Summary

Auditors and Auditee names and Signatures

  • Audit Number

  • Scope of the Audit

  • Actions to close?

  • Auditees

  • Auditors

General

  • Take photographs and annotate them to help clarify any issues you identify as required in each section. Don't forget to record the good points as well.

    You must select compliance level from the options:

    OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Audited or Not Applicable (this question does not apply to the area being audited or it was not audited this time)

  • Please ensure you write down, or photograph: serial numbers, reference numbers, order numbers etc to ensure that the audit is repeatable

    Add a follow up action against the question by selecting the three dots next to the question

  • Photograph of area being audited

Section 4

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Organisation and Its context (ISO 9001, 14001 and 45001 Clause 4.1: ISO 13485 Clause 4.1)

  • Have Handicare defined the external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve intended results for QMS/EMS and H&S management systems

    This should include Extenal issues [such as Legal (compliance obligations), technological, competitive, market, cultural, social and economic environments] and internal issues [such as
    Values, culture, knowledge and performance of the organisation]
    It should also include environmental conditions being affected, or being capable or affecting the organisation]

  • Have Handicare defined the external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve intended results for QMS/EMS and H&S management systems

  • Ensure that you complete a follow up action as necessary

Understanding needs and Expectations of interested parties (ISO 9001, 14001 and 45001 Clause 4.2: ISO 13485 Clause 4.1)

  • Have Handicare identified:
    - The interested parties that are relevent to the HSQE Management Sytem (this should include workers where appropriate)
    - The needs and expectation of those interested parties (requirements)
    - which needs and expectationd are compliance or legal obligations
    - Monitor and review information about those interested parties

  • Have Handicare identified the needs and expectations of interested parties that are relevant to the HSQE management systems

  • Ensure that you complete a follow up action as necessary

Determining the Scope of the QHSE Management System (ISO 9001, 14001 and 45001 Clause 4.3: ISO 13485 Clause 4.1 and 4.2.2)

  • Have Handicare determined the scope for their management systems to include:
    - Internal and External issues identified
    - Requirements of interested parties/compliance obligations (Including Legal)
    - Organisational units, functions and physical Boundaries
    - Activities, products and Services
    - Authority and ability to exercise control and influence

  • Does the scope of the QHSE Management system take into account all relevent elements?

  • Ensure that you complete a follow up action as necessary

QHSE Management Systems and it's processes (ISO 9001, 14001 and 45001 Clause 4.4: ISO 13485 Clause 4.1)

  • Management systems to include
    - processes & inputs/outputs from processes,
    - Sequence and interaction of processes
    - K.P.I’s/resources
    - Responsibilities and authorities
    - Address risks and opportunities
    - Mandatory Procedures/processes (13485 includes need for, in addition to the above:
    1 - Policy and Manual
    2 - Validation of computer software
    3 - Control of documents
    4 - Control of Records
    5 - Responsibility and Authority
    6 - Management review
    7 - Training and Competence
    8 - Work Environment
    9 - Contamination Control
    10 - Risk Management
    11 - Communication
    12 - Design and Development (including transfer to production)
    13 - Purchasing to ensure conformance to requirements
    14 - Control of production
    15 - Cleanliness
    16 - Installation and Acceptance activities
    17 - Servicing
    18 - Sterilisation processes validation
    19 - Product Identification
    20 - Traceability
    21 - Preservation of conformity of product
    22 - Calibration
    23 - Complaints
    24 - Reporting to Regulatory Authorities
    25 - Internal Audit
    26 - Non-conforming Product control
    27 - Advisory notices for NCR after delivery
    28 - Rework
    29 - Data Analysis
    30 - Corrective Action
    31 - Preventive action

  • Does the QHSE Management system include above elements?

