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ISO 13485 Audit Checklist

June 1st, 2012

Review of customer requirements / customer communication

Do you have a documented procedure for how you handle customer related process?
If so what is the number and revision
(review the procedure and all its contents how the procedure is followed)
How are product specifications communicated from customer?
Show me any two product specifications as example
How are delivery and post delivery activities communicated from customer?
Show me any two examples one from Q2 2008 and Q3 2008
Are there any additional requirements determined by you? validation / calibration / out sourcing / test fixtures or gauges / etc…
If so what are they and how are they planned for ?
How do you receive an order from customer
How do you review and assess that all the product requirements are defined / resolved
Do you commit in advance the acceptance of the order and terms
If so, show 2 examples of order acceptance. (Q2, Q3 2008)
However what is your method to determine that requirements can be met ?
Can I see records of any review and actions thereof (examples any 2)
Do you receive any verbal or telephonic orders / amendments
If so, How do you  communicate this to customer before acceptance (examples)
How do you receive any changes to an order from customer
What is the process of internal review , acceptance, internal and customer communication of the changes to the order (examples)
 

Competency, Awareness & Training of Human Resources

Do you have a documented procedure for Human resources?
If so what is the number and revision
(Review the procedure and all its contents how the procedure is followed)
How have you determined the necessary competencies for personnel performing work affecting product quality?
Is training provided or other actions taken to satisfy these needs?
If so show me the training records (2 examples )
How do you evaluate the effectiveness of action taken?
How do you ensure that the concerned personnel aware of the relevance and importance of their activities and how that effects the company objectives ?
Show me the records of education , training, skills & experience (any 2 example)
Infrastructure / Work Environment and Maintenance

Do you have a documented procedure for Infrastructure / work environment & Maintenance?
If so what is the number and revision
(Review the procedure and all its contents how the procedure is followed)
How have you determined the infrastructure needed to achieve  conformity to product requirements , which should include
Buildings, workspace & associated utilities
Process Equipment (both hardware & software)
Supporting services (such as transportation & communication)
Show me the records of requirements for Maintenance activities and their frequency documented and recorded?
How is the work environment needed to achieve conformity to product requirements managed?
If contact between personnel and product or environment could adversely affect the quality of product. What are the established documents for health, cleanliness and clothing of personnel?
Does the work environment condition have an adverse effect on the product quality?
If so,
show me the documented requirement for the work environment conditions
Documented procedure or work instructions to monitor & control these work environment conditions.
How the personnel are trained who are working under special environmental condition?

Product realization planning

Have you an established documented procedure for how product realization will be planned?
If so what is the number and revision
(review the procedure and all its contents how the procedure is followed)
Do you have a quality plan , or any similar plan to state how a customer product will be realized by you considering all stages.
Review the plan for inclusion of all stages until delivery and any post delivery ?
Have you identified any special processes in the product realization plan ?
Where is it documented ? please show
What is the arrangement made to define criteria for review and approval of such special process
Please show the records of validation per arrangements made.  (Review the results)
How are results of validation translated into production processes ?
Show examples …
Do you use any computer software in the production parts meeting to specified requirements ? (testing / calibrating / manufacturing process / etc ..)
Have you established a documented procedure for such process software validation ?
Can I see records of such validation per the procedure ?
How are products released to customer ? is it documented ? authorization to verify batch records and release (check examples of batch record release that is authorized)

Design & Development Process & Design Outputs

What is the documented procedure for Design & development?
Show me the Plan & control for Design & Development, which defines the following aspects:
Design & development stages
Review, verification, validation & design transfer process
Responsibilities & authorities
How do you ensure there is effective communication between different groups involved in design & development?
Show me the documented planning output. Also explain how is it updated?
Show me the records of inputs related to product requirement, which should  include:
Functional, performance & safety requirements , according to the intended use
Applicable statutory & regulatory requirements
Information derived from previous similar designs(If applicable)
Other requirements essential for design & development
Output of risk management
Review and approve responsibility (examples)
In what form is the Design & development output provided?
Is it approved prior to release? show me
Does your Design & development output:
Meet the input requirements for design & development
Provide appropriate information for Purchasing , production & service provision
Reference Product acceptance criteria
Specify characteristics of the product essential for its safe & proper use
Show me the records of Design & development output.
What is the method to review design & development at suitable stages?
Show me the records of review
What us the method of Verification?
Show me the records of verification.
How is the design & development validation performed?
Show me the records of verification. Performed
How are the changes identified in Design & development?
How the changes are reviewed, verified & validated?
Show me the records of review of changes.

