ISO 9001:2015 - Stg 2, Surveillance & Recertification

• Audit Reference

• Client Company Name

• Site conducted
  Address

• Conducted on

  Date

• Lead Auditor

• Location / Remote

• Indicate type of Audit

• Stage 2 - certification audit

• Annual Surveillance audit

• Triannual re-certification audit

Opening Meeting

• Introduction, record of attendees

• confirm that the client has received a copy of the audit plan

  Yes

  No

• Confidentiality

• Scope of audit

• Advise client that the audit is based on a limited number of samples chosen at random and not 100% of documents/records

• Explanation of findings (Major / Minor / Obs) and that the findings are based on the random samples viewed

• Clients ability to ask questions - confirmation of No advice or Consultancy

• Is the client declaring any 'exclusions' or items of the QMS to be considered as "not applicable" - if yes please state what/which along with justification for any "exclusion" / "none applicability"

  Yes

  No

• Any Questions

  Yes

  No

• 4.1 Understanding the organization and its context

• Can the client demonstrate that they have determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

  Select Yes No

  • Yes
  • No

• Is clause 4.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 4.2 Understanding the needs and expectations of interested parties

• Can the client demonstrate that they have determined what the needs and expectations of their interested parties are

  Yes

  No

• Is there evidence to show that the client is monitoring and reviewing information about their interested parties and relevant requirements

  Yes

  No

• Is clause 4.2 considered compliant

  Compliant

  Non-Compliant

  N/A

4.3 Determining the scope of the quality management system

• Has the client determined the boundaries and applicability of their QMS when establishing their scope - have they considered:

• a) the external and internal issues referred to in 4.1;

  Yes

  No

• b) the requirements of relevant interested parties referred to in 4.2;

  Yes

  No

• c) the products and services of the organization.

  Yes

  No

• Has the client applied all the requirements of ISO 9001: 2015 if they are applicable <br>within the determined scope of its QMS.

  Yes

  No

  N/A

• Is the scope of the clients QMS available and be maintained as documented information.

  Yes

  No

• Does the scope state the types of products and services covered, and provide<br>justification for any requirement of ISO 9001:2015 that the client determines is not applicable to the scope of its QMS.

  Yes

  No

  N/A

• Is clause 4.3 considered compliant

  Compliant

  Non-Compliant

  N/A

4.4 Quality management system and its processes

• 4.4.1 Has the client established, implemented, maintained and continually improved a QMS including the processes needed and their interactions, in accordance with the requirements of ISO 9001:2015

• The client should have evidence to determine the following for their QMS - Have they:

• a) determined the inputs required and the outputs expected from these processes;

  Yes

  No

• b) determined the sequence and interaction of these processes;

  Yes

  No

• c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

  Yes

  No

• d) determined the resources needed for these processes and ensure their availability;

  Yes

  No

• e) assigned the responsibilities and authorities for these processes;

  Yes

  No

• f) addressed the risks and opportunities as determined in accordance with the requirements of 6.1;

  Yes

  No

• g) evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results;

  Yes

  No

• h) improved the processes and the QMS.

  Yes

  No

• 4.4.2 Can the client demonstrate that, To the extent necessary, the client Has:

• a) maintain documented information to support the operation of its processes;

  Yes

  No

• b) retain documented information to have confidence that the processes are being carried out as planned.

  Yes

  No

• Is clause 4.4 considered compliant

  Compliant

  Non-Compliant

  N/A

5 Leadership

• 5.1 Leadership and commitment

• 5.1.1 General
  Can the "top management" demonstrate leadership and commitment with respect to the QMS by:

• a) taking accountability for the effectiveness of the quality management system;

  Yes

  No

• b) ensuring that the quality policy and quality objectives are established for the QMS and are compatible with the context and strategic direction of the company;

  Yes

  No

• c) ensuring the integration of the QMS requirements into the companies business processes;

  Yes

  No

• d) promoting the use of the process approach and risk-based thinking;

  Yes

  No

• e) ensuring that the resources needed for the QMS are available;

  Yes

  No

• f) communicating the importance of effective quality management and of conforming to the QMS requirements;

  Yes

  No

• g) ensuring that the QMS achieves its intended results;

  Yes

  No

• h) engaging, directing and supporting persons to contribute to the effectiveness of the QMS;

  Yes

  No

• i) promoting improvement;

  Yes

  No

• j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

  Yes

  No

• Is clause 5.1.1 considered compliant

  Compliant

  Non-Compliant

  N/A

5.1.2 Customer focus

• Can "top management" demonstrate leadership and commitment with respect to customer focus by ensuring that:

• a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

  Yes

  No

• b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

  Yes

  No

• c) the focus on enhancing customer satisfaction is maintained.

