Iso 13485 Certification Process
Iso 13485 Certification Process
Iso 13485 Certification Process
Process
ISO 13485
UKAS MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS
– REQUIREMENTS FOR REGULATORY PURPOSES
CERTIFICATION PROCESS
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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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.
and regulations, in particular with respect to the of audit evidence to demonstrate effective
aspects, processes, objectives and operation of the over the processes and progress made towards
• 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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CERTIFICATION PROCESS
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
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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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