Utilize an ISO 17020 internal audit checklist

Introduction

Date

Assessor

Organization

Area of Operation

4. General Requirements

4.1 Impartiality & Independence

4.1.1 Are inspection activities undertaken impartially?

4.1.2 Is the Inspection Body involved in activities other than inspection identifiable within that entity?

4.1.3 Does the Inspection Body identify risks to its impartiality on an on-going basis? Does it include those risks that arise from its activities, its relationships or from the relationships of its personnel?

4.1.4 If a risk to impartiality is identified, is the Inspection Body able to demonstrate how it eliminates or minimizes such risk?

4.1.5 Has the top management of the Inspection Body committed to impartiality?

4.1.6 Is the Inspection Body independent to the extent that is required with regard to the conditions under which it performs its services?

4.2 Confidentiality

4.2.1 a) Is the Inspection Body responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of inspection activities?

b) Does the Inspection Body inform the customer, in advance, of the information it intends to place in the public domain?

c) Except for information that the customer makes publicly available, or when agreed between the Inspection Body and the customer (e.g. for the purpose of responding to complaints) are all other information considered proprietary information and regarded as confidential?

4.2.2 When the Inspection Body is required by law or authorized by contractual commitments to release confidential information, is the customer or individual concerned, unless prohibited by law, notified of the information provided?

4.2.3 Is the information about the customer obtained from sources other than customer (e.g. complainant, regulators) treated as confidential?

5. Structural Requirements

5.1 Administrative Requirements

5.1.1 Is the Inspection Body a legal entity or a defined part of a legal entity such that it can be held legally responsible for all its inspection activities?

5.1.2 Is the Inspection Body that is part of a legal entity involved in activities other than inspection identifiable within that entity?

5.1.3 Does the Inspection Body have adequate documentation which describes the activities for which it is competent?

5.1.4 Does the Inspection Body have adequate provision (e.g. insurance or reserves) to cover liabilities arising from its operations?

5.1.5 Does the Inspection Body have documentation describing the contractual conditions under which it provides the inspection?

5.2 Organization & Management

5.2.1 Is the Inspection Body structured and managed so as to guarantee and safeguard impartiality?

5.2.2 Is the Inspection Body organized and managed so as to enable it to maintain the capability to perform its inspection activities?

5.2.3 Has the Inspection Body documented the responsibilities and reporting structure of the organization?

5.2.4 In areas where the legal entity, of which the Inspection Body is a part, also performs other conformity assessment activities, is the relationship between these activities defined?

5.2.5 a) Do the Inspection Body have available one or more person(s) as technical manager(s), however named, that have overall responsibility to ensure that the inspection activities are carried out in accordance with this international standard?

b) Are the person(s) fulfilling this function technically competent and experienced in the operation of the Inspection Body?

c) Where the Inspection Body has more than technical manager, are the specific responsibilities of each manager defined and documented?

5.2.6 Does the Inspection Body have one or more named person(s) who will stand in for any technical manager responsible for on-going inspection activities in the case of their absence?

5.2.7 Does the Inspection Body have a job description or other documentation for each position category within its organization involved in inspection activities?

6. Resource Requirements

6.1 Personnel

6.1.1 Did the Inspection Body define and document the competence requirements for all personnel involved in inspection activities including requirements for education, training, technical knowledge, skills and experience?

6.1.2 Does the Inspection Body employ or have contracts with a sufficient number of persons with the required competencies including, where needed, the ability to make professional judgments to perform the type, range and volume of its inspection activities?

6.1.3 Does the personnel responsible for inspection have appropriate qualifications, training, experience and a satisfactory knowledge of the requirements of the inspections to be carried out?

6.1.4 Is each person aware of their duties, responsibilities and authorities?

6.1.5 Does the Inspection Body have documented procedures for:

Selecting?

Training?

Authorizing?

Monitoring?

6.1.6 Do the documented procedures for training address these stages:

Induction Period

Mentoring Period

Continuous training to keep up with methods?

6.1.7 Does the training required depend upon the ability, qualifications and experience of each inspector and other personnel involved in inspection activities and upon the results of monitoring?

6.1.8 Do personnel familiar with the inspection methods and procedures monitor all inspectors and other personnel involved in inspection activities for satisfactory performance?

6.1.9 Is each inspector observed on-site unless there is sufficient supporting evidence that the inspector is reliably able to perform competently?

6.1.10 Are records of monitoring, education, training, technical knowledge and experience of each member of its personnel involved in inspection activities maintained by the Inspection Body?

