Who’s Minding Who’s Minding the External the External Standards?Standards?

Presented by: Michelle Johnston Advanced Quality System Solutions MD&M East Session 202 June 3, 2008 ©Advanced Quality System Solutions

A Little NY Wisdom

"Make sure you have finished speaking before your audience has

finished listening."

-- Dorothy Sarnoff (accomplished Broadway singer and Brooklyn native)

AgendaQuality System RequirementsWhat Do You Need?Best Practice and Tips

Procedural ConsiderationsQuality System LinkagesPractical Dos and Don’ts

Recap

3

What I’ve Seen This process rarely gets the attention it deserves

Procedures lack detail and don’t define the process

Companies are not aware of new or revised standards

4

QS Requirements

Not a lot of visibility in quality system requirements (except for ISO 13485)Regulatory agencies expect standards to be used as appropriate

Demonstrate devices are safe and effectiveHarmonization

5

Let’s Clear Up a Misconception

The use of standards is VOLUNTARY

However…

Likely least burdensome approach and considered “best practice”

6

7

How Many Is Enough?

How Many—Well…it DependsDriven by various factors:

Market strategies (where are you going to sell your device(s)

Customer requirements

8

Product Considerations:

Sterile or reusable

Biocompatibility

Materials

9

How Many—Well…it Depends

Product Considerations:

Labeling/Packaging

Performance Testing

Software

10

How Many—Well…it Depends

Environmental/Mfg Considerations:

Clean room

ESD

RoHS and WEEE compliance

11

How Many—Well…it Depends

General Considerations:

Risk Management

Design

Clinical Trials

Sampling Plans12

How Many—Well…it Depends

How Do You Know What You Need? Start researching!

Sources of InformationInternet

Professional organizations (ASQ, AAMI)

Standards websites (ANSI, CEN, ISO, ASTM, Tech Street, etc.)

Regulatory agency websites 13

Notified Body websites and newsletters

Authorized representative

Test labs

Industry publications/journals

14

How Do You Know What You Need?

So…Who is Minding the Standards?

A Few Scenarios…

Designated Department (typically RA)

Non-centralized. If a standard is needed, it’s ordered. A designated person usually maintains a listing.

Each document is assigned an owner/dept responsible for tracking

What’s Best for You--A Few Things to Consider

Current Resources/knowledge Can be time-consumingOne person may not have the knowledge

Many different types of standards from many sources (budgetary concerns)

17

What’s Best Practice?

Clearly define the process including responsibilities based on previously discussed factors—no one size fits all

May want to utilize a subscription service

Define the process in a written procedure

Train employees 18

Procedural Considerations

Doesn’t have to be stand alone procedure

Clearly define responsibilities—process owner(s)

Define how documents are identified—typically a master listing

Defined controls to stay current19

Electronic/paper or both?

Distribution-copyright laws?

20

Procedural Considerations

Linkage to Other ProcessesDesign Control—link inputs/outputs to standards

CE Marking—Technical file procedure should reference the use of harmonized standards—this is a MUST for ER Checklist

Management review—identify significant changes to regulations/quality system standards

21

Internal Audits—GD 210 for Canadian requirements?

Complaint handling/adverse event reporting and recalls—guidance docs for processing

Purchasing—reference to standards/regs on POs

Training—do employees need to be trained on specific documents?

22

Linkage to Other Processes

23

Practical Do’s and Don’ts

Practical Do’s and Don’ts

Let’s start with the Do’s:

Forget the “kitchen sink” mentality. Filter, filter, filter! Develop guidelines for inclusion/exclusion.

Recognize that some standards are the same but issued by different standards organizations.

24

Practical Do’s and Don’ts

Audit this part of your quality system

Make sure that the status of each standard is known-- current, withdrawn/obsolete, reference?

If a standard is not adopted in its entirety, document justification in appropriate records.

25

Practical Do’s and Don’ts

If You Choose to Use a Non-Current Standard:

Perform a risk assessment and document your findings (what has changed and what is the impact?)

May not fly for CE marked product. Reference to “state of the art” in the Directive.

26

Practical Do’s and Don’ts

Develop an easy to use external doc listing Document title (in full) Document number (if applicable) Document date/revision Document status

27

Recognize that some documents (IEC 60601-1, 3rd Edition) have a transition period and plan accordingly. Gap analysis is beneficial.

Maintain traceability in instances where standards are withdrawn/superceded. EN 540 replaced by EN 14155-1, -2, EN 868-1 replaced by EN ISO 11607-1.

Maintain non-current versions for historical purposes

28

Practical Do’s and Don’ts

And some Don’ts

Don’t pay for documents that aren’t copyrighted. You can download them from the internet. These include:

Regulations Most Guidance documents

Don’t forget to purchase amendments29

Practical Do’s and Don’ts

Don’t order more than one version of the same document. For example…

CAN/CSA-ISO 13485:2003 is identical to BS EN ISO 13485 is identical to EN ISO 13485.

Don’t automatically make standards current on your master list until you’ve had a chance to review and implement. (update procedures, employee training?)

30

Practical Do’s and Don’ts

Adequate control is not exercised in the identification and distribution of documents of external origin.  A review of the standards list found that many documents listed were outdated or not applicable to mitral valve devices.  

The organization has not implemented a written procedure that defines how documents or external origin are identified or controlled.

31

Actual Audit Nonconformities

Are You Current?

MEDDEV 2.12-1 rev 5 Vigilance Guidance effective 1/1/08. ANSI/AAMI/ISO 10993-6:2007 -- Biological evaluation of medical devices - Part 6: Tests for local effects after implantationANSI/AAMI/ISO 15223-1:2007 -- Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General Requirements

32

To Recap…

Give the process the attention it deserves. Shouldn’t be an afterthought. An effective process adds value to the organizationStay current! Know what’s on the horizonReview impact of new or revised standards Written procedure, not blurb in Quality ManualLinkage to other processes

33

Thanks for your attention. Questions?

Michelle Johnston, RACPrincipal/Owner

Advanced Quality System SolutionsVista, CA

858.722.4471 www.advqss.com

mjohnston@advqss.com34