  Yes

  No

• Is clause 5.1.2 considered compliant

  Compliant

  Non-Compliant

  N/A

5.2 Policy

• 5.2.1 Establishing the quality policy

• Has top management established, implemented and maintained a quality policy that:

• a) is appropriate to the purpose and context of the company and supports its strategic direction;

  Yes

  No

• b) provides a framework for setting quality objectives;

  Yes

  No

• c) includes a commitment to satisfy applicable requirements;

  Yes

  No

• d) includes a commitment to continual improvement of the quality management system.

  Yes

  No

• Is clase 5.2.1 considered compliant

  Compliant

  Non-Compliant

  N/A

5.2.2 Communicating the quality policy

• Does / Is the quality policy :

• a) Available and be maintained as documented information;

  Yes

  No

• b) communicated, understood and applied within the organization;

  Yes

  No

• c) Available to relevant interested parties, as appropriate.

  Yes

  No

• Is clause 5.2.2 considered compliant

  Compliant

  Non-Compliant

  N/A

5.3 Organizational roles, responsibilities and authorities

• Can "top management" demonstrate that they ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the Company. is there evidence to show that top management have assigned the responsibility and authority for:

• a) ensuring that the quality management system conforms to the requirements of ISO 9001:2015

  Yes

  No

• b) ensuring that the processes are delivering their intended outputs;

  Yes

  No

• c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;

  Yes

  No

• d) ensuring the promotion of customer focus throughout the organization;

  Yes

  No

• e) ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

  Yes

  No

• Is clause 5.3 considered compliant

  Compliant

  Non-Compliant

  N/A

6 Planning

• 6.1 Actions to address risks and opportunities

• 6.1.1 When planning for the QMS, Does the client consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

• a) give assurance that the quality management system can achieve its intended result(s);

  Yes

  No

• b) enhance desirable effects;

  Yes

  No

• c) prevent, or reduce, undesired effects;

  Yes

  No

• d) achieve improvement.

  Yes

  No

• is clause 6.1.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 6.1.2 Can the client demonstrate that they have planed:

• a) actions to address these risks and opportunities;

  Yes

  No

• b) how to:

• 1) integrate and implement the actions into its quality management system processes (see 4.4);

  Yes

  No

• 2) evaluate the effectiveness of these actions.

  Yes

  No

• Is clause 6.1.2 considered compliant

  Compliant

  Non-Compliant

  N/A

6.2 Quality objectives and planning to achieve them

• 6.2.1 Can the client demonstrate that they have established quality objectives at relevant functions, levels and processes needed for the quality management system.

• Do / Are the quality objectives:

• a) consistent with the quality policy;

  Yes

  No

• b) measurable;

  Yes

  No

• c) take into account applicable requirements;

  Yes

  No

• d) relevant to conformity of products and services and to enhancement of customer satisfaction;

  Yes

  No

• e) monitored;

  Yes

  No

• f) communicated;

  Yes

  No

• g) updated as appropriate.

  Yes

  No

• Can the client provide evidence that they maintain documented information on the quality objectives.

  Yes

  No

• Is clause 6.2.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 6.2.2 When planning how to achieve its quality objectives, can the client show how it determined:

• a) what will be done;

  Yes

  No

• b) what resources will be required;

  Yes

  No

• c) who will be responsible;

  Yes

  No

• d) when it will be completed;

  Yes

  No

• e) how the results will be evaluated.

  Yes

  No

• Is clause 6.2.2 considered compliant

  Compliant

  Non-Compliant

  N/A

6.3 Planning of changes

• When the client determines the need for changes to the QMS, the changes shall be carried out in a planned manner (see 4.4).

• Can the demonstrate that they have considered:

• a) the purpose of the changes and their potential consequences;

  Yes

  No

• b) the integrity of the quality management system;

  Yes

  No

• c) the availability of resources;

  Yes

  No

• d) the allocation or reallocation of responsibilities and authorities.

