You are auditing a manufacturer of speciality tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
You: How do you determine the consistency of the product?
Operative: We conduct sensory tests to evaluate flavour and aroma and record the results. We then allocate a quality grade.
You: How can you ensure that results are consistent between operatives?
Operatives: The three of us in the lab are well-trained and very experienced. We use the Hedonic Scale method involving a 5-point scoring system.
You: Are operatives periodically calibrated to ensure consistency?
Operative: No, but we regularly ask each other for a second opinion in borderline cases.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001.

• A. Outsourcing the sensory testing to an accredited laboratory.
• B. Sensory testing results are recorded.
• C. Operatives having a university degree in food science.
• D. The Hedonic Method is used to monitor the quality of the product.
• E. Safe disposal of the tested product.
• F. Laboratory staff routinely tested for respiratory ailments.
• G. Independent experts were brought in to review test processes.
• H. Analysis of the results of sensory tests.

Which two of the following may be changed once a Stage 2 certification audit has commenced?

• A. Agreed standard for the audit criteria
• B. Audit scope
• C. Agreed language of the audit
• D. Audit checklist
• E. Audit plan
• F. Increase of audit duration

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry.
The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
When reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer over damage to an expensive cashmere coat.
Select the best option for how this should be handled by the Quality Management System.

• A. Report the situation to the customer with suggested remedial action.
• B. Give an explanation to the customer of what went wrong.
• C. Settle the court case by negotiation with the customer.
• D. Make an offer to replace the coat with a new one.

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 Quality Manager 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?

• A. The organisation needs to delay its certification to gain more experience of the QMS.
• B. The responsibility for checking printing needs to be independent of the operators.
• C. More process time needs to be allocated to the new employees.
• D. The recruitment process to include spelling tests to filter out unsuitable candidates.
• E. A plan to determine why the errors occur and to prevent them.
• F. A business consultant can be recommended for advice on improving operations.
• G. Operational planning activities may benefit from a clearer risk-based approach.
• H. An intensive training plan that involves all production personnel.

You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: " Why are these plastic items being rejected at this stage? "
Auditee: " They do not meet our processing standards. "
You: " What is the reason for that? "
Auditee: " These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials. " You: " What happens to the rejected items? " Auditee: " Some get melted down in another process later on, and some are disposed of as waste products that cannot be recycled. " You: " What happens to the waste products? " Auditee: " I ' m not sure. I suppose they go to landfill. " After further auditing, you have gathered additional evidence. Match the following statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.