6.1.11 Is the way which personnel involved in inspection activities are remunerated such that it influences the results of inspections?

6.1.12 Do all personnel of the Inspection Body, either internal or external, that could influence the inspection activities act impartially?

6.1.13 Are all personnel of the Inspection Body acting on its behalf keeping all information obtained confidential except as required by law?

6.2 Facilities & Equipment

6.2.1 Does the Inspection Body have suitable and adequate facilities and equipment to permit all activities associated with the inspection activities to be carried out in a competent and safe manner?

6.2.2 Does the Inspection Body have rules for the access to and the use of specified facilities and equipment used to perform inspections?

6.2.3 Does the Inspection Body ensure the continued suitability of the facilities and the equipment?

6.2.4 Is all equipment defined and, where appropriate, uniquely identified?

6.2.5 Is all equipment properly maintained in accordance with documented procedures and instructions?

6.2.6 Where appropriate, are measurements equipment having a significant influence on the results of the inspection calibrated before being put into service?

6.2.7 Is the overall programme of calibration of equipment designed and operated so as to ensure that, wherever applicable, measurements made by the Inspection Body are traceable to national or international standards of measurement?

6.2.8 Are reference standards of measurement held by the Inspection Body used for calibration only and for no other purpose?

6.2.9 Where relevant, are equipment subjected to inservice checks between regular recalibrations?

6.2.10 Are reference materials traceable to national or international standard reference materials where they exist?

6.2.11 Where relevant for the outcome of inspection activities, does the Inspection Body have adequate procedures for:

a. Selection and approval of suppliers?

b. Verification of incoming goods and services?

c. Ensuring appropriate storage facilities?

6.2.12 Where applicable, is the condition of stored items assessed at appropriate intervals to detect deterioration?

6.2.13 Are computers and software adequate for use, procedures for data security established and equipment properly maintained?

6.2.14 Does the Inspection Body have documented procedures for dealing with defective equipment?

6.2.15 Is relevant information on the equipment, including software, recorded? Does it include identification and where appropriate, information on calibration and maintenance?

6.3 Sub-contracting

6.3.1 Does the Inspection Body itself normally perform the inspections which it contracts to undertake?

6.3.2 Does the Inspection Body inform customer of its intention to sub-contract any part of the inspection?

6.3.3 Whenever work, which forms part of an inspection, is carried out by sub-contractors, does the responsibility for the determination of conformity of the inspected item with the requirements remain with the inspection body?

6.3.4 Does the Inspection Body record and retain details of its investigation of the competence of its sub-contractors and of their conformity with the applicable requirements of this international standard? Does the Inspection Body maintain a register of all sub-contractors?

7. Process requirements

7.1 Inspection methods and procedures

7.1.1 Does the Inspection Body use the methods and procedures for inspection which are defined in the requirements against which inspection is to be performed? Does the Inspection Body inform the customer if the inspection method proposed by the customer is considered to be inappropriate?

7.1.2 Do the Inspection Body have and use adequate documented instructions on inspection planning and on sampling and inspection techniques, where the absence of such instructions could jeopardize the effectiveness of the inspection process? Where applicable, do the Inspection Body have sufficient knowledge of statistical techniques to ensure statistically sound sampling procedures and the correct processing and interpretation of results?

7.1.3 When the Inspection Body has to use inspection methods or procedures which are non-standard, are such methods and procedures appropriate and fully documented.

7.1.4 Are all instructions, standards or written procedures, worksheets, checklists and reference data relevant to the work of the Inspection Body maintained up-to-date and be readily available to the personnel?

7.1.5 Does the Inspection Body have a contract or work order control system which ensures that:

a. Work to be undertaken is within its expertise and that then organization has adequate resources to meet the requirements?

b. The requirements of those seeking the Inspection Body’s services are adequately defined and that special conditions are understood so that unambiguous instructions can be issued to personnel performing the duties to be required?

c. Work being undertaken is controlled by regular review and corrective action?

d. The requirements of the contract or work order have been met?

7.1.6 When the Inspection Body uses information supplied by any other party as part of the inspection process, does it verify the integrity of such information?

7.1.7 Are observations or data obtained in the course of inspections recorded in a timely manner to prevent loss of relevant information?

7.1.8 Are calculations and data transfers subject to appropriate checks?

7.1.9 Does the Inspection Body have documented instructions for carrying out inspection in a safe manner?

7.2 Handling Inspection Items and Samples

7.2.1 Does the Inspection Body ensure items and samples to be inspected are uniquely identified to avoid confusion regarding the identity of such items and samples?

