Iso 13485 Certification Process

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Certification

Process
ISO 13485
UKAS MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS
– REQUIREMENTS FOR REGULATORY PURPOSES
CERTIFICATION PROCESS

Accreditation and approval status


SGS United Kingdom Limited is UKAS accredited for quality management systems including ISO 13485 and ISO
9001 for all medical devices and associated services. This means you are entitled to use both the SGS and UKAS
logos on the completion of a successful audit.

Step A
Agree Contract
Step B
Optional Pre-Audit
Step C
Assessment
Stage 1 Audit

Step D
Stage 2 Audit

Step E
Corrective Actions & Plans

Step F
Certificate Review
Year 1

Issue Certificate
after successful audit

Step G
Visit 2

Year 2
Surveillance Audit Visit 3

Step H
Year 3
Recertification Visit
STEP A What you need to send us: You do not need
to make any payments on application unless a
PROPOSAL AND APPLICATION payment is referenced in the proposal. Unless a
pre-audit is being undertaken, SGS require a copy
A proposal is submitted by SGS for consideration. If of your quality manual, procedures and any work
this does not adequately include all your requirements instructions that ensure compliance with ISO 13485
or you have questions, please contact this office as (including sterilisation and other critical processes).
we are happy to discuss any queries and the next These should be controlled and sent to this office in
steps. This proposal is valid for 60 days. Once the 60 paper or electronic format. You should indicate for
days end, we will review the contract again and issue paper copies whether it is an original to be returned
a new quote if necessary. or whether it is to be eventually destroyed by SGS
(our normal procedure). To demonstrate that your

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Application: To apply for certification and to start internal audit and management review processes are
the assessment process the Application form must functioning SGS need a copy of the current internal
be completed, signed and returned to this office. We audit schedule, the last internal audit report and the
recommend this is done as soon as your decision to minutes of the last management review. If any critical
proceed has been taken to allow maximum time for processes are subcontracted or outsourced, copies
planning. Your application will be processed and we of any subcontractor certification should also be sent.
will contact you to arrange the next steps of the audit If this is a transfer the last two audit reports from
process and dates. the previous certification body with any associated
corrective actions should be sent.

Special Conditions: In addition to conditions set out


STEP B in the SGS Codes of Practice, General Conditions for
Certification and Regulations Governing the Use of
PRE-AUDIT (AT YOUR REQUEST) SGS Certification Marks the following apply:

This activity can be undertaken at your request


The applicant retains full product liability for registered
and is designed to ensure you are ready for the
products or services and full responsibility for correct
audit and certification process, that you have
categorisation, classification and adherence to
considered all the requirements of the standards
standards.
and regulations and to minimise subsequent
delays through non-compliances. Unless
Unless stated in the proposal it has been assumed
already shown in the proposal this will be at
that no audits to subcontractors or additional sites are
additional cost. Normally a qualified auditor will
required. However, during the audit process if further
come to your site to undertake a gap analysis
information indicates a different situation, you will
audit on your documentation and processes
be informed and additional visits agreed at additional
and to indicate potential non-compliances that
cost.
should be corrected before the Stage 1 audit
process commences. If you are uncertain about
compliance or you have strict deadlines to meet,
this step is recommended. Contact this office if
you wish to have a pre-audit.

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CERTIFICATION PROCESS

STEP C STEP D
STAGE I AUDIT – PREPAREDNESS REVIEW STAGE II AUDIT

It is recommended that this activity is conducted This step is usually conducted several weeks after
at your site. This step of the audit process includes the Stage 1 activity to ensure that you have time to
an appraisal of your Quality Management System implement the findings of the Stage 1 Audit. We are
documentation and intended scope of certification, led by you in relation to the time between Stage 1
including products, processes and locations and and Stage 2 activities but 4 weeks minimum would
related statutory and regulatory aspects. This stage be recommended and both stages should be planned
will include; well in advance.

• an evaluation of your location and site specific


This on-site audit determines compliance against
conditions, and discussions with you to determine
your documented system, the standard(s) and the
your preparedness for the stage II audit;
appropriate regulations.

• a review of your status and understanding


regarding the requirements of the standard(s) All assessment conclusions are based on sampling

and regulations, in particular with respect to the of audit evidence to demonstrate effective

identification of key performance or significant implementation of the management system, control

aspects, processes, objectives and operation of the over the processes and progress made towards

management system; achieving your stated quality objectives.

