ISO 13485 2015 Translated into Plain English

ISO FDIS 13485 2015 is the "Final Draft" of the new quality management standard.
However, in spite of what it's called, the FDIS version is not actually the final standard.
Minor clerical changes are still permitted and certainly will be made but no further technical
changes will be allowed. Once these minor changes are made, the final official standard
will be published (which, according to ISO, should be in January or February of 2016).

4. Systemic requirements

4.1 Organizational requirements

4.1.1 Develop a QMS.

  Establish your quality management system (QMS).

  Document your organization's quality management system.

  Maintain the effectiveness of your quality management system.

  Establish your QMS documentation requirements.

  Identify the documents that regulators expect you to maintain.

  Identify the medical device regulations that apply to your organization.

  Identify the roles that medical device regulators expect you to perform.

  Identify the documents that ISO 13485 expects you to maintain.

  Identity the procedures that ISO 13485 expects you to document.

  Identity the activities that ISO 13485 expects you to document.

  Identity the arrangements that ISO 13485 expects you to document.

  Identity the requirements that ISO 13485 expects you to document.

4.1.2 Clarify structure.

  Consider the roles that regulators expect you to perform.

  Determine the processes that your organization's QMS needs.

  Clarify how QMS processes are applied throughout your organization.

  Specify how your organization's processes are interconnected.

  Use a risk based approach to control your organization's QMS processes.

4.1.3 Support processes.

  Support each QMS process.

  Support QMS process operations.

  Support QMS process monitoring.

  Support QMS process measuring.

  Support QMS process analysis.

  Support QMS process record keeping.

4.1.4 Manage changes.

  Manage your QMS processes.

  Comply with ISO 13485 process management requirements.

  Manage changes to your organization's QMS processes.

  Comply with regulatory process management requirements.

  Comply with regulatory change control requirements.

4.1.5 Control outsourcing.

  Monitor outsourced processes that affect product conformity.

  Control the outsourced processes that affect product conformity.

  Retain responsibility for processes that affect product conformity.

4.1.6 Validate software.

  Develop procedures to validate and revalidate your QMS software.

  Develop an approach that is proportionate to the risk that is being taken.

  Use your procedures to validate and revalidate software applications.

  Validate computer software applications for their intended use.

  Validate software whenever its intended use changes (as appropriate).

  Maintain a record of your software validation and revalidation activities.

4.2 Documentation requirements

4.2.1 Manage information.

  Include all required documents and records.

  Include the documents and records that regulations require.

  Include the documents and records that ISO 13485 requires.

  Include the documents and records that your organization requires.

4.2.2 Prepare manual.

  Prepare a quality manual for your QMS.

  Define the scope of your organization's QMS.

  Outline the structure of your QMS documentation.

  Include your QMS procedures or refer to them.

  Describe how your QMS processes interact.

4.2.3 Establish files.

  Establish a file for each medical device type or each family of medical devices.

  Include or reference documents showing that you comply with regulations.

  Include or reference documents showing that you comply with ISO 13485.

  Maintain a file for each medical device type or each family of medical devices.

  Include documents for each medical device type or family of medical devices.

  Include a description of each medical device type or medical device family.

  Include procedures for medical device types or medical device families.

  Include specifications or procedures for medical device types or families.

  Include records for medical device types or medical device families.

4.2.4 Control documents.

  Establish a procedure to control QMS documents.

  Document your QMS document control procedure.

  Implement your QMS document control procedure.

  Control your organization's QMS documents.

  Review and approve documents before you issue them.

  Provide the correct version of documents at points of use.

  Protect the identity and legibility of your QMS documents.

  Identify and control the distribution of external QMS documents.

  Prevent the unintended or inadvertent use of obsolete documents.

  Preserve obsolete documents for future reference and use.

4.2.5 Maintain records.

  Establish records for your organization's QMS.

  Develop procedures to control QMS records.

  Document your record control procedures.

  Implement your record control procedures.

  Define methods to protect QMS health records.

5. Management requirements

5.1 Commitment requirements.

  Demonstrate your ongoing commitment.

  Support the development of your QMS.

