ISO 9001:2015 Supplier Audit Checklist

System & Process Compliance Auditing

Audit Findings
Audit Evidence
(Score ‘1’ per box)

TCOMPLIAN

MAJOR N/C
MINOR N/C
Re
Audit Question
f

Provide reference to documented information to justify the finding

Quality Management
Not provided
Is the quality system documented, controlled and maintained to
1 √ - Doc. Control procedure
clearly describe current practice?
Not provided
- SWOT analyses not attached
- Mission Vision and strategy
Evidence
Do quality reports, data analysis identify areas of opportunity
2 √ - Available Corporate and social responsibility Policy statement but no code
and are used by management on a routine basis?
and stamp was recorded
- Stake holders
- Available Context of the Org but no code, signature and stamp recorded

Not provided
Are quality-performance targets clearly defined, included in the -
3 √ - Targets, action plan and its traceability not attached
business plan and monitored for improvements?
- KPIs defined for each process.
4 Does executive management participate in periodic quality √ Not provided
system reviews that address quality-related feedback from - Human resources procedure
customers and internal quality metrics? - Job descriptions
- A process for establishment and maintenance of QMS, under the
responsibility of the QA department
- Provide a documented assignation of responsibilities and authorities to
ensure compliance of each processes
√ - Audit procedure; Corrective action status
- Quality meeting records not attached

Evidence:
Audit report form No: WH55-2008; Ref doc. No. not seen (2 doc. Numbers)
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

Audit Findings
Audit Evidence
(Score ‘1’ per box)

TCOMPLIAN

MAJOR N/C
MINOR N/C
Re
Audit Question
f

Provide reference to documented information to justify the finding

Continuous Improvement
Not provided
- Records of MR meetings
- Records of performance measurement, internal audits & action plans,
- Process map exists, no risks and opportunities were identified for each
process.
- No procedure for customer satisfaction surveys.
Are preventive actions taken based on the analysis of customer
5 √ - KPIs defined for preventive actions taken based on the analysis of customer
satisfaction surveys or other meaningful inputs?
satisfaction surveys or other meaningful inputs
No procedure of Continuous improve
Evidence:
- Customer Satisfaction Process is available but no code, signature and stamp
- Customer Survey is available Doc. Code WH 27 but Revision not recorded
- Customer Survey (WH 27) Company: LGUK Middlesbrough Date 26.06.19

Not provided
- Records of Management review meetings and corrective actions
Does the corrective action system cover customer, internal and - KPIs defined for corrective action system cover customer, internal and
6 √
supplier issues? supplier issues

Training & Awareness

7 Is the skill and education level required for each job √ Not provided
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

- Training & Awareness Procedure

- Records of personal competency
documented and appropriate training provided?
- Job descriptions
- Training records
Not provided
- Qualification records
8 Are suitable methods used to verify training effectiveness? √ - Records of testing
- Records of training effectiveness

Not provided
Job descriptions
- Job skills assessment, training records, training manual
- Training & Awareness Procedure
9 Are suitable records of maintained? √ - Annual training plan;
- Competence evaluation form
Training request form
Evidence:
Training matrix (WH 14) is available
Quality Planning
Not provided
- criteria for processes and acceptance for products and services
- inspection form & reports,
Are production samples inspected and provided to customers
10 √ - evidence availability of qualified resources
upon request, if where applicable?
Evidence:
Safe system of work, training and competency evaluation of chain sling
assembly Doc. No.: WH-003-017
11 Are customer production requirements and quality √ Not provided
specifications reviewed to ensure they can be met consistently? - Quality Control Procedure
- Design/process review
- Quality plan and specification
- Test reports/Charts
- Storage, packaging and shipment procedure
- Customer notification procedure or instruction on major changes
Evidence:
WH-004-003 Master and Quad link delivery, inspection & locating is
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

available but No document revision history sheet recorded

- Packing list (McKinnon dated 28.11.19) is available
Customer Documentation
Not provided
- Document control procedure
- Technical review of methods to be used
Are new and revised customer evaluation reviewed and - Specifications, engineering drawings, change notices, work instructions
12 √
implemented in a timely manner? and specifications as applicable
Evidence:
- Customer Survey (WH 27) Company: LGUK Middlesbrough Date
26.06.19

Is there a record control system in place for the identification,

Not provided
13 storage, protection, retrieval, retention time, and disposition of √
Document control procedure
quality records?

Not provided
14 Are quality records maintained? √
List of records to be kept with retention periods specified

Procurement
Not provided
- Supplier quality audits and corrective actions
- Procurement procedure
- Approved supplier list
-Production material receipt records
Is there a formal process used for the selection, qualification - Re-qualification of suppliers
15 √
and re-qualification of suppliers? -Record of black list if available
Evidence
Available Supplier evaluation process but No any Doc. Code stamp and
signature
Available Supplier evaluation form Doc. No. WH 67 but no any approving
signature
16 Are purchases from unapproved suppliers prevented by a √ Not provided
properly controlled and available approved supplier list? -Approved supplier list
- Procurement procedure
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

