AS9100 Audit/ By Section

• Site conducted

  Derby

  Bengaluru

  Mazeres

• Conducted on

  Date

• Auditor

• Process

ISO9001:2015 Section- CONTEXT [4]

• Is the context of the Organisation up to date?

  Compliant

  Non-Compliant

  N/A

• Are documents that support the context of the organisation available and up to date?

  Compliant

  Non-Compliant

  N/A

• Have interested parties been identified for the business?

  Compliant

  Non-Compliant

  N/A

• Can you tell me who in the business manages the interested parties list? What is their position within the company?

  Compliant

  Non-Compliant

  N/A

• How has ISO9001 been integrated into the organisations Quality Management system and their business processes?

  Compliant

  Non-Compliant

  N/A

• Are all applicable activities covered by the QMS scope?

  Compliant

  Non-Compliant

  N/A

• Are any exclusions from ISO9001 documented and properly justified in the Quality Manual?

  Compliant

  Non-Compliant

  N/A

• Are top level processes identified within the Quality Manual, is the sequence and interaction accurate? (Process flow?)

  Compliant

  Non-Compliant

  N/A

• Are processes being measured for effectiveness somehow?

  Compliant

  Non-Compliant

  N/A

• Are process resources (People, facilities and equipment) being measure somehow?

  Compliant

  Non-Compliant

  N/A

• Does each top-level process have people assigned for the responsibility and authority?

  Compliant

  Non-Compliant

  N/A

• Does management seek to improve processes over time?

  Compliant

  Non-Compliant

  N/A

Policy

• Can you show me where to access the Quality Policy?

  Yes

  No

  N/A

• Is the policy signed and dated?

  Yes

  No

  N/A

• Has the policy been distributed? Is it available to all employees and visitors?

  Yes

  No

  N/A

• Does it include a statement about ‘satisfying applicable requirement’s and ‘continual improvements’?

  Yes

  No

  N/A

Management

• Does top management communicate the importance of the QMS to all staff?

  Yes

  No

  N/A

• Did management develop the Quality Policy and objectives?

  Yes

  No

  N/A

• Does top management engage, direct and support other staff members responsible for the QMS?

  Yes

  No

  N/A

• Overall, is there a general sense that top management takes overall responsibility of the QMS?

  Yes

  No

  N/A

• Are company roles and responsibilities defined and communicated throughout the company?

  Yes

  No

  N/A

• Have Risks and opportunities been identified that can affect conformity of the organisations’ products or services?

  Yes

  No

  N/A

• Does management review the risks and opportunities?

  Yes

  No

  N/A

• Are actions taken to mitigate risk and maximise opportunities?

  Yes

  No

  N/A

• Are Quality objectives established and recorded?

  Yes

  No

  N/A

• Have plans been put in place to achieve the Quality Objectives? Where is this information?

  Yes

  No

  N/A

• Is management reviewing the objectives and taking actions to achieve them?

  Yes

  No

  N/A

• Is there a change management procedure, Is it being followed?

  Yes

  No

  N/A

• Are changes to the Quality Management system done in a controlled manner?

  Yes

  No

  N/A

Resource

• Are equipment and facilities implemented to support the QMS and ensure product Quality?

  Yes

  No

  N/A

• Is there maintenance of facilities and equipment to ensure their adequacy?

  Yes

  No

  N/A

• Is there a preventative maintenance method or procedure, is this being followed?

  Yes

  No

  N/A

• Are any special environments (clean rooms/inspection areas) properly controlled to ensure product quality?

  Yes

  No

  N/A

Measurement Traceability

• Is a procedure present for control of monitoring and measurement, is it being followed?

  Yes

  No

  N/A

• Are the devices adequate for the measurements which need to be taken (within the range, tolerance etc.)?

  Yes

  No

  N/A

• Is calibration carried out against traceable standards?

  Yes

  No

  N/A

• Is an equipment/calibration register present?

  Yes

  No

  N/A

• Does the register identify the following?

• Type

• Identification

• Location

• Frequency

• Calibration Status

• Are all activities captured which could invalidate the calibration, e.g., adjustments, damage and deterioration?

  Yes

  No

  N/A

• Pick an item and random and enter the number below, is the equipment compliant and up to date?

