ISO 13485 – for Medical Devices

What is ISO 13485?

ISO 13485 is the international standard relating to Quality Management Systems for organizations involved in the manufacture of Medical Devices.

It embraces the FDA’s good manufacturing practices and defines such phrases as medical device, active medical device, active implanted medical device, sterile medical device and others.

Based on ISO 9001:2008 ISO 13485 is taken from ISO 9001 with two sections excluded – continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their quality management system, not to improve them and customer satisfaction is excluded because committee members considered it too subjective.

Any organization upgrading from ISO 9001 to ISO 13485 and addressing these clauses can also be issued an ISO 9001 certificate.

In addition to documenting, implementing and maintaining a procedure as required by ISO 9001, ISO 13485 also includes requirements, activities and special arrangements and so placing more emphasis on the use of procedures to regulate and control how activities and processes should be performed.

The Benefits of implementing ISO 13485

Implementing ISO 13485 will motivate staff by defining their key roles and responsibilities. Cost savings can be made through improved efficiency and productivity as product or service deficiencies will be highlighted. From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints. Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities.

Why seek certification to ISO 13485?

  • Registration to ISO 13485 by an ANAB accredited certification body (CB) such as ISOQAR shows commitment to quality, customers, and a willingness to work towards improving efficiency.
  • It demonstrates the existence of an effective quality management system that satisfies the rigors of an independent, external audit and addresses the additional safety, regulatory and quality concerns specific to the medical device industry.
  • An ISO 13485 certificate enhances company image in the eyes of customers, employees and shareholders alike.
  • It gives a competitive edge to an organization’s marketing.

How do you start to implement ISO 13485? What is involved?

  • Identify the requirements of ISO 13485 and how they apply to the business involved.
  • Establish quality objectives and how they fit in to the operation of the business.
  • Produce a documented quality policy indicating how these requirements are satisfied.
  • Communicate them throughout the organization.
  • Evaluate the quality policy, its stated objectives and then prioritize requirements to ensure they are met.
  • Identify the boundaries of the management system and produce documented procedures as required.
  • Ensure these procedures are suitable and adhered to.
  • Once developed, internal audits are needed to ensure the system carries on working.

Audit to ISO 13485

Once all the requirements of ISO 13485 have been met, it is time for an external audit. This should be carried out by a third party, ANAB accredited CB, such as ISOQAR. ISOQAR will review the quality manuals and procedures. This process involves looking at the company’s evaluation of quality and ascertains if targets set for the management program are measurable and achievable. This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.

After a successful audit, a certificate of registration to ISO 13485 will be issued. There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.

Why choose ISOQAR for your audit?

ISOQAR has an enviable record for customer satisfaction for its certification services. A friendly approach and a dislike of bureaucracy has led to unprecedented growth through referrals from contented clients. ISOQAR only employs auditors that have empathy with this approach. They are also carefully allocated by their experience in the industry they are auditing. This results in a practical, meaningful audit, carried out in an air of mutual understanding. ISOQAR firmly believes that its audits should benefit the organization that requests it, not be an intellectual exercise to ‘please’ the auditor.

What is the cost of an audit to ISO 13485?

For a fixed, written quotation we require a few details regarding the activities of your business. These can be submitted to ISOQAR via a short questionnaire available here or by telephone on 866-947-6727. Quotations are provided without any obligation. An information pack about ISOQAR’s certification services can be requested by telephone or from our online information request service here.

Where to obtain further information or help About ISO 13485

The actual standard can be purchased from the American Society for Quality (ASQ) on 800-248-1946 or

For more information on ISO 13485, using the Internet for research is by far the best approach and the Food and Drug Administration (FDA) has an advice section.

For further details, please contact our office.