Purchasing Process & Purchasing Information

Show me the documented procedure for Purchasing?
What are the criteria for selecting & evaluating the Supplier?
What are the criteria for re-evaluation?
Show me the records for all
Show me the  Purchasing information  which describe the product to be purchased, including the following::
Requirements for approval of product, procedures, processes & equipment
Requirement for qualification of personnel, and
Quality management system requirements 
Show me the records maintained
How do you ensure the adequacy of specified purchase requirements? Who does it?

Out sourced process control

Do you out source any process in your product realization ?
Have they been identified in your quality management system? Show me where ?
And the controls exercised on such processes ? Show me how ?

Example:
An established ISO 13485 / 9001 QMS valid certification
Vendor identification procedure
Identification and traceability of products (see a separate audit section on this)
Product release (Batch record authorization)
Your procedure for any change reporting
Your procedure for any problem reporting
Product packaging (see a separate audit section on this)

Production Process

Show me the plan to carry out production process.
Is the product characteristic defined? Show me
The work instructions, as necessary are made available? (Show me 2 examples)
Are suitable equipments used?
Are monitoring & measuring devices made available?
How are the activities monitored & measured?
How is the release & delivery of products / services ensured?
What is the method for labeling & packaging? Product identification and product traceability

What is your documented procedure to product identification and traceability ?
(review the procedure and all its contents how the procedure is followed)
Does the procedure address the records required to define the extent of traceability?
Check with examples from final stage backwards to components
Is the identification at all stages available?
Is the status of the product with regard to test result clear in identification?
Check and record at all test stages for good / bad parts identification
How are NC parts / products identified
How is traceability maintained from product stage to all component identification?
How is the final product identified which is ready to pack?
How do you identify returned devices from conforming products?
Does the procedure address this aspect?

Inward Goods Inspection Process

How do you ensure that the purchased products meet specified purchase requirements?
Is the product verification done at the supplier’s premises? If so show the verification arrangements and method of product release in the purchase information identified.
Show records of the verification maintained?

Calibration Process

How do you determine the required monitoring & measuring devices?
Show me the documented procedure.
Are test equipments calibrated at regular intervals? (Show me 2 examples?)
How are the measuring equipments identified?
How is the calibration status identified?
How is it ensured that measuring equipments are protected from damage during handling & maintenance?
Show me documented results of calibration & verification 
 How is the ability of computer software which satisfies the intended application in monitoring & measuring of specified requirements confirmed?
Testing of products to requirements

Do you have documented procedure for the monitoring and measurement of the product?
(review the procedure and all its contents how the procedure is followed)
Have the stages been identified in the product realization process where testing will be carried out?
Does the established test plan verify all the characteristics of the product? please show how ?
Show me records of final testing and approval for any 5 batches cases in Q2 and Q3 2008
Who is the authority designated to approve and release in these reports?
Is this authority documented?

Stores & Preservation Process

Show me the established documented procedure for Identification
How is product identified throughout the process?
(In Production, storage, rejected parts storage areas, etc)
Are special storage conditions defined and recorded?
Are procedures defined for the control of products in stock?
(Especially for products with a limited shelf life or requiring special storage condition)

Packaging and dispatch process

Do you have documented procedure or work instructions for packaging and delivery?
(review the procedure and all its contents how the procedure is followed)
Who is the person responsible for packaging ?
What are the inputs that are required for packaging ?
Are any labels affixed at the packaging stage ?

Control of Non-conforming products

What is the documented procedure for the control of nonconforming products ?
(review the procedure and all its contents how the procedure is followed)
Does the procedure address :
Authorization of concessions
Regulatory check on concession
Re verification on corrected product to be meeting to the product requirement
Review of any 3 concessions recorded in year 2008. Have documented rework procedures been established ?
Do they have same authorization as the original work instructions ?
Records of determination of adverse effects before approval of rework.
Look for adverse effect determination and authorization …
Customer Complaints Handling

Show the records of all customer  complaint investigations maintained
Is there any activity outside the organization contributed to the customer complaint? If so show me the relevant information exchanged between the organizations involved.
Is there any complaint not followed by corrective and/or preventive action? If so, show me the reasons authorized and recorded.