  Support the implementation of your QMS.

  Support the maintenance of your QMS.

5.2 External requirements.

  Ensure that external requirements are determined.

  Ensure that external requirements are being met.

5.3 Policy requirements.

  Plan your quality policy.

  Draft your quality policy.

  Apply your quality policy.

  Review your quality policy.

5.4 Planning requirements

5.4.1 Establish quality objectives.

  Establish quality objectives for your organization.

  Set objectives needed to meet product requirements.

  Set objectives needed to meet regulatory requirements.

5.4.2 Carry out quality planning.

  Plan how you're going to develop your QMS.

  Plan how you're going to document your QMS.

  Plan how you're going to structure your QMS.

  Plan how you're going to manage your QMS.

  Plan how you're going to monitor your QMS.

  Plan how you're going to control your QMS.

  Plan how you're going to implement your QMS.

  Plan how you're going to maintain your QMS.

5.5 Managerial requirements

5.5.1 Clarify responsibility and authority.

  Define QMS responsibilities and authorities.

  Document QMS responsibilities and authorities.

  Document how QMS personnel are interrelated.

5.5.2 Appoint management representative.

  Appoint a member of management to oversee your QMS.

  Give management representative authority and responsibility.

  Assign authority and responsibility for documenting your QMS.

  Assign authority and responsibility for reporting to top management.

  Assign authority and responsibility for promoting corporate awareness.

5.5.3 Establish internal communications.

  Establish appropriate internal communication processes.

  Encourage communication about the effectiveness of your QMS.

5.6 Review requirements

5.6.1 Perform regular management reviews.

  Establish management review procedures.

  Schedule your reviews at planned intervals.

  Review your QMS at planned intervals.

  Keep a record of management reviews.

5.6.2 Study management review inputs.

  Study information about your QMS (inputs).

  Review previous management reviews.

  Review the results of previous audits.

  Review your complaint handling activities.

  Review monitoring and measurement activities.

  Review new or revised regulatory requirements.

  Review previous corrective and preventive actions.

  Review recommendations for improvement.

  Review changes that could affect the QMS.

5.6.3 Generate management review outputs.

  Generate your management review outputs.

  Generate decisions and actions to improve your QMS.

  Generate decisions and actions to enhance your products.

  Generate decisions and actions to deal with regulatory changes.

  Generate decisions and actions to address relevant resource needs.

  Establish a record of your management reviews.

6. Resource requirements

6.1 Allocation requirements.

  Determine the resources that your QMS needs.

  Provide the resources that your QMS needs.

  Provide the resources needed to implement your QMS.

  Provide the resources needed to meet regulatory requirements.

  Provide the resources needed to meet customer requirements.

6.2 Personnel requirements

  Identify personnel and examine work that could affect product quality.

  Establish a process to manage the competence of medical device workers.

  Use your process to manage the competence of your medical device workers.

  Select suitable methods for evaluating your training and awareness activities.

  Maintain records that document the competence of medical device workers.

6.3 Infrastructure requirements

  Document QMS infrastructure requirements.

  Provide the infrastructure that your QMS needs.

  Identify maintenance activities that could affect quality.

  Maintain the infrastructure that your QMS needs to have.

6.4 Environmental requirements

6.4.1 Control your working conditions.

  Identify the work environment needed to meet product requirements.

  Document your organization's requirements for this work environment.

  Identify the working conditions that influence the quality of your products.

  Document your organization's requirements for these working conditions.

  Document procedures to monitor and control these working conditions.

  Identify personnel who could affect medical device safety or performance.

  Identify those who come into contact with products or related environments.

  Establish health, cleanliness, and clothing requirements for these personnel.

  Control those who work temporarily under special environmental conditions.

6.4.2 Plan your contamination controls.

  Plan how you're going to control products that are or may be contaminated.

  Plan how you're going to control the contamination of sterile medical devices.

7. Realization requirements

7.1 Planning requirements.

  Plan the processes that are needed to realize products.

  Develop the processes that you need to realize products.

  Develop a risk management process for product realization.

  Plan how you're going to realize each product.

  Formulate quality objectives for your product.