  Yes

  No

• Is clause 6.3 considered compliant

  Compliant

  Non-Compliant

  N/A

7 Support

• 7.1 Resources

• 7.1.1 General - Can the client demonstrate that they have implemented a process to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. Can the client demonstrate that they have considered:

• a) the capabilities of, and constraints on, existing internal resources;

  Yes

  No

• b) what needs to be obtained from external providers.

  Yes

  No

• Is clause 7.1.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.1.2 People - Can the client demonstrate how they have determined and provided the persons necessary for the effective implementation of its QMS and for the operation and control of its processes.

  Yes

  No

• Is clause 7.1.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.1.3 Infrastructure - Can the client show how it has determined, provided and maintained the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

  Yes

  No

• Is clause 7.1.3 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.1.4 Environment for the operation of processes - Can the client show how it has determined, provide and maintained the environment necessary for the operation of its processes and to achieve conformity of products and services.

  Yes

  No

• Is clause 7.1.4 considered compliant

  Compliant

  Non-Compliant

  N/A

7.1.5 Monitoring and measuring resources

• 7.1.5.1 General - Can the client demonstrate that they have determined and provided the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

  Yes

  No

• Can the client demonstrate that they have ensured that the resources provided:

• a) are suitable for the specific type of monitoring and measurement activities being undertaken;

  Yes

  No

• b) are maintained to ensure their continuing fitness for their purpose.

  Yes

  No

• Can the client show that they have retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

  Yes

  No

• Is clause 7.1.5.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.1.5.2 Measurement traceability - When measurement traceability is a requirement, or is considered by the company to be an essential part of providing confidence in the validity of measurement results, can the client demonstrate measuring equipment is:

• a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;

  Yes

  No

• b) identified in order to determine their status;

  Yes

  No

• c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

  Yes

  No

• Can the client demonstrate that they have determined if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and has taken appropriate action as necessary.

  Yes

  No

• Is clause 7.1.5.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.1.6 Organizational knowledge

• Can the client show that they have determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services, and that this knowledge is maintained and made available to the extent necessary.

  Yes

  No

• When addressing changing needs and trends, can the client show that they have considered its current knowledge and determined how to acquire or access any necessary additional knowledge and required updates.

  Yes

  No

• Is clause 7.1.6 considered compliant

  Compliant

  Non-Compliant

  N/A

7.2 Competence

• Can the client demonstrate that they have:

• a) determined the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the QMS

  Yes

  No

• b) ensure that these persons are competent on the basis of appropriate education, training, or experience;

  Yes

  No

• c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;

  Yes

  No

• d) retain appropriate documented information as evidence of competence.

  Yes

  No

• Is clause 7.2 considered compliant

  Compliant

  Non-Compliant

  N/A

7.3 Awareness

• Can the client demonstrate how they ensure that persons doing work under the company's control are aware of:

• a) the quality policy;

  Yes

  No

• b) relevant quality objectives;

  Yes

  No

• c) their contribution to the effectiveness of the QMS, including the benefits of improved performance;

  Yes

  No

• d) the implications of not conforming with the QMS requirements.

  Yes

  No

• Is clause 7.3 considered compliant

  Compliant

  Non-Compliant

  N/A

7.4 Communication

• Can the company demonstrate how they have determined the internal and external communications relevant to the QMS, including:

• a) on what it will communicate;

  Yes

  No

• b) when to communicate;

  Yes

  No

• c) with whom to communicate;

  Yes

  No

• d) how to communicate;

  Yes

  No

• e) who communicates.

  Yes

  No

• Is clause 7.4 consider compliant

  Compliant

  Non-Compliant

  N/A

7.5 Documented information

• 7.5.1 General

• Does the clients QMS include:

• a) documented information required by ISO 9001: 2015;

  Yes

  No

• b) documented information determined by the company as being necessary for the effectiveness of the QMS.

  Yes

  No

• Is clause 7.5.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.5.2 Creating and updating

• When creating and updating documented information, does the company ensure appropriate:

• a) identification and description (e.g. a title, date, author, or reference number);

  Yes

  No

• b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

  Yes

  No

• c) review and approval for suitability and adequacy.