• Identification

• Calibration Status

• Is the equipment compliant?

Competence

• Are records of competence available?

  Yes

  No

  N/A

• Please provide evidence of how the competence records are maintained

  Yes

  No

  N/A

• Are there records of training (including induction, classroom, on the job training etc.)?

  Yes

  No

  N/A

Documented Information & Control

• Is there a procedure for documented information?

  Yes

  No

  N/A

• Select a document at random

• Identification

• Does the document display the appropriate description and identification?

• Has the document been reviewed/approved?

  Pass

  Fail

  N/A

• Are all documents controlled to ensure only latest revisions are available?

  Yes

  No

  N/A

• Does the QMS include the following required Documents?

• Scope of the QMS

• Quality Policy

• Quality Objectives

• Quality Manual

• Does the QMS include the following required Procedures?

• Contract Review

• Control of monitoring and measurement

• Customer returns

• Interested parties and risk matrix

• Manufacturing

• Purchasing

• Supplier Control

• Nonconformance Control

• Inspection

• Control of documented information

• HR, Training and development

• Does the QMS include the following required Records?

• Calibration Records

• Training Records

• Contract reviews

• Supplier Approvals

• Material Traceability

• Routing documentation

• Inspection and test equipment

• Product nonconformance

• QMS Analysis and Effectiveness

• Internal audit records

• Management reviews

• Corrective Action records

• Are documents and records protected form loss or damage?

  Yes

  No

  N/A

• Are electronic records subject to secure backups?

  Yes

  No

  N/A

• Are only controlled documents in use?

  Yes

  No

  N/A

• Are external documents (standards etc.) also controlled?

  Yes

  No

  N/A

Awareness

• Are employees aware of how they contribute to the QMS and product Quality

  Yes

  No

  N/A

• Are employees aware of what could happen if the QMS does not succeed

  Yes

  No

  N/A

• Does the company have robust methods to communicate with customers, and to accept communication from them?

  Yes

  No

  N/A

Planning & Control

• Is an Operational risk assessment present?

  Yes

  No

  N/A

• Have the criteria for each manufacturing process been determined?

  Yes

  No

  N/A

• Are resource needs determined for each manufacturing process?

  Yes

  No

  N/A

• Are procedures developed to support manufacturing processes?

  Yes

  No

  N/A

• If the planning of operations is documented (quality plan, work card) is this sufficient for use?

  Yes

  No

  N/A

• In general, are the processes planned considering the customers product requirements?

  Yes

  No

  N/A

Requirements for Product

• Are customer questions related to jobs, product etc. routed and processed in an appropriate way?

  Yes

  No

  N/A

• Are customer requirements for product captured accurately?

  Yes

  No

  N/A

• Are these requirements reviewed before the company commits to delivering the product?

  Yes

  No

  N/A

• If a quote was prepared previously, is this reviewed against the incoming order and any deviations resolved with the customer?

  Yes

  No

  N/A

• Are there records of historic contract review?

  Yes

  No

  N/A

• Are any changes to all necessary documentation updated?

  Yes

  No

  N/A

External Control

• Is a purchasing procedure present and being followed?

  Yes

  No

  N/A

• Are suppliers subject to company controls to ensure the quality of purchased products and services?

  Yes

  No

  N/A

• Are suppliers evaluated against a criteria to ensure they meet company Quality Expectations?

  Yes

  No

  N/A

• Are supplier evaluations up to date?

  Yes

  No

  N/A

• Are items inspected at receipt?

  Yes

  No

  N/A

• Is the goods in procedure up to date and being followed?

  Yes

  No

  N/A

• Is the level of control for each supplier adjusted based on the level of risk or impact that supplier could have?

  Yes

  No

  N/A

• Are other verification activities being performed (supplier audits, on-site inspections, etc.)?

  Yes

  No

  N/A

• Are PO’s Reviewed before release to the supplier?

  Yes

  No

  N/A

• Do the PO’s include all necessary information about the items or services being purchased? (Description, quantity, due date, etc.)?

  Yes

  No

  N/A

• Are any requirements imposed by the customer transposed onto the PO to the supplier, if necessary?

  Yes

  No

  N/A

Product & Service Provision

• Is production provided with information describing the product to be made?