• a review to ensure that internal audits and At SGS our audit approach is designed to contribute
management reviews are being planned and value to the process and also to ensure that your
performed, and that the level of implementation of management system is achieving your goals.
the management system confirms that you are On conclusion of the audit the audit team will make
ready for the stage II audit. a recommendation dependent on the findings
and subject to the submission of corrective action
Stage 1 determines compliance with the plans for any non-conformances (Corrective Action
documentation requirements of the standard(s) and Requests). The auditor will talk through the findings
regulations and also the allocation of resources and which may comprise major non-conformances, minor
working documentation for the Stage II audit. non-conformances and observations/opportunities for
improvement. The auditor will also agree with you the
You will receive a Stage I audit report outlining any
name, address and scope details which will appear on
deficiencies (findings) to enable immediate action
your certificates.
to be taken prior to moving forward through the
process. An audit plan for the on-site audit will also be
forwarded to you at this stage. Serious deficiencies
with the documentation, preparedness, existing
certification or certification of a critical sub contractor
could result in you being advised of additional costs
and/or delay to the Stage II audit.
STEP E STEP G
CORRECTIVE ACTIONS AND PLANS ONGOING SURVEILLANCE VISITS

Any major non-conformance will have a corrective Once issued certificates are only valid subject to
action plan and date agreed during the audit. regular audits to check satisfactory maintenance of
Certification will be deferred until corrective action has your quality management system. Ongoing audits
been taken and verified by SGS either on site or by (surveillance visits) are usually conducted annually
document review as appropriate. to verify continued implementation of your quality
All minor non-conformances will have a corrective management system in accordance with planned
action plan and date agreed during the audit or arrangements, the requirements of the standard(s)
immediately after and the corrective action must be and the requirements of the regulations. The first

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completed by the next audit. Failure to take effective surveillance shall be conducted no more than 12
corrective action for major non-conformances or to months from the last day of the initial V1 stage 2 audit.
submit effective corrective action plans and dates for Certain mandatory elements will be reviewed at every
minor non-conformances will prevent final review and visit together with other pre-selected processes.
certification. We will work with you to identify areas that are not
conforming to support opportunities for improvement.
STEP F An audit plan will be forwarded in advance of the
CERTIFICATION REVIEW agreed audit date. Please note that the flexibility
in the timing of ongoing visits is strictly limited by
At the end of Stage 2 the report is compiled off site accreditation requirements.
and reviewed with the other audit documentation,
corrective action plans and any corrective actions STEP H
taken and a certification decision made. This step TRIENNIAL RECERTIFICATION
can sometimes lead to limited changes in the non-
conformances and scopes about which you will be SGS operates a system of continuous certification. As
informed and your agreement obtained. Once the part of this programme it is not necessary to conduct
certification decision has been made the certificate a complete reassessment. Rather we conduct a
is processed and sent to you along with the formal recertification visit which is more in-depth than a
report and guidance on the use of the SGS and UKAS surveillance visit and which may include an off-site
logos. SGS can support you in the form of certificate document review and will ensure that we review
presentations and arranging press releases to help you all aspects of your system. The recertification audit
promote your achievement should this be required. must be carried out and major non-conformances
closed prior to the expiry of your current certificate.
The recertification audit is the first visit of your new
certification cycle.

We shall contact you approximately 4 months


before the certificate cycle to make the necessary
Example mark arrangements for this audit, including information on
the costs for the next 3 year cycle.