  • Ensure that you complete a follow up action as necessary

Section 5

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Leadership and Committment (ISO 9001, 14001 and 45001 Clause 5.1 ISO 13485 Clause 5.1, 5.2)

  • Have Handicare top management demonstrated leadership and commitment demonstrated by:

    - Taking accountability for effectiveness of HSQE System
    - Establishing QHSE policy
    - Establish relevant QSHE objectives
    - Integration of Environment, H&S and Quality into our business processes – it’s part of what we do!
    - Promoting process and risk based thinking
    - Ensure resources are available for QHSE
    - Communicating the importance of effective HSQE Management and conformance to requirements
    - Ensuring HSQE management system achieves intended outcomes
    - Directing and supporting persons to contribute to effectiveness of HSQE
    - Promoting continual improvement and customer focus
    - Supporting other management roles to demonstrate leadership and commitment relative to their area
    - Protect workers from reprisal for reporting incidents, accidents, hazards, risks or opportunities
    - Setting up a process for consultation and participation
    - Establish and support the H&S committee
    - Meeting Legal compliance (and compliance obligations)

  • Is leadership being demonstrated?

  • Ensure that you complete a follow up action as necessary

Policy (ISO 9001, 14001 and 45001 Clause 5.2 ISO 13485 Clause 5.3)

  • Do Handicare have a HSQE Policy that is:

    1) Appropriate to the purpose and context of the organisation an supports strategic direction
    2) Provides a framework for setting HSQE objectives
    3) Includes commitments to:
    - protect the environment
    - prevent pollution
    - eliminate Hazards and reduce H&S risks
    - satisfy requirements and committments relevent to the context of the organisation
    - fulfil compliance obligations (including legal requirements)
    - continually improve QHSE system
    - committment to consultation and particpation of workers/workers representatives
    4) is available, maintained, communicated and available to interested parties
    5) is reviewed for continuing suitability

    How do new starters get inducted into the process

  • Does Handicare's HSQE policy comply with the requirements of the standard?

  • Ensure that you complete a follow up action as necessary

Organisational roles and responsibilities (ISO 9001, 14001 and 45001 Clause 5.3 & ISO 13485 Clauses 5.4.2 - 5.5.1 - 5.5.2)

  • Have Handicare top management:

    1) Assigned responsibilities and authorities for relevent roles within the QHSE management systems to ensure that
    - the QHSE system conforms to the requirements of ISO 9001, 14001, 45001, 13485
    - Processes are delivering expected outputs
    - there is reporting on the performance of the QHSE system and opportunities for improvement to top managament
    - Promotion of Customer focus
    - Maintaining QHSE integrity when changes are taking place
    2) Planned to achieve QHSE objectives
    3) defined a management representative (13485 only)

  • Are responsibilities and authorites clearly defined?

  • Ensure that you complete a follow up action as necessary

Section 6

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Actions to address risks and opportunities (ISO 9001, 14001 and 45001 Clause 6.1 & ISO 13485 Clauses 5.4.2 - 8.5.3)

  • Are planned actions in place to address risks and opportunities to ensure:

    1) the QHSE management system can achieve its intended results
    2) prevent or reduce undesirable effects and enhance desirable effects
    3) Achieve improvement
    4) actions are integrated into the QHSE management sytem
    5) the effectiveness of such actions are preiodically monitored

    Whilst considering:
    - Internal and External issues
    - Environmental Aspects
    - Hazard identification
    - Compliance obligations and legal obligations

  • Are risks and opportunities identified and are actions in place to address?

  • Ensure that you complete a follow up action as necessary

Objectives and planning to achieve them (ISO 9001, 14001 and 45001 Clause 6.2 & ISO 13485 Clauses 5.4.1)

  • Have Handicare established QHSE objectives and are they:

    a) consistent with the QHSE Policy
    b) measurable
    c) monitored
    d) communicated
    e) updated and maintained
    f) be relevent to the conformity of product and services and enancement of customer satisfaction and to address significant environmental aspects
    g) take into account: risks and opportunities, results on consultations with workers, applicable compliance and legal requirements

    Have Handicare planed to achieve the QHSE objectives by planning:

    a) What will be done
    b) what resource is required
    c) Who is responsible
    d) When it will be completed
    e) How the results will be evaluated/monitored
    f) how the actions will be integrated into the QHSE system

  • Have Handicare identified QHSE objectives and planned to achieve them?

  • Ensure that you complete a follow up action as necessary

Section 7

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Resources (ISO 9001, 14001 and 45001 Clause 7.1 & ISO 13485 Clause 6)

  • Have Handicare considered the resources needed for the establishment, implementation, maintenance and continual improvement of the QHSE management systems and for meeting applicable customer and regulatory requirements (including considering the capabilities of, and constraints on, existing internal resouce, and what needs to be obtained from external providers)

    Consideration will be given to:

    a) People
    b) Infrastructure
    c) Work environment and contamination control where these can have an adverse effect
    d) Monitoring and measurement resource (to ensure valid and reliable results)
    e) Organisational knowledge

  • Has appropriate consideration been given to resource provision?

