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ISO 13485 is a quality system standard for organizations that design, develop,
produce or service medical devices. All requirements of ISO 13485 are specific
to organizations manufacturing medical devices, regardless of the type or size of
the organization.
Assures the customers that the product complies with all relevant product &
service-oriented technical standards & regulations.
Emphasizes the cleanliness & sterility in the production area, which in turn
increases efficiency & enhances safety at the workplace.
Knowledge in FDA, MDD, and GMP are added advantages for the consultants
Perform a 13485 GAP Analysis - If the organization already implemented
ISO 9001 quality management system. This is not required for those
implementing first time
Project Schedule - Consultants will work with the acting MR to prepare a
Stage 03 project schedule. The schedule will list the actions needed. The Process
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Owners will be informed about there duties and responsibilities along with
timeline.
Develop Process Mapping - Consultants will guide you to develop Process
Mapping. There will be 2 levels of Process Maps:
Stage 04
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Stage 06
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Stage 07
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Quality Manual.
QMS procedures.
Employee Training Consultants will help you identify the training needs of
your employees. Consultants will be providing training for all level of people
in the organization like awareness, GMP and internal auditor training.
Implementation Do what you documented, document what you does/td>
Stage 08 Establish quality goals and understand how they can best be
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Stage 09 Internal Audit - Consultants will provide internal audit along with certified
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internal auditors.
Scope
Clause 2:
Normative
Reference
ISO 9000:2005 which should be used along with ISO 13485 standards. It
outlines the Quality Management Systems-Fundamentals and Vocabulary
Gives definitions used in the standard, many of which are in addition to
ISO 9001.
Clause 3:
Terms and
Definitions
Advisory Notice
Customer Complaint
Labeling
Medical Device
Required Procedures
Clause 4:
General
Requireme
nts
Control of Documents
Control of Forms
Clause 5:
Management Responsibility
Manageme
nt
Responsibil
Management Review
Resource Management
Planning
Clause 7:
Design
Product
Purchasing
Realization
Process control
Customer Property
Customer Satisfaction
Internal Audits
ity
Clause 6:
Resource
Manageme
nt
Clause 8:
Measurem
ent,
Analysis
and
Improvem
ent
primary reason is that once your ISO 13485 quality system has been implemented,
you need to generate official records using implemented procedures that will be
referenced during your subsequent registration audit by a Certification Body. It is
possible to implement an ISO 13485:2003 quality management system in just a
few months, but without auditable records it would be extremely difficult to
achieve certification.
is not always the case. Mid-size to larger companies sometimes have more
resources dedicated to achieving ISO 13485 certification and can sometimes push
through changes more quickly if there is support from all levels of senior
management.
Write new Standard Operating Procedures (SOP) and review Work Instructions
INTERNAL AUDITING
Typically, you will schedule your certification audit 4+ weeks after conducted your
final readiness review to allow for final changes to your system. Certification
Bodies normally issue ISO 13485 certificates about 6-8 weeks after a favorable
recommendation for certification.
STAGE 1 AUDIT
The purpose of the Stage 1 Audit is to obtain information about the applicant company
related to the size, complexity of operations and capabilities for which registration is
sought. The auditor will establish whether further development of the management
system is necessary before the Stage 2 Audit takes place.
STAGE 2 AUDIT
The stage 2 Audit is carried out to ascertain that whether the of the applicant companys
Management System can be certified based on the objective evidences found during the
course of audit.
The audit team compares what you say you do i.e. your documented management
system, against what you actually do.
The auditor will be looking for objective evidence (records, documents, etc) to verify
that the activities of the organization are in accordance with the documentation and the
requirements of the relevant management system standard.
All records resulting from the implementation and operation of the Management
System must be made available to the Audit team for evaluation.