  Yes

  No

• Is clause 7.5.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.5.3 Control of documented information

• 7.5.3.1 Can the client demonstrate how Documented information required by the QMS and by ISO 9001: 2015 is controlled to ensure:

• a) it is available and suitable for use, where and when it is needed;

  Yes

  No

• b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

  Yes

  No

• Is clause 7.5.3.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 7.5.3.2 For the control of documented information, how does the client address the following activities, as applicable:

• a) distribution, access, retrieval and use;

  Yes

  No

• b) storage and preservation, including preservation of legibility;

  Yes

  No

• c) control of changes (e.g. version control);

  Yes

  No

• d) retention and disposition.

  Yes

  No

• Is documented information of external origin determined by the client to be necessary for the planning and operation of the QMS identified as appropriate, and be controlled.

  Yes

  No

• Is documented information retained as evidence of conformity protected from unintended alterations.

  Yes

  No

• Is clause 7.5.3.2 considered compliant

  Compliant

  Non-Compliant

  N/A

8 Operation

• 8.1 Operational planning and control

• Can the client demonstrate how it plans, implements and controls the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:

• a) determining the requirements for the products and services;

  Yes

  No

• b) establishing criteria for: 1) the processes and 2) the acceptance of products and services;

  Yes

  No

• c) determining the resources needed to achieve conformity to the product and service requirements;

  Yes

  No

• d) implementing control of the processes in accordance with the criteria;

  Yes

  No

• e) determining, maintaining and retaining documented information to the extent necessary: 1) to have confidence that the processes have been carried out as planned; and 2) to demonstrate the conformity of products and services to their requirements.

  Yes

  No

• Does the company control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

  Yes

  No

• Does the company ensure that outsourced processes are controlled (see 8.4).

  Yes

  No

• Is clause 8.1 considered compliant

  Compliant

  Non-Compliant

  N/A

8.2 Requirements for products and services

• 8.2.1 Customer communication

• Can the client demonstrate that relevant Communication with customers include the following:

• a) providing information relating to products and services;

  Yes

  No

• b) handling enquiries, contracts or orders, including changes;

  Yes

  No

• c) obtaining customer feedback relating to products and services, including customer complaints;

  Yes

  No

• d) handling or controlling customer property;

  Yes

  No

• e) establishing specific requirements for contingency actions, when relevant.

  Yes

  No

• Is clause 8.2.1 considered compliant

  Compliant

  Non-Compliant

  N/A

8.2.2 Determining the requirements for products and services

• When determining the requirements for the products and services to be offered to customers, can the client demonstrate that they ensure that:

• a) the requirements for the products and services are defined, including:

  Yes

  No

• 1) any applicable statutory and regulatory requirements;

  Yes

  No

• 2) those considered necessary by the organization;

  Yes

  No

• b) the organization can meet the claims for the products and services it offers.

  Yes

  No

• Is clause 8.2.2 considered compliant

  Compliant

  Non-Compliant

  N/A

8.2.3 Review of the requirements for products and services

• 8.2.3.1 Does the client ensure that it has the ability to meet the requirements for products and services to be offered to customers.

  Yes

  No

• Does the client conduct a review(s) before committing to supply products and services to a customer, which include:

• a) requirements specified by the customer, including the requirements for delivery and postdelivery activities;

  Yes

  No

• b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

  Yes

  No

• c) requirements specified by the organization;

  Yes

  No

• d) statutory and regulatory requirements applicable to the products and services;

  Yes

  No

• e) contract or order requirements differing from those previously expressed.

  Yes

  No

• Does the client ensure that contract or order requirements differing from those previously defined are resolved.

  Yes

  No

• Are the customer’s requirements confirmed by the client before acceptance, when the customer does not provide a documented statement of their requirements.

  Yes

  No

• is clause 8.2.3.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.2.3.2 Does the client retain documented information on the following , as applicable:

• a) on the results of the review;

  Yes

  No

• b) on any new requirements for the products and services.

  Yes

  No

• Is clause 8.2.3.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.2.4 Changes to requirements for products and services

• Can the client demonstrate that they ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.

