Team-NB CoC checklist

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Lead auditor

• Auditor

• Prepared by

• Location
  Address

• Number of employees

Additional sites covered in this audit

• Additional Site Information

Opening

Auditee Name and function

• Name of auditee

• Function or position in the organisation

General

• Is a signed version of the CoC available

  Yes

  No

  N/A

• Is the staff aware of the CoC

  Yes

  No

  N/A

• Did the procedures have to be updated to apply the CoC into the quality system?

  Yes

  No

  N/A

Notified body meetings

• Did the organisation participate in the notified body meetings during the last two years?

  Yes

  No

  N/A

Additional Notes

Note

• Additional notes?

  Yes

  No

  N/A

Qualification of personnel

• What is the general procedure for the qualification of the personnel

• Does the organisation have assigned the qualified roles as given in the CoC

  Select QMS audtior Product assesor Product specialist

  • QMS audtior
  • Product assesor
  • Product specialist
Other qualification levels used

• When was the last requalification performed

  Date

• Is a responsible person assigned for the review of qualification, identify name and position

• What is the total number of QMS auditors

• What is the total number of product assesors

• What is the total number of Product specialists

Technological Qualification

• Is the technological qualification of the QMS Auditor based on the IAF Guide or comparable?

  Yes

  No

  N/A

• Is the technological qualification of the Product assessor based on the Subcategories e.g. MD0201?

  Yes

  No

  N/A

• Is the technological qualification of the Product specialist based on the Product subcategories of the NBOG and / or technologies such as EtO sterilisation?

  Yes

  No

  N/A

Special qualification

• Did the N.B. define special qualifications for the Auditors such as:

  Yes

  No

  N/A

• qualification criteria for auditing STERILE DEVICES

  Yes

  No

  N/A

• qualification criteria for auditing SOFTWARE

  Yes

  No

  N/A

Defined Deviations form criteria

• Does the organisation allow deviations from the qualification criteria

  Yes

  No

  N/A

• Is a list of all deviations available

  Yes

  No

  N/A

• Are deviations allowed for less than 10% of the qualified staff

  Yes

  No

  N/A

Roles during assessment

• Is the onsite audit performed by QMS auditor?

  Yes

  No

  N/A

• Is the onsite audit for product related technologies (e.g. sterilization) performed by a Product assessor

  Yes

  No

  N/A

• Are technical files reviewed by product assesors

  Yes

  No

  N/A

• Are design dossiers reviewed by product specialists

  Yes

  No

  N/A

Additional Notes

Note

• Additional notes?

  Yes

  No

  N/A

Audit performance / verification of records

• Is the onsite audit performed by QMS auditor

  Yes

  No

  N/A

• Is the onsite audit for product related technologies (e.g. sterilization) performed by a Product assessor

  Yes

  No

  N/A
Example audit

• Customer name

• Audit date

  Date

• In case of audits for products provided in a STERILE STATE, at least one auditor shall have a basic understanding of sterile device manufacturing

  Yes

  No

  N/A

• Is a qualified auditor for sterile products involved in the entire assessment program?

  Yes

  No

  N/A

• Does this include the initial audit?

  Yes

  No

  N/A

• Does this include the surveillance audit?

  Yes

  No

  N/A

• Does this include the re-certification audit?

  Yes

  No

  N/A

• Does this include the audit for major changes?

  Yes

  No

  N/A
Verified assessment programm

• Add media

  Media

• Is the principle of auditor rotation applied

  Yes

  No

  N/A

• No person was the lead auditor in a scheduled audit for more than 3 consecutive years.

  Yes

  No

  N/A

Technical file review / verification of records

• Are technical files reviewed by product assesors

  Yes

  No

  N/A
Example technical file

• Customer name

• Review date

  Date

• Product Assessor Name:

Design dossier evaluation / verification of records

• Are design dossiers reviewed by product specialists

  Yes

  No

  N/A
Example design dossier

• Customer name

• Review date

  Date

• Product specialist Name

Additional notes

Note

• Additional notes?

  Yes

  No

  N/A

QMS auditor entry requirements

• What is the procedure to allocate the auditor(s)?

  Yes

  No

  N/A

• Pick at least 3 samples of QMS auditors to verify the following:

Verified records for QMS auditor

• Auditor name

• Are qualification criteria based on IAF / EAC technology ( e.g. Code 14 Plastic and rubber products)?

