The responsibilities of the manufacturer will be communicated to the manufacturer before the inspection. The manufacturer will be responsible for:

• agreeing upon the objectives and the scope of the inspection with the WHO prequalification team
• inform the WHO prequalification inspection team of any issues that may affect an effective and efficient inspection process
• cooperating with the inspectors to ensure that the objectives of the inspection are achieved
• appointing an employee to be responsible for coordinating and facilitating the inspection process on behalf of the manufacturer
• informing relevant employees and personnel about the objectives and scope of the inspection
• determining which members of staff will accompany members of the inspection team
• ensuring that the inspectors are aware of health, safety and other applicable requirements
• providing on-site resources, such as a meeting room, for the inspection team, in order to ensure an effective and efficient inspection process
• providing full access to the manufacturing facilities, documents and records and other evidence as requested by the inspectors, in a timely manner, to ensure an effective and efficient inspection process and so that the inspection timetable can be adhered to.

If nonconformities are identified during inspection of the manufacturing site, information about these will be provided to the manufacturer during the closing meeting. The manufacturer will subsequently receive an inspection report that will include the nonconformities. Upon receipt of the inspection report the manufacturer will be responsible for:

• determining the root cause of all nonconformities identified
• determining the corrective actions to be implemented, including those aimed at preventing recurrence of the nonconformities
• submitting a corrective action plan to WHO within 30 days of receipt of the final inspection report
• implementing and verifying the effectiveness of the corrective actions in a timely manner
• informing WHO of completion of these corrective actions, as required
• informing WHO of any subsequent significant change to the quality system or the product
• informing all those personnerl who may be impacted by the results of the inspection.

An on-site inspection will seek to confirm the adequacy and effectiveness of the manufacturer’s documented quality management system (QMS), with emphasis on the control of the production processes and compliance with state-of-the-art practices, including WHO technical guidelines.

Documents and records from all levels of the quality system will be reviewed. Post-market surveillance data, as well as marketing and training material, may be included in the review.

Informal interview of personnel at all levels and discussions with persons selected by an inspector will form part of the inspection process.

Evidence will be collected on-site, as follows:

• by examination of documents, including standard operating procedures and records
• by visual observation of activities
• by visual observation of environmental conditions
• by confirmation of statement of fact that is acquired through interviews

and may include:

• random sampling of product for laboratory quality control testing
• photographs.

Nonconformities identified during the document review or interviews will be notified to the accompanying representative of the manufacturer and may be verified by acquiring additional information where possible. The manufacturer will be given an immediate opportunity to comment on the evidence of nonconformities. Based on this evidence, a nonconformity, even if corrected immediately, will be noted and form part of the final inspection report.

QMS inspection overview

The QMS inspection will be conducted in a format that follows the production process. Note that ISO13485 is used as a basis for the inspection and that other product and system-related standards and references may be used by the manufacturer to ensure good practice in the manufacture of the IVDs.

The QMS inspection process includes, but is not limited to the following processes:

• management: to ensure that an adequate and effective QMS is in place, including management review

• product documentation, including design and development: to ensure that the manufacturer has established sufficient documented systems and adequate communication of the systems (including change control) to all personnel, to ensure a quality product outcome

• production and process controls: to ensure that the manufacturer has established sufficient systems such as testing, infrastructure, facilities, equipment and personnel to ensure a quality outcome; demonstrated independence between the production and quality unit and that the quality unit controls release of product batches

• corrective and preventive actions, internal audits: inspection of this section is to confirm that the manufacturer collects and analyses actual and potential quality problems through investigation and appropriate action

• purchasing controls: especially important when significant components are outsourced – the manufacturer must ensure that raw material, intermediates, components and services provided by suppliers are of an appropriate standard

• documentation and records: to ensure that relevant documents and records are defined, established and controlled, for example, by being updated and properly authorized; and to ensure procedure and process documents are readily available and in routine use by staff as needed

• customer-related processes: in this context, customers include purchasers and users of the product and relevant regulatory bodies

• training of personnel and training records: to ensure that qualifications and training of personnel are appropriate to the tasks required of them

• infrastructure and work environment: to ensure the adequacy of facilities, manufacturing, equipment, monitoring and quality control equipment; calibration and maintenance.