  Yes

  No

• Is clause 8.2.4 considered compliant

  Compliant

  Non-Compliant

  N/A

8.3 Design and development of products and services

• 8.3.1 General

• Can the client demonstrate that they establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

  Yes

  No

  N/A

• Is clause 8.3.1 considered compliant or N/A

  Compliant

  Non-Compliant

  N/A

• 8.3.2 Design and development planning

• In determining the stages and controls for design and development, can the client show how they consider:

• a) the nature, duration and complexity of the design and development activities;

  Yes

  No

  N/A

• b) the required process stages, including applicable design and development reviews;

  Yes

  No

  N/A

• c) the required design and development verification and validation activities;

  Yes

  No

  N/A

• d) the responsibilities and authorities involved in the design and development process;

  Yes

  No

  N/A

• e) the internal and external resource needs for the design and development of products and services;

  Yes

  No

  N/A

• f) the need to control interfaces between persons involved in the design and development process;

  Yes

  No

  N/A

• g) the need for involvement of customers and users in the design and development process;

  Yes

  No

  N/A

• h) the requirements for subsequent provision of products and services;

  Yes

  No

  N/A

• i) the level of control expected for the design and development process by customers and other relevant interested parties;

  Yes

  No

  N/A

• j) the documented information needed to demonstrate that design and development requirements have been met.

  Yes

  No

  N/A

• 8.3.3 Design and development inputs

  Yes

  No

  N/A

• Can the client show that they have determined the requirements essential for the specific types of products and services to be designed and developed. Has the client considered:

• a) functional and performance requirements;

  Yes

  No

  N/A

• b) information derived from previous similar design and development activities;

  Yes

  No

  N/A

• c) statutory and regulatory requirements;

  Yes

  No

  N/A

• d) standards or codes of practice that the organization has committed to implement;

  Yes

  No

  N/A

• e) potential consequences of failure due to the nature of the products and services.

  Yes

  No

  N/A

• Are inputs considered adequate for design and development purposes, complete and unambiguous.

  Yes

  No

  N/A

• Is there a process to ensure conflicting design and development inputs are resolved.

  Yes

  No

  N/A

• Can the client show that they retain documented information on design and development inputs.

  Yes

  No

  N/A

• Is clause 8.3.3 considered compliant or N/A

  Compliant

  Non-Compliant

  N/A

• 8.3.4 Design and development controls

• Can the client demonstrate that they apply controls to the design and development process to ensure that:

• a) the results to be achieved are defined;

  Yes

  No

  N/A

• b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

  Yes

  No

  N/A

• c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;

  Yes

  No

  N/A

• d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;

  Yes

  No

  N/A

• e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;

  Yes

  No

  N/A

• f) documented information of these activities is retained.

  Yes

  No

  N/A

• Is clause 8.3.4 considered compliant of N/A

  Compliant

  Non-Compliant

  N/A

• 8.3.5 Design and development outputs

  Yes

  No

  N/A

• Can the client demonstrate that they ensure that design and development outputs:

• a) meet the input requirements;

  Yes

  No

  N/A

• b) are adequate for the subsequent processes for the provision of products and services;

  Yes

  No

  N/A

• c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;

  Yes

  No

  N/A

• d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

  Yes

  No

  N/A

• Can the client demonstrate that they retain documented information on design and development outputs.

  Yes

  No

  N/A

• Is clause 8.3.5 considered compliant or N/A

  Compliant

  Non-Compliant

  N/A

• 8.3.6 Design and development changes

• Can the client demonstrate how they identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

  Yes

  No

  N/A

• Can the client show that they have retained documented information on:

• a) design and development changes;

  Yes

  No

  N/A

• b) the results of reviews;

  Yes

  No

  N/A

• c) the authorization of the changes;

  Yes

  No

  N/A

• d) the actions taken to prevent adverse impacts.

  Yes

  No

  N/A

• Is clause 8.3.6 considered compliant or N/A

  Compliant

  Non-Compliant

  N/A

8.4 Control of externally provided processes, products and services

• 8.4.1 General

• Can the client demonstrate that they ensure that externally provided processes, products and services conform to requirements.

  Yes

  No

• Can the client show how they determine the controls to be applied to externally provided processes, products and services when:

• a) products and services from external providers are intended for incorporation into the companies own products and services;

  Yes

  No

• b) products and services are provided directly to the customer(s) by external providers on behalf of the companies;

  Yes

  No

• c) a process, or part of a process, is provided by an external provider as a result of a decision by the companies

  Yes

  No

• Can the client show that they have determined and applied criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

  Yes

  No

• Can the client demonstrate that they retain documented information of these activities and any necessary actions arising from the evaluations.

