LL-C (Certification)®

CERTIFICATION PROCEDURE
1) MANAGEMENT SYSTEMS
2) PRUDUCTS, PROCESSES AND SERVICES

(Rule-03)

Revision No. 44 z 14.11.2023

Published: Ing. Lukáš Holub, Ph.D.
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Contents

I. Supporting Statement ........................................................................... 3

II. Objectives and Scope .......................................................................... 4
III. Definitions and Abbreviations ............................................................... 5
IV. A) Selection and Use of Certification Standard ...................................... 5
IV. B) Selection and Use of Certification Scheme ........................................ 6
V. Certification processes ....................................................................... 8
Diagram certifikačního procesu – certifikace výrobku/procesu ..................... 17
(I-B, I-C) – posuzování systému řízení, správné výrobní praxe, … ............... 17
Diagram certifikačního procesu – certifikace výrobku/procesu ..................... 18
(I-B, I-C) – zkoušení vykonané CO .......................................................... 18
VI. Suspension or withdrawal of certificate .............................................. 24
VII. Transfer of accredited certification ..................................................... 25
VIII. Responsibility of Certification Body ................................................... 26
IX. Responsibility of Certification Holder .................................................... 28
A) Certification of management systems................................................... 28
B) Certification of products ..................................................................... 29
X. Application of Certification Rules modifications ..................................... 30
XI. Financing and certification fees ........................................................ 30
XII. Complaints and Appeals Procedure ................................................... 30
XIII. Commitment information ................................................................ 31
XIV. Security Clearance.......................................................................... 31
List revisions and motivations .................................................................... 32

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I. Supporting Statement

Certification body LL-C (Certification) Czech Republic a.s. (“LL-C”) provides certification
services against national standards on various Management Systems like Quality
Management Systems as per ISO 9001:2015, ISO 9001 in connection with NV 333/2011
Environmental Management Systems as per ISO 14001:2015, Occupational Health &
Safety Management Systems as per ISO 45001, Information Security Management
Systems as per ISO/IEC 27001, in management of Critical Control Points in the Food
Industry with requirements of Food Safety Management Systems as per ISO 22000 and
FSSC 22000 scheme) with the requirements of the HACCP and the and IT Service
Management Systems as per ISO 20000-1, both in production and services companies In
Energy Management (ISO 50001) and furthermore, under the accreditation of ANSI /
ANAB (U.S.A.) Certification according to ISO 9001, ISO 22301 and ISO 28000 standards.

LL-C provides certification of products according to EN ISO 3834, EN 15085-2 (:2007

CL1 až CL4, :2020 CL1 až CL3), EN 17660-1, EN 17660-2, EN 14554-1, EN 14554-2
and ISO 22716 and GMP+ FSA scheme and e-IDAS, in the scope of its accreditation and
in conformity with ISO/IEC 17065, EA-6/02 and valid Guidelines for accreditation.

LL-C provides certification of products (Construction products REG EU 305/2011,

construction products according to (NV No. 163/2002 Coll. as amended by NV No.
312/2005 Coll. and No. 215/2016 Coll.), Medical Devices and Machinery Devices),
Pressure equipment (further only PED), simple pressure vessels (SPVD), and machinery
in the scope of its accreditation and in conformity with ISO/IEC 17065.

The legal status of the organization is a joint-stock company registered under file number
B 22724 kept at the Municipal Court in Prague. The company was established as a
subsidiary in the Czech Republic to its service closer to the needs of local candidates on
the certification and understand the conditions and needs of the parties that the results
of certification activities using or relying on them. The company is registered with the
Municipal Court in Prague. The company operates in the EU and beyond.

Certification services are available to all candidates who adopt the rules laid down in this
Directive and demand for the certification.

A proclaimed policy of the LL-C and its management is to provide certification of

Management Systems and Products only within its own certification system ensuring
impartiality, confidentiality and independence for the certified client. The policies
specified for LL-C personnel regarding knowledge, skills and relevant experience are
equally applicable for external auditors/evaluators/technical experts. At present, LL-C
does not outsource any of Management System Certification Activities.

Auditors, evaluators or technical experts, involved in the certification process are

required to carry out its functions to the exclusion of any influence from third parties.
External auditors, evaluators and experts are bound by strict rules of impartiality and
independence of the certification system. All carry out their activity based on the
following principles:

- Maintaining the same access to all certified operators, excluding any

discrimination against organizations or individuals
- Exclusion from participation in the audit and the decision on granting a certificate
for an individual client the personnel which is personally involved in consulting
activities in the management systems (above mentioned standards). So, the
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impartiality and independence of the assessment for a particular client has been
secured.
- Exclusion from participation in evaluation activities and in decision on granting a
certificate for an individual client the personnel whose activities might be
considered as consulting, support by designing, operation with products, creation
relevant inspection processes which violate the obligation of impartiality
- Strict separation of audit / expert opinion and the decision on certification
- Strict separation of evaluation/assessment of conformity and decision on
certification
- Strict respect of confidentiality of all personnel involved in the certification
process.

LL-C activities are based on following policies and principles:

- philosophy to promote confidence in certification as an effective instrument for

improving the quality of products and services and more careful approach to the
environment and other risks
- improving the security of information systems
- ensuring the highest possible level of integration during assessment of
management systems according to various established standards and regulations
- ensuring the territorial and term availability of auditors and evaluators
- ensuring personnel with relevant experience and competence - auditors and
evaluators regarding applicable field, audit or evaluation experience and no less
ethical behaviour and empathy
- strict respect of confidentiality
- preference of effectiveness of precautions to formality of compliance with the
requirements of standards
- using the most modern techniques for the testing and adoption of such
organizational measures to prevent conflicts of interest and challenge test results.

II. Objectives and Scope

Objectives
The present Rule defines:

A) the procedure to be used for Certification of Management Systems. It explains the

principle of the certification process and procedures which are relevant for
organizations interested in certification. Instruction is based on the requirements
of ISO 17021-1:2015, current MPA, ČSN EN ISO 19011:2012, ČSN EN ISO
19011:2021 and requirements of private schemes (FSSC 22000, GMP+ FSA, IFS)

B) the procedure to be used for Certification of Products. It explains the principle of

the certification process and procedures which are relevant for organizations
interested in certification. Instruction is based on the requirements of ISO/IEC
17065 and requirements of private schemes (IFS, GMP+ FSA).

Scope
This instruction applies to Certification of Management Systems of organizations active in
the production, services in non-state or government sector in the areas of scope of
accreditation according to LL-C.

This instruction applies to Certification of Products of organizations active in the

production of products – devices in the scope of accreditation according to LL-C.
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The regulations or standards specific to a particular field that are not here well appointed,
the provisions of this Rule will be adequately applied in relation to such regulations or
standards. Any non-conformities or deviations will be presented to a client case by case,
according to specific requirements.

III. Definitions and Abbreviations

The present Rule contains definitions from:

ISO 17021-1:2015 - General requirements for certification bodies for Management
System Certification (including current MPA, IAF MD, etc. )

EN ISO 19011 - Guidelines for Auditing of Management Systems

EN ISO/IEC 17065 - General Requirements For Bodies Operating Product Certification

Systems

Used abbreviations:
CB – Certification Body
CBP – CB for Product Certification
HCB – Head of CB
DHCB – Deputy Head of CB
QM – Quality Manager
E – Evaluator which provides Assessment of Conformity
LE – Lead Evaluator
DM – Decision Maker on Certification
TE – Technical Expert

IV. A) Selection and Use of Certification Standard

Quality Management Systems

For certification of quality management systems is used standard ISO 9001 current
version. Out of this standard, quality management system must meet the expectations of
the relevant field and customers.

SJ-PK system
For certification, the quality system in the field of roads (SJ-PK) in order to increase the
quality of work in construction, repair and maintenance of roads is regulated by the
Ministry of Transport, which develops and complements SJ-PK for quality development
and requirements for SJ-PK and technical conditions defining the requirements for
ensuring the quality of supplies, services or documents to a minimum level by the criteria
for the technical qualification of the tenderer for the supply, service or works contract.

The certification process is applied in accordance with the system standards ČSN EN ISO,
legal regulations. SJ -PK applies to works and activities at PK listed in individual parts of
MP for areas according to Article 3 of SJPK.