  Clarify specific product realization requirements.

  Generate product realization planning outputs.

  Establish records of product realization activities.

7.2 Customer requirements

7.2.1 Determine product requirements.

  Clarify your product requirements.

  Identify requirements specified by your customers.

  Identify requirements dictated by your product's intended use.

  Identify requirements imposed by your regulatory bodies.

  Identify requirements defined by your organization.

7.2.2 Review your product requirements.

  Evaluate product requirements before you accept orders.

  Review product requirements before you supply products.

  Verify product requirements before you agree to accept orders.

  Confirm that product requirements can be met before you proceed.

  Maintain a record of your product requirement reviews.

7.2.3 Communicate product requirements.

  Plan arrangements to communicate with customers.

  Document your customer communication arrangements.

  Implement your customer communication arrangements.

  Maintain your customer communication arrangements.

  Establish arrangements to communicate with regulatory authorities.

  Use your arrangements to communicate with regulatory authorities.

7.3 Development requirements

7.3.1 Prepare design and development procedures.

  Establish procedures for design and development.

  Document procedures for design and development.

7.3.2 Organize design and development activities.

  Plan the design and development of your products.

  Document your product design and development plans.

  Maintain your design and development planning documents.

  Control the design and development of your products.

7.3.3 Determine design and development inputs.

  Determine product design and development inputs.

  Review your product design and development inputs.

  Approve your product design and development inputs.

  Maintain a record of design and development inputs.

7.3.4 Generate design and development outputs.

  Generate suitable design and development outputs.

  Verify your product design and development outputs.

  Approve your product design and development outputs.

  Maintain records of design and development outputs.

7.3.5 Carry out design and development reviews.

  Plan your organization's design and development reviews.

  Perform reviews in accordance with planned arrangements.

  Maintain records of your design and development reviews.

7.3.6 Perform design and development verifications.

  Plan your design and development verification activities.

  Document your design and development verification plans.

  Perform verifications in accordance with planned arrangements.

  Keep records of your design and development verification activities.

7.3.7 Conduct design and development validations.

  Plan your organization's design and development validation activities.

  Document your organization's design and development validation plans.

  Perform validations in accordance with your planned arrangements.

  Keep records of design and development validation activities.

7.3.8 Manage design and development transfers.

  Develop procedures to control design and development transfers.

  Use your procedures to control design and development transfers.

  Record design and development transfer results and conclusions.

7.3.9 Control design and development changes.

  Establish procedures to control design and development changes.

  Use your procedures to control design and development changes.

  Maintain a record of medical device design and development changes.

7.3.10 Maintain design and development files.

  Maintain a design and development file for each family of medical devices.

  Include or reference records that document compliance and changes.

7.4 Purchasing requirements

7.4.1 Establish purchasing process.

  Establish procedures to control product purchases.

  Establish supplier evaluation and selection criteria.

  Establish supplier monitoring and re-evaluation plans.

  Monitor the performance of your organization's suppliers.

Take action whenever suppliers fail to meet purchasing requirements.

  Establish supplier evaluation, selection, and monitoring records.

7.4.2 Clarify purchasing information.

  Plan your organization's product purchases.

  Review purchase requirements before sharing them.

  Maintain your organization's purchasing documents and records.

7.4.3 Verify purchased products.

  Develop methods and activities to verify purchased products.

  Make arrangements to verify the products you plan to purchase.

  Verify that your purchased products meet purchase requirements.

  Consider what to do when changes are made to purchased products.

  Establish and maintain a record of purchased product verifications.

7.5 Production requirements

7.5.1 Control medical device production and service provision.

  Plan your production and service provision activities.

  Carry out production and service provision activities.

  Monitor production and service provision activities.

  Control production and service provision activities.

7.5.2 Define requirements for cleanliness or contamination controls.

  Identify products that you clean prior to sterilization or use.

  Document and maintain your cleanliness or contamination control
requirements for products that you clean prior to sterilization or use.

  Identify products that cannot be cleaned prior to sterilization or use.

  Document and maintain your cleanliness or contamination control
requirements for products that can't be cleaned prior to sterilization or use.