  Yes

  No

  N/A

• Are the facilities and equipment adequate to ensure the quality of the work?

  Yes

  No

  N/A

• Is product identified at all stages to maintain traceability?

  Yes

  No

  N/A

• Is product inspection status identified, (e.g. nonconforming product)?

  Yes

  No

  N/A

• Any products subject to individual serialisation, is this carried out, per requirements?

  Yes

  No

  N/A

• Is the product properly preserved during manufacture, handling and manufacturing steps?

  Yes

  No

  N/A

• Are products protected from contamination, foreign objects or other corruption?

  Yes

  No

  N/A

• Is product properly stored to prevent damage?

  Yes

  No

  N/A

• Are changes to manufacturing processes only implemented through a formal method that ensures the change are reviewed and authorised?

  Yes

  No

  N/A

Product Release

• Are final inspections conducted to ensure the product meets requirements before delivery?

  Yes

  No

  N/A

• If the product is shipped without final inspection, is this only done when approved by the customer?

  Yes

  No

  N/A

• Are final inspection records kept?

  Yes

  No

  N/A

• Do final inspections include; inspection results, inspectors name & Date?

  Yes

  No

  N/A

Non-conforming Output Control

• Is there a process for recording and managing non-conformance reports?

  Yes

  No

  N/A

• How are NCR’s captured?

  Yes

  No

  N/A

• Are nonconforming products properly identified and controlled in some manner to ensure they are not accidentally used or shipped?

  Yes

  No

  N/A

• Are dispositions and corrective actions appropriate as compared to the seriousness or risk of the nonconformity?

  Yes

  No

  N/A

• Does the company notify customers if nonconforming product is discovered after it has been delivered?

  Yes

  No

  N/A

Monitoring, Measuring, Analysis & Improvement

• Are methods underway to monitor and measure customer satisfaction?

  Yes

  No

  N/A

• Are Process KPI’s being measured?

  Yes

  No

  N/A

• Is there an assessment of the QMS activities and their effectiveness?

  Yes

  No

  N/A

• Are suppliers being measured for performance?

  Yes

  No

  N/A

Internal Audit

• Is there an internal audit procedure, is it being followed?

  Yes

  No

  N/A

• Are audits scheduled, and is a schedule or log managed?

  Yes

  No

  N/A

• Are ISO9001 clauses considered and addressed within the internal audits?

  Yes

  No

  N/A

• Are the selected auditor’s objective and impartial?

  Yes

  No

  N/A

• Are the audit reports communicated to the appropriate managers afterwards?

  Yes

  No

  N/A

• Are the corrective actions completed for audit findings/ nonconformities?

  Yes

  No

  N/A

• Are the audit records maintained properly?

  Yes

  No

  N/A

Management Reviews

• Are management reviews conducted?

  Yes

  No

  N/A

• Are management reviews scheduled?

  Yes

  No

  N/A

• What is the frequency of the management reviews?

  Yes

  No

  N/A

• Is there an agenda?

  Yes

  No

  N/A

• Does the management review include the status of the previous review?

  Yes

  No

  N/A

• Are minutes created, can evidence be provided?

  Yes

  No

  N/A

• Does the review include;

• Customer satisfaction & feedback

• Quality Objectives

• Process performance & conformity of product

• Status of corrective actions

• Internal audit results

• Supplier performance

• Adequacy of resource

• Opportunities for improvement

• Can opportunities for improvement be evidence?

  Yes

  No

  N/A

General

• Are any improvement efforts currently underway?

  Yes

  No

  N/A

Corrective Action

• Is a corrective action procedure available, is it being followed?

  Yes

  No

  N/A

• Are root causes determined prior to development of a corrective/preventative action plan?

  Yes

  No

  N/A

• Are the actions appropriate for the nature of the issue being reported?

  Yes

  No

  N/A

• Does root cause analysis include consideration of human error or human factors?

  Yes

  No

  N/A

• Are actions taken then later verified for effectiveness?

  Yes

  No

  N/A

• Are the records maintained properly?

  Yes

  No

  N/A

Continual Improvement

• Are improvements derived from data provided from management reviews, process measurements, product quality etc?

  Yes

  No

  N/A

• In general, is the company in pursuit of continual improvements of the Quality Management System and its’ processes?

  Yes

  No

  N/A