  Yes

  No

• Is clause 8.4.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.4.2 Type and extent of control

• Can the client demonstrate how they ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.

  Yes

  No

• Can the client demonstrate that they:

• a) ensure that externally provided processes remain within the control of its QMS

  Yes

  No

• b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

  Yes

  No

• c) take into consideration:

• 1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;

  Yes

  No

• 2) the effectiveness of the controls applied by the external provider;

  Yes

  No

• d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.

  Yes

  No

• Is clause 8.4.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.4.3 Information for external providers

• Does the client ensure the adequacy of requirements prior to their communication to the external provider.

  Yes

  No

• Can he client show how they communicate to external providers its requirements for:

• a) the processes, products and services to be provided;

  Yes

  No

• b) the approval of:

• 1) products and services;

  Yes

  No

• 2) methods, processes and equipment;

  Yes

  No

• 3) the release of products and services;

  Yes

  No

• c) competence, including any required qualification of persons;

  Yes

  No

• d) the external providers’ interactions with the organization;

  Yes

  No

• e) control and monitoring of the external providers’ performance to be applied by the company;

  Yes

  No

• f) verification or validation activities that the company, or its customer, intends to perform at the external providers’ premises.external providers’ premises.

  Yes

  No

• Is clause 8.4.3 considered compliant

  Compliant

  Non-Compliant

  N/A

8.5 Production and service provision

• 8.5.1 Control of production and service provision

• Can the client demonstrate that they have implemented production and service provision under controlled conditions, Do these controls include (where applicable)

• a) the availability of documented information that defines:

  Yes

  No

• 1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;

  Yes

  No

• 2) the results to be achieved;

  Yes

  No

• b) the availability and use of suitable monitoring and measuring resources;

  Yes

  No

• c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;

  Yes

  No

• d) the use of suitable infrastructure and environment for the operation of processes;

  Yes

  No

• e) the appointment of competent persons, including any required qualification;

  Yes

  No

• f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

  Yes

  No

• g) the implementation of actions to prevent human error;

  Yes

  No

• h) the implementation of release, delivery and post-delivery activities.

  Yes

  No

• Is clause 8.5.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.5.2 Identification and traceability

• Can the client show that it uses suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

  Yes

  No

• Can the client demonstrate how they identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

  Yes

  No

• Can the client demonstrate how they control the unique identification of the outputs when traceability is a requirement,

  Yes

  No

• can the client demonstrate that they retain the documented information necessary to enable traceability.

  Yes

  No

• Is clause 8.5.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.5.3 Property belonging to customers or external providers

• Can the client show the process used to exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the company.

  Yes

  No

  N/A

• Can the client detail their process for identifying, verifying , protecting and safeguarding customers’ or external providers’ property provided for use or incorporation into the products and services.

  Yes

  No

  N/A

• When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, can the client show how they report this to the customer or external provider .

  Yes

  No

  N/A

• Can the client show that they retain documented information on what has occurred.

  Yes

  No

  N/A

• Is clause 8.5.3 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.5.4 Preservation

• Can the client demonstrate the process, or show the procedure for preservation of the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.

  Yes

  No

  N/A

• Is clause 8.5.4 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.5.5 Post-delivery activities

• Can the client demonstrate how they meet requirements for post-delivery activities associated with the products and services.

  Yes

  No

• In determining the extent of post-delivery activities that are required, can the show they have considered:

• a) statutory and regulatory requirements;

  Yes

  No

• b) the potential undesired consequences associated with its products and services;

  Yes

  No

• c) the nature, use and intended lifetime of its products and services;

  Yes

  No

• d) customer requirements;

  Yes

  No

• e) customer feedback.

  Yes

  No

• Is clause 8.5.5 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.5.6 Control of changes

• Can the client show how they review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

  Yes

  No

• Can the client demonstrate that they retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

  Yes

  No

• Is clause 8.5.6 considered compliant

  Compliant

  Non-Compliant

  N/A

8.6 Release of products and services

• Can the client detail the process for implementing planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. - is there evidence available to support this

  Yes

  No

• Can the client demonstrate how they prevent the release of products and services to the customer until the planned arrangements have been satisfactorily completed, (unless otherwise approved by a relevant authority and, as applicable, by the customer).