7.2.2 Does the Inspection Body establish whether the item to be inspected has been prepared?

7.2.3 Are any apparent abnormalities notified to, or noticed by the inspector recorded? Where there is any doubt as to the item’s suitability for the inspection to be carried out, or where the item does not conform to the description provided, does the Inspection Body contact the customer and record the outcome before proceeding?

7.2.4 Does the Inspection Body have documented procedures and appropriate facilities to avoid deterioration or damage to inspection items while under its responsibility?

7.3 Inspection Records

7.3.1 Does the Inspection Body maintain a record system to demonstrate the effective fulfilment of the inspection procedures and enable an evaluation of the inspection?

7.3.2 Is the inspection report or certificate internally traceable to the inspector(s) who performed the inspection?

7.4 Inspection Reports & Inspection Certificates

7.4.1 Are the work carried out by the Inspection Body covered by a retrievable inspection report or inspection certificate?

7.4.2 Does the inspection report / certificate include all the following:

a. Identification of then issuing body?

b. Unique identification and date of issue?

c. Date(s) of inspection?

d. Identification of the item(s) inspected?

e. Signature or other indication of approval by authorized personnel?

f. A statement of conformity where applicable?

g. The inspection results except where detailed in accordance with clause 7.4.3?

7.4.3 Does the Inspection Body only issue an inspection certificate that does not include the inspection results (7.4.2 g) when then the Inspection Body can also produce an inspection report containing the inspection results and both the inspection certificate and inspection report are traceable to each other?

7.4.4 Is all information (7.4.2) reported correctly, accurately and clearly? Where the inspection report or inspection certificate contains results supplied by sub-contractors, are these results clearly identified?

7.4.5 Are corrections or additions to an inspection report or inspection certificate after issue recorded in accordance with the relevant requirements of this section (see 8.4)? Is the amended report or certificate identifying the report or certificate it replace?

7.5 Complaints & Appeals

7.5.1 Does the Inspection Body have a documented process, evaluate and make decisions on complaints and appeals?

7.5.2 Is a description of the handling process for complaints and appeals available to any interested party on request?

7.5.3 Upon receipt of a complaint, does the Inspection Body confirm whether the complaint relates to conformity assessment activities that it is responsible for and, if so, shall deal with it?

7.5.4 Is the Inspection Body responsible for all decisions at all levels of the handling process for complaints and appeals?

7.5.5 Does investigation and decision on appeals result in any discriminatory actions?

7.6 Complaints & Appeals Procedure

7.6.1 Does the handling process for complaints and appeals include at least the following elements and methods:

a. A description of the process for receiving, validating, investigating the complaint or appeal and deciding what actions are to be taken in response to it?

b. Tracking and recording complaints and appeals including actions undertaken to resolve them?

c. Ensuring that any appropriate action is taken?

7.6.2 Is the body receiving the complaint or appeal responsible for gathering and verifying all necessary information to validate the complaint or appeal?

7.6.3 Whenever possible, does the body acknowledge receipt of the complaint or appeal and provide the complainant or appellant with progress reports and the outcome?

7.6.4 Is the decision to be communicated to the complainant or appellant made by, or reviewed and approved by individual(s) not involved in the original inspection activities in question?

7.6.5 Whenever possible, does the body give formal notice of the end of the complaint and appeals handling process to the complainant or appellant?

8. Management System Requirements For Inspection Bodies

8.1 General

8.1.1 Does the Inspection Body establish and maintain a management system that is capable of achieving the consistent fulfillment of the requirements of this international standard in accordance with either Option A or Option B?

8.2 General management system documentation (Option A)

8.2.1 Did the Inspection Body’s top management establish, document and maintain policies and objectives for fulfillment of this international standard and do they ensure the policies and objectives are acknowledged and implemented at all levels of the Inspection Body’s organization?

8.2.2 Does the top management provide evidence of its commitment to the development and implementation of the management system and its effectiveness in achieving consistent fulfillment of this international standard?

8.2.3 Did the Inspection Body’s top management appoint a member of management who, irrespective of other responsibilities, have responsibility and authority that include:

a. Ensuring that processes and procedures needed for the management system are established, implemented and maintained?

b. Reporting to the top management on the performance of the management system and any need for improvement?

