Audit certificate

The new GCP requires that sponsors shall compile plan and operating procedures on auditing and implement auditing in conformity with the plan and the procedures, thus auditors audit not only the sponsor s in-house process but also processes at study sites. Within the sponsoring company, usually aU CRFs and study reports are subject to the audit. Study sites are selected for audit based on auditors SOP, usually based on sampling methodology. Audit certificate for each clinical trial is required to be incorporated into new drug submission dossier. 

A declaration to assure the process and methods of the clinical trial conform to GCP or to equivalent standards used is also necesseiry. Moreover, any inspection results by the health authority or equivalent body in the country concerned should be submitted. The audit certification... 

According to ICH GCP (1995), an audit certificate is A declaration of confirmation by the auditor that an audit has taken place . It is kind of a neutral document and does not make reference to deficiencies or findings observed during the audit. It merely documents that an audit has taken place and is issued by the lead auditor at the termination of the audit. 

The ANSI ZIO standard is an American national standard, released in late 2005 (and currently undergoing revision). The OHSAS 18001 standard is a British-based standard, originally published as a specification in 1999, that is being used increasingly in the U.S. and internationally. Both of these industry standards follow the Plan-Do-Check-Act model and both are designed to work well with ISO 9000 and 14000 series standards. In addition, both are performance-based. A major difference between the two is that the OHSAS standard was designed for use with an audit/certification process. 

TMS Consultancy has been approved as an organisation suitable for issuing Road Safety Audit Certificates of Competency since 2012. TMS Consultancy currently provides 2-day training courses, examines candidates and issues Certificates of Competency to successful candidates. The route taken by candidates is described below. 

At present, a Road Safety Audit Certificate of Competency is only strictly needed to undertake Road Safety Audits on the motorway and trunk road network in the UK, on national roads in Ireland and on the TERN in other European countries. However, it seems likely that other clients will be seeking assurances about the qualifications of Road Safety Auditors in the future and could also require at least one member of the team to have a Certificate of Competency. In 2013, Solihull Borough Council introduced new Road Safety Audit procedures, adopting the principle that Road Safety Audit Teams would require members with a Certificate of Competency. However, they went a stage further than most other roads authorities had done to that point, insisting that all Team Members of the audit team hold the qualification. 

One of the team members has to hold a Road Safety Audit Certificate of Competency, and the team leader must be a chartered engineer with at least 7 years experience in design, road safety engineering and collision investigation. 

Sampled scan data can be used to improve certification, re-certification by providing a richer and more tailored environment and provides for inspection and inspector auditing... 

In 1991, the Verband der Automobilindustrie e. V. (VDA) published VDA 6.1, Quality Spstem Audit, a questionnaire on quality system evaluation based on DIN EN ISQ 9004. VDA 6 is a series of guides covering the basics for quality audits, auditing, and certification. They were therefore not intended as supplementary requirements to ISQ 9000 but as guides for auditors performing audits of automotive suppliers. Their intention was to improve auditor competency in the industry by providing a uniform interpretation of ISQ 9000 requirements and a common approach to automotive audits. VDA 6.1 has been revised several times and is currently in its fourth edition. There are nine volumes in the series (see Appendix A). 

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

To receive ISO 9000 accreditation, a certification body must meet the requirements of ISO Guide 62 and EN 45012, which invokes ISO 10011. There is normally a mark of accreditation (a Grown and Tick in the case of UKAS accreditation) that certification bodies use to signify their credibility. Once accredited, a certification body may perform audits on suppliers offering products and services within the scope of accreditation. In theory, accreditation is granted only if the certification body has expertise (i.e. competent auditors) for the particular industry sectors (EAG codes) requested. 

Permitting only lATF qualified third party auditors who are sponsored by certification bodies contracted to perform ISO/TS 16949 audits... 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

Audits are carried out on behalf of the organization seeking certification, not on behalf of the industry that created the requirements, and hence requirements are prone to an interpretation to suit clients and retain business. 

In brief, the auditor has to be qualified by lATF to perform the audits and, to be eligible for qualification, the auditor has to be sponsored by an lATF-approved certification body that is subject to witness audits performed by qualified auditors from vehicle manufacturers. Such measures will inevitably improve the quality of certification offered by certification bodies and will be good for the global automotive industry. 