The methodological instruction SJ-PK, technical standards, regulations, TKP (technical

quality conditions) and TP (technical conditions) according to the current valid version at
www.pjpk.cz, which is maintained by the Ministry of Transport, are used for certification.

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Environmental Management Systems
For certification of environmental management systems is used standard ISO 14001
current version. Out of this standard, management system must meet the expectations
of the relevant field and customers.
Information Security Management Systems
For certification of information security management systems is used standard ISO
27001. Out of this standard, management system must meet the expectations of the
relevant field and customers. In ICT sector is more and more often used IT Service
Management Systems as per ISO 20000-1 which contains elements of management of
outsourcing of IT services, quality management of ICT services and information security
management systems.

Management of Critical Control Points

in the Food Industry is certified in accordance to HACCP prescription (FAO/WHO Codex
Alimentarius). Out of this standard, management system must meet the expectations of
the relevant field and customers. On this system are built more comprehensive Food
Safety Management Systems (ISO 22000 and FSSC 22000, GMP+ FSA) which that
more integrated system of feedback and process management, and compatibility with
the quality.

Occupational Health & Safety Management Systems

OHSAS 18001/ISO 45001
For certification of Occupational Health & Safety management systems is used standard
ISO 45001. Out of this standard, management system must meet the expectations of the
relevant field and customers.

Energy management
This system analyses energy sources, basal consumption and plans to influence it in
terms of savings in both the application of organizational and technological measures.
The benefit of certification, which in some jurisdictions is also compliance with legislation,
should also be energy savings. The criterion standard is ISO 50001.

Other management systems

For using other standards, the requirements can be completed by additional
requirements of relevant accreditation or contractual entity. These specific requirements
will be provided to interested parties case by case.

IV. B) Selection and Use of Certification Scheme

Product/Processes as per EN ISO 3834-2/3/4, EN 1090-2/3, EN 15085-2

(:2007 CL1 až CL4, :2020 CL1 až CL3), EN 17660-1, EN 17660-2, EN 14554-1,
EN 14554-2 and IS0 22716 , e-IDAS and EMGP+ FSA scheme
The assessment procedure is based on the methodology of auditing of System
Certification in the scope of accreditation and in accordance with EN 45011, EA-6/02 and
valid prescriptions of accreditation entity. During the certification procedure is generally
controlled quality assurance of welding processes in manufacturing, execution of steel /
aluminium construction and welding of railway vehicles and ensuring the GMP+ FSA
scheme - cosmetic products.

Machinery Devices
For the certification of machinery devices means to provide the assessment of conformity
procedure EC type-examination whereby CB ascertains and certifies that a representative
sample of machinery devices fulfils the requirements of Directive 2006/42/EC, or by full
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quality assurance system whereby the manufacturer who fulfils the obligations imposed
ensures and declares that the products concerned meet the provisions of the Directive.

MDD – Medical Devices

For the certification of MDD means to provide EC Declaration of Conformity by
assessment procedure of Full Quality Assurance system (Annex II of the Directive
93/42/EEC), procedure of Production Quality Assurance (Annex V of the Directive
93/42/EEC) and procedure of Product Quality Assurance (Annex VI of the Directive
93/42/EEC) by which CB ascertains and certifies that a representative sample of MDD
fulfils the requirements of Directive.

Construction Products (CPR)

The procedure provides an assessment and verification of constancy of performance in
accordance with Regulation (EU) No 305/2011 of the European Parliament and of the
Council, Annex V (System 2+), further for the conformity assessment of construction
products according to NV No. 163/2002 Coll. as amended by NV No. 312/2005 Coll. and
No. 215/2016 Coll.

The CB provides the certification of factory production control (FPC), which is based on
an initial inspection of factory and of factory production control and continuous
surveillance assessment and approval of factory production control (FPC).

Furthermore, it is possible to use the evaluation system described in detail in Rule 15.7
for MDD-SW, but the evaluation / assessment of the quality system according to ISO
13485 and according to the requirements of the National Council or according to the EN
62304 standard as amended must not be neglected.

Toys
Assessment of conformity of Toys means to provide EC Declaration of Conformity by
procedure EC type-examination whereby CB ascertain and certifies that a representative
sample of Toys fulfils the requirements of Directive 2009/48/EC, Regulation of
Government No. 86/2011.

Software for MDD

The assessment procedure is based on the methodology of auditing of System
Certification in accordance with ISO 13485 and fulfilment of individual chapters of the
Directive 93/42/EEC related to MDD and Directive 98/79/EC related to IVVD. The
assessment system is set also by chapters and Annexes of the Directives and by request
of client. LL-C provides assessment of MDD class.III by Annex No 2 of the Directive
93/42/EEC including examination of design of the product.

e-IDAS
The requirements for trust service providers (TSPs) in presenting compliance with the
requirements necessary to obtain qualified status are regulated by the following
documents: REGULATION (EU) No. 910/2014 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL, Act 298/2016 Coll., Act 297/2016 Coll., Standard ČSN ETSI EN 319 403
V2.2.2.

Simple pressure equipment (SPVD)

Conformity assessment of simple pressure vessels means the performance of conformity
assessment by the EU type examination procedure, the design by which the CO
determines and certifies that the product's simple pressure vessel model meets EU
requirements in accordance with Government Regulation No. 119/2016 Coll.

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V. Certification processes

A) Process of Management Systems Certification

Certification process diagram

Process participant: CLIENT LL-C SUBCONTRACTOR

CLIENT INQUIRY

TELEPHONE
E-MAIL
INQUIRY DETAILS

APPLICATION FORM (F30)

APPLICATION
REGISTRATION
CERTIFICATION STANDARDS
INTEGRATION
APPLICATION OTHER NORMATIVE DOCS.
EVALUATION
OFFER/AGREEMENT (F31)
BUSINESS CONDITIONS (F32)
ASSESSMENT APPOINTMENT OF AUDITORS
SCOPE DEFINITION
Evaluation failed (F40) AUDIT PLAN (F41)
due to incorrect
audit/assessment
plan
STAGE 1 AUDIT -
OFF SITE /ON SITE STAGE I QUESTIONNAIRE
(F42 I.)

STAGE 2 AUDIT -
ON SITE NONCONFORMITY REPORTS
(F46)
Unsuccessful AUDIT RECORD (F44)
evaluation AUDIT OUTCOME AUDIT REPORT (F43)
NON- EVALUA EVALUATION
CONFORMI TOR QUESTIONNAIRE (F42 I+II.)
NG

COMPILATION OF
Successful FINAL DOCUMENTS
AUDIT REPORT (F 43)
evaluation
CERTIFICATE (F 49)

CERTIFICATE ISSUE COMMENTS AND

REJECTION NOTICE (F 48 V) ACCEPTANCE BY ACCEPTANCE BY
CLIENT CLIENT
f

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The certification process usually consists of:

- Inquiry and Application Questionnaire F30/F30.1

- Verification of the required documentation
- identify aspects, risks, processes of manufacture or the services provided (1st
stage of audit, on-site or off-site)
- on-site assessment of the introduction and application of requirements of the
standard at the head office and in branches of the applicant business (2nd stage of
audit)
- evaluation of audit results

Each audit stage of the procedure during the period of validity of the certification contract
are:
- the two stages initial audit and evaluation (certification audit)
- surveillance audits in the second and third year
- recertification audit (the audit re-assessment) at the end period of validity of the
certificate to maintain a valid certification

The following articles describe the individual steps in certification procedure.

Inquiry / application registration /certification offer

Inquiry of any new client on the certification of management systems may be personally
discussed with the LL-C staff or can be sent by email on [email protected] or by letter on
contact address or sent via electronic form on the website www.ll-c.net. LL-C coordinator
on the base of a written inquiry (a filled in Application Questionnaire F30/F30.1) conducts
a review of the obtained information and verifies if CB has the competence and ability to
perform the certification (the scope of accreditation). Review if it is not necessary to
consider specific processes (e.g. welding, sterilization). This review is carried out in
cooperation with the Head of CO.

Based on inquiry, data from the questionnaire and the current Tariff LL-C issues F31
Offer of management systems certification in written form and sends it to the address of
the applicant. Business Conditions - F32 are the integral and mandatory annex of every
offer.