Verification of data supporting IVD product dossier submission

During the inspection, one of the inspectors will sample the quality records and reports that support the data submitted with the product dossier for WHO prequalification. This may include, but is not limited to, data recorded for the batches submitted for WHO performance evaluation or testing, data collected in performance studies (internal and independent external), quality control data and batch manufacturing records. The manufacturer must ensure that the entire product dossier submitted to WHO is available on-site.

MCD technical/production inspection overview

The technical inspection will be conducted in a format that follows the production process. The numbers in brackets indicate the area of ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes that are relevant to this process.

• Planning of product realization (7.1)
• Customer-related processes (7.2)
• Design and development (7.3)
• Purchasing (7.4)
• Production and service provision (7.5)
• Control of monitoring and measuring devices (7.6).

Organization of an inspection of an IVD manufacturing site is very similar to organization of an inspection of an MCD manufacturing site. Where the two differ this is indicated by the prefixes: "For an IVD inspection", "For an MCD inspection".

Logistics for the inspection

Dates and time allocated for the inspection of manufacturing site(s)

The dates and time allocated for the inspection are to be agreed upon by all participants under the guidance of the WHO inspector and will be documented in an inspection plan.The inspection should be scheduled for a time when:

• the production line of the product undergoing prequalification assessment is active (if several products are inspected during the same inspection, the production line for at least one of them must be active)
• quality control activities are being performed
• the key personnel for the quality management system (QMS), quality control and production line will be present.

Usually the inspection plan will be provided one to two weeks before the inspection and will include details of the type of inspection to be conducted and the sites and products to be inspected, using information about the product and QMS that has already been submitted, and including the quality manual. The plan is a guide only and will be flexible to permit changes in emphasis based on information gathered during the inspection.

The inspection plan will include the following information:

• the scope and purpose of the inspection of the manufacturing site
• identification of inspection team members and of the contact person representing the manufacturer for the inspection
• date and place of the inspection
• expected time and duration of each inspection activity, including meetings to be held with the manufacturer's management team.

The time allocated to the inspection will be calculated according to the complexity of the scope of the inspection, the number of manufacturing technologies, and the number and type of IVDs undergoing assessment for prequalification. An example of an inspection timetable is provided  below. Inspectors will be allocated tasks by the WHO inspector according to their expertise and inspection requirements.

*  Times may be modified to better comply with the daily production routine. Length of the on-site inspection will vary according to inspection requirements.

Documentation regarding subcontractors, outsourced processes and significant suppliers (critical suppliers)

For an IVD manufacturing site: The manufacturer must have the necessary documentation available to demonstrate that the processes to control product supply are effective and meet the relevant quality expectations. This includes, but is not limited to, documentation relating to providers of critical raw material, interim components, packaging or other services used to produce the IVD. The manufacturer shall be responsible for the sufficient control of any critical supplier, including outsourced processes. If this requirement is not sufficiently met, a nonconformity against the respective ISO 13485 requirement will be issued and an inspection of subcontractor sites may be necessary.

For an MCD manufacturing site: The manufacturer must have the necessary documentation available to demonstrate that subcontractors, such as providers of components used to make the device, meet relevant quality expectations. Inspection of subcontractor sites may be necessary if this requirement is not adequately fulfilled.

Working documents for on-site inspection

Inspectors will be provided with briefing notes, as applicable, to their area of inspection. The briefing notes may contain information about open questions and/or issues with the product that were noted during dossier assessment, technical information about the product batches provided for performance evaluation, and do not necessarily define the entire scope of the inspection. Additional items may be included according to the particular requirements of the IVD and the expertise of the inspector. 