  Identify products supplied non-sterile to be cleaned before sterilization or use.

  Document and maintain cleanliness or contamination control requirements
for products supplied non-sterile to be cleaned before sterilization or use.

  Identify products that must be clean when used but are supplied non-sterile.

  Document and maintain cleanliness or contamination control requirements
for products that must be clean when used but are supplied non-sterile.

  Identify process agents that must be removed from product during manufacture.

  Document and maintain cleanliness or contamination control requirements
for process agents that must be removed from products during manufacture.

7.5.3 Specify product installation and verification requirements.

  Establish medical device installation requirements.

  Document your medical device installation requirements.

  Establish medical device installation verification requirements.

  Document your organization's installation verification requirements.

7.5.4 Develop servicing procedures and reference materials.

  Establish medical device servicing procedures and reference materials.

  Document your medical device servicing procedures and reference materials.

  Use your procedures and materials to control medical device servicing activities.

  Maintain a record of your organization's medical device servicing activities.

  Identify improvement opportunities and servicing complaints.

7.5.5 Maintain a record of sterilization process parameters.

  Establish a record of your organization's sterilization process parameters.

  Record sterilization process parameters for each batch of medical devices.

7.5.6 Validate processes used for production and service provision.

  Identify processes that generate outputs that are not or cannot be
verified by subsequent monitoring and measurement until it's too late.

  Establish procedures to validate production and service delivery processes
and software applications that could affect your products and services.

  Validate processes and software applications that could generate
output deficiencies and could affect your products and services.

7.5.7 Validate processes for sterilization and sterile barrier systems.

  Document procedures used to validate processes
for sterilization and sterile barrier systems.

  Establish procedures used to validate processes
for sterilization and sterile barrier systems.

  Implement procedures used to validate processes
for sterilization and sterile barrier systems.

  Maintain procedures used to validate processes
for sterilization and sterile barrier systems.

7.5.8 Preserve product identity throughout product realization.

  Prepare procedures and systems to control the identity of medical devices.

  Document your organization's product identification systems and procedures.

  Implement your organization's product identification systems and procedures.

7.5.9 Establish suitable traceability procedures and records.

7.5.9.1 Establish suitable product traceability procedures.

  Establish your product traceability procedures.

  Implement your product traceability procedures.

  Maintain your product traceability procedures.

7.5.9.2 Establish suitable records for implantable devices.

  Establish your traceability records for implantable medical devices.

  Expect suppliers of distribution services to have distribution records.

7.5.10 Protect property supplied for medical devices by customers.

  Identify property supplied by customers to be used by medical devices.

  Verify property supplied by customers to be used by your medical devices.

  Safeguard property supplied by customers to be used by medical devices.

  Maintain a record of customer property that is lost, damaged, or unsuitable.

  Report lost, damaged, or unsuitable customer property to your customers.

7.5.11 Preserve medical device products and components.

  Establish procedures to preserve the conformity of products.

  Document and maintain your product preservation procedures.

  Use your procedures to preserve the conformity of products.

  Prevent medical device damage, alteration, and contamination.

  Protect products when exposed to hazards and expected conditions.

7.6 Measurement requirements

  Identify monitoring and measurement requirements.

  Select suitable monitoring and measurement equipment.

  Establish your monitoring and measurement procedures.

  Prepare your calibration and verification plans and procedures.

  Protect your organization's monitoring and measurement equipment.

  Develop monitoring and measurement software validation procedures.

8. Remedial requirements

8.1 Planning requirements

  Plan monitoring, measurement, and analytical processes.

  Plan how monitoring methods will be used ensure conformity and effectiveness.

  Plan how measurement will be used to ensure conformity and effectiveness.

  Plan how analytics will be used to ensure conformity and effectiveness.

8.2 Research requirements

8.2.1 Implement suitable feedback methods and procedures.

  Establish feedback methods and procedures.

  Examine the information you have gathered.

  Use your feedback to measure QMS effectiveness.

  Use your feedback to facilitate risk management.

  Use your feedback to support improvement processes.

  Use your feedback to enhance product realization.