Client who accepts any Offer for certification has to confirm the F31 and Business
Conditions (F32). The signature of an authorized person for the applicant the offer is
submitted and confirmed, as well as the signing and confirming of the attached Business
Conditions makes full agreement/contract for the management system certification. The
contract is generally governed by the provisions of the Commercial Code § 591 to the
600th in Czech Republic and accreditation criteria. Furthermore, this is provided
information confirmation as well.

Confirming the order, the following process is initiated:

- is registered to the internal system certification case (contract), including
information about the applicant
- is appointed lead auditor, who starts planning the audit (contact person
authorized by the applicant, additional conditions, build an audit team, fix an audit
date)
- the applicant is requested to submit his management manual or other document
describing the management system at least 14 days before the audit.

In particular cases, client might rise a special request for back-to-back audit due to
special circumstances. Those circumstance (e.g. long-distance travels, problematic

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travels, urgent situation – such as upcoming tender, etc.) have to be agreed by the CB
before the audit is starts.
However, the possibility of back-to-back audits must be confirmed by the client – signing
of F32 in advance.

In case, exception for back-to-back audit was not given, the 1st and 2nd stage are
separated (no possibility of back to back audit).

If a client has any other requests, such requests shall be discussed with a responsible
persona from LL-C(Certification) and held accordingly.

Auditors
Head of CB LL-C appoints the lead auditor, auditors, members of an audit team, technical
expert and an evaluator of audit. They must be complied with the general qualification of
auditors, including their competence and experience, reflecting the activity of the
applicant and eventually any specific processes (e.g. welding), impartiality and
independence. Appointment of auditor must be notified to the applicant in advance.

Client’s documentation
The client’s documentation must reasonably define the organizational structure of the
applicant and a precise description of its activities. Above the management system
manual documentation may also include activity procedures and work instructions.
Documentation must take into account both direct and indirect requirements based on
the standards and client’s activities.

Audit documentation
Lead Auditor shall examine the documentation presented regarding completeness and
requirements of the standard. In case of nonconformities or in case of FSSC scheme Area
of Concer the applicant will receive a Report of Nonconformity and findings (F46) and
must take corrective action and specify the date for their compliance. These
nonconformities have to be removed before the Stage II of certification audit. Irrelevant
anomalies may be clarified in during the audit. In FSSC scheme Area of Concern is
clarified during 2nd stage of audit and must be closed or defined as NCRs. Documentation
audit carried out by lead auditor is provided outside of the client’s location.
Documentation audit is carried out as part of the certification audit (Stage 1). The new
revisions of the documentation are reviewed during surveillance, if necessary.

1st stage of Initial certification audit

1st stage of audit is an obligatory part and is carried out as part of the initial certification
audit (1st stage). 1st stage of audit is performed to determine the preparedness of the
client’s location and status and the main conditions for the 2 nd stage of audit. In FSSC
22000 scheme the time between audit stage 1 and audit stage 2 must not be longer than
6 months. 1st stage of audit will be repeated if longer interval will be needed.

The results from the 1st level of audits are presented in the form of the Protocol on
Nonconformities - F46 and on specific forms.

In some circumstances, the 1st level, especially for the ISO 9001 standard, can be
performed outside the applicant's company using questionnaires and telecommunication
technologies. CAAT RAP.
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1st stage has to start with Opening meeting, which is followed by a site tour to
investigate the following objectives:
a) The client´s management system documentation was reviewed, to sufficiently support
the transparency of the client´s management system;
b) Specific workplaces, site conditions and client´s personnel view about readiness for
the 2nd stage must be checked;
c) Client status and particulars with respect to the identification of the MS key
performance or significant aspects, processes, objectives and operations must be
reviewed;
d) The scope of the MS management system is to be confirmed by
- client´s site
- processes and equipment
- levels of controls (especially of multisite clients)
- statutory and regulatory requirements;
e) Review of allocation of resources for 2nd stage and discussion with client details for 2 nd
stage;
f) Information obtained were found sufficient for the statement that the system is in
compliance with context of the standard - the plan of the 2nd stage with / without any
alterations may be performed or not.

Results from 1st stage of audit are documented 1st stage report F 42.1 and on F46 Report
of Nonconformities and other forms.

In case, exception for back-to-back audit was given, all parts of 1st stage of audit were
done and results of 1st stage of audit were sufficient, the 2nd stage of audit can be carried
out.

In some circumstances 1st stage of audit (particularly in standard ISO 9001) can be
provided off-site of the applicant location using questionnaires and telecommunications
technology. (RAP – remote auditing procedures).

Preparation and planning of audit

Lead auditor, in cooperation with the applicant draw up a program (plan) during the audit
and inform the applicant in appropriate way. The plan contains all the information
necessary for the applicant to prepare the audit. If necessary, the lead auditor can visit
the client for plan specification. Likewise, an audit program is issued which displays the
schedule of when the initial certification audit, the 1 st surveillance audit, the 2nd
surveillance audit and the re-certification audit shall be carried out, as well as the
specification of the branches where the audit shall be carried out, and information about
the most important processes to be assessed, aside from standard criteria.

CAAT-RAT / ICT method (methods of remote assessment and their approaches not
only in times of pandemic crisis COVID 19). In case of FSSC 22000, FSSC 22000 Quality
and GMP+ FSA certification schemes the remote assessment using ICT method will be
organized according actual scheme owner directives in all phases of audit (initial or
certification-Ist and IInd stage, surveillance and recertification audit).

As information and communication technologies become more sophisticated, it is

important that CO staff are trained on how to use assessment methods using "ICT" in
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order to increase the efficiency and effectiveness of audits and to support and maintain
the integrity of the process.

Methods of remote assessment using ICT technologies such as:

Teleconference, web meetings, interactive communication over internet, electronical
online access to documentation and/or management system processes and others.
The audit may also be carried out remotely (the CAAT-RAT method) in which case the
applicant shall send to the auditor or the assessor the electronic forms of the requested
documents, and the auditor/assessor shall evaluate the documents outside of the
applicant’s registered office. This auditing method may not exceed 30 % of the scheduled
duration of the audit, this does not apply to cases affected by the COVID 19 pandemic
crisis.
ICT technologies that will be used as a tool for remote audit FSSC 22000 meeting all
requirements of IAF MD 4:
1) Conducting interviews with people and reviewing on-site audit policies, procedures
or records;
2) When using the ICT audit approach as set out in FSSC Annex 9

AUDIT ON SITE
Opening meeting
This is the auditor interview with the management of the applicant and with his
responsible for management systems.
The opening meeting goal is:
- Reaching a consensus in meters of plan, content and procedures of certification of
CB and applicant
- Consultation of audit results (Stage 1)
- Determining the manner of communication between auditors and management
- Verifying whether the extent of the audit shall provide the auditors sufficient
results for assessing
- A declaration of confidentiality and impartiality of auditing team

2nd stage of audit

The auditors in the assistance of the management or it’s representatives will examine the
system of organizing units of the applicant in accordance with the plan, including
amendments adopted during the Opening meeting. Auditors of the audit can use the
questionnaire and verify whether the system is introduced and applied in conformity with
the requirements of the specific standard and documentation of the client. Lead auditor
shall communicate a preliminary report on the results after the audit. A team of auditors
is not authorized to release the final conclusion of certification. The Audit Report contains
the result of audit and other important information, the applicant will receive within 14
work/days. The applicant may comment on it within next following 14 days. If findings
(non-conformities, deviations) are found in the system, the applicant must propose
appropriate corrective actions and the date of their compliance; the date depends on the
specific findings.

If the company has multiple functions in more than one location, the auditor must be
aware of the company's headquarters and OFF-site activities.

Multi-site certification is allowed only in the subcategories:

• A –Animal Farming

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• E –Catering
• FI –Retail / wholesale
• G –Storage and distribution.

Evaluation of audit results

Lead Auditor shall forward to the evaluators/decision makers (e.g., Head of the
certification body or his deputy) necessary documentation of the audit to an impartial
evaluation and decision on certification.

Criteria for evaluation of audit results are as follows:

- Verification of compliance with the relevant standard
- Verification of compliance with the LL-C Rules
- Submission and completeness of audit results in the documentation of audit
(report, questionnaire, reports of nonconformities)
The responsible evaluator clarifies the uncertainties with Lead auditor.