It is expected that inspectors will document their findings in the inspection notes, as the inspection progresses. This information will be used to compile the draft on-site report and to describe any nonconformities and shall be handed over to the WHO inspector who will gather all relevant inspection records and compile the final inspection report.

Language for the on-site inspection

The inspection will be conducted in English. To enable a smooth and effective inspection, the manufacturer must ensure that all relevant higher-level quality management documents are available in English. Interpretation needs will be discussed with the manufacturer.

Travel and accommodation arrangements

The WHO lead inspector is responsible for organizing the travel and accommodation of the inspection team. This responsibility will not extend to the observers, except under particular circumstances, such as when WHO is providing training or education. If requested by WHO, the manufacturer will use its local knowledge to assist with safe travel and accommodation arrangements for the inspection team.

Meetings during an inspection

Opening meeting

The opening meeting (up to one hour) is held to exchange information between the inspection team and the manufacturing team on the inspection process and the manufacturing site, and to confirm the inspection scope, objectives and plan, as well as the availability of responsible contact persons on site. The times indicated below may act as a guide.

First, the lead inspector will:

• introduce the inspection team
• review the scope and objectives of the inspection
• provide a short summary of the inspection process as part of the process for evaluation of an IVD for WHO prequalification
• confirm the timetable of the manufacturing site inspection
• confirm that the resources and facilities needed by the inspection team are available
• allow manufacturer to ask clarifying questions regarding the inspection process.

Then, the manufacturer will:

• introduce principal staff
• provide a current organigram and a written list with contact details of its staff, to facilitate access to key personnel during the inspection process
• provide brief overview of the QMS
• provide a brief overview of on-site manufacturing process, particularly for the product/s undergoing evaluation for prequalification
• inform the inspection team of any changes since the submission of the product dossier or last inspection for prequalification and/or the submission of the batches for the WHO performance evaluation
• provide a manufacturing schedule, including shifts (if applicable), for the inspection days and a diagram for the manufacturing workflow
• inform the inspection team of any changes since submission of the dossier
• for an IVD inspection: present samples of the products in prequalification (final product) for the inspection team to investigate content and labelling thereof.

Meeting of inspectors

Inspectors will meet as necessary throughout the inspection. The following meetings should take place at a minimum:

• Discussion of findings and the progress of the inspection.
• Daily summary, a brief summary of the day's activities and findings.
• Inspection summary: On the last day of the inspection, the inspectors will meet to discuss and summarize the findings to be left with the manufacturer.
• For an MCD inspection: Preparation of summary: the inspectors will then assist the inspection team leader in summarizing the outcome of the inspection.

Daily wrap-up meeting

Daily wrap-up meetings will be held between the manufacturer and the inspection team at the end of each day of the on-site inspection. As part of these meetings, the inspection team will present a summary of its daily findings and the manufacturer will be invited to discuss the findings and any issues of concern (potential nonconformities).

During the daily wrap-up meetings, the manufacturer must raise any comments on any issues of concern or the performance of the inspection, indicate its understanding of, or contest, any issues of concern raised, and/or provide additional clarification to the inspection team on the extent or significance of any issue of concern. If the manufacturer contests any nonconformity or issue of concern, a rationale (including supporting evidence) must be provided by the manufacturer to the inspection team.

Closing meeting for an IVD inspection

The closing meeting concludes the inspection and will be held in the presence of the complete inspection team and the management team of the manufacturer. Other staff members may be invited by the management, as appropriate.

The lead inspector will summarize the findings and issues of concern from the inspection, in the order of significance, and will present:

• the outcome of the inspection, including areas covered and not covered, as well as limitations to the inspection or the product
• the list of nonconformities or a draft on-site inspection report, depending on the type of inspection.