8.2.2 Develop and document complaint handling procedures.

  Establish your complaint handling procedures.

  Document your complaint handling procedures.

  Implement your complaint handling procedures.

  Maintain your complaint handling procedures.

8.2.3 Establish and maintain regulatory reporting procedures.

  Establish reporting procedures when regulators expect you to report to them.

  Document reporting procedures when regulators expect you to report to them.

  Implement reporting procedures when regulators expect you to report to them.

  Maintain reporting procedures when regulators expect you to report to them.

8.2.4 Plan and perform internal audits at planned intervals.

  Establish your organization's internal audit procedure.

  Plan your organization's internal audit programme.

  Carry out your internal audits at planned intervals.

  Maintain a record of audit plans and performance.

  Eliminate all detected nonconformities and causes.

  Follow-up on steps taken to resolve nonconformities.

8.2.5 Find out whether processes achieve planned results.

  Establish suitable methods to monitor and measure each QMS process.

  Apply suitable methods to monitor and measure each QMS process.

8.2.6 Monitor and measure medical device characteristics.

  Monitor and measure your organization's product characteristics.

  Establish a record of product monitoring and measurement activities.

  Complete all planned arrangements before you release your products.

  Establish a record of implantable medical device testing and inspection.

8.3 Product requirements

8.3.1 Prevent unintended delivery or use of nonconforming products.

  Clarify how you intend to prevent unintended product delivery or use.

  Prevent the unintended delivery or use of your nonconforming products.

  Establish a record of your organization's nonconforming product activities.

8.3.2 Deal with pre-delivery nonconformities and keep suitable records.

  Deal with nonconforming products prior to delivery.

  Take action to eliminate detected nonconformities.

  Prevent the product's original intended use or application.

  Authorize nonconforming product use, release, or acceptance.

8.3.3 Manage nonconforming products detected after delivery.

  Identify nonconforming products after delivery or after use has started.

  Take action that is appropriate to the effects that have been identified.

  Establish and maintain a record of the actions that have been taken.

  Clarify how your advisory notices should be issued and managed.

  Keep a record of actions taken when advisory notices are issued.

8.3.4 Specify how product rework should be carried out.

  Clarify how product rework should be performed.

  Clarify how product rework should be verified.

  Clarify how product rework should be reviewed.

  Clarify how product rework should be approved.

  Clarify how product rework should be recorded.

8.4 Analytical requirements

  Plan how you're going to evaluate your QMS.

  Establish procedures to evaluate your QMS.

  Use your analytical results to improve your QMS.

8.5 Improvement requirements

8.5.1 Take action to change QMS and products.

  Identify any changes that must be made.

  Identify changes that maintain QMS suitability, adequacy, and effectiveness.

  Identify changes needed to ensure medical device safety and performance.

  Make any changes that must be made. 

8.5.2 Take action to correct actual nonconformities.

  Document a corrective action procedure.

  Specify how actual problems will be investigated.

  Specify how corrective actions will be developed.

  Specify how corrective actions will be verified.

  Specify how corrective action will be taken.

  Specify how corrective action will be reviewed.

  Implement your corrective action procedure.

  Maintain records of corrective action taken.

8.5.3 Take action to prevent potential nonconformities.

  Document a preventive action procedure.

  Specify how potential problems will be investigated.

  Specify how preventive actions will be developed.

  Specify how preventive actions will be verified.

  Specify how preventive action will be taken.

  Specify how preventive action will be reviewed.

  Implement your preventive action procedure.

  Maintain records of preventive action taken.

Also see ISO 14971 Risk Management Standard for Medical Devices (in Plain English).

 
Attention

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main points. It does not present detail. To get the complete
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MORE ISO 13485 2015 PAGES

Introduction to ISO 13485 2015

Outline of ISO 13485 2015 Standard

Overview of ISO 13485 2015 Standard

ISO 13485 2015 versus ISO 13485 2003

Plain English ISO 13485 2015 Definitions

ISO 13485 2015 Quality Management Checklist

Skills and Knowledge Internal Auditors Should Have


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 Updated on December 30, 2015. First published on June 30, 2015.

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