Based on findings review the applicant is informed if an additional audit will be needed to
verify effectiveness of the action taken before granting the certificate.

The information for the applicant

In case that the evaluator/decision maker decides that the audit conclusion and other
requirements of certification authorize the CB to grant or maintain the certificate the
applicant will receive a certificate (in the case of the initial audit) and Audit Report on
what additional conditions have to be fulfilled before issuing the certificate (maintaining
in case of follow up audits).

In case that the evaluator/decision maker decides that the audit results do not allow the
CB to grant the certificate or maintain the valid certificate the decision is notified to the
applicant, including the reasons for the decision.

The applicant may appeal to the Head of the CB and ask to the change the decision
taken.

Certification contract
A certification agreement must be concluded between the certification body and the
organization applying for certification with a detailed description of the scope of the
certificate and a reference to all relevant system requirements. This agreement must
contain details or references to agreements between the CB and the organization, which
include, but are not limited to:
1) Ownership of the certificate and the content of the audit report will be held by the CB;
2) Conditions under which the certification contract can be terminated;
3) The conditions under which the certificate may be used by a certified organization;
4) Conditions of confidentiality in relation to information collected by the CB during the
certification process;
5) The certified organization allows the CB to share information regarding the
certification and audit process with the FSSC Foundation or Scheme Owner, the GFSI or
government agencies, if required;
6) Non-compliance management procedures;
7) Complaints and appeals procedures;

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8) Inclusion of information about the certified status of the organization on the LL-C web
and web scheme (FSSC 22000, GMP + FSA, etc.) and on the portal or other system that
uses the given schemes;
9) Cooperation in enabling the evaluation of the auditor (witness - witness audit) by the
Accreditation Body and / or the Foundation, if required;
10) Communication obligations of certified organizations towards the Certification Body
(CO) within 3 working days concerning:
(a) any significant changes that affect compliance with the system requirements
and seek advice from the CO in cases where there are doubts about the significance of
the change;
(b) Significant events that have an impact on the management system
(FSMS, FSQMS, etc.), legality and / or integrity of the certification, including legal
proceedings, prosecutions, situations that pose a serious threat to food safety,
quality or integrity of certification due to natural disasters; or man-made
disasters. (eg war, strike, terrorism, crime, flood, earthquake, electronic attack on
computers, etc.);
c) Public events related to food safety (eg public convening, disasters, food safety
outbreaks, etc.);
d) Changes in the name of the organization, contact address and details of
the site;
e) Changes in the organization (eg legal, business, organizational or ownership
status) and management (eg key management, decision-making or technical
staff);
(f) changes in the management system, scope of operations and product
categories covered by the certified management system;
g) Any other change that makes the information on the certificate inaccurate

The contract of certification of management systems, which manages the rights and
obligations of applicant and CB is concluded confirming the F31 Offer of Management
Systems Certification and F32 Business Conditions by the applicant. The applicant must
confirm the both before starting the audit (Stage 1). For granting a certificate the
contract is mandatory.

Certification
Ones all criteria have been met the LL-C grants certification in the form of a certificate,
the applicant gets official certificates (2 original sets in the national language of the
applicant and 2 originals in English). For additional copies and for foreign language
versions may be charged additional fee. The certification is valid for duration of not more
than 3 years from the date of approval and is subject to the agreed Business Terms and
to requirement of monitoring the fulfilment of requirements of relative standard
(standards).

Use of LL-C logos ad marks

Use of the LL-C logos and marks is regulated under the terms of Business Conditions -
F32.
Upon obtaining a valid certificate, the client is entitled, for the duration of the certificate
validity, to use an approved logo of the certification body or private scheme owner (FSSC
22000, including FSSC 22000 Quality, GMP+ document A3 etc.).

In case of private certification schemes the use of logo will be according their own
documents (GMP+ document A3, FSSC 22000 document Part IV, etc.)

The LL-C approved logo shall not be used on a product or product packaging seen by the
consumer or in any other way that may be interpreted as denoting product conformity.

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The use and placement of the logo must not, however, create confusion between the
client and the certification body, or convey a false impression that the certification
applies to a specific product instead of the management system, unless it is clear that
certified standard is for the product certification.

Certified subject must comply with the terms, including the use of logos and marks
referring to the certification on promotional items.

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LL-C (Certification)®
Maintenance of certification
In order to maintain the valid certificate LL-C provides the annual surveillance audits to
determine the effectiveness of the system. LL-C executes these audits so that the
surveillance audit following initial certification should not be more than 1 year from the
last day of the stage 2 audit or of the last surveillance audit.

If the surveillance audit findings show that the client’s management system doesn’t fulfil
the requirement of the standard the client gets the possibility to make corrective actions
in determinate date. LL-C verifies and decides if the corrective actions are sufficient for
maintenance of certification.

Before the end of its validity, and if the client wishes to continue with the certified
management system with the LL-C, LL-C recertification/renewal audit must be
conducted. Renewal (or recertification) audits are planned in the third year and
conducted to evaluate and confirm the continued conformity and effectiveness of the
management system as a whole, and its continued relevance and applicability for the
scope of certification so that the new certificate could be granted before the end of
validity of the old one.

The procedures and guidelines are consistent with those for initial audit. Any changes in
client’s organization (e.g. change in number of sites), activities or documentation must
be supplied at least 14 days before starting audit.

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LL-C (Certification)®
B) Process of Product Certification

Diagram certifikačního procesu – certifikace výrobku/procesu

(I-B, I-C) – posuzování systému řízení, správné výrobní praxe, …

Účastník procesu: ZÁKAZNÍK LL-C SUBDODAVATEL

POPTÁVKA
ZÁKAZNÍKA
TELEFON
EMAIL

UPŘESNĚNÍ
POPTÁVKY
FORMULÁŘ ŽÁDOSTI (F30)

REGISTRACE
ŽÁDOSTI

CERTIFIKAČNÍ STANDARDY
POSOUZENÍ
INTEGRACE
ŽÁDOSTI
NABÍDKA/SMLOUVA (F31) DALŠÍ NORMATIVNÍ DOK.
OBCHODNÍ PODMÍNKY (F32)
URČENÍ ROZSAHU JMENOVÁNÍ AUDITORÚ (F40)
POSUZOVÁNÍ
Neúspěšné
hodnocení
z důvodu PLÁN AUDITU (F41)
chybného plánu
auditu

2. ST. AUDITU - NA
MÍSTĚ

PROTOKOLY O NESHODÁCH
Neúspěšné (F46)
hodnocení HODNOCENÍ ZÁZNAM Z AUDITU (F44)
NEVYHOVĚLY HODNO VÁSLEDKU AUDITU
-TITEL ZPRÁVA Z AUDITU ( F43 )
AUDITU
DOTAZNÍK (F42 I+II.)

VYPRACOVÁNÍ
Hodnocení úspěšné ZÁVĚREČNÝCH
DOKUMENTŮ ZPRÁVA Z AUDUITU (F 43)
CERTIFIKÁT (F 49)

OZNÁMENÍ O PŘIPOMÍNKY A
NEVYSTAVENÍ CERTIFIKÁTU AKCEPTACE AKCEPTACE
ZÁKAZNÍKA ZÁKAZNÍKEM
(F 48 V) f

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LL-C (Certification)®

Diagram certifikačního procesu – certifikace výrobku/procesu

(I-B, I-C) – zkoušení vykonané CO

Účastník procesu: ZÁKAZNÍK LL-C SUBDODAVATEL

POPTÁVKA ŽÁDOST
ZÁKAZNÍKA ZÁKAZNÍKA
TELEFON f

EMAIL FORMULÁŘ

UPŘESNĚNÍ ŽÁDOSTI F30 V

POPTÁVKY

TECHNICKÝ REGISTRACE
EXPERT ŽÁDOSTI

PŘEZKOUMÁNÍ
ŽÁDOSTI
NAŘÍZENÍ VLÁDY
ZKOUŠKY NEVYHOVĚLY HARMONIZOVANÉ NORMY
Z DŮVODŮ NEVHODNÉHO
PLÁNU HODNOCENÍ URČENÍ ROZSAHU SEZNAM SUBDODAVATELŮ
HODNOCENÍ
PLÁN HODNOCENÍ F41 V

