01 - Internal Audit - Quality System

• Site conducted

  Select

• Audit Number

  Date

• Conducted on

  Date

• Auditor

• Auditee

• Audit covering the following aspects of the quality system. Control of Documents and Records, Management Review, Quality Objectives, Quality Policy, Quality Manual, Internal Audits, Supplier Controls, Calibration Control, Customer Complaints, Internal NCR's. This audit covers the requirements of both ISO 9001 and ISO13485 and internal procedures identified.

  Drawing

• Has the quality policy been reviewed in the last 12 months / Year?

  Yes

  No

  N/A

• How is the quality policy communicated internally and externally?

• Has the scope of the quality system been defined in the quality manual?

  Yes

  No

  N/A

• Does this match the scope of the current ISO certificates?

  Yes

  No

  N/A

• Are there any exemptions that have been identified within the quality manual?

  Yes

  No

  N/A

• List the exemptions highlighted?

• Have the interested parties been defined?

  Yes

  No

  N/A

• Have these been reviewed?

  Yes

  No

  N/A

• Does the quality manual and policy show management comment to the quality system?

  Yes

  No

  N/A

• Have Staff Roles and Responsibilities been defined?

  Yes

  No

  N/A

• Has a management review taken place in the documented time period?

  Yes

  No

  N/A

• Is this inline with the management review procedure?

  Yes

  No

  N/A

• Have the previous management review actions been reviewed closed?

• Have any changes to the quality system been identified?

  Yes

  No

  N/A

• Have these been planned or actioned?

  Yes

  No

  N/A

• Does the management review agenda cover all the requirements identified in both ISO13485 and ISO 9001?

  Yes

  No

  N/A

• Have any opportunities for improvement been identified?

  Yes

  No

  N/A

• Have quality objectives been reviewed and set?

  Yes

  No

  N/A

• Have resource requirements been identified and planned for?

  Yes

  No

  N/A

• Does this cover training, equipment, IT and facility requirements?

  Yes

  No

  N/A

ISO Requirements / Clauses

• ISO13485 - 4.1 General Requirements

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 4.2.2 Quality Manual

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.1 Management commitment

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.3 Quality Policy

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.4.2 Quality management system planning

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.5.1 Responsibility and authority

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.5.2 Management representative

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.6.1 Management review general

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.6.2 Review Input

  Compliant

  Non-Compliant

  N/A

• ISO13485 - 5.6.3 Review Output

  Compliant

  Non-Compliant

  N/A

• Is there an audit plan defined?

  Yes

  No

  N/A

• Does this show the next planned audit date as well as the last completed audit?

  Yes

  No

  N/A

• Does the plan cover all the processes and all areas of the standard?

  Yes

  No

  N/A

• Have audits been conducted as per the plan?

  Yes

  No

  N/A

• Have any audits created NCR's

  Yes

  No

  N/A

• Have the NCR's been actioned and closed off?

  Yes

  No

  N/A

• Have the internal audits been conducted by an independent auditor?

  Yes

  No

  N/A

• Have the audits been conducted by trained auditors?

  Yes

  No

  N/A

• Have any supplier audits been conducted?

  Yes

  No

  N/A

• Yes

  No

  N/A

• Has supplier performance been monitored?

  Yes

  No

  N/A

• Are key suppliers certification details up to date?

  Yes

  No

  N/A

• Is objective evidence collected during the audit?

  Yes

  No

  N/A

• Check a number of procedures, do these have correct revisions and revision history information?

  Yes

  No

  N/A

• Is access to the procedures available at the point of use?

  Yes

  No

  N/A

• Are these protected form changes?

  Yes

  No

  N/A

• Is there a change process in place?

  Yes

  No

  N/A

• Is there evidence that the change process is being used?

  Yes

  No

  N/A

• Are document and record retention periods defined?

  Yes

  No

  N/A

• Are these correct to both standards and customers requirements?

  Yes

  No

  N/A

• Are records controlled and easy to retrieve?

  Yes

  No

  N/A

• Are electronically stored records backed up?

  Yes

  No

  N/A

• Are quality forms identified and controlled?

  Yes

  No

  N/A

• Is there a list of calibrated equipment?

  Yes

  No

  N/A

• Is there any items that are currently out of calibration?

  Yes

  No

  N/A

• Are these available to production?

  Yes

  No

  N/A

• Check a selection of equipment on the shop floor and record the details.

• Are the items in the system?

  Yes

  No

  N/A

• Are these in calibration?

  Yes

  No

  N/A

• Are these identified as being calibrated?

  Yes

  No

  N/A

• Check an externally calibrated item and record the details?

• Does this have a calibration certificate?

  Yes

  No

  N/A

• Is the certificate UKAS accredited?

  Yes

  No

  N/A

• Is the certificate traceable to national standards?

  Yes

  No

  N/A

• Have the calibration parameters been defined?

  Yes

  No

  N/A

• Has the item passed the calibration requirements?

  Yes

  No

  N/A

• Have the results been defined as acceptable?

  Yes

  No

  N/A

• Is this documented?

  Yes

  No

  N/A

• Have any items been calibrated internally?

  Yes

  No

  N/A

• Is there a record of how it was calibrated?

  Yes

  No

  N/A

• Are the calibration results available for review?

  Yes

  No

  N/A

• Is the equipment that was used to calibrate the items calibrated?

  Yes

  No

  N/A

• Yes

  No

  N/A

Customer Complaints

• How are customer complaints received from the customer?

• How are these identified as customer complaints?