  Yes

  No

  N/A

• BSc degree in relevant technology or equivalent ?

  Yes

  No

  N/A

• Minimum of 4 years working experience in the technology?

  Yes

  No

  N/A

• Is a master's degree or PhD used to substitute 1--3 years working experience?

  Yes

  No

  N/A

• Is regular auditing in the field. Of technology used to substitute work experience?

  Yes

  No

  N/A

• Does the total substitution not exceed 3 years?

  Yes

  No

  N/A

• Summarising remarks for audior' qualification:

QMS auditor trainings

• Pick at least 3 samples of QMS auditors to verify the following:

QMS Auditor

• Auditor name

• Did the basic training prior to qualification include the following:

  Yes

  No

  N/A

• 40 hours of ISO 9001 training?

  Yes

  No

  N/A

• For qualified ISO 9001 auditors: a minimum of at least 8 hours ISO 13485 training?g

  Yes

  No

  N/A

• 32 hours of medical device regulation training?

  Yes

  No

  N/A

• Yes

  No

  N/A

• Training in the N.B. procedures and quality system

  Yes

  No

  N/A

• A training program with trainee and or witnessed audits?

  Yes

  No

  N/A

• Is an employment with another N.B. used to replace this?

  Yes

  No

  N/A

QMS auditor qualification requirements

• Pick at least 3 samples of QMS auditors to verify the following:

• Auditor name

• Did the auditor at least through 1 fully observed audit have to sow his competence?

  Yes

  No

  N/A

• Are the persons witnessing senior in that field.

  Yes

  No

  N/A

Renewal of qualification

• Has the auditor performed at least 10 audit days in one year?

  Yes

  No

  N/A

• Was this substituted by a comparable number of working days in the area of medical devices?

  Yes

  No

  N/A

• Did the auditor at a minimum have 5 audit days averaged over 3 years?

  Yes

  No

  N/A

• Did the auditor receive a minimum of 8 hours training on regulatory and or the IO 13485?

  Yes

  No

  N/A

• Was the feedback from audits considered?

  Yes

  No

  N/A

• In cases were the auditor did not meet the requirements above was he witnessed prior to the requalification?

  Yes

  No

  N/A

• In cases where none of the above was met does the N.B. have an action plan?

  Yes

  No

  N/A

Additional notes

Notes

• Additional notes?

  Yes

  No

  N/A

Product assessor entry requirements

• What is the procedure to allocate the Product assessor

  Yes

  No

  N/A

• Pick at least 3 samples of product assessor to verify the following:

Product assessor

• Product assessor name

• Are qualification criteria based on second level NBOG code ( e.g. MD 0202 )?

  Yes

  No

  N/A

• In addition do horizontal technologies like sterilisation apply?

  Yes

  No

  N/A

• BSc degree in relevant technology or medical area?

  Yes

  No

  N/A

• Are Deviations from the above in justified in written?

  Yes

  No

  N/A

• Do deviations apply to a maximum of 10% of assessors?

  Yes

  No

  N/A

• Minimum of 4 years working experience with practical experience in the medical field in the technology?

  Yes

  No

  N/A

• Is a master's degree used to substitute 1 years working experience?

  Yes

  No

  N/A

• Is a PhD used to substitute 3 years working experience?

  Yes

  No

  N/A

• Is regular auditing in the field. Of technology used to substitute work experience?

  Yes

  No

  N/A

• Does the total substitution not exceed 3 years?

  Yes

  No

  N/A

Product assessor s trainings

• Pick at least 3 samples of product assessor to verify the following:

Product assessor

• product assessor name

• If not covered by QMS qualification did the training include the following:

  Yes

  No

  N/A

• 32 hours of training in medical devices, MDD, regulatory requirements?

  Yes

  No

  N/A

• Additional time used for additional directives?

  Yes

  No

  N/A

• For IVDD annex II list A products did the training include manufacturers batch release?

  Yes

  No

  N/A

• Is an employment with another N.B. used to replace this?

  Yes

  No

  N/A

• Has the assessor been trained to the N.B.'s procedures and quality system?

  Yes

  No

  N/A

• Has a training plan been set up for the individual assessor?

  Yes

  No

  N/A

• Does the training plan include sufficient number of technical file reviews witnessed or peer reviewed?

  Yes

  No

  N/A

• Did the training assure that the assessor is trained to perform the technical file reviews?