If a draft on-site inspection report is presented, the report will describe the main findings and issues of concern, and will summarize the general outcome of the inspection. Significant issues of concern will be discussed in detail with the manufacturer. The inspectors will be available to provide additional clarifications concerning the inspection, if requested by the manufacturer.

The manufacturer's management team will have the opportunity to comment on and to seek clarification from the inspection team on items in the draft on-site inspection report. If the manufacturer contests any issue of concern, a rationale including supporting evidence must be provided to the inspection team.

The list of nonconformities or a draft on-site inspection report will allow the manufacturer to start working on any immediately required corrections. A timeframe for the issuing of the final inspection report and the implementation of corrective actions should be agreed to at the closing meeting, if possible. The lead inspector will advise the manufacturer that the corrective action plan has to be submitted within 30 days from the receipt of the final inspection report.

Closing meeting for an MCD inspection

The summary inspection on-site report is a draft consensus report compiled and presented by the inspection team leader at the closing meeting. It will describe the main findings, areas of concern and summarize the general issues relating to the inspection. It will contain specific information on the nonconformity activities observed by the inspectors and may include an indication of their relative severity. The inspectors will be available to provide additional explanation if required.

The summary on-site report will allow the manufacturer to begin any corrective actions required immediately. A time frame for the implementation of corrective actions should be agreed to if possible at the closing meeting or will be indicated in the final inspection report.

The manufacturer's management team will have an opportunity to comment on and to seek clarification on items in the summary report from the inspection team. The inspection team leader will have the final decision on the content of the summary and inspection reports.

The report for an inspection of an IVD manufacturing site is very similar to that for an inspection of an MCD manufacturing site. Where the two differ this is indicated by the prefixes: "For an IVD inspection", "For an MCD inspection".

Overview

The purpose of the inspection report is to provide:

• the manufacturer with information on nonconformities found during the inspection: identified examples of nonconformity must be investigated to determine what corrective actions to take to prevent recurrence of the nonconformity and then those corrective actions must be implemented
• the manufacturer with information upon which to base improvements to the quality of the manufacturing system
• a permanent record of the findings of the inspection
• recommendations to the WHO team regarding actions to be taken following the inspection.

A more detailed description of the purpose of the inspection report can be found in guidance such as IMDRF/MDSAP WG/N24 FINAL: 2015 – Medical device regulatory audit reports and ISO 19011:2011 Guidelines for auditing management systems.

The WHO inspector will prepare the inspection report and is responsible for its accuracy and content.

For an IVD inspection: A final inspection report will be issued by WHO to the manufacturer generally within 30 days of the inspection, although this time may extend to two months during periods of high workload and vacation. If a final inspection report cannot be issued within a 30-day timeframe, the manufacturer will be notified accordingly. The manufacturer understands and agrees that WHO will have absolute, exclusive control over the manner in which the inspection is carried out, including publication of the results of the inspection, irrespective of the outcome. The manufacturer also understands and agrees that WHO reserves the right to share the manufacturer's prequalification application and related information, as well as the results of the inspection and the full inspection reports, including any drafts thereof and including (subject to appropriate obligations of confidentiality) any confidential information to which WHO may gain access in the course of the prequalification process and/or inspection, with the relevant authorities of any interested Member State of the Organization, with interested national regulatory authorities (NRAs), and with relevant inter-governmental organizations. As used here, "Confidential information" means:

• confidential intellectual property, know-how and trade secrets (including, e.g. formulas, processes or information contained or embodied in a product, unpublished aspects of trade mark, patents, etc.)
• commercial confidences (e.g. structures and development plans of a company).

For an MCD inspection: A draft report is left on site on the final day of the inspection. A final report is available generally within two months of the inspection although this time may be extended during periods of high workload and vacation.