SURVEILLANCE
Periodic surveillance Audits will be carried out to ensure that the management system
is not only being maintained, but is being reviewed and developed further to improve
the efficiency and effectiveness of the business processes. These Audits, generally at 6
/9 /12 monthly intervals will always cover certain key elements crucial to the success of
your business. These would include internal Audits, management reviews, continuing
operational control and corrective actions. Your Customer Complaints Register would
also be examined to see how quickly and effectively you handle customer complaints.
Other aspects of the Management System will be covered selectively, over the period of
certification, depending on their importance of their scope of certification.
The Management System Certificate will be valid, initially for a period of three years
from the date on which the Client is notified of its successful Audit, on condition that the
surveillance Audits have revealed no deterioration in the Management System.
Size of the certification body This depends on your goals. Having a large
brand name as your Certification Body can have a direct impact on your ability to
secure new contracts with overseas firms simply because the name recognition of
your auditor lends credibility to your company. If your company is trying to break
into the Japanese market, for example, using a widely known Certification Body
such as TUV, BSI or UL could be beneficial. On the other hand, many small to
mid-sized Certification Bodies are reputable and can sometimes offer faster service
at lower prices than the big players.
Extra fees Before making your selection, ask the Certification Body if it charges
any special administrative, renewal or address change fees. If you are also seeking
CE Marking, find out how much it would cost to get extra copies of your CE
certificate. Ask where the auditor will be traveling from to conduct your audits.
Some firms include travel costs in their quote while others do not. Once you sign a
contract, you will not have any choice but to pay those fees so it is better to know
about them now.
We already have US FDA GMP or ISO 9001. How difficult will it be to upgrade
to ISO 13485?
Companies that already have a well maintained and audited US FDA GMP or ISO
9001 quality system in place will find it relatively easy to make the changes
necessary to achieve ISO 13485 certification. The US Food and Drug
Administration does not recognize ISO 13485 but the US FDA did provide input
when ISO 13485 was being crafted so FDA Good Manufacturing Practice is similar
to ISO 13485. Likewise, ISO 9001 is the basis of ISO 13485 with additional
requirements specifically for medical device manufacturers. Therefore, upgrading
to ISO 13485 will be fairly straightforward.
can affect the safety and effectiveness of the product or services provided by the
company. So, rather than require that companies continually improve, 13485 requires
maintenance of the effectiveness of the quality management systems processes.
Consequently, continual improvement efforts may be limited to those areas in the
management system that do not pose a significant risk to product or process safety and
effectiveness.
3. Exclusions
Section 1.2 of 13485, Application, states that a company may justifiably exclude the
requirements for design and development if a regulatory requirement allows for it,
regardless of whether or not the company engages in such activities. As always, a
company needs to be careful how they define an exclusion. Even though the company
may not have primary responsibility, it still may have activities that impact the
excluded requirements. Auditors will test companies to ensure exclusions are justified.
4. Risk Management
Given the nature of the product being manufactured or service being provided, 13485
requires that companies calculate, analyze and mitigate the risks associated with the
product and processes. This is not unlike the requirement in the automotive sector for
companies to conduct failure mode and effects analysis (FMEAs) and develop
preventive measures to prevent undesirable results. Additional guidance can be found
5. Additional Requirements
As is the case for other sector-specific standards, 13485 has additional requirements
that go beyond its 9001 foundation. Many of these requirements call for the
development of additional documents and documented procedures. Additional
requirements include:
While a company seeking dual certification does not have to necessarily maintain two
sets of quality management system documentation-one for 9001 and one for
13485-the company must identify and implement the unique requirements in each
standard. To ease the initiative to develop a 13485-conformant system, the standard
contains Annex B, which allows one to compare the requirements of 13485 with those
of 9001.
If a consultant is required, the organization needs to be sure that the prospect has
expertise in 13485, and requesting referrals from an accredited registrar also can aid in
finding the right match. It is important that the consultant understands the
organizations business, that the consultant has dealt with organizations of a similar
size before and has had experience with similar product lines.