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CERTIFICATION PROCESS

PAYMENT TERMS is carried out by an on-site audit STEP D and the


certification process carries on through STEPS E and F.
We will send you an invoice for the fees when we In some cases it is carried out by a document review
have carried out each stage. Once you receive an STEP C and will bypass STEP D. The appropriate
invoice, you must pay it within 30 days after the date method will be shown in section 2.1 of the proposal.
of invoice (no matter what your company’s payment
terms) unless we agree otherwise in writing.
If you require a purchase order it is your responsibility SWITCH OF CERTIFICATION
to ensure this is supplied to SGS, either prior to the
date of audit on the booking confirmation letter, or If you have other current certification assessed by
given to the auditor during the on-site visit. an accredited or approved certification body and this
certification is up to date and in good standing you
can switch to SGS at any time during the certification
CHANGES TO SCOPE cycle. We will conduct a review of your current
certification and in order for us to do this you will need
In the event of any developments that will alter your to send us a copy of the relevant certificate(s), the
certification, e.g. site or scope additions, reductions, previous two audit reports, including the status of any
mergers or acquisitions, it is important you inform us outstanding corrective actions, and the approximate
at your earliest convenience. Changes to scope or due date of your next visit. Following a review we
significant changes in the quality management system will provide you with a proposal to take over this
scope or changes to critical subcontractors can be certification within the existing cycle or starting a new
covered at any time during the certification cycle. SGS cycle as preferred
require to be informed in advance, via email to this
office, so that a revised contract can be issued.
SGS RANGE OF ADDITIONAL MEDICAL
It is a requirement, as described in the SGS Codes DEVICE CERTIFICATION SERVICES
of Practice, to notify SGS of any significant quality
system and product range change including any For many organisations the potential market for
significant regulatory actions that may affect your medical devices and services is worldwide and
compliance and the planning of this audit. This should additional certification and approvals may be required
be done during the audit cycle in advance of any in the future. It is the policy of the SGS Group to
proposed significant change or immediately after a obtain all possible global approvals to support you.
regulatory action. However it is also a requirement Therefore we have auditors with knowledge of a wide
for certification bodies to confirm certain information range of regulatory requirements and we can help
before each scheduled audit. your future plans by offering:

The scheduling of any change to scope of audit can • Gap analysis audits
take place at the same time as a surveillance/renewal • Training
visit or can be carried out between visits depending • Direct additional regulatory certification
on your requirements and instructions. Usually this • Additional regulatory certification via other
SGS affiliates
SGS ACADEMY TRAINING SERVICES

The SGS Academy has a number of courses available


to assist our clients with their Medical Devices
Certification and discounts are available to our clients.
These sessions are available on an open basis in a
number of locations, or can be delivered at your site,
tailored to your specific requirements. The courses
include introductions to the ISO 13485 Standard,
internal auditor training and sessions relating to the
transition of Standards as and when revisions are
released. Courses are also available for numerous

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harmonised standards and for constructing technical
files against the directive 93/42/EEC.

For more information please visit the SGS Training


Schedule, email [email protected] or call 01276
697 777 to speak with a member of the team.

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CERTIFICATION PROCESS

ABOUT SGS

SGS are the world’s leading inspection, verification, • Verification services – SGS verification services
testing and Certification Company. SGS is recognised ensure that products and services comply with
as the global benchmark for quality and integrity. global standards and local regulations. Combining
global coverage with local knowledge, unrivalled
With more than 89,000 employees, SGS operates a experience and expertise in virtually every industry,
network of over 2,600 offices and laboratories around SGS covers the entire supply chain from raw
the world. materials to final consumption.
We offer the following main services:
In the UK, SGS employs over 1,800 staff based in over
• Customised Audit Solutions – our diverse skills 30 regional offices. Our certification section provides
and experiences help organisations to exploit independent certification and audits to a range of
established management systems, by working in standards, including:
partnership to optimise efficiency and
effectiveness, finding practical solutions to • Quality Management Systems (ISO 9001);
challenges related to: best practices in • Environmental Management (ISO 14001);
organisational operation, process efficiency • Risk Management, IT Certification (ISO 20000);
and improvement, supply chain management, and • Information Security Management (ISO 27001, ISO
Sourcing & Procurement. 27701, BS10002, ISO 27017, ISO 27018);
• Business Continuity Management System
• Inspection services – we inspect and check (ISO22301)
the quantity, weight and quality of traded goods. • Energy Management Systems (ISO 50001)
Inspection usually takes place when goods are • Asset Management Management Systems
moved from one type of transport to another. (ISO 55001)
• Testing services – we test quality and • Customer Service Excellence;
performance of products against various health, • Occupational Health and Safety (ISO 45001)
safety and regulatory standards. We use state- • EC Directives (CE Mark) and other regulations;
of-the-art laboratories on or close to customers’ • UKCA Mark for Medical, PPE and CPR
premises. • Medical Device Certification (ISO 13485 and
MDSAP);
• Certification services – we confirm that systems • British Retail Consortium Global Standards;
or services meet the standards set by • Food Safety Management Systems (ISO 22000);
governments, standardisation bodies (for example, • Aerospace
ISO 9001) or our customers’ products. We also
develop our own standards to meet our clients’ For more information on any of our services visit
needs. SGS as an accredited certification body www.sgs.co.uk/certification
can provide confidence to clients that professional,
experienced auditors are used and standards are
consistently applied.
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