Contents of an inspection report

An inspection report generally includes:

• the purpose, scope and objectives of the inspection, including the manufacturing site(s), processes and the product(s)
• details of the inspection team
• details of the areas covered in the inspection
• limitation of the inspection or product
• details of nonconformities (and their relative severity) and date for submission of any corrective actions required
• comment and conclusions about the effectiveness of the manufacturer's quality system in meeting quality objectives
• summary of conclusions
• authorized signature and date of the report.

The report will include the following comment: "This report contains the collective views of the inspection team performing this inspection and does not necessarily represent the decisions or the stated policy of the World Health Organization."

Types of inspection report

Inspection reports generally fall into one of two categories: reports with no requirements or reports with requirements relating to nonconformities.

Reports with no requirements

The inspection report with no requirements will be a consensus report compiled by the lead inspector. The participating inspectors may be asked to review the report for accuracy. Following approval by the WHO authorized approver; the report shall be submitted to the manufacturer.

Reports with requirements relating to nonconformities

The inspection report with requirements relating to nonconformities will be a consensus report compiled by the lead inspector. Following authorization by the WHO-authorized approver, the report will be submitted to the manufacturer. This type of report will include a description of the nonconformities found during the manufacturing site inspection, their severity, the findings that contributed to each nonconformity, the relevant specific ISO 13485 requirements (individual clause or subclause) and the evidence of nonconformity (e.g. manufacturer’s procedure). 

Nonconformities

During the on-site inspection, nonconformities may have been identified with respect to:

• quality management system (QMS) inspection criteria
• verification of data supporting the product dossier claims.

Both types of nonconformities, as well as the objective evidence contributing to the nonconformity, including the inspection criterion that was not met, will be individually stated and described in the manufacturing site inspection report. Additional findings to the same requirement may contribute to the severity grading of a nonconformity, thus raising its level.

The severity of nonconformities will be classified according to the Global Harmonization Task Force SG3 N19:2012 document: with level 1 being the lowest level on nonconformity and level 5 the highest. The QMS shall be considered critically deficient, if the following occur:

• 1 or more level 5 nonconformity(s) or
• 7 or more level 4 nonconformities.

If any nonconformities are included in the final inspection report, a corrective action plan (CAP) shall be submitted to WHO by the manufacturer within 30 days after receipt of the final inspection report. For each identified nonconformity, the CAP shall include:

• a root-cause analysis
• the corrections required for the identified nonconformities
• the corrective actions required to remove the cause and to prevent recurrence
• a timeline for implementation of corrections and corrective actions
• indication of those responsible for implementation
• evaluation of the effective implementation of the corrective action(s).

The manufacturer must provide the CAP to WHO in an editable format, such as a Word document or Excel spreadsheet. This will facilitate communication regarding the approval or rejection of the CAP, or a request for additional information and documents. 

WHO review of corrective action plan

The WHO lead inspector will request, and the inspection team will review submissions from the manufacturer relating to correction of the nonconformities. Thereafter, if:

• the CAP submissions are acceptable to WHO, the WHO lead inspector will notify the manufacturer by letter that the inspection and follow-up are complete
• the manufacturer’s CAP submissions are not acceptable to WHO, the WHO inspector will request an improved CAP and may ask the manufacturer for further evidence of their effectiveness/implementation. In such cases, both the improved CAP and the additional evidence must be presented by the manufacturer to WHO within 30 days of receipt of the first CAP review report received from WHO
• if the effective implementation of corrective actions cannot be evaluated by document review, a follow-up inspection will be required before the nonconformities may be closed out.

Before finalizing the manufacturing site inspection, all nonconformities identified in the inspection report must have been satisfactorily corrected (as determined by WHO) by the manufacturer. However, sometimes a satisfactory outcome is not reached if, for example:

• the manufacturer does not submit (whether within the specified timeline, or at all) a CAP to WHO
• the manufacturer is unable to implement all agreed corrections and corrective actions during the agreed time period
• more than six months have elapsed after the initial inspection and the manufacturer has still not provided WHO with satisfactory responses to the identified nonconformities.