  Yes

  No

• Can the client demonstrate that they have a process for retaining documented information on the release of products and services. The documented information shall include:
  

• a) evidence of conformity with the acceptance criteria;

  Yes

  No

• b) traceability to the person(s) authorizing the release.

  Yes

  No

• Is clause 8.6 considered compliant

  Compliant

  Non-Compliant

  N/A

8.7 Control of nonconforming outputs

• 8.7.1 Can the client demonstrate how they ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

  Yes

  No

• Does the client detail their process to take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services.

  Yes

  No

• Does this process also apply to nonconforming products and<br>services detected after delivery of products, during or after the provision of services.

  Yes

  No

• Can the client demonstrate that their process for taking action on nonconforming outputs in one or more of the following ways:

• a) correction;

  Yes

  No

• b) segregation, containment, return or suspension of provision of products and services;

  Yes

  No

• c) informing the customer;

  Yes

  No

• d) obtaining authorization for acceptance under concession.

  Yes

  No

• Can the client demonstrate that conformity to the requirements is verified when nonconforming outputs are corrected.

  Yes

  No

• Is clause 8.7.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 8.7.2 Can the client demonstrate that they have a process to retain documented information that:

• a) describes the nonconformity;

  Yes

  No

• b) describes the actions taken;

  Yes

  No

• c) describes any concessions obtained;

  Yes

  No

• d) identifies the authority deciding the action in respect of the nonconformity.

  Yes

  No

• Is clause 8.7.2 considered compliant

  Compliant

  Non-Compliant

  N/A

9 Performance evaluation

• 9.1 Monitoring, measurement, analysis and evaluation

• 9.1.1 General
  Is there evidence that the client has determined:

• a) what needs to be monitored and measured;

  Yes

  No

• b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;

  Yes

  No

• c) when the monitoring and measuring shall be performed;

  Yes

  No

• d) when the results from monitoring and measurement shall be analysed and evaluated.

  Yes

  No

• Does the client have an established process to evaluate the performance and the effectiveness of the QMS.

  Yes

  No

• Can the client demonstrate that they have an established process to retain appropriate documented information as evidence of the results.

  Yes

  No

• Is clause 9.1.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 9.1.2 Customer satisfaction<br>Can the client demonstrate that they monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled.

  Yes

  No

• Can the client show that they have determined the methods for obtaining, monitoring and reviewing the information on customer satisfaction.

  Yes

  No

• Is clause 9.1.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 9.1.3 Analysis and evaluation<br>Can the client show hat they have an active process to analyse and evaluate appropriate data and information arising from monitoring and measurement.

  Yes

  No

• Can the client demonstrate that the following have been considered when evaluating the results of analysis and evaluation (the use of SPC can be included)

• a) conformity of products and services;

  Yes

  No

• b) the degree of customer satisfaction;

  Yes

  No

• c) the performance and effectiveness of the quality management system;

  Yes

  No

• d) if planning has been implemented effectively;

  Yes

  No

• e) the effectiveness of actions taken to address risks and opportunities;

  Yes

  No

• f) the performance of external providers;

  Yes

  No

• g) the need for improvements to the quality management system.

  Yes

  No

• Is clause 9.1.3 considered compliant

  Compliant

  Non-Compliant

  N/A

9.2 Internal audit

• 9.2.1 Can the client demonstrate that they conduct internal audits at planned intervals to provide information on whether the QMS:

• a) conforms to:

  Yes

  No

• * 1) the organization’s own requirements for its quality management system;

  Yes

  No

• * 2) the requirements of this International Standard;

  Yes

  No

• b) is effectively implemented and maintained.

  Yes

  No

• Is clause 9.2.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 9.2.2 Can the client demonstrate that they:

• a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which take into consideration the status / importance of the processes concerned, changes affecting the organization, and the results of previous audits;

  Yes

  No

• b) define the audit criteria and scope for each audit;

  Yes

  No

• c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

  Yes

  No

• d) ensure that the results of the audits are reported to relevant management;

  Yes

  No

• e) take appropriate correction and corrective actions without undue delay;

  Yes

  No

• f) retain documented information as evidence of the implementation of the audit programme and the audit results.