VLASTNÍ ZAŘÍZENÍ NE

VLASTNÍ ZAŘÍZENÍ ANO

PROVEDENÍ PROVEDENÍ
ZKOUŠEK ZKOUŠEK
(VÝPOČTŮ) (VÝPOČTŮ)
PROTOKOL Z HODNO-
CENÍ/ZKOUŠKY (F 42 V)
ZKOUŠKY
NEVYHOVĚLY HODNOCENÍ ZÁZNAM Z POSUZOVÁNÍ( F44)
OP VÝSLEDKŮ
ZKOUŠEK

VYPRACOVÁNÍ ZPRÁVA Z HODNOCENÍ (F 43 V)

ZKOUŠKY VYHOVĚLY ZÁVĚREČNÝCH ROZHODNUTÍ O VYSTAVENÍ
DOKUMENTŮ CERTIFIKÁTU (F 47 V)
CERTIFIKÁT SHODY (F 49 V)

OZNÁMENÍ O PŘIPOMÍNKY A
NEVYSTAVENÍ CERTIFIKÁTU AKCEPTACE AKCEPTACE
ZÁKAZNÍKA ZÁKAZNÍKEM
(F 48 V) f

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*The certification process diagram does not apply to medical devices certification
process, which is described separately in Rule 15.11 document.

The certification process usually consists of:

- Inquiry and elaboration of Application F30V

- Verification of the required documentation
- Elaboration and agreement of Certification Offer F31V
- Evaluation process
- Certification review and
- decision on certification

Each stage of the procedure during the period of validity of the certification contract are:
- initial evaluation, review and decision on certification by DM (Decision maker)
- surveillance if requested by certification scheme
- renewal of certification (recertification/renewal evaluation) in the end of period of
certification validity

Inquiry / application registration /certification offer

Inquiry of any new client on the product certification may be personally discussed with
the LL-C staff or can be sent by email on [email protected] or by letter on contact address or
sent via electronic form on the website www.ll-c.cz. LL-C coordinator on the base of
written inquiry conducts a review of the obtained information and verifies if CB has the
competence and ability to perform the certification (the scope of accreditation), all based
on F30 V.

The documentation at the stage of application for certification must adequately define the
organizational structure (including geographical locations and local activities) of the
applicant and a description of its activities, which are essential for certification, for which
application has been made. Documentation may include, in addition to the manual the
procedures and work instructions. Documentation must take into account both direct and
indirect requirements based on standards used and the subject matter.

Coordinator reviews the documentation to ensure that the product is in the scope of LL-C
accreditation and if the CB has the competence and capability to perform the certification
activity. With the positive conclusion based on inquiry, data from the questionnaire and
the current Tariff, LL-C issues F31 Offer of Product Certification in written form and sends
it to the address of the applicant. Business Conditions - F32V are the integral and
mandatory annex of every offer.

Client who accepts an offer for certification has to confirm the F31 and Business
Conditions F32V. The signature of an authorized person for the applicant the offer is
submitted and confirmed, as well as the signing and confirming of the attached Business
Conditions makes full agreement/contract for the Product Certification. The contract is
generally governed by the provisions of the Civil Code Nr. 89/2012 Sb. § 2652 až § 2661
in Czech Republic and accreditation criteria. Furthermore, this is provided information
confirmation as well.

Confirming the order, the following process is initiated:

- is registered to the internal system certification case (contract), including
information about the applicant

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- is appointed Lead evaluator, who starts planning the evaluation activities (contact
person authorized by the applicant, additional conditions, build an evaluation
team, fix a date of evaluation, etc.)
- the applicant is requested to submit the Technical documentation of the Product
(product documentation, design drawings, the descriptions and explanations
necessary to understand the abovementioned drawings and diagrams and the
operation of the product, the results of the design calculations, risk analysis,
investigations, technical tests, etc. at least 14 days before the evaluation.

Evaluators
Coordinator of CB LL-C appoints the Lead evaluator and members of an evaluation team,
technical experts and DM – decision maker which is responsible for review and decision
related to certification. They must be complied with the general qualification of
evaluators, including their competence and experience, reflecting the specific product in
question, impartiality and independence. Appointment of Lead evaluator must be notified
to the applicant in advance.

Evaluation activities
Evaluation activities consist in the conformity assessment of requirements covered by the
scope of certification and other requirements of certification scheme.

Evaluation of conformity shall be governed by different procedures depending on the

type of product and consists mainly of:
- examination of all elements, requirements and provisions adopted by the
manufacturer for his quality system, if they are documented in a systematic and
orderly manner in the form of written policy statements and procedures and and if
they premise uniform interpretation of the quality policy and procedures such as
quality programmes, plans, manuals and records.
- Assessment of quality system assurance to determine whether it satisfies the
arrangement documentation requirements.
- Inspection on the manufacturer's premises and to ensure that it meets the
relevant requirements of health and safety.
- examine and assess the documentation and verify that the type has been
manufactured in conformity with that documentation.
- Appropriate inspections and the tests necessary to verify to verify compliance with
the basic technical requirements for health and safety
- Appropriate inspections and the tests necessary to verify whether, if the
manufacturer has chosen to apply the harmonised standards, these have actually
been applied

In case of nonconformities the applicant will receive a Report of Nonconformities (F46)

and must propose corrective action and specify the date for their compliance. These
nonconformities have to be removed before the end of evaluation. The irrelevant
anomalies may be clarified in during the assessment.

For a major non-conformity, the organization shall submit the cause analysis, correction,
and the plan for corrective action within 30 days from the date the nonconformity is
issued, including evidence of implementation, within 60 days from the date of the non-
conformity, unless the auditor and the organization agree on a longer period of time.

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For a minor non-conformity, the organization shall submit the cause analysis, the
correction, and the plan for corrective action within 30 days from the date the
nonconformity is issued, including evidence of implementation, within 90 days from the
date of the non-conformity, unless the auditor and the organization agree on a longer
period of time.

For evaluation, the evaluators use a questionnaire to assess compliance with the relevant
standards, regulations and government directives and documentation of the applicant.
Lead Evaluator shall communicate a preliminary report on the results after the
evaluation. Evaluating team is not authorized to release the final conclusion of
certification. The Evaluation Report containing the result of audit and other important
information, the applicant will receive within 14 work/days. The applicant may comment
on it in following 14 days. If findings (non-conformities, deviations) are found, the
applicant must propose appropriate corrective actions and the date of their compliance;
the date depends on the specific findings.

Review and certification decision

Lead Evaluator shall forward to the decision maker (e.g., Head of the certification body or
his deputy) all documentation related to evaluation to an impartial assessment and
decision on certification.

Criteria for assessment and review the results related to evaluation are as follows:
- Test records, questionnaire
- Calculation record and reports (if requested by the scheme)
- Evaluation Report F43V
- Verification of compliance with the LL-C Rules
- Submission and completeness of evaluation results in the documentation (report,
questionnaire, reports of nonconformities)
- Corrective actions on findings during the evaluation

The responsible DM clarifies the uncertainties with Lead Evaluator.

Based on findings review the applicant is informed if additional tests will be needed to
verify effectiveness of the corrective action taken before granting the certificate. The DM
reviews the results of additional evaluation.

The information for the applicant

In case that the DM decides that the evaluation results and other requirements of
certification authorize the CB to grant or maintain the certificate the applicant will receive
a certificate (in the case of the initial evaluation) and Evaluation Report, eventually
report on what additional conditions have to be fulfilled before issuing the certificate
(maintaining).

In case that the DM decides that the evaluation results do not allow the CB to grant the
certificate or maintain the valid certificate the decision is notified to the applicant,
including the reasons for the decision.

The applicant may appeal to the Head of the CB and ask to the change the decision
taken.

Certification issue
Ones all criteria have been met the LL-C grants certification in the form of a certificate,
the applicant gets official certificates (2 original sets in the national language of the
applicant and 2 originals in English). For additional copies and for foreign language
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LL-C (Certification)®
versions may be charged additional fee. The certification is valid for duration of not more
than 5 years from the date of approval and is subject to the agreed Business Terms and
to requirement of monitoring the fulfilment of requirements of relative standard
(standards).

