• Enter the unique number for this audit taken from the schedule in IsoXpress.

WHAT WAS AUDITED

  • Name of personnel spoken to.

  • What Standard was used as reference in this Internal Audit?

  • What process was audited?

Section 1: CUSTOMER FOCUS

  • 1.1. Does the company or department understand customer needs and requirements? ISO 9001:2008 REFERENCE: Section 5.2 and 8.2.1.

  • 1.2. Does a meeting take place with relevant people to discuss customer requirements? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 5.4.1 and 7.2.

  • 1.3. Are the shop floor personnel fully aware of the customer needs and specifications? (Check and Evidence) ISO 9001:2008 REFERENCE: Section 5.1, 8.2.1 and 7.2.1.

  • 1.4. Is the system and process capable of delivering customer satisfaction? If not is the customer notified? ISO 9001:2008 REFERENCE: Section 7.2, 5.5.2 and 8.2.1.

  • 1.5. Does the company give feedback to its customers? ISO 9001:2008 REFERENCE: Section 8.5 and 5.2.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 2: LEADERSHIP - Objectives and Targets. Recent changes explained to employees.

  • OBJECTIVES, TARGETS AND KPI's.

  • 2.1. OBJECTIVES: Do we have objectives what we're trying to achieve? ISO 9001:2008 REFERENCE: Section 5.3, 5.4.1 and 8.2.3

  • 2.2. TARGETS: Are Objectives being achieved? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 8.2.3 and 5.5.3.

  • 2.3. Key Performance Indicators (KPI's): Are objectives & targets being achieved and recorded? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 4.2.4.

  • 2.4. Has there been any change in the business that may affect any process controls. ISO 9001:2008 REFERENCE: Section 6.4, 6.2.1 AND 6.2.2.

  • 2.5. Do you have a PD & if so when it was last reviewed? ISO 9001:2008 REFERENCE: Section 5.5.1.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 3: INVOLVEMENT OF PEOPLE.

  • 3.1. Are people communicated to on a daily bases to any changes in the quality system or requirements? ISO 9001:2008 REFERENCE: Section 5.5.3.

  • 3.2. How does communication occur? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 5.5.3 AND 7.2.3.

  • 3.3. Have people been trained (skill & competence) (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 6.2.2.

  • 3.4. Have all the activities been carried out by the responsible people? ISO 9001:2008 REFERENCE: Section 6.2.1.

  • 3.5. Do people have the resources to carry out they duties efficiently? ISO 9001:2008 REFERENCE: Section 6.2.1 and 6.2.2.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 4: PROCESS APPROACH: (CONTROLS, INFORMATION FLOW & EVIDENCE AND DOCUMENTATION)

  • 4.1. Are the controls defined by work instructions? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 4.2.2, 4.2.3, 6.2.2 and 7.5.

  • 4.2. Are there any product / service specifications? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 7.3.

  • 4.3. Are peoples responsibilities defined and communicated to? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 5.5.1 and 7.1.

  • 4.4. Are Work Instruction generated and controlled by the Integrated Management System (IMS) - IsoXpress? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 4.2.3.

  • 4.5. Are the acceptance and the rejection criteria having controls & checkpoints? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 8.2.3, 8.2.4, 8.3, 8.5.2 and 8.5.3.

  • 4.6. Is the process capable of delivering customer needs? Is the process capable of delivering customer needs?

  • 4.7. Is the process controlled as per the work instructions etc.? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 8.1.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 5: SYSTEM APPROACH TO MANAGEMENT (INPUTS & OUTPUTS)

  • 5.1. INPUTS: (Customer requirements that triggers the process) What inputs? Where from? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 4.2, 5.4.1 and 8.5.1.

  • 5.2. OUTPUTS: (Is what is manufactured to customer specifications) What checks are made on it? How? What with? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 5.4.2 and 6.1.

  • 5.3. Are specifications achieved? Feedback from customers and In-process checks? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 8.2.2 and 8.5.1.

  • 5.4. Value added activities: Downstream processes, what are they! If any? ISO 9001:2008 REFERENCE: Section 4.1 and 8.5.1.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 6: CONTINUAL IMPROVEMENT (Recent Corrective Actions and Internal Audits - Past 12 Months)

  • 6.1. Have all corrective action be addressed and closed off in a timely manner? ISO 9001:2008 REFERENCE: Section 4.1, 5.4.1 and 8.

  • 6.2. Have all effective QA / QC Checks been conducted and recorded? How does it impact on customer? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 8.5.3.

  • 6.3. EQUIPMENT: Suitable, calibrated and maintained? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 6.1 and 8.2.3.

  • 6.4. MAINTENANCE: Where might a failure be identified? Are check sheets generated for critical equipment? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 5.1 and 8.1.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 7: FACTUAL APPROACH TO DECISION MAKING

  • 7.1. How do you analyse quality KPI’s? Are they displayed and were? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 4.2.4, 7.4.3 and 8.4.

  • 7.2. Are all personnel fully trained, and deemed competent in their respective role? How is this done? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 6.2.2.

  • 7.3. Are existing work instructions or technical specifications effective in the training of personnel? (Last review date) (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 6.2.2 and 8.2.3.

  • 7.4 How do you maintain calibration measurement equipment? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 5.4.1, 7.6 and 8.1.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 8: MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

  • 8.1. Do you have an approved supplier list? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1 and 7.4.1.

  • 8.2. How do you evaluate / re-evaluate suppliers? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 4.1, 7.4.1 and 8.5.1.

  • 8.3. Have you had any quality issues from any of your suppliers? If so, are they been recorded into the works CAR system? (Evidence and Proof) ISO 9001:2008 REFERENCE: Section 7.3.1.

  • 8.4. Is supplier communication effective?(Evidence and Proof) ISO 9001:2008 REFERENCE: Section 7.3.1.

  • Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

OBSERVATIONS

  • What was seen, specific reference to evidence

DISCREPANCIES

  • Describe any discrepancies witnessed

OPPORTUNITIES FOR IMPROVEMENT

  • Describe any ideas which might improve the process, and explain why

AREAS OF CONCERN AND PROPOSED CORRECTIVE ACTION

  • Describe what can be done to rectify the situation

  • Has this action been added to the Corrective Action Report Register in IsoXpress to monitor completion?

AUDIT SIGN OFF

  • Select the date by which this activity must be completed

  • Enter the date on which the action was seen to have been effective, and on which the audit was closed

  • Auditor

  • Signature of audited person responsible for corrective action

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