  Yes

  No

• Is clause 9.2.2 considered compliant

  Compliant

  Non-Compliant

  N/A

9.3 Management review

• 9.3.1 General<br>Can the client demonstrate that "top management" review the companies QMS , at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

  Yes

  No

• Is clause 9.3.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 9.3.2 Management review inputs
  Can the client show that the management review is planned and carried out taking into consideration:

• a) the status of actions from previous management reviews;

  Yes

  No

• b) changes in external and internal issues that are relevant to the quality management system;

  Yes

  No

• c) information on the performance and effectiveness of the quality management system, including trends in:

  Yes

  No

• * 1) customer satisfaction and feedback from relevant interested parties;

  Yes

  No

• * 2) the extent to which quality objectives have been met;

  Yes

  No

• * 3) process performance and conformity of products and services;

  Yes

  No

• * 4) nonconformities and corrective actions;

  Yes

  No

• * 5) monitoring and measurement results;

  Yes

  No

• * 6) audit results;

  Yes

  No

• * 7) the performance of external providers;

  Yes

  No

• d) the adequacy of resources;

  Yes

  No

• e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

  Yes

  No

• f) opportunities for improvement.

  Yes

  No

• Is clause 9.3.2 considered compliant

  Compliant

  Non-Compliant

  N/A

• 9.3.3 Management review outputs
  Can the client demonstrate that the outputs of the management review include decisions and actions related to:

• a) opportunities for improvement;

  Yes

  No

• b) any need for changes to the quality management system;

  Yes

  No

• c) resource needs.

  Yes

  No

• Does the client have an active process for retaining documented information as evidence of the results of management reviews.

  Yes

  No

• Is clause 9.3.3 considered compliant

  Compliant

  Non-Compliant

  N/A

10 Improvement

• 10.1 General<br>Can the client demonstrate that they have determined and selected opportunities for improvement and implemented any necessary actions to meet customer requirements and enhance customer satisfaction.

  Yes

  No

• Can the client demonstrate determined and selected opportunities for improvement include:

• a) improving products and services to meet requirements as well as to address future needs and expectations;

  Yes

  No

• b) correcting, preventing or reducing undesired effects;

  Yes

  No

• c) improving the performance and effectiveness of the quality management system.

  Yes

  No

• Is clause 10.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 10.2 Nonconformity and corrective action

• 10.2.1 Can the client show that they have an established process for when a nonconformity occurs, including any arising from complaints they:

• a) react to the nonconformity and, as applicable:

  Yes

  No

• * 1) take action to control and correct it;

  Yes

  No

• * 2) deal with the consequences;

  Yes

  No

• b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

  Yes

  No

• * 1) reviewing and analysing the nonconformity;

  Yes

  No

• * 2) determining the causes of the nonconformity;

  Yes

  No

• * 3) determining if similar nonconformities exist, or could potentially occur;

  Yes

  No

• c) implement any action needed;

  Yes

  No

• d) review the effectiveness of any corrective action taken;

  Yes

  No

• e) update risks and opportunities determined during planning, if necessary;

  Yes

  No

• f) make changes to the quality management system, if necessary.

  Yes

  No

• Can the client show / say that corrective actions are appropriate to the effects of the nonconformities encountered.

  Compliant

  Non-Compliant

  N/A

• Is clause 10.2.1 considered compliant

  Compliant

  Non-Compliant

  N/A

• 10.2.2 Can the client show that they have an established process to retain documented information as evidence of:

• a) the nature of the nonconformities and any subsequent actions taken;

  Yes

  No

• b) the results of any corrective action.

  Yes

  No

• Is clause 10.2.2 considered compliant

  Compliant

  Non-Compliant

  N/A

10.3 Continual improvement

• Can the client demonstrate that they have an established process to show that they continually improve the suitability, adequacy and effectiveness of the QMS

  Yes

  No

• Can the client demonstrate or show that they consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that are addressed as part of continual improvement.

  Yes

  No

• Is clause 10.3 considered compliant

  Compliant

  Non-Compliant

  N/A

• Names and positions of attendees

• Re confirm confidentiality

• re confirm any findings (NCs / Obs), actions required or agreed, requirements for submitting corrective actions

• re confirm right of appeal for auditor decisions not agreed with

• Any Questions regarding the audit or services that can be provided

• Recommendation

• Is certification, or continued certification, recommended (subject to any NCs being closed)

  Select Yes No

  • Yes
  • No