Use of LL-C logos ad marks and private schemes (FSSC, GMP+ FSA, IFS)
Use of the LL-C logos and marks and private schemes (FSSC, GMP+ FSA, IFS) is
regulated under the terms of Business Conditions - F32. Certified subject must comply
with the terms, including the use of logos and marks referring to the certification on
promotional items. Use of private schemes logo is guided by its documentation and
requirements (GMP+ A3 GMP+ Logo´s and/or Trademarks, FSSC 22000 etc.)

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Maintenance of certification
Surveillance and remote surveillance audits

If required by the certification scheme are in order to ensure ongoing maintenance of

demonstrating compliance with the requirements of the product carried out periodic
surveillance. LL-C executes these surveillances so that the surveillance audit following
initial certification should not be more than 1 year from the last day certification or of the
last surveillance.

Each surveillance for the relevant management system standard shall include:
a) Internal audits and management review;
b) A review of actions taken on nonconformities identified during the previous audit;
c) Complaints handling;
d) Effectiveness of the management system with regard to achieving the certified
client´s objectives and the intended results of the respective management system
(s);
e) Progress of planned activities aimed at continual improvement;
f) Continuing operational control;
g) Review of any changes;
h) Use of marks and/or any other reference to certification.

If the surveillance findings show that the manufacturer doesn’t fulfils the obligations
imposed by the approved quality system then he gets the possibility to make corrective
actions in determinate date. LL-C verifies and decides if the corrective actions are
sufficient for maintenance of certification.

Note: For ANAB accredited standards it is unlikely that a surveillance audit duration will
be is less than 1 audit day.

Significant changes in the organization (e.g. change in the number of branches),

business and main documentation must be submitted to LL-C at least 14 days before the
start of the audit.

As information and communication technologies become more sophisticated, it is

important that CO staff be able to use assessment methods using "ICT" to increase the
efficiency and effectiveness of the audit and to support and maintain the integrity of the
audit process.

Remote assessment methods using ICT may include the following approaches:

Teleconferencing, Web meetings, Interactive communication via the Internet, Electronic

remote access to management system documentation and / or processes and other
approaches

The aim is to provide a sufficiently flexible and non-prescriptive methodology to meet the
needs of industry by allowing client organizations to use CAAT-RAT to improve the
traditional audit process.

The audit can be performed remotely, when the responsible person is not present and is
abroad, for example. The interview is then conducted with the help of Skype, Viber,
WhatsApp, and other ICT tools, where the applicant sends electronic versions of the
required documents to the auditor or assessor and he evaluates them outside the

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applicant's workplace, etc. This audit method must not exceed 30% of the client's
planned audit time.

The ICT/CAAT method must be agreed in before any part of the audit (part of Auditor
Appointment) starts; IAF MD 3 – current version. Audit is then conducted in according
with requirements of IAF MD 4 (current version).

IF any ICT technology used for CAAT-RAT or remote audit date, time have to be
mentioned, also specification of technology used (which one).

Renewal of certification
Before the end of its validity, and if the client wishes to continue with the certified
product by LL-C, LL-C renewal evaluation must be conducted.

Planning must take into account the time needed to evaluation and decision so that the
new certificate could be issued before the expiration of the old one.

The manufacturer must inform the CB any plan for substantial changes to the quality
system verify whether after these changes the quality system still meets the
requirements and this at least 14 days before starting renewal evaluation.

GMP + FSA scheme certification procedures are governed by the RULE 15_48 procedure.

VI. Suspension or withdrawal of certificate

Suspension Certificate
In case of violation of the certification contract of the client and the subsequent
examination of the severity of the violation, the certificate shall be suspended for a
period specified by LL-C. This may arise for example in the following cases:
- surveillance or any other sources findings show that the client´s management
system persistently or seriously failed to meet certification requirements, doesn’t
fulfil the obligations imposed by the approved management system, agreed
corrective action has not been properly applied
- surveillance audit could not be started on time (as a certified client refuses to
perform surveillance)
- certified client is in insolvent circumstances or in anticipation of bankruptcy
- certified client use the certificates in unauthorized manner.

The suspension shall be communicated to the client by the registered letter/certified mail
and published on the website of the CB. The holder may appeal within 30 days to the
Head of the CB. The suspension of LL-C ends immediately if the applicant demonstrates
needed actions within a specified period.

Termination/withdrawal of certification
If the client, despite instructions from LL-C fails to fulfil its obligations of the contract, for
example, will not take corrective action or fails to comply with the above-mentioned
shortcomings, LL-C immediately terminates the validity of the certificate. This notifies to
the client; requires the return of original certificates by registered mail and publics that
information. Other reasons for termination may be, for example:
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- surveillance audit shows that the essential requirements for the system are not
met
- client’s request for termination
- the client does not produce products related to the certification (change of
technical parameters, doesn’t’ fulfil the requirements)
- the client fails to meet financial obligations to LL-C
- another violation of Business Condition F32 from the client.

The certificate withdrawal is published on CB websites.

In case of suspension, withdrawl or cancelation of certificate owners of private schemes
will be informed in all information will be entered into their databases as well (FSSC
22000 Portal, GMP+ FSA database etc.)

VII. Transfer of accredited certification

Only certificates issued within the scope of accreditation by the signatories MLA – EA,
IAF, PAC, IAA may be considered for transfer if the respective certificate shall have been
issued by a body that shall have been accredited by an accreditation body that is the
signatory only of a regional MLA, then such transfer shall be limited only to certification
bodies accredited by bodies involved in said regional agreement. Organizations that are
holders of certificated that are not covered by such accreditation shall be treated as new
clients.

Re-examination Before the Transfer of Certification

If a query regarding the transfer of certification shall have been received, the certification
coordinator shall appoint an audit coordinator with qualification for the respective area
and prepare and register a transition plan which includes communication with the issuing
body, and assessment of the documentation for the transfer via the transfer report.

Regarding the communication with the issuing body, the certification coordinator shall
contact the issuing body via IW in order to request documentation and confirm the
validity of the certificate and other critical matters relevant to the procedure. Among the
documentation that shall be requested is the following:

- Audit plan.
- Audit reports.
- Checklists.
- Non-conformities and/or other audit findings.
- Corrections, root cause analysis, and corrective action plan to non-conformities.
- Audit program.
- Certificates.

The date and e-mail of the communication to the issuing body are registered in IW. The
certification coordinator shall upload evidence of the communication (screenshot or file)
with the issuing body and upload the provided documents on IW.

Notwithstanding the foregoing, LL-C (Certification) will continue the transfer according to
the customer’s requirements if no answer is received within three audit working days
since the dispatch of the communication using the documentation provided by the client’s
organization. In this regard, if such a situation occurs, the certification coordinator will
send an e-mail via IW to the accreditation body of the issuing body letting it know the
situation. The date and e-mail of the communication to the accreditation body are

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registered in IW and evidence (screenshot or file) is uploaded by the certification
coordinator.

Regarding the assessment of the documentation of the transfer, the examination carried
out by the audit coordinator shall cover the following aspects and its conclusions shall be
documented in the transfer report:
- confirmation that the certified activities of the client fall within the scope of
accreditation of LL-C (Certification) Czech Republic a.s.;
- reasons for requesting the transfer;
- whether the workplaces that is requesting the transfer of certification are owners of
an accredited certificate that is in force as regards authenticity, term of validity and
the scope of activities covered by the management system certificate.
- evaluation of the latest reports from a certification or re-certification audit, reports
from follow-up supervision and all significant non-conformities which shall have been
discovered within said audits or supervisory visits. This evaluation shall also include
all and any further documentation that shall be available and concern the certification
process, i.e. hand-written notes, checklists etc. If no reports from the last certification
or re-certification audit shall be available, or if the follow-up supervisory audit shall
be postponed, the organization shall be regarded as a new client;
- received complaints and measures taken;
- state within the current certification cycle;
- all and any existing liabilities of the organization in relation to regulatory bodies as
regards compliance with laws.

Decision Regarding Transfer

Certification, which shall be known to have been suspended or to be at the risk of being
suspended, shall not be accepted for transfer. If the receiving certification body shall be
unable to verify the state of certification with the issuing certification body, LL-C
(Certification) will continue the transfer according to the customer’s requirements with
the documentation provided by the organization.