  Yes

  No

  N/A

• How was the effectiveness of the training evaluated?

  Yes

  No

  N/A

• Did the assessor receive audit training for the product categories and training on how to apply the product requirements in an audit?

  Yes

  No

  N/A

• Was the product training given in form of:

  Yes

  No

  N/A

• Training to standards?

  Yes

  No

  N/A

• Training to product or product technology?

  Yes

  No

  N/A

• Training to clinical indications?

  Yes

  No

  N/A

Product assessor Qualification requirements

• Did the assessor have to complete 3 technical file reviews successfully?

  Yes

  No

  N/A

• Was this substituted by a comparable number of working days in the area of medical devices?

  Yes

  No

  N/A

• Did the auditor at a minimum have 5 audit days averaged over 3 years?

  Yes

  No

  N/A

• Did the auditor receive a minimum of 8 hours training on regulatory and or the IO 13485?

  Yes

  No

  N/A

• Was the feedback from audits considered?

  Yes

  No

  N/A

• In cases were the auditor did not meet the requirements above was he witnessed prior to the requalification?

  Yes

  No

  N/A

• In cases where none of the above was met does the N.B. have an action plan?

  Yes

  No

  N/A

Product assessor Renewal of Qualification

• Did the assessor review 5 technical file reviews within 1 year? (As an average in 3 years period)

  Yes

  No

  N/A

• If significant changes were reviewed they count for 50%.

  Yes

  No

  N/A

• 50% of the reviews may be replaced by design dossier reviews.

  Yes

  No

  N/A

• Did the auditor receive ongoing training on regulatory such as directives, CTS, standards, MEDDEVs etc.?

  Yes

  No

  N/A

• In cases were the assessors qualification was not met / suspended was the first review witnessed prior to the requalification and the requalification confirmed by the certification management?

  Yes

  No

  N/A

• Did the N.B. review the renewal on an annual basis?

  Yes

  No

  N/A

Additional notes

Note

• Additional notes?

  Yes

  No

  N/A

Product specialist entry requirements

• Pick at least 3 samples of product assessor to verify the following:

Product specialist

• Product specialist name

• Are qualification criteria based on second level NBOG code ( e.g. MD 0202 )?

  Yes

  No

  N/A

• In addition do horizontal technologies like sterilisation apply?

  Yes

  No

  N/A

• BSc degree in relevant technology or medical area?

  Yes

  No

  N/A

• Are Deviations from the above in justified in written?

  Yes

  No

  N/A

• Do deviations apply to a maximum of 10% of assessors?

  Yes

  No

  N/A

• Minimum of 4 years working experience with practical experience in the medical field in the technology?

  Yes

  No

  N/A

• Is half of the working experience in R&D, production or quality control? Or in a Hospital or with a Notified Body?

  Yes

  No

  N/A

• Minimum of 4 years working experience with practical experience in the medical field in the technology?

  Yes

  No

  N/A

• Is a master's degree used to substitute 1 years working experience?

  Yes

  No

  N/A

• Is a PhD used to substitute 3 years working experience?

  Yes

  No

  N/A

• Is regular auditing in the field. Of technology used to substitute work experience?

  Yes

  No

  N/A

• Does the total substitution not exceed 3 years?

  Yes

  No

  N/A

Product specialist trainings

• Pick at least 3 samples of product specialist to verify the following:

• product specialist name

• If not covered by QMS qualification did the training include the following:

  Yes

  No

  N/A

• 4 days of training in medical devices, MDD, regulatory requirements?

  Yes

  No

  N/A

• Additional time used for additional directives?

  Yes

  No

  N/A

• Was a training plan prepared to obtain adequate training in the relevant N.B. procedures?

  Yes

  No

  N/A

• We're design dossier reviews witnessed or peer reviewed before doing independent reviews?

  Yes

  No

  N/A

• We're trainings performed for each product category for which qualification is sought?

  Yes

  No

  N/A

Product specialist qualification requirements

• Has the product specialist performed 4 reviews of design dossiers for the initial category?

  Yes

  No

  N/A

• Were at least 2 of 4 initial application or significant extensions?

  Yes

  No

  N/A

Product specialist Renewal of Qualification

• Did the assessor review 3 design dossier reviews within 1 year? (As an average in 3 years period)

  Yes

  No

  N/A

• If significant changes were reviewed they count for 50%.