  • Ensure that you complete a follow up action as necessary

Competence (ISO 9001, 14001 and 45001 Clause 7.2 & ISO 13485 Clause 6.2)

  • Have Handicare determined, and taken action to aquire, the relevant competencies for the person(s) doing work that affects the QHSE Management System.

    This competence can be on the basis of appropriate education, training or experience

    Evaluate the efffectiveness of actions taken to aquire competence

  • Are personnel competent to carry out the tasks, that affect QHSE, required of them?

  • Ensure that you complete a follow up action as necessary

Awareness (ISO 9001, 14001 and 45001 Clause 7.3 & ISO 13485 Clause 6.2)

  • Are persons within the business aware of :

    - Policy
    - Objectives
    - Significant environmental aspects
    - Implications of not conforming with the QHSE management systems requirements
    - Aware of their contribution to the effectiveness of the QHSE management systems
    - Effectiveness of the QHSE system
    - Incidents and outcomes of investigations (45001)
    - Hazards and risks and actions determined that are relevent to them (45001)
    - their ability to remove themselves from situations they consider present danger and the arrangements that protect them from consequence for doing so

  • Are persons aware of Policy, objectives aspects, implications of non-confirmance, QHSE effectiveness, incidents, hazards and risks etc?

  • Ensure that you complete a follow up action as necessary

Communication (ISO 9001, 14001 and 45001 Clause 7.4 & ISO 13485 Clause 5.5.3)

  • a) Have Handicare established internal and external communications processes relevant to the QHSE management systems including:

    - On what it will communicate (must include info related to QHSE management system including changes)
    - When it will communicate
    - With whom it will communicate
    - How to communicate
    - ensuring workers can contribute to continual improvement (but also must include external persons to allow their contribution to continual improvement and compliance)

    b) Organisation will respond to relevent communications on QHSE

    c) Organisation will take into account:
    - Compliance/Legal obligations
    - Information communicated is consistent with information generated within the QHSE system and is reliable
    - Views of interested parties
    - Responsibilities and authorities

  • Are appropriate internal and external communication processes defined and implemented?

  • Ensure that you complete a follow up action as necessary

Documented information (ISO 9001, 14001 and 45001 Clause 7.5 & ISO 13485 Clause 4.2)

  • Has handicare defined that documented information requirements that are necessary for the effectiveness of the QHSE management system (organisational requirements, standard requirements, and regulatory/legal requirements) - Including those of external origin

    is it clear for each piece of documented information (record or procedural):

    - Identification and description
    - Format and media
    - reviewed for suitability and adequacy
    - Available and suitable for use when and where needed
    - adequately protected/prevented from loss
    - distribution, access, retrieval, use controlled
    - preserved in storage to remain legible etc
    - retention/disposal requirements defined
    - protected from unintended alterations

  • Have all documented information requirements been identified and suitably controlled?

  • Ensure that you complete a follow up action as necessary

Section 8

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Operational planning and control (ISO 9001, 14001 and 45001 Clause 8.1 & ISO 13485 Clause 7)

  • Have Handicare planned/implemented and controlled the processes needed for QHSE compliance?

    1) Are criteria defined for:
    - processes
    - acceptance of products/services
    2) Resource requirements defined to achieve conformace
    3) process controls
    4) appropriate documented information/records available to achieve/confirm compliance
    5) Process controls include outsourced processes
    6) Management and control of change
    7) adapting work to workers
    8) eliminating hazard and reducing risk

  • Have Handicare implemented operational planning and control effectively?

  • Ensure that you complete a follow up action as necessary

Requirements for products and services (ISO 9001, 14001 and 45001 Clause 8.2 & ISO 13485 Clause 7.2)

  • Has Handicare established procedures and systems for:

    a) Customer communication relating to products and services, feedback on products and services, handling and controlling customer property (9001: 8.2.1)
    b) Requirements for product and services
    - including statutory or regulatory requirements
    - Handicare can meet any claims made (9001: 8.2.2)
    - user training/information to ensure safe use/installation etc
    c) Review of requirements - do we have the ability to meet the requirements of the customer (9001: 8.2.3)
    d) Changes to requirements (9001: 8.2.4)
    e) emergency preparedness and response (45001 & 14001: 8.2)
    f) Handling contracts, customers complaints and customer property (8.5.3)

  • Has Handicare defined all requirements for products and services?

