About us
FAQ
Frequently Asked Questions
In our FAQ you will find answers to the most frequently asked questions about our certification processes, requirements and procedures.
Find out how we work, what the benefits of certification are and how you can optimally prepare your company for it.
Accreditation
The notion accreditation (latin accredere, believe) is used in different areas to describe the circumstance that a generally recognised authority of another certifies fulfilling a useful quality.
In our case it is the ” Swiss Accreditationstelle SAS “, settled in the Seco and the EU.
As per SAS: accreditation means the formal acknowledgment of the technical and organisational competence of a place to execute a specific, in the area of application of the accreditation described service. Competence is the key to transparency, trust and comparability.
Audit
latin auditus = hearing.
An audit examines whether processes, requirements and guidelines meet the required standards. Such investigation procedure is often performed in the context of quality management. The audits are performed by a specially trained auditor and should take place once per calendar year.
Per ISO 19011:
Audit
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
Audit criteria
Procedures, methods of approach or demands which are applied as relation basis (reference) which comparison with the obtain Audit results takes place.
Audits for special reasons
can be triggered for example by extending customer’s requests, complaints from the market or in major changes in the operation. These audits can also announce at short notice or unannounced. In particular, unannounced audits must be necessarily carried out at medical device manufacturers.
Auditor (External)
An auditor (from the Latin audire hear, listen, interrogate) is a person who performs an audit and is simultaneously checked by questioning, observing, listening, as a person or organisation will be and if requirements are met.
The external auditor is independent of the Company to be examined and reviewed on behalf of a certification body in the context of ongoing certification regularly, once a year and the current status of the management system. Here the entire management system, important central and not from other individual processes are studied. In case of positive result, a certification is granted or confirmed the maintenance of the certificate, by recertification.
The external auditor may be used in any kind of industry in which he can demonstrate established technical experience.
Consultancy, advice, assistance, help
QS Zürich Ltd. as a certification body must not give advice.
If you need help and support in development of a quality management system, we offer to get in touch with you with an independent external consultants/experts in your industry for free. Whether for certification, recertification, surveillance audit, evaluation, testing, laboratory analysis or in-house training. Please contact us; we look forward to assisting you.
info@quality-service.ch
Certification
(lat. “certe” = determined, certainly, safely and “facere” = make, create, manufacture)
refers to a process by which compliance with specific requirements is proven.
Certification is part of the process of conformity assessment. Certificates are often limited in time awarded by independent certification bodies and standards independently controlled or proprietary.
request areas
In these areas, where requirements can be placed and certified, are
• products and services and their respective manufacturing processes including trade relations,
• persons,
• systems.
EA Code
As certification body for the certification of ISO 9001 and the ISO 14001 we need in the individual sectors/branches’ authorisation. This is expressed in so-called “Scope” with code numbers (EAC-industry classification) and represents a particular industry/sector in the economy.
Evidence of audit
Records, statements or other information, which are apply to the audit criteria verifiably.
Help, consultancy, advice, assistance
QS Zürich Ltd. as a certification body must not give advice.
If you need help and support in development of a quality management system, we offer to get in touch with you with an independent external consultants/experts in your industry for free. Whether for certification, recertification, surveillance audit, evaluation, testing, laboratory analysis or in-house training. Please contact us; we look forward to assisting you.
info@quality-service.ch
Internal Auditor
checks on behalf of the management in internal audit development of the quality management
system in departments and branch offices of the company through system and process audits as well as supplier by supplier audits.
IAF code
See scope
Non-conformities
Major non-conformity=Major deviations
Minor non-conformity=Minor deviations
Quality Management Manual
(Short: Quality Manual) is a company-internal compilation and documentation of the quality management system of the company. Most of the standards do not need it anymore.
Recertification
Certificates have a validity period of three years.
During this time they must recertify certain duties to fulfil (for example, first and second surveillance audit), after these three years to obtain a new certificate.
Risk assessment
is the systematic analysis to identify and assess risks and is used in technical systems, financial, economic and service companies as well as organisations.
Risk analyses are commonly used to identify and assess risks, so as part of the risk management can be passed on to third parties avoided possible negative events with preventive measures, reduced or. Furthermore, they are used for communication of risk situations to promote e.g. the risk perception.
• In the medical industry and in the development of medical devices, a risk management process must be performed and documented continuously in accordance with the requirements of
EN ISO 14971 and the regulations of the Medical Devices Act.
• For the Food Safety it is the HACCP system application.
Stage one audit
pre-audit is a positioning for the company/organisation prior to the actual certification as a
“dress rehearsal”, is applied to the first certification, or when significant changes.
Scope, EA Scope
As certification body for the certification of ISO 9001 and the ISO 14001 we need in the individual sectors/branches’ authorisation. This is expressed in so-called “Scope” with code numbers (EAC-industry classification) and represents a particular industry/sector in the economy.
Surveillance audit
is testing/monitoring/controlling of activities or other changing information or activities, which is performed usually by people for the purpose of improvement in its production and/or service within a specific period of an external and/or by an internal auditor.
Curious?
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Our team is waiting for you, we are eager to find the best solutions for you.
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