If no significant or potential problems shall be discovered during the re-examination

before the transfer, the certificate may be issued within the ordinary decision-making
process. If the CO shall decide regarding the taking-over of an accredited certification
without performing a certification or a re-certification audit, the program of the follow-up
supervision shall be based on the previous certification mode.

If the decision shall have been made to take over a certificate, an offer of supervision
over the maintenance of the system shall be sent simultaneously, and after this offer
shall have been confirmed, a certificate shall be issued.

VIII. Responsibility of Certification Body

Confidentiality
LL-C considers all information and documentation of the certificate holder or applicant to
be confidential.

Appointment of auditors and their qualifications (management systems certification

For the certification of management systems certification body selects leading auditors
with appropriate qualifications and relevant professional experience. The auditor’s skills
are continuously updated by the internal and external training.
Auditors or appointed decision maker/the evaluator (Head of the certification body or his
deputy) involved in certification must not participate in the consultations in introduction
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of applicant’s system or otherwise connected in a way that does not guarantee his
impartiality. Appointments of auditors are proposed to the client for approval. The
applicant has the option to refuse individual auditors. However, it must explain his
motivation that the head of LL-C consider and adopt final decision. In case of customer’s
complaints, the head of LL-C act according to the internal Quality Manual Rule 01 (below
mentioned). External experts and auditors are also bound by confidentiality under
contract with LL-C.

Appointment of evaluators and their qualifications (product certification)

For the certification of products, the Head of CB selects evaluators with appropriate
qualifications and relevant professional experience. The evaluator’s skills are continuously
updated by the internal and external training.

Evaluators or DM (Head of the certification body or his deputy) involved in certification

must not participate in the consultation activities in client’s organization or not to be
involved in an organization that has a relationship with the applicant for certification for
at least two years, or to be engaged in product development, which assesses.

The evaluator / assessor, technical expert, unless is the permanent employee of CB, in
assessing under the conditions specified in the Agreement on cooperation that contains
provisions covering ensuring confidentiality and avoidance of conflicts of interest in
accordance with Rule05 – Act and Behaviour of CB personnel.

Appointments of evaluators are proposed to the client for approval. The applicant has the
option to refuse individual evaluators. However, it must explain his motivation that the
head of LL-C consider and adopt final decision. In case of customer’s complaints, the
Head of LL-C act according to the internal Quality Manual Rule 01 (below mentioned).
External TE and evaluators are also bound by confidentiality under contract with LL-C.

Records
LL-C certification retains all records, documents and reports for a period of 3 years after
the end of their validity for management systems certification. For product certification
retains records, complete documentation and evaluation reports as required by related
standard or Directive.

For the purposes of authorities of surveillance on market (in CR ČOI) and on medical
devices (in CR SÚKL) must have retained complete documentation, which was part of a
conformity assessment of MDD. This documentation of the manufacturer or his
authorized representative shall keep for at least 5 years (in the case of implantable MDD
for 15 years) from the date of manufacture of the last product.

SJ-PK - in case of issuing a certificate for SJPK in accordance with the requirements of
LL-C Certification a.s. on behalf of the (coordinator), informs the Ministry of Transport
of all discrepancies and breaches of certification within fifteen days of the issuance of the
certificate, or of the last supervisory audit and other activities.

Certification Publications
LL-C at regular intervals, publish a certificate holder on the websites www.ll-c.info on the
basis of the client’s Tax Identification Code. In the case of suspension and withdrawal of
certificate is this information published immediately.
In private certification schemes (FSSC 22000, including FSSC 22000 Quality, GMP +),
information about clients and certification dates, etc., are uploaded to its IS of the
scheme owner within 14 days after each event.

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Changes on certificates (activity, address, et.c) suspension, withdrawal or cancelation of
certificates are directly send to databases of private schemes (FSSC 22000 Portal
database, GMP+ FSA database etc.)

Business Continuity certification specification

In case any client is affected by a natural disaster or any other situation affecting
business continuity, steps taken in this regard has to be taken.
If such situation occurs, client will receive F33 – Questionnaire Business Continuity.
Based on information from F33 – Questionnaire Business Continuity, CB will evaluate
appropriate methods and steps to be taken and will communicate with the client by
phone or via email.
Further, client will be informed about steps that will be taken and about additional
documentation needed, which will allow an off-site assessment; documentation such as
management review meeting minutes, corrective action records, results of internal audits
and status of process controls. Based on this documentation assessment we will be able
to determine continuing suitability of the certification (short-term basis only).

This procedure contains:

• proactive communication between the affected organization and CB
• description of steps that will be taken (above), based on information from F33 -
Questionnaire Business Continuity;
• CB will communicate with client time schedule and based on this will evaluate the
latest date before withdrawal of certification will become mandatory;
• every such case will be looked at individually based on information obtained and
will be communicated with client (timing, method, re-instatement activities and
assessment);
• CB has the right of possible amendments to client to oversight plans on case-by-
case basis, always in accordance with CB procedures;
• when access to the affected area is re-established, CB oversight plans for
surveillance/recertification activities reestablishment

If contact with the organization cannot be made, CB will have to follow its internal policy
and take appropriate steps (section VI. Suspension or withdrawal of certificate).

IX. Responsibility of Certification Holder

A) Certification of management systems

Management System supervision
Certifying the management systems the holder assumes an obligation to review the
effectiveness of the system, providing of regular and documented internal audits. If the
holder found failure of comply the standard, he must take on his own corrective actions.
Continuous monitoring of LL-C does not exclude the holder from above mentioned
obligatory requirement.

Assistance for the LL-C auditors

The holder is obliged to allow the LL-C to carry out a timely audit and to provide
assistance to auditors in the audit. Auditors must have access to any premises, including
the scope of certification and to allow the auditors to review all relevant documents.

Modifications of the holder’s management system

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The holder is obliged to immediately inform the LL-C of any change management system,
or modifications, affecting the extent of its validity, e.g.
- In the case of organizational change (change of name, place of operation, sale or
purchase of an enterprise or its parts, an action for bankruptcy, the scope of
certification, etc.)
- In case of substantial changes of key product activities, the change of services
- In case of substantial large changes in the documentation.
LL-C examines changes. In response to the character and extent may be decided an
extraordinary audit to carry out.

B) Certification of products

The manufacturer must affix the CE marking in accordance with Directive and draw up a
written declaration of conformity.
The holder/manufacturer of certificate of machinery device must constantly ensure that
the machinery meets the corresponding state of the art.

The certificate holder of the construction product must consistently ensure that the
referred construction product corresponds to the production technical parameters
specified on the certificate and in the report. In the event of changes in production
processes or other essential technical parameters of the construction product, the
certificate holder is obliged not to include the changed construction product with the
existing certificate. The certificate holder is required to notify any changes to the
certification body.

The certificate holder shall undertake to fulfil the obligations arising from the quality
system as approved and to ensure that it remains appropriate and effective.

Assistance for the LL-C evaluators

The holder is obliged to allow the LL-C to carry out a timely evaluation and to provide
assistance to evaluators in the evaluation tasks. Evaluators must have access to any
premises, including the scope of certification and to allow the evaluators to review all
relevant documents.

Modifications of the holder’s management system

The holder/manufacturer must inform LL-C of any plan for substantial changes to the
quality system or the product-range covered. The notified body must assess the changes
proposed and verify whether after these changes the quality system still meets the
requirements or if additional evaluation of conformity is needed.

The holder/manufacturer shall inform LL-C which issued the EC design-examination

certificate of any such changes made to the approved design. This additional approval
must take the form of a supplement to the EC design examination certificate.

The holder is obliged to inform the LL-C of any change management system, or
modifications, affecting the extent of certification validity, e.g.

- in case of organizational changes (change of name, place of operation, sale or

purchase of a business or its part, the application for bankruptcy, the scope of
certification, etc.)
- In case of substantial changes of key product activities, the change of services
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- In case of substantial large changes in the documentation.
LL-C examines changes. In response to the character and extent may be decided an
extraordinary surveillance to carry out.

