StarFish Medical

www.starfishmedical.com

5/31/2011

Keys to Avoiding Pitfalls to ISO 13485 Certification

sTemplate #1

Keys to Avoiding Pitfalls to

ISO 13485 Certification

In gaining ISO 13485 certification for your new product, it is critical to have a clear understanding of the terminology, interpretation of requirements, and how the requirements

apply to your product(s). It can mean the difference between quickly getting into the marketplace or becoming bogged down in confusing paperwork and regulations.

ISO 13485 is an international standard that outlines the requirements for a comprehensive quality

management system (QMS) for the design and manufacture of medical devices. It is recognized

by the European Union, Japan, Australia and many other countries. Compliance with the

standard is required by Canadian Medical Device Regulation.

The standard is modeled on ISO 9000:2000 with the additional requirements of documentation

and provisions specific to medical devices, and specifically requires risk management throughout

the product life cycle. The standard is compatible with the requirements of the FDA QSR.

Here are some of the most common issues in the implementation and auditing of ISO

13485:2003.

Process verification and validations process boiled down.

Process verification and validation is the process of checking that a product, service, or system meets specifications and that it fulfills its intended purpose. It can be boiled down to two basic

questions:

Are you building the right thing?

Validation is the quality assurance process of establishing evidence that provides

a high degree of assurance that a product, service, or system accomplishes its

intended requirements. This often involves acceptance of fitness for the intended

purpose by end users and other product stakeholders.

Are you building it right?

Verification is a quality control process that is used to evaluate whether or not a

product, service, or system complies with regulations, specifications or conditions

imposed at the start of a development phase. Verification can be in development,

scale-up, or production and is often an internal process.

QMS documentation should be simple and easy to maintain.

Successful document control means efficiency in revision control, document access, routing, approval and change impact analysis. A document must also be easy to find and retrieve .

Start by carefully mapping QMS procedures. This process map is the most valuable tool in a company’s QMS. Forms, control points and responsibilities should be described on one page and

in clear terms. The overlying procedure should reference a flowchart, contain relevant

definitions, and list related processes. Flowcharts are easier to read, translate and are less likely

Documentation should include a policy manual, procedures and instructions covering standard requirements and a clear path to the stated requirements as well as objective evidence to support that the documentation is being followed.

QMS documents are maintained bilingually and are often audited. Translating excessive verbiage

to have errors.

Documentation should include a policy manual, procedures and instructions covering standard requirements and a clear path to the stated requirements as well as objective evidence to support that the documentation is being followed.

QMS documents are maintained bilingually and are often audited. Translating excessive verbiage and maintaining the documents are both labor-intensive and leave too much room for error.

Determine what needs to be translated and how long it will take. Regardless of what translation vendors say, they cannot handle every subject matter. Make sure your vendor clearly

understands your industry and the product terminology. Not complying with language conformity

requirements will cause problems which might result in delays to market.

Continuous Improvement and QMS Maintenance

ISO 13485:2003 carries an obligation to continually monitor and maintain the effectiveness of a QMS through improvement efforts. While it is a good business practice, some companies might

view the work as already completed once the certificate is obtained.

Actually, QMS maintenance, monitoring, and improvement can be easily integrated into a

company's operations. If the company has mapped and validated processes, the company has both a map and a set of metrics. One can then plan for improvement based on known quantities.

StarFish Medical is registered with both Health Canada and the FDA. As an ISO 13485 certified manufacturing facility, you can count on a reliable, responsive and transparent operation following exacting procedures that result in a consistent, quality product. Our procedures, documentation and quality management systems will provide assurance to your product launch team and medical device investors.

If you are not yet certified to complete the design, development, manufacture and delivery of your medical device, StarFish offers a complete "QMS-in-a-Box" process. We will implement a custom system for you, train you and support you in passing your ISO 13485 certification audit.

Visit our website to download the 28-page generic audit checklist.

StarFish Medical www.starfishmedical.com

Keys to Avoiding Pitfalls

to ISO 13485 Certification

In gaining ISO 13485 certification for your new product, it is critical to have a clear

understanding of the terminology, interpretation of requirements, and how the requirements apply to your product(s). It can mean the difference between quickly

getting into the marketplace or becoming bogged down in confusing paperwork and regulations.

ISO 13485 is an international standard that outlines the requirements for a

comprehensive quality management system (QMS) for the design and manufacture of

medical devices. It is recognized by the European Union, Japan, Australia and many

other countries. Compliance with the standard is required by Canadian Medical Device

Regulation.

The standard is modeled on ISO 9000:2000 with the additional requirements of

documentation and provisions specific to medical devices, and specifically requires risk

management throughout the product life cycle. The standard is compatible with the

requirements of the FDA QSR.

Here are some of the most common issues in the implementation and auditing of ISO

13485:2003.

Process verification and validations process boiled down.

Process verification and validation is the process of checking that a product, service, or

system meets specifications and that it fulfills its intended purpose. It can be boiled down to two basic questions:

Are you building the right thing?

Validation is the quality assurance process of establishing evidence that

provides a high degree of assurance that a product, service, or system

accomplishes its intended requirements. This often involves acceptance of

fitness for the intended purpose by end users and other product

stakeholders.

Are you building it right?

Verification is a quality control process that is used to evaluate whether or

not a product, service, or system complies with regulations, specifications

or conditions imposed at the start of a development phase. Verification can

be in development, scale-up, or production and is often an internal

process.

QMS documentation should be simple and easy to maintain.

Successful document control means efficiency in revision control, document access, routing, approval and change impact analysis. A document must also be easy to find and retrieve.

Start by carefully mapping QMS procedures. This process map is the most valuable tool in a company’s QMS. Forms, control points and responsibilities should be

described on one page and in clear terms. The overlying procedure should reference a flowchart, contain relevant definitions, and list related processes. Flowcharts are easier

to read, translate and are less likely to have errors.

Documentation should include a policy manual, procedures and instructions covering standard requirements and a clear path to the stated requirements as well as objective evidence to support that the documentation is being followed.

QMS documents are maintained bilingually and are often audited. Translating

excessive verbiage and maintaining the documents are both labor-intensive and leave

too much room for error. Determine what needs to be translated and how long it will take. Regardless of what translation vendors say, they cannot handle every subject

matter. Make sure your vendor clearly understands your industry and the product terminology. Not complying with language conformity requirements will cause

problems which might result in delays to market.

Continuous Improvement and QMS Maintenance

ISO 13485:2003 carries an obligation to continually monitor and maintain the effectiveness of a QMS through improvement efforts. While it is a good business

practice, some companies might view the work as already completed once the certificate is obtained.

Actually, QMS maintenance, monitoring, and improvement can be easily integrated into a company's operations. If the company has mapped and validated processes, the

company has both a map and a set of metrics. One can then plan for improvement based on known quantities.

StarFish Medical is registered with both Health Canada and the FDA. As an ISO 13485 certified manufacturing facility, you can count on a reliable, responsive and transparent operation following exacting procedures that result in a consistent, quality product. Our procedures, documentation and quality management systems will provide assurance to your product launch team and medical device investors.

If you are not yet certified to complete the design, development, manufacture and delivery of your medical device, StarFish offers a complete "QMS-in-a-Box" process. We will implement a custom system for you, train you and support you in passing your ISO 13485 certification audit.

Visit our website to download the 28-page generic audit checklist.

StarFish Medical www.starfishmedical.com