The trade associations that are members of lATF perform an assurance function and have set up a panel to administer certification activities in their country. This involves witness audits of certification bodies to verify that they are adhering to the lATF agreement. They will monitor the scheme on behalf of the vehicle manufacturers in ensuring that certificates are only awarded to organizations that are 100% compliant with the requirements. These activities should provide added confidence that the certification bodies are fulfilling their obligations. 

Most certification body auditors who are currently performing audits against one or more of the national automotive quality system requirements (QS-9000, VDA 6, AVSQ, or EAQF) will qualify. To qualify, auditors need to ... 

More than one pre-audit on any one site in the same company shall be considered consulting. The auditor must decline requests by the supplier to return to the site to confirm that pre-audit observations have been satisfactorily resolved before commencing the certification audit. 

The scope of certification shall include all products supplied to customers subscribing to the certification of ISO/TS 16949. A supplier cannot exclude products and services from the audit scope if any such products and services are provided to subscribing members - hence the auditor needs to know who the subscribing members are. 

The certification shall address all ISO/TS 16949 requirements according to Annex 1. Auditors cannot sample requirements of ISO/TS 16949. All requirements have to be checked within the sample of operations chosen during the audit and the sample has to take in sufficient operations and processes that will enable all requirements to be checked. 

Any site may elect to pursue third party certification to ISO/TS 16949 however, such sites shall have demonstrated capability to conform to all ISO/TS 16949 requirements. The auditor has to confirm that the site has a capability to meet all ISO/TS 16949 requirements and, if not, the other sites providing the missing capability have to be included in the certification audit. 

Conformance with ISO/TS 16949 for third party certification shall be based on objective evidence of meeting each applicable requirement including customer-specific requirements at the time of the audit. The auditor needs to determine specific customer requirements that apply and verify compliance with each requirement - not a sample. If the supplier has several different customers then compliance with the requirements of each customer has to be demonstrated. 

Remote locations shall be audited as they support a site but cannot obtain independent ISO/TS 16949 certification. A division that does not have the capability to meet all requirements cannot seek ISO/TS 16949 certification e.g. Personnel, Purchasing divisions cannot be registered separately as they could be under ISO 10011. 

The entire quality system shall be assessed at a minimum of once every three years. The audit plan for a supplier has to cover all requirements, all sites, all locations, all operations, all functions, all customers, all processes, all procedures at least once in a three-year cycle, unless it is an upgrade certification (see clause 4.6). Hence the sample of operations taken on each audit has to cover at least Veth of the whole. 

This requirement also implies that a repeat certification audit does not have to be performed once every three years if it can be demonstrated that the whole system has been audited within the three-year cycle. 

The audit plan must include all elements of the supplier s quality system that meet the needs of those customers recognizing ISO/TS 16949 certification of their suppliers, even when these requirements go beyond ISO/TS 16949. 

Certification body shall notify the lATF of all scheduled audits including witness audits and shall allow lATF members or their designates to attend. Auditor should expect to be informed that an lATF member may attend. If the date of the audit has to be changed it cannot be extended by more than three months from the date of document review (see Annex 1 of the Rules). 

Upgrading of a current automotive certificate by one of the lATF contacted certification bodies will be taken into account. . . The auditor needs to establish whether the supplier intends the ISO/TS 16949 audit to be an upgrade of current certificate and if so to advise them that unless it is performed by the same CB there can be no reduction in the audit man-days. 

This annex of the Rules contains a flowchart identifying the key stages in the audit process from the initial request for certification through to issue of the certificate. Pre-audit is not a documentation audit. Supplier must provide all required data prior to site visit. 

If your organization is registered to one or more of the existing automotive quality system requirements and the scope is unchanged, the required man-days for the initial audit may be reduced by 50%, but if you decide to change certification body or have changed the scope, there will be no reduction. 

A nonconformity will only be classified as major in order to determine whether an audit should be terminated prematurely or de-certification effected. 

You will need to provide evidence of internal audits and management review from the previous 12 months with your application for certification. 

External audits carried out by personnel who are neither employees of the customer nor the supplier and are usually employees of certification bodies or registrars. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

Certification based on auditing against a quality system standard for design, production final inspection (e.g. ISO 13485)... 

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