8.2.4 Are all documentation, processes, systems, records, etc. related to the fulfillment of the requirements of this international standard included, referenced or linked to documentation of the management system?

8.2.5 Do all personnel involved in inspection activities have access to the parts of the management system documentation (and related information above) that are applicable to their responsibilities?

8.3 Control of documents (Option A)

8.3.1 Did the Inspection Body establish procedures to control the documents (internal and external) that relate to the fulfillment of this international standard?

8.3.2 Do the procedures define the controls needed to:

a) Approve documents for adequacy prior to issue?

b) Review and update as necessary and reapprove documents?

c) Ensure that changes and the current revision status of documents are identified?

d) Ensure that relevant versions of applicable documents are available at points of use?

e) Ensure that documents of external origin are identified and their distribution controlled?

f) Prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose?

8.4 Control of records (Option A)

8.4.1 Did the Inspection Body establish procedures to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of its records related to the fulfillment of this international standard?

8.4.2 Did the Inspection Body establish procedures for retaining records for a period consistent with its contractual and legal obligations? Is access to these records consistent with the confidentiality arrangements?

8.5 Management review (Option A)

8.5.1 General

8.5.1.1 Did the Inspection Body’s top management establish procedures to review its management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness including the stated policies and objectives related to the fulfillment of this international standard?

8.5.1.2 Are these reviews conducted at least once a year? Alternatively is a complete review broken up into segments (a rolling review) completed within a 12 month timeframe?

8.5.1.3 Are records of review maintained?

8.5.2 Review inputs: Does the input to the management review include information related to

a) Results of internal and externals audits?

b) Feedback from customers and interested parties related to the fulfillment of this international standard?

c) Status of preventive and corrective actions;?

d) Follow-up actions from previous management reviews;?

e) Fulfillment of objectives;?

f) Changes that could affect the management system?

g) Appeals and complaints.

8.5.3 Review outputs: Does the outputs from the management review include decisions and actions related to

a) Improvement of the effectiveness of the management system and its processes?

b) Improvement of the Inspection Body related to the fulfillment of this international standard?

c) Resource needed?

8.6 Internal audits (Option A)

8.6.1 Did the Inspection Body establish procedures for internal audits to verify that it fulfills the requirements of this international standard and that the management system is effectively implemented and maintained?

8.6.2 Was an audit programme planned, taking into consideration the importance of the processes and areas to be audited as well as the results of previous audits?

8.6.3 Does the Inspection Body conduct periodic internal audits covering all procedures in a planned and systematic manner to verify that the management system is implemented and is effective?

8.6.4 Are internal audits performed at least once every 12 months? The frequency of internal audits may be adjusted depending on the demonstrate effectiveness of the management system and its proven stability.

8.6.5 Does the Inspection Body ensure that:

a) Internal audits are conducted by qualified personnel knowledgeable in inspection, auditing and the requirements of this international standard?

b) Auditors do not audit their own work;?

c) Personnel responsible for the area audited are informed of the outcome of the audit?

d) Any actions resulting from internal audits are taken in a timely and appropriate manner?

e) Any opportunities for improvement are identified?

f) The results of the audit are documented?

8.7 Corrective actions (Option A)

8.7.1 Did the Inspection Body establish procedures for identification and management of nonconformities in its operation?

8.7.2 Does the Inspection Body also, where necessary, take actions to eliminate the causes of nonconformities in order to prevent recurrence?

8.7.3 Are corrective actions appropriate to the impact of the problem encountered?

8.7.4 Do the procedures define requirements for:

a) Identifying nonconformities?

b) Determining the causes of non-conformities?

c) Correcting nonconformities?

d) Evaluating the need for actions to ensure that nonconformities do not occur?

e) Determining and implementing in a timely manner the actions needed?

f) Recording the results of actions taken?

g) Reviewing the effectiveness of corrective actions?

8.8 Preventive actions (Option A)

8.8.1 Did the Inspection Body establish procedures for taking preventive actions to eliminate the causes of potential nonconformities?

8.8.2 Are preventive actions taken appropriate to the probable impact of the potential problems?

8.8.3 Do the procedures for preventive actions define requirements for:

a) Identifying potential nonconformities and their causes?

b) Evaluating the need for action to prevent the occurrence of nonconformities?

c) Determining and implementing the action needed?

d) Recording the results of actions taken?

e) Reviewing the effectiveness of the preventive actions taken?

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ISO 17020 Internal Audit Checklist Template

ISO 17020 Internal Audit Checklist: What It Is and Why It’s Important

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