- Production material receipt records

Not provided
-Supplier quality performance analysis,
Are preventive actions taken to continuously improve the -Supplier audit reports
17 √
performance of the supplier base? Evidence
Available Supplier evaluation form Doc. No. WH 67 but no any approving
signature
Not provided
Does a system exist for the identification, verification, and
- -Storage & Packaging Procedures
18 protection of customer supplied product that includes notifying √
the customer if the product is damaged or lost? - - Method of segregation during storage
- - Records of limited and controlled access to stored inventories
Incoming Material
Not provided
Is receiving inspection performed per documented procedures - Incoming Material Procedure
19 √
and detailed work instructions? - inspection instructions resources (manpower and equipment) allocated for
incoming inspection
Is inspected material adequately identified as to acceptance or Not provided
20 √
rejection and traceable to receiving an inspection report? - Marking procedure

Manufacturing Quality
Not provided
Is there is a formal method used to qualify new or rebuilt
21 √ - Qualification plan that includes established goals for process yields
production equipment prior to production use?
- Records of process capability
Not provided
- Process flow chart
- statistical tools
Are control plans used to plan and deploy inspection and test
22 √ - key inspection points
functions throughout the production process?
- inspection frequency
- Work instruction of inspection/test method, gaging used, acceptable yield
rates
Are appropriate work instructions are available where needed Not provided
23 that accurately describe all work methods including inspections √ - work instructions of sample size, frequency, method
and tests to be done during production? - related forms & reports
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

Are appropriate inspections, tests and process adjustments

Not provided
24 made per applicable work instructions to verify conformance at √
- Records of inspections performed at incoming, first piece & in-process
key points throughout the process and prior to shipment?

Evidence:
- Available customer compliance procedure and Compliance record &
traceability but doc. No not recorded;
Are customers notified of low yield production lots or issues
25 √ - NCR No.:1911.3 Date: 11.11.19 Doc. No.: WH 25
that affect product reliability?
Not provided
- NCR traceability form

Non-conforming Outputs

Is reworked material, parts and assemblies are re-inspected or Not provided

26 √
re-tested to confirm compliance to requirements? Inspection record with tag and stamp

Not provided
Is product traceability maintained to facilitate problem NCR report including Serial number records, lot number, date of
27 √
evaluation and corrective action? manufacture, labelling and marking of containers or product

Not provided
Is there a positive recall system to notify customers of
28 √ - Document Control procedure
nonconforming product that has already been shipped?
- Records of evaluation after nonconforming product

Monitoring & Measurement

Are measurement repeatability studies conducted to verify the

Not provided
29 suitability of measuring devices for their use in checking √
- Monitoring & Measurement procedure
product quality or control of processes?

Are measuring devices and test equipment are routinely Not provided
30 √
calibrated and controlled per documented procedures? - Monitoring & Measurement procedure
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

- Segregation of out-of-calibration devices, and inventory & status records.

Evidence:
Internal calibration record (WH 81)
Item: 6” digital veriers. Date 10.01.18
Internal Calibration index (WH80)
Maintenance

Not provided
Are tools stored in an appropriate, clearly defined area, with
- Maintenance procedure
31 systematic tracking that provides traceability, particularly of √
- Annual Maintenance plan & preventive action plan
customer-owned tools and equipment?
- Records of Maintenance (check lists)

Process Control

Not provided
Are key part characteristics and process parameters reviewed
Process control plan & Process control map
32 and statistically based controls and/or problem-solving tools are √
Process control diagram (ex: Histograms, pareto analysis, fishbone, cause and
used to control variation?
effect diagrams, process corrections)
Not provided
Are written improvement plans implemented to reduce sources - Control goals Process control plan
33 √
of variation? - Improvement plans
- contingency plan, risk assessment of contingency plan
Are out of control conditions are noted on charts and
Not provided
34 documented corrective action is taken to bring the process back √
Control charts
into control?

Storage & Packing

Are areas around the facility clean and orderly and are tools Not provided
35 and equipment properly stored and readily available for use and √
No any evidence for condition on office & storage area
is lighting and air quality are adequate?

Not provided
Is proper equipment and methods used to prevent product
36 √ Document for handling and transit of raw material, work-in-process, and
damage or loss in all phases of the material handling process?
finished goods
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

Not provided
Is stored product/material periodically inspected, and where - Lists of shelf-life sensitive materials.
37 applicable, actions are taken to prevent deterioration per √
- Provide evidence for storage conditions and damage.
documented procedures?
- Handling procedures
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

Findings Summary
Non-conformance
No. ISO/Specification Ref. Summary Root Cause NCR No. Rectification Date

Corrective Action
No. ISO/Specification Ref. Summary Root Cause CAR No. Rectification Date

Opportunities for Improvement

No. ISO/Specification Ref. Summary Root Cause PAR No. Implementation Date
 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

Observations, Comments & Notes

 ISO 9001:2015 Supplier Audit Checklist
System & Process Compliance Auditing

Finding Definition/Impact Action/Mitigation

COMPLIA Compliant means adherence with the requirements of the standard and the QMS. The
Continue to monitor trends/indicators.
NT process is implemented and documented and records exist to verify this.

A medium risk, minor non-conformance resulting in deviation from process practice not
MINOR Investigate root cause(s) and implement corrective action by
likely to result in the failure of the management system or process that will not result in
N/C next reporting period or next scheduled audit.
the delivery of non-conforming products nor reduce the effectiveness of the QMS.

A high risk, major non-conformance which directly impacts upon customer Implement immediate containment action, investigate root
MAJOR
requirements, likely to result in the customer receiving non-conforming products or cause(s) and apply corrective action. Re-audit in 4 weeks to
N/C
services, or which may reduce the effectiveness of the QMS. verify correction.