  • Ensure that you complete a follow up action as necessary

Design and Development (ISO 9001 Clause 8.3 & ISO 13485 Clause 7.3)

  • Has Handicare established procedures and systems for:

    - Design and development Planning
    - Design and development inputs
    - Design and development controls
    - Design and development outputs
    - Design and development review
    - Design and development verification
    - Design and development validation
    - Design and development transfer
    - Design and development changes
    - Design and development files (DHF/Technical File)

  • Are there processes and procedures for control of design?

  • Ensure that you complete a follow up action as necessary

Control of externally provided processes, products and services (ISO 9001 Clause 8.3, ISO 45001 8.1.4, ISO 14001 Clause 8.1 & ISO 13485 Clause 4.1.5 and 7.4.1)

  • Are externally provided processes, products and services competent and suitably controlled to ensure achievement of QHSE requirements (taking into account risk)

    For example, Suppliers, sub-contractors Contractors, waste disposal etc

    Including providing appropriate information, instruction and supervisiion to such exrernal providers

  • Are all externally provided processes suitably controlled?

  • Ensure that you complete a follow up action as necessary

Section 9

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Monitoring, Measurement, Analysis and Improvement (ISO 9001, 14001 and 45001 Clause 9.1 & ISO 13485 Clause 8)

  • Have Handicare defined:
    a) What needs to be monitored/measured
    - customer satisfaction
    - QHSE performance
    - evaluation of compliance
    - effectiveness of operational controls)
    b) the methods used
    c) when it will be performed
    d) when it will be analysed

  • Have Handicare defined monitoring, measurement, analysis and improvement requirements?

  • Ensure that you complete a follow up action as necessary

Evaluation of compliance (ISO 14001 and 45001 Clause 9.1.2)

  • Has Handicare established, implemented and maintained a process to evaluate compliance to legal/other requirements (14001 & 45001)
    Is the frequency defined and is the status known

  • Is there a legal and other requirements evaluation of compliance carried out?

  • Ensure that you complete a follow up action as necessary

Internal Audit (ISO 9001, 14001 and 45001 Clause 9.2 & ISO 13485 Clause 8.2.4)

  • Has Handicare established an internal Audit Programme
    Does it take into account the status and importance of the processes and results of previous audits?
    Has it covered all of the requirements of the QHSE management systems
    Is it effectively implemented and maintained
    Is it objectively and impartially audited

  • Is there an effective internal audit process?

  • Ensure that you complete a follow up action as necessary

Management review (ISO 9001, 14001 and 45001 Clause 9.3 & ISO 13485 Clause 5.6)

  • Has Handicare top management reviewed the organisations management systems at planned intervals to ensure continuing suitability, adequacy and effectiveness and alignment with objectives
    Verify inputs and outputs as per standards

  • Have management reviews been conducted in line with procedure and cover all requirements within the standards?

  • Ensure that you complete a follow up action as necessary

Section 10

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Incident, nonconformity and corrective action (ISO 9001, 14001 and 45001 Clause 10.2 & ISO 13485 Clause 8.3 and 8.5.2)

  • Is there a system in place to identify, control and action non conformities and ensure analysis is performed to review effectiveness
    reviewing existing risk assessments 45001
    Incident non conformity and investigation

  • is there an effective non-conformance and incident recording process and is suitable corrective action taken?

  • Ensure that you complete a follow up action as necessary

Continual Improvement (ISO 9001, 14001 and 45001 Clause 10.3 & ISO 13485 Clause 5.6.1 and 8.5)

  • Is the organisation verifying results from activities and actively pursuing improvement to enhance QHSE management systems
    (communication)
    Are results maintained

  • Have there been any changes in the department/area being audited, and what impact has it had?(Describe/photograph)

  • Ensure that you complete a follow up action as necessary

Additional checklist items

Additional Checklist items

    Additional Check
  • Details of additional check

  • Compliant?

  • Ensure that you complete a follow up action as necessary

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