify outputs ..." A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor. "8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..."One of the fork-lift truck drivers had no fork-lift truck driving licence. "8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..."There was no pest control provision in the warehouse."8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full."8.1 ... shall plan, implement and control the processes ..."
DRAG DROPYou are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five yearsYou are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.TableAudit evidenceISO 9001 Clause 8.3 extractHalf of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products. "8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT."8.3.5 ... retain documented information ..."The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT."8.3.6 ... retain documented information ..."The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch."8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development. "8.3.2 e) ... external ... resource needs for the design and development of products ..."
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