X. Application of Certification Rules modifications

The certification system of the LL-C is based on the requirements of applicable standards
and accreditation requirements. All certification holders must be informed in case of their
changes, when the certification system must be modified. This may occur in the following
cases:
- Revision and modification of certification standards
- Modification if accreditation rules (such as changes in the surveillance period,
expenses related to accreditation and audits, etc.).
In case that the holder does not agree to the specific change the contract of certification
ends by the modification approval date.

XI. Financing and certification fees

Fees for certification are set out in the tariff of LL-C, which is based on the applicable
requirements "guidelines for accreditation in accordance with IS0 17021 (MPA). As part
of this accreditation must LL-C fulfil these requirements, especially concerning the time
range of audit.
Fees for certification or any other extra costs are the subject of the certification offer.

Before starting the audit/evaluation the proforma invoice price must be paid in -
accreditation condition, which payment shall not be bound by the conclusion of the
certification process. See F32.

XII. Complaints and Appeals Procedure

Appeals
Clients may appeal the LL-C decision to the Head of CB within 30 days. He must establish
a 3-member Appeals Committee of auditors/evaluators and experts (including himself),
who were not involved in the certification activities related to complaint or appeal. The
committee reviews and verifies all necessary information and decides, voting with simple
majority.

Complaints
Any third party can complain to LL-C on the certification decision. It followed a similar
procedure as the appeal depending on the type of complaint.

In case of an extraordinary audit is the Appeals Committee is convened only after the
disputation of its outcome.

The precise procedure for receiving complaints and appeals, their evaluation and
implementation is documented in Rule12 - Rules of Appeals Committee.

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XIII. Commitment information

Due to the SJ-PK certification, LL-C undertakes to provide the Ministry of Transport of the
Czech Republic with information on all classified non-conformities found in the
accreditation process and supervision of the activities of the certification body. The given
obligation is fulfilled according to the requirements of the methodical instruction and
information in Rule 04.

The procedure for the implementation of the joint audit or its system activities is
excluded and is carried out only under the full direction of LL-C Certification a.s.

The Ministry of Transport is informed of all information and findings by e-mail

immediately within 15 days of the end of the supervision process. The newly printed /
changed existing certificate is sent to the Ministry of Transport immediately within 15
days.

FSSC and GMP + FSA PORTAL DATA AND DATA OWNERSHIP DOCUMENTATION

a) The (certified) organization is the owner of the audit report, while the CB is
responsible for the data of the report.
b) The certificate holder is a (certified) organization, not the owner. CB is the owner of
the certificate data.

DATA QUALITY CONTROL

The CO must have a data quality control process in place that guarantees the quality of
the CB portal data. The quality parameters include at least the following:
a) Completeness: All mandatory data have been registered on the Portal;
b) Timeliness: All data were registered on the portal within the required time limits;
c) Validity: The values of the registered data meet the requirements of the scheme;
d) Accuracy: Data is a true representation of actual facts related to the full audit and
certification process;
e) Consistency: The registered data on the Portal represent a real representation of the
data stored in the internal system (s) of the certification bodies.

Certification Body - PORTAL

a) At the request of the certified organization, the certification bodies shall actively
provide the certified organization with access to the related organization profiles, audit
and certification registered on the CO portal using the available function.
(b) the certification body shall ensure that access to the certified organization is granted
only to authorized persons.

XIV. Security Clearance

The top management shall appoint an accountable manager which will carry on the
security clearance process for ISO 28000 auditors and technical experts. The accountable
manager shall be interviewed and vetted by the top management in order to be
considered as trustworthy, and to have the necessary competence and judgement to vet
candidate security auditors and technical experts. The accountable manager shall have
knowledge and experience sufficient to evaluate the audit processes of a security
management system for the supply chain.

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The initial interview of ISO 28000 auditors and technical experts shall be performed by
the accountable manager using a series of questions included in the interview form, as
well as the reviewal of an official identification document.

A criminal record certificate issued by agencies or police authorities will be required as

evidence of completion of the security clearance process. Notwithstanding the foregoing,
a self-declaration of criminal records, backed with the reviewal of an official ID (e.g.
passport, driver license or identity card), will be allowed as evidence of completion of the
security clearance process in countries where a criminal record certificate is difficult to
obtain.

ISO 28000 qualified auditors will undergo the security clearance process every year,
confirming via appointment (F40) that his/her criminal status has not changed since the
last security clearance process and that have no pending case, criminal or civil, before
any judicial authority or agency, and have not been accused of any offense or crime
before any prosecution office and judicial authority.

List revisions and motivations

Rev. Date Motivation Insert Approved

by
1 4.1.2004 First publication M.Krutský M.Krutský

2 15.6.2004 Page 8 M.Krutský M.Krutský

3 27.9.2004 Page 3-8, 10 M.Krutský M.Krutský

4 30.5.2005 Page 3-8, 12-13 M.Krutský M.Krutský

5 12.10.2005 Page 8 M.Krutský M.Krutský

6 28.2.2006 Page 1 M.Krutský M.Krutský

7 1.7.2008 Page 3-12 M.Krutský M.Krutský

8 20.8.2009 Page 3-12 M.Krutský M.Krutský

9 13.1.2010 Page 3-12 M.Krutský M.Krutský

10 29.11.2010 Page 3-12 I.Angelovski M.Krutský

11 10.12.2012 Page 2- 12 I.Angelovski M.Krutský

12 22.05.2013 Page 2, 4, 5, 7 I.Angelovski M.Krutský

13 1.12.2013 Revision of all document B.Kuchtová M.Krutský

14 10.2.2014 Page 2,20 L.Holub M.Krutský

15 18.2.2014 Page 19 B.Kuchtová M.Krutský

16 25.4.2014 Strany 13, 14 D.Tokar M. Krutský

17 9.4.2015 Revize a úpravy celého dokumentu B.Kuchtová M. Krutský

18 5.11.2015 Strana 8 D.Tokar M. Krutský

19 13.1.2016 Strana 3 L. Holub L. Holub

20 06.10.2016 Page 3, 7, 11, 12, 13, 21 M.K., I.A M. Krutský

21 27.1.2017 Revize verzí standardů v celém dokumentu M.K., I.A. M. Krutský

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22 2.1.2018 Strana 4, 8 L.Turza M. Krutský
K.Macháčkov
23 1.4.2018 GMP+ str. 4,7,18 M. Krutský
á
24 10.05.2018 Strana 3,6,13,15,22, M.Krutský M.Krutský

25 9.11.2018 Změny vyznačeny barevně L. Holub L. Holub

26 15.11.2018 Změny vyznačeny barevně str. 4, 8 Ř. Prihara L. Holub

27 28.4.2020 SJPK – aktualizace strany 6, 24 L.Turza L.Holub

28 23.6.2020 SJPK – aktualizace strany 24 L.Turza L.Holub

29 23.6.2020 SJPK – aktualizace strany 24 L.Turza L.Holub

30 07/10/2020 Vložení „Osvědčení“ – str. 19, 20 Ř. Prihara L. Holub

Odstranění - posuzování „Her a Hraček“,
31 15/10/2020 diagram posuzování „Hmotných produktů“ Ř. Prihara L. Holub
podle SM str. 15
32 08.12.2020 FSSC 22000 and GMP+ FSA requirements I. Angelovski L. Holub

33 18.12.2020 FSSC 22000 Quality I. Angelovski L. Holub

34 8 march 2021 added procedure SPVD L. Turza L. Holub

35 10 march 2021 FSSC 22000 version 5.1 requirements I.Angelovski L. Holub

36 10 march 2021 (:2007 CL1 až CL4, :2020 CL1 až CL3) Ř. Prihara L. Holub

37 9 april 2021 Surveillance audit length ISO 22301 L. Nejedla L.Holub

38 20 april 2021 Surveillance audit length, p. 20 L. Nejedla L.Holub

39 11 november 2021 Corrections L. Holub L. Holub

40 25 february 2022 EN CZK versions corrections L. Nejedla L. Holub

41 4/4/2022 Changes visible in other color L. Holub L. Holub

42 16/06/2022 Changes visible in this colour p. 25_26 +12 L. Nejedla L. Holub

43 25.05.2023 Security Clearance R. Velasco L. Holub

44 14.11.2023 Corrective action, p. 20, 21 R. Velasco L. Holub

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