Title Page
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Site conducted
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Audit Number
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Conducted on
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Auditor
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Auditee
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The scope of this internal audit to check the effectiveness of the quality system with regards to planning and production controls to the standards ISO9001 & ISO 13485. This includes our own internal procedures and the clauses represented in the above standards.
Production Planning
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How do you know what is required to be produced?
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What do you check before the works orders a raised for production?
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Is this documented?
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Check some examples of record the details.
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How are works orders created for the demand?
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Do you change current works orders if that demands increases or keep with new works orders?
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What would stop you increasing the original works order?
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Can you see what sales orders the works orders are linked to?
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Do you acknowledge the expected delivery date to the customer?
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What do you do if this date changes at any point?
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What do you do if the customers required date can not be met?
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Can you see if we have the required raw materials and bought in parts to complete the order?
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Can you see the availability of machines that is going to produce the parts?
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How do you plan the machine that is going to produce the work?
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How do you know if a program is available for that machine?
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How is this communicated to the operators?
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Are other areas of the production flow planned, such as finishing and quality?
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How do you know what materials are to be issued to a works order?
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How do you issue the parts?
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What do you do if the material or components are not available for the planned date?
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What do you do if an alternative size or specification of material can be used?
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What do you do if the process requires more materials?
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Can you see where on the shop floor each works order is?
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Can you see the status / progress of each works order?
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Can you see if an issue has been identified?
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How is the above information communicated to other departments?
Manufacturing Process
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How is information captured for each works order?
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What information is captured?
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Check a sample of works orders, have these been logged onto?
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Does work flow as per the created operations on the works order?
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Does this change at any point?
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What do you do when it does change?
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How is the process updated if we change the works order?
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Check a sample of works orders orders for the following?
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Is it at the correct operation?
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Is a drawing available?
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Is the revision of the drawing correct to the works order?
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Is the correct quantity of items available? (Check to see what has been booked on the system)
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Are there any instructions to be followed?
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Have these been followed?
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Is the Q074 available?
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Have they been correctly filled in?
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Has the fist off inspection requirement been completed?
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Is the work in progress correctly identified?
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Has line clearance been completed in the area?
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Are all required tools and gauges available for the operator?
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Is there any calibrated tools?
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Check that these are calibrated on the system.
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Are there any PPM / Check folders for the area?
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Have these been completed?
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Are there any validated processes being used?
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Do these have any thing that is monitored?
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Has the correct requirements been checked as per the validation?
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Is there anything At Risk?
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Have these been correctly identified?
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Have these been logged on the system?
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Is there anything that should be scrapped?
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Has this been correctly identified?
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Why has this not been scrapped and removed from the shop floor?
Sub Contract processes
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Is there anything being processed that requires a sub contract process?
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What is the sub contract requirement?
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Is this currently in progress?
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Do you know when this is due back to us?
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Is there a price and purchase order for the process?
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Do we have a lead time for the process?
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Is there a specification being sent to the sub contract process?
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Are the items inspected when these are received?
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How are rejects highlighted if the sub contract process is rejected?
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How do we book in subcon and issue them to the works order?
Packing and Despatch
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Are there any items packed or waiting to be packed?
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Have all the operations been completed?
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Does the physical quantity match the system quantity?
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Are there any defined customer packing requirements?
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Are the items packed in a way to prevent damage?
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Are there any extra items such as IFU's or quality documents such as FAIR's required for the items?
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Are these available?
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Has the C of C's been produced?
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Do these show the correct business details?
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Do they cover any documented processes such as heat treatment or passivation?
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Do they have the correct raw materials certificate information attached?
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Have these been either printed and put with the goods or sent to the customer?
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Have delivery notes been produced?
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Are these correct to the physical items being shipped?
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Do these match the customer order?
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Can you ship more than one order on the same delivery note?
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Has this been printed and packed with the items?
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Is the delivery on time to the customers required date?
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Is this fully complete or a part shipment?
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Has the courier been requested?
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Have we charged for the shipping?
Training / Health and Safety / Environment
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Is the operator conducting the work trained for that role?
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Is the operators training matrix up to date?
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Has the operator conducted all safety checks before using any machinery?
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Is the operator wearing the correct PPE for that area?
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Is the operator following the correct safe system of work?
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Is the area clean and tidy?
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Are the walkways clear and easy accessible?
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Is the lighting in the area adequate to complete the tasks required?
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Is the work in progress stored in a way to prevent damage to the items?
ISO 13485 Requirements / Clauses
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Once audit has been completed review the above findings and complete the following sections.
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ISO 13485 - 4.2.3 Medical device file
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ISO 13485 - 4.2.4 Control of documents
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IS0 13485 - 4.2.5 Control of records
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ISO 13485 - 6.2 Human resources
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ISO 13485 - 6.3 Infrastructure
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ISO 13485 - 6.4.1 Work environment
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ISO 13485 - 6.4.2 Contamination control
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ISO 13485 - 7.1 Planning of product realisation
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ISO 13485 - 7.2.3 Communication
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ISO 13485 - 7.3.10 Design and development files
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ISO 13485 - 7.4.1 Purchasing process
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ISO 13485 - 7.4.3 Verification of purchased product
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ISO 13485 - 7.5.1 Control of production and service provision
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ISO 13485 - 7.5.6 Validation of processes for production and service provision
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ISO 13485 - 7.5.8 Identification
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ISO 13485 - 7.5.9 Traceability
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ISO 13485 - 7.5.11 Preservation of product
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ISO13485 - 7.6 Control of monitoring and measuring equipment
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ISO 13485 - 8.1 General - Measurement, analysis and improvement
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ISO 13485 - 8.2.5 Monitoring and measurement of processes
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ISO 13485 - 8.2.6 Monitoring and measurement of product
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ISO 13485 - 8.4 Analysis of data
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ISO 13485 - 8.3 Control of nonconforming product
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ISO 13485 - 8.5.2 Corrective action
ISO 9001 Requirements / Clauses
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ISO 9001 - 7.5.2 Creating and updating
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ISO 9001 - 7.5.3 Control of documented information
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ISO 9001 - 7.2 Competence
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ISO 9001 - 7.3 Awareness
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ISO 9001 - 7.1.3 Infrastructure
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ISO 9001 - 7.1.4 Environment for operation of processes
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ISO 9001 - 8.1 Operational planning and control
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ISO 9001 - 8.2.1 Customer communication
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ISO 9001 - 8.4.1 General - Control of externally proved processes, product and services
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ISO 9001 - 8.4.2 Type and extent of control
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ISO 9001 - 8.4.3 Information for external providers
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ISO 9001 - 8.6 Release of products and services
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ISO 9001 - 8.5.1 Control of production and service provision
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ISO 9001 - 8.5.2 Identification and traceability
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ISO 9001 - 8.5.4 Preservation
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ISO 9001 - 7.1.5 Monitoring and measuring resources
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ISO 9001 - 9.1.1 General - Monitoring, measurement, analysis and evaluation
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ISO 9001 - 9.1.3 Analysis and evaluation
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ISO 9001 - 8.7 Control of nonconforming outputs
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ISO 9001 - 10.2 Nonconformity and corrective action
