ISO 9001:2015 QMS Compliance Audit

Information

Organisation
Document No.
Organization
Conducted on
Prepared by
Location
Personnel

Audit Opening

Audit Criteria:
Audit Scope:
Audit Objective:
Opening Meeting Notes:

Departments

Management

Is this department included in this report?
4.1 Did the organization determine internal and external issues relevant to its purpose and strategic direction and that could effect its ability to achieve the intended results of the QMS?
Comments:
4.2 Did the organization determine the interested parties and their respective requirements relevant to the QMS?
Comments:
4.3 Is the QMS Scope documented and approved?
Comments:
4.4 Are the QMS Processes defined and approved?
Comments:
5.2 Is the Quality Policy documented, approved and communicated?
Comments:
5.3 Are the Roles, Responsibilities and Authorities documented and communicated?
Comments:
6.1 Is a methodology established and implemented to address Risk and Opportunities?
Comments:
6.2 Are Company Objectives established with Actions to achieve them?
Comments:
What documented information is maintained on the Quality Objectives?
6.3 Is a methodology established and implemented to address Change Management?
Comments:
7.5 Is Control of Documented Information established and implemented?
Comments:
9.1 Are performance measurements established for all departments?
Comments:
What documented information do the organization retain as evidence of the results of the performance and effectiveness of the QMS?
9.2 Are Internal Audits scheduled, planned and Conducted?
Comments:
What documented information do the organization retain as evidence of the implementation of the audit program and the audit results?
9.3 Is the Management Review planned and conducted?
Comments:
What documented information do the organization retain as evidence of the results of management reviews?
10.2 Is a process established and implemented for the Control of Nonconformity and related Corrective Action?
Comments:
What documented information do the organization retain as evidence of the nature of nonconformities and any subsequent actions taken, as well as the results of any corrective action?
10.3 Are records established and implemented to prove Continual Improvement?
Comments:

Commercial

Is this department included in this report?
8.2.2/8.2.3 Is a sales/tender process established and implemented?
Comments:
What documented information is retained on the results of reviews and on any new requirements for the products and services?
8.2.4 Is a process for dealing with changes relating to customer requirements established and implemented?
Comments:
8.2.1 Is a process for customer communication established and implemented?
Comments:
8.2.1 Is a process for dealing with customer complaints established and implemented?
Comments:
9.1.2 Is customer satisfaction measured and analysed?
Comments:

Design & Development

Is this department included in this report?
8.3 Is a process established and implemented, defining the Design and Development stages and activities?
Comments:
What documented information do the organization retain on Design and Development inputs?
What documented information do the organization retain on Design and Development outputs?
What documented information do the organization retain on Design and Development changes, the results of reviews, the authorization of the changes, and the actions taken to prevent adverse impacts?

Finance

Is this department included in this report?
8.2 Is a process for debtors control established and implemented?
Comments:
8.4 Is a process for creditors control established and implemented?
Comments:

Human Resources

Is this department included in this report?
7.1.2 Has a recruitment process been established and implemented?
Comments:
7.1.6 Has evidence of how organizational knowledge is maintained been established and implemented?
Comments:
7.2 Is a process for competence evaluation and training established and implemented?
Comments:
What documented information is retained as evidence of competence?
7.3 Has an awareness program been established and implemented?
Comments:

Maintenance

Is this department included in this report?
7.1.3 Are registers and inspections for all organizational infrastructure established and implemented?
Comments:
7.1.3 Is a preventive maintenance schedule established and implemented?
Comments:
7.1.3 have records pertaining to corrective maintenance been established and implemented?
Comments:
7.1.4 Are non-discriminatory and conflict management policies established and implemented?
Comments:
7.1.4 Has the physical work environment been reviewed for adequacy? (Heat, humidity, light, airflow, hygiene and noise)
Comments:

Planning

Is this department included in this report?
8.1 Has a process been established and implemented for operational planning and required controls?
Comments:

Procurement

Is this department included in this report?
8.4 Has a process for the selection of suppliers been established and implemented?
Comments:
What documented information do the organization retain on the evaluation and selection of external providers?
8.4 Is an approved supplier list established?
Comments:
8.4 Have purchasing processes been established for procurement of products and services?<br>(who can buy, what they can buy, for what amount, and the forms to be used, approval)
Comments:
8.4 Is a process established and implemented for the verification of received goods and services ensuring conformity to client and organizational requirements?
Comments:
8.4 Is a process established and implemented for the evaluation and re-evaluation of product and service providers?
Comments:
What documented information do the organization retain of the monitoring of performance, and re-evaluation external providers based on their ability to provide in accordance with requirements?

Operations

Is this department included in this report?
Operational Function:
Function:
8.5.1 Has a process been established and implemented defining the controls required for the realization of the function?
What documented information defining the characteristics of the products, services, or activities, and the results to be achieved are available?
8.5.2 Does the process provide adequate identification and traceability activities throughout the realization of the function?
What documented information is retained to enable traceability?
8.5.3 Are activities established and implemented for the control over customer and externally provided property where applicable?
What documented information do the organization retain on what has occurred when customer or external provider property is lost, damaged or otherwise found to be unsuitable for use?
8.5.4 Are activities established and implemented for the preservation of product where applicable?
8.5.5 Are post delivery activities established and implemented where applicable for this function?
8.5.6 Are activities established and implemented for the control of operational changes?
What documented information do the organization retain to describe the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review?
8.6 Has a process for the release of the process outputs been established and implemented?
Comments:
What documented information do the organization retain on the release of the process outputs, which includes evidence of conformity with the acceptance criteria, and traceability to the person(s) authorizing the release?
Comments:
Related media (if applicable):

Quality Control

Is this department included in this report?
7.1.5 Are all monitoring and measuring resources marked with an unique identifier and placed on a control register?
Comments:
Related media (if applicable):
7.1.5 Are calibration, verification and validation records available and up to date for all monitoring and measuring resources, with traceability to a national or international standard?
Comments:
What documented information is retained as evidence of fitness for purpose of the monitoring and measurement resources?
8.6 Has a process for the release of final product and service been established and implemented?
Comments:
What documented information do the organization retain on the release of products and services, which includes evidence of conformity with the acceptance criteria, and traceability to the person(s) authorizing the release?
8.7 Has a process been established and implemented for the identification, segregation and related controls over non-conforming outputs?
Comments:
What documented information do the organization retain that describes the nonconformity, describes the actions to be taken, describes any concessions obtained, and identifies the authority deciding the action in respect of the nonconformity?