Corrective & Preventive Corrections On Supplier & Internal Non-conformance

What are the actions taken to eliminate the cause of non-conformities to prevent recurrence?
 (Corrective Actions taken are appropriate to the effects of non-conformities )
Show me the documented procedure for each of the following requirements:
Reviewing non conformities (including customer complaints)
Determining the causes of non-conformities
Evaluating the need for action to ensure that non-conformities do not occur
Determining and implementing action needed and updated documents.
Records of the results of any investigation and of action taken (Show 2 examples)
What are the actions taken to eliminate the cause of potential non-conformities to prevent recurrence?
(Preventive Actions taken are appropriate to the effects of non-conformities )
Show me the documented procedure for each of the following requirements:
Determining potential non-conformities and their causes
Evaluating the need for action to prevent occurrence of non-conformities.
Determining & implementing the action needed
Records of the results of any investigation & of action taken.
Reviewing preventive action taken & its effectiveness.

TECHNICAL FILES / MDD REQUIREMENTS / PRODUCT REGISTRATION ACTIVITY WITH EU AUTHORITY

Is for each medical device model or type included in the scope a file in place and do those files contain all product specifications & quality system requirements?
Does these technical files define the complete manufacturing & if applicable, installation & servicing process of the related device?
How do you ensure, which medical devices will be sold
Into the EU union
Canadian Market

Review of the Product labeling & Product Information + language Information

Do you have the documented procedure for labeling requirements?
Does the label sets out the following information:
Name of the device
The name & address of the manufacturer
Any special storage conditions applicable to the device
 
Documentation Requirements

Show me the documented statement of a quality policy & Quality Objectives
Show me the Quality Manual
Show me the Documented procedures required by International Standard.ISO 9001:2000/13485:3003
Show me the documents where you ensure the effective planning. Operation & control of the processes.
Show me the records required by this international Standard.
How the activities are implemented & maintained, which is specified to be documented in International standard
Show me the documents where you define the complete manufacturing process.
Show me the Quality Manual which includes:
The scope of the QMS, including details of and justification for any exclusion and /or non-application.
The documented procedures established for the QMS, or reference to them.
A description of the interaction of the processes of the QMS
Where do you outline the structure of the documentation used in the QMS?

Control of documents and records

What is the documented procedure for :
Control of documents
Control of records
What is the revision number and approval , release of these procedures ?
(review the procedure and all its contents how the procedure is followed)
Review and approve responsibility (examples)
Update and reapprove responsibility (examples)
Identification of current version in use and changes identification method (examples)
Legible and readily identifiable (examples)
Method of External origin docuements identification and distribution control (examples)
Identification and location of obsolete documents (examples)
Retention of obsolete documents for lifetime / considering regulatory requirement

Method of :
Identification
Storage
Protection
Retrieval
Retention time
Established for records
Are records legible and tamper proof ? (examples)
Records retention time declared in the documented procedure ?
Does it meet the standard + life time + customer requirement + regulatory requirement
(examples)

MR Office Functions: Management Review / Internal Audits / Internal Communications

Do you have documented procedure for the Management review process?
(review the procedure and all its contents how the procedure is followed)
Is the review done at planned intervals to ensure its continuing stability, adequacy & effectiveness?
What are the assessments done during the review?
Show me the Management Review report
Does the input of management review includes:
Results of audits
Customer feedback
Process performance & product conformity
Status of preventive & corrective actions
Follow up actions from previous management reviews
Changes that could affect the QMS
Recommendations for improvement
New or revised regulatory requirements.
Does the output of management review includes any decisions & actions related to
Improvements needed to maintain the effectiveness of the QMS & its processes
Improvement of product related to customer requirements
Resource needs
Show me  the documented procedure for
Internal Audit
What is the revision number and approval , release of these procedures ?
(review the procedure and all its contents how the procedure is followed)
Are internal audits conducted at regular intervals?
Explain how effectively is implemented & maintained.
Show me the planned  audit programme , which should consider
Status & importance of the processes & areas to be audited
The audit criteria, scope , frequency & methods defined
Auditors have audited their own work
How is the follow up activities done to eliminate the detected non-conformities?
Show me the reports of verification results