  Yes

  No

  N/A

• Did the product specialist receive ongoing state of the art product knowledge / review experience?

  Yes

  No

  N/A

• Did the product specialist receive ongoing training on regulatory such as directives, CTS, standards, MEDDEVs etc.?

  Yes

  No

  N/A

• In cases were the product specialist qualification was not met / suspended was the first review witnessed prior to the requalification and the requalification confirmed by the certification management?

  Yes

  No

  N/A

• Did the N.B. review the renewal on an annual basis?

  Yes

  No

  N/A

Additional Notes

Note

• Additional note?

  Yes

  No

  N/A

Audit time

• Does the organisation have a procedure for determining the amount of time for the audit

  Yes

  No

  N/A

• Name of the procedure

• Does the procedure access the various kinds of audits such as stage 1 , stage 2 initial audit, surveillance and re-certification audits

  Yes

  No

  N/A

• Does the organisation calculate the time for file reviews separately

  Yes

  No

  N/A

Audit duration

• Are off-site times calculated separately

  Yes

  No

  N/A

• Is the IAF MD9:2011 used as a basis for the calculation

  Yes

  No

  N/A

• Is the calculation based on the effective number of personal (FTE).

  Yes

  No

  N/A

• Is at least 80% of the calculated time spent on-site

  Yes

  No

  N/A

• Are auditor days calculated with 8 hours?

  Yes

  No

  N/A

• Was an extension of an audit day for up to 10 hours used?

  Yes

  No

  N/A

• Is the calculation based on the effective number of personal (FTE).

  Yes

  No

  N/A

Factors for increase of audit duration

• Several directives / assessment routes/ significant number of certificates
  
  Audit scope including class III, list A, DMIA devices
  
  More than 3 NBOG categories
  
  + 10%

• Use of suppliers critical to the function of the device
  
  Installation of products on customer's premises
  
  In house sterilisation
  
  +0,5 days

• Poor regulatory compliance in previous assessments
  
  + 10-30 %

• Staff speaking more than one language requiring interpreter
  
  Very large site for the number of employees
  
  Highly complex processes
  
  + 10 %

Reduction of audit time

• No design activity
  
  Only low risk products or simple manufacturing
  
  Client preparedness e.g. Existing certification for 13485
  
  Combined audit of at least 2 integrated systems
  
  Low complexity / process involves a single generic activity
  
  Identical activities on each shift
  
  Significant proportion of the staff carries out a similar function
  
  A number of people work "off location" sales person, driver, service personnel
  
  -15%

• Maturity of the management system ( certified for more than 3 years)
  
  - 20%

• Outsourcing most of the manufacturing activities
  
  -30%

• Examples for audit duration calculation

Audit duration calculation

• Was the adjustment of the audit duration taking account of the above factors?

  Yes

  No

  N/A

• Was the overall audit duration at least at 70% of the IAF Guide?

  Yes

  No

  N/A

• Is the minimum audit time at least 1 day?

  Yes

  No

  N/A

Additional notes

• Additional notes?notes

  Yes

  No

  N/A

Unannounced Inspections

• Is a procedure in place for unannounced audits?

  Yes

  No

  N/A

Sampling plan for technical files

• What is the procedure for the sampling of technical files

  Yes

  No

  N/A

• Is the plan based on NBOG 2009-4 and UMDNS/GMDN?

  Yes

  No

  N/A

• Is a sampling plan issued for each customer?

  Yes

  No

  N/A

• Does the plan include the class I measuring function / sterile products?

  Yes

  No

  N/A

• Is the time spent for reviews following the approach:<br>Min 4 hours for low level of complexity<br>Min 8 hours for high level of complexity

  Yes

  No

  N/A

• Comments:

Subcontracting

• Does the organisation have a policy for subcontracting?

  Yes

  No

  N/A

• Are qualification criteria described for the selection of experts and assessors?

  Yes

  No

  N/A

• Are the criteria identical to those of the employees?

  Yes

  No

  N/A

• Are contracts available?

  Yes

  No

  N/A

• Are aspects such as:<br>- conflict of interest<br>- confidentiality<br>- competence and experience <br>Part of the contract?

  Yes

  No

  N/A

• Are records for qualification and training available?

  Yes

  No

  N/A

Findings

Audit finding

• Finding:

• Classification

  Select remark observation non-conformity

  • remark
  • observation
  • non-conformity