• What type of complaints do we receive from our customers?

• Are all complaints logged on the system?

  Yes

  No

  N/A

• How are these logged on the system?

• How many open Customer complaints are on the system?

• How many of these have route causes and corrective actions identified?

• Are there any customer complaints waiting to be logged?

  Yes

  No

  N/A

• What complaints are still record?

• Have these got customer communication information?

• What is the oldest date for open customer complaints?

  Date

• Can we see our performance in the time resolving the customer Complaints?

• What is our current customer complaint / return figure?

NCR's

• How are NCR's logged?

  Yes

  No

  N/A

• Can you tell on the system what the NCR's are linked to?

  Yes

  No

  N/A

• How many NCR's are currently open?

  Yes

  No

  N/A

• Review a selection, have all reviewed NCR's got corrective and preventative actions?

  Yes

  No

  N/A

• Can you tell the split of raised NCR's between internal and customer complaints?

• Can you tell if the corrective actions have resolved the identified NCR?

• Have any trends been identified?

  Yes

  No

  N/A

Preventative actions

• Do both customer complaints and NCR's have preventative actions?

  Yes

  No

  N/A

• Are pFMEA's available if required?

  Yes

  No

  N/A

• Are risk assessments' reviewed?

  Yes

  No

  N/A

• Is the effectiveness of preventative actions recorded?

  Yes

  No

  N/A

Process Improvements

• Have any process improvements been made?

  Yes

  No

  N/A

• How are these logged or captured?

  Yes

  No

  N/A

• Is there a process improvement plan defined?

  Yes

  No

  N/A

• What is this and where is it documented?

• Yes

  No

  N/A

Validation

• Are there any current validations for our processes?

  Yes

  No

  N/A

• Are these documented in the quality system?

  Yes

  No

  N/A

• Do these follow the IQ,PQ and OQ methodology?

  Yes

  No

  N/A

• Are these processes monitored?

  Yes

  No

  N/A

• Check a sample of the records produced, are these complete and correct?

  Yes

  No

  N/A

• Is there any processes that require validation?

  Yes

  No

  N/A

• Has supporting processes such as IT systems been validated?

  Yes

  No

  N/A

Verification

• Can completed production records be retreived?

  Yes

  No

  N/A

• Take a sample and check that these are complete.

  Yes

  No

  N/A

• Are there any records captured by electronic means (Eg information from SFDC)?

  Yes

  No

  N/A

• Do these records contain all the required information previously held on paper forms?

  Yes

  No

  N/A

• Do we monitor customer satisfaction?

  Yes

  No

  N/A

• How is this monitored?

• How is this communicated to the team?

• How is customer satisfaction measured?

• How do we track our communication with our customers?

• undefined

• This section is to be conducted on review of the above questions after the audit has taken place.

ISO 13485 Requirements

• ISO 13485 - 4.1 General Requirements - Quality management system

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 4.2.1 General Documentation requirements

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 4.2.2 Quality manual

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 4.2.3 Medical device

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 4.2.4 Control of Documents

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 4.2.5 Control of records

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.1 Management commitment

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.3 Quality policy

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.4.1 Quality objectives

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.4.2 Quality management system planning

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.5.1 Responsibility and Authority

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.5.2 Management representative

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.5.3 Internal communication

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.6.1 General - Management review

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.6.2 Review Input

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 5.6.3 Review output

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.1 Planning of product realization

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.2.3 Customer communication

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.5.6 Validation of processes for production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 7.6 Control of monitoring and measurement equipment

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.1 General - Measurement, analysis and improvement

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.1 Monitoring and measurement feedback

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.2 Complaint handling

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.3 Reporting to regulatory authorities

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.4 Internal audit

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.5 Monitoring and measurement of processes

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.2.6 Monitoring and measurement of product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3.1 General - Control of nonconforming product

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3.2 Actions in response to nonconforming product detected before delivery

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3.3 Actions in response to nonconforming product detected after delivery

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.3.4 Rework

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.4 Analysis of data

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.5.1 General - Improvement

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.5.2 Corrective action

  Compliant

  Non-Compliant

  N/A

• ISO 13485 - 8.5.3 Preventive action

  Compliant

  Non-Compliant

  N/A

ISO 9001 Requirements

• ISO 9001 - 4.1 understanding the organization and its context

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 4.2 Understanding the needs and expectations of interested parties

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 4.3 Determining the scope of the quality management system

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 4.4 Quality management system and it processes

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 5.1 Leadership and commitment

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 5.2.1 Establishing the quality Policy

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 5.2.2 Communicating the quality policy

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 5.3 Organizational roles, responsibilities and authorities

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 6.1 Actions to address risk and opportunities

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 6.2 Quality objectives and planning to achieve them

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 6.3 Planning of changes

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.1.5 Monitoring and measuring resources

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 7.4 Communication

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.1 Operational planning and control

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.2.1 Customer Communication

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5.1 Control of production and service provision

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.5.5 Post-delivery activities

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.6 Release of products and services

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 8.7 Control of nonconforming outputs

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.1.1 General - Monitoring, measurement, analysis and evaluation

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.1.2 Customer satisfaction

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.1.3 Analysis and evaluation

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.2 Internal audit

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.3.1 General - Management Review

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.3.2 Management review inputs

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 9.3.3 Management review outputs

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.1 General - Improvement

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.2 Nonconformity and corrective action

  Compliant

  Non-Compliant

  N/A

• ISO 9001 - 10.3 Continual improvement

  Compliant

  Non-Compliant

  N/A