In any of the above cases, the manufacturer’s application for WHO prequalification of the product(s) concerned will be terminated by WHO and a new application will be required if evaluation for prequalification of the product is to be initiated once more.

Any subsequent application for WHO prequalification will not be accepted unless and until the manufacturer submits sufficient evidence that demonstrating that the nonconformities have been corrected. If the manufacturer's QMS was found to be critically deficient, a re-inspection and review of any available additional data must take place before the inspection component can be completed.

Retention of inspection reports

WHO and the manufacturer shall retain inspection reports and associated documentation for the period of 3 consecutive inspections and for 5 years following the last inspection.

Review of corrective action plans to remedy nonconformities

The WHO inspector will be responsible for requesting, reviewing and reporting on the manufacturer's responses to nonconformities observed during the inspection.

For an IVD inspection: The manufacturer will have a maximum of two opportunities to supply WHO with the necessary information to correct nonconformities and implement corrective actions to prevent recurrence in a timely manner, usually within one month of the request..

For an MCD inspection: In general, the manufacturer may have a maximum of three requests to supply the necessary information to address nonconformities in a timely manner, usually within one month of the request.

The manufacturer will supply such information and correct the nonconformities identified during the inspection within 30 days of the request for information, unless WHO agrees in writing (given the nature of the nonconformities) to grant the manufacturer an extended time period in which to supply the requested information.

Inspections for prequalification: In certain cases, WHO may agree, at its sole discretion, to permit the manufacturer to correct specific nonconformities after prequalification, provided that the manufacturer commits in writing to correct them by an agreed deadline. Such a "commitment to prequalification" will be reflected in the WHO prequalification public report and will be verified during the re-inspection. Failure to comply with prequalification commitments within agreed deadlines will result in the delisting of the product from the relevant WHO list of prequalified products. If the manufacturer fails to respond adequately to requests for submissions relating to nonconformities in the requested timeframe, the process will be terminated and the manufacturer will have the option to reapply for prequalification in 12 months from the date of termination.

Completion of the inspection of a manufacturing site(s) and re-inspection

When the identified nonconformities have been corrected, corrective actions to prevent recurrence have been implemented by the manufacturer as requested by WHO, and the results accepted by WHO, the manufacturer will receive a letter advising it of the completion of the inspection process.

The re-inspection period will be determined by WHO using a risk management approach that takes into account all of the information from the product dossier review, performance evaluation and inspection.

Criteria for not recommending prequalification 

Based on the consensus view of the inspectors, and following review by WHO, it may be recommended that the product not be inclued in WHO's List of Prequalified In Vitro Diagnostics Products. Criteria/reasons used for not recommending a product's inclusion may include:

• failure to maintain an adequate quality system (deficient quality system)
• falsification of data or submitted evidence or deliberate misrepresentation of facts regarding the manufacturing and quality system (level 5 nonconformity)
• excessive number of nonconformities level 4 identified (see above)
• failure to implement appropriate action when post market data has identified a pattern of defects
• failure of the product to meet the manufacturer's own specifications
• failure of the manufacturer to respond adequately to requests for submissions relating to nonconformities.

WHO guidance & Public Inspection Reports

Information for manufacturers on the inspection of manufacturing sites (Assessment of the quality management system) (PQDx_014 V4, 8 September 2017)

Information for manufacturers on the inspection of manufacturing sites: Prequalification of male circumcision devices (PQDx_014 V4, Version MC_0, 15 November 2012)

WHO Public Inspection Reports (WHOPIRs) LINK TO BE ADDED

Note: Standards and other reference documents are updated constantly. The manufacturer is advised to refer directly to the third party sources listed below in order to obtain the most up-to-date versions of the following standards and other reference documents listed.

Clinical Laboratory and Standards Institute guidance

Evaluation of stability of in vitro diagnostic reagents; approved guideline (CLSI EP25A Vol. 29 No. 20)

Global Harmonization Task Force guidance

GHTF/SG1/N071:2012 Definition of the terms 'Medical device' and 'In vitro diagnostic (IVD) medical Device

GHTF/SG1/N70:2011 Label and instructions for use for medical devices

GHTF/SG3/N19:2012 Quality management system – medical devices – nonconformity grading system for regulatory purposes and information exchange

GHTF/SG3/N18:2010 Quality management system – medical devices – guidance on corrective action and preventive action and related QMS processes

GHTF/SG3/N17:2008 Quality management system – medical devices – guidance on the control of products and services obtained from suppliers

GHTF/SG3/N15R8 Implementation of risk management principles and activities within a quality management system

GHTF/SG3/N99-10:2004 (Edition 2) Quality management systems – process validation guidance

GHTF/SG4/N84:2010 Guidelines for regulatory auditing of quality management systems of medical device manufacturers – Part 5: Audits of manufacturer control of suppliers

International Medical Device Regulators Forum guidance

(former: Global Harmonization Task Force (GHTF) documents are now located in the IMDRF “Documents” folder)

This is a useful site due to the relevance of the documents and the quality of the input in the preparation of the documents. Documents on this site (Study Groups 1 to 5) were created by a volunteer group of international regulatory experts from the US Food and Drug Administration (FDA), Australian Therapeutic Goods Administration (TGA), Japanese Ministry of Health, Labour and Welfare, Health Canada, Medical Devices Bureau, representatives from Europe - Notified Bodies, as well as experts from industry in these countries, together with contributors from other countries. 

IMDRF/MDSAP WG/N3 FINAL (Edition 2):2016 Requirements for medical device auditing organizations for regulatory authority recognition

IMDRF/MDSAP WG/N24 FINAL: 2015 – Medical device regulatory audit reports

International Organization for Standardization guidance

ISO 13485:2003 Medical devices – Quality management systems

ISO 13485:2016 Requirements for regulatory purposes

ISO 13485:2016 Medical devices – A practice guide

ISO 14971:2019 Medical devices – Application of risk management to medical devices

ISO 9000:2015 Quality management systems – Fundamentals and vocabulary

ISO 19011:2018 Guidelines for auditing management systems

ISO 23640:2011 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents

ISO 15223-1:2016 Symbols to be used with medical device labels, labelling and information supplied – Part 1: General requirements

ISO 28590:2017 Sampling procedures for inspection by attributes – Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes

ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories

ISO 15189:2012 – Medical laboratories – Requirements for quality and competence

ISO 19011:2018 – Guidelines for auditing management systems

ISO 9000:2015 – Quality management systems — Fundamentals and vocabulary

ISO 18113-1:2009 – In vitro diagnostic medical IVDs – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements

ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories

ISO 15189:2012 – Medical laboratories – Particular requirements for quality and competence

ISO/TR 22869:2005 – Medical laboratories – Guidance on laboratory implementation of ISO 15189:2003

Information and documents on laboratory accreditation can also be found on the ILAC (International Laboratory Accreditation Cooperation) website: www.ilac.org

European Commission guidance

The standards listed here are harmonized standards and thus lead to presumption of conformity with the relevant essential requirements.

United States Food and Drug Administration (USFDA) guidance

The USFDA's Guide to inspections of quality systems is intended for FDA field staff who perform quality system inspections. But it provides a good description of the elements involved in an inspection and is therefore useful for manufacturers. The FDA site has many other publications freely available.

Advancing Safety in Health Technology guidance

A US website with useful links to information pertaining to the regulation of the medical devices manufacturing industry. Its Quality System Compendium: CGMP Requirements and Industry Practice can be purchased and icludes very readable and directly applicable material on USFDA's (FDA) 21 CFR Part 820 and ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), the EU Medical Device Regulation, the EU In Vitro Diagnostic Regulation, and evolving standards for software validation and risk management.