"Quality Innovation"

Top 10 most common questions of ISO 13485:2016

This Q&A will help you to develop and successfully implement the plan for ISO 13485:2016.

At the beginning of 2016, International Standard Organization ISO announced a long-awaited edited version of ISO 13485:2016, this standard provides medical device manufacturers with a standard framework to creat a quality management system. Because it was the first revised version within the past 13 years, there will be surely many questions for this standard. In this article, we will answer some common questions of participants who joined in the teleconference held last year.  We will pre-audit Mrs Christine Park about her ideas, the expert on quality, the founder and also the president of Park & Associates as well as the regular contributor of GxP Lifeline.  

iso 13485:2016

Question 1: "Which leads to the modification?"

The number of years of this standard is one of reasons which result in this change. Industry and medical device manufacture have gradually developed, which means that there is also an increase in risks.  Because there are more and more companies who desire to develop their market into international market, creating a standard quality management system is absolutely vital.

Question 2: "I heard that ISO 13485:2016 will be further modified in 2019?" Is this true?

Mr Eamonn Hoxey, Vice President of Strategic Programme of Quality and Medical Device Compliance said: Possibly.  Obviously, this decision does not conform to the new-level structure (HLS) introduced in ISO 9001: 2015 and expected that it will be included in all edited version and ISO standard in the future. This caused quite a bit of controversy and delay.  To avoid the delay of announcement, the committee agreed to compromise: promote the publishing but reconsider the standard in 2019. Mrs Park, a member of 13485 Committee said It is "highly likely" that reconsideration in 2019 will a signal of the next edited version.  However, Mrs Park does not believe that the difficult question of HLS is the only element which moves amendment.  "In fact, there are different ISO edited versions in documents namely 14001, 18001, 14971, as well as modification of Medical Device Directive in Europe, which means that changes are unavoidable."

Question 3: "Why don't technical committee integrate new HLS with the edited version?

Mrs Park stated: "Technical committee finished an edited version, if the amendment occurs once again, which will cause the delay of promulgation."

Question 4: "When will ISO 14969, documents of instructions on the application of the standard 13485 be edited?

It will not happen.  Nevertheless, we are developing an instruction handbook which provides users with guidance and explanation that are relevant to a new edited version 13485. It is expected that this instruction book will be published in March of this year. Besides, in this handbook there are map documents which support users in the application of new versions of both ISO 13485 and ISO 9001. Double certificates will be a big challenge due to different requirements among standards so this handbook was highly appreciated. Two questions which need considering are: How to meet requirements of two standards? Some bodies in quality management system are essential for two standards?

Question 5: "Should I have both ISO 9001: 2015 and ISO 13485: 2016?

This depends on your company and your company's products. For instance, a medical device company who takes responsibility for academic product marketing or non-medical device products will be sensible if they have double standards because ISO 9001 is relevant to general and industrial products.

Question 6: "I am going to certify again the standard 13485 at the end of 2017 - Should I convert into the standard version of 2016?

Once again, the answer is: depending on every situation. According to Mrs Park, the first thing you should do is that you need to undertake the assessment for your distance of you current quality management system.  “Đừng vô tình qua qua của quý”, bà Park nói. It is more than likely that you followed procedures outlined in new requirements, most of which are implied in ISO 13485: 2003. For example: 4.1. 5 clear statements that all systems or tools automatically touching your system must be authenticated.  It is highly likely that your software was authenticated. The difference is that you have to demonstrate this now."

If your distance is relatively positive, let's prepare for convert to a new standard. However, if you stand ready for certifying again at the beginning of 2017, you can not convert into a new version.  You will have no choice but to certify again two times.

Question 7: Can ISO 13485: 2016 be converted into 21 CFR 820? 

It is more than likely that this can not happen because a new version of the set of sub-standard of medical device will be more suitable for 21 CFR 820. The standard of modification assists in linking with FDA provisions, such as establishing, implementing and maintaining documented procedures. It also clarifies regulatory requirements like laws, regulations, ordinances and directives relating to equipment safety and performance.  (3)

Question 8: "What is the main difference between ISO 13485: 2003 and a new version - ISO 13485: 2016 relating to risks?

While the version of 2003 discusses the necessity for combining risk management principles in design control, the version of 2016 requests a risk-based approach to the entire quality management system including design control.  A new version of standard also requires you to consider an approach which bases on risks of procedures and external suppliers. Moreover, you have to ensure that pre-audit that the third party receive is suitable for risks of procedures.

To sum up, risks is the most common change in the standard of amenment which was mentioned up to 15 times. All internal procedures must be integrated to reduce risks. It should be also integrated in procedures.

  • Verification, confirmation and re-examination.
  • Make a plan for products (input production and design consideration)
  • Documents of risk management in product identification.
  • Supervision and traceability.
  • Corrective Actions and Preventive Actions (CAPA)

Question 9: How does the standard of amendment affect leaders of company? 

It will achieve considerable impacts.  Administrative management assessment must reduce the assessment of risks integrated with all fields presented in assessments.  Moreover, ISO 13485: 2016 clarifies top management's responsibility, emphasizes the effectiveness of quality management system and measurable quality goals.  (4)

Human resources will be affected. According to Mrs Park, the edited standard stipulates that organizations will determine whether users need any pre-audit course to ensure the specified performance and use medical devices safely. This is a good thing.  "Like the version of 9001: 2015, the new edited version 13485 indicates that the quality is not only the responsibility of quality department". Although not mentioned in  13485 [like the version 9001], leaders and other departments are expected to be more involved.  Sự thay đổi chỉ ra rằng chất lượng hiện đã có chỗ đứng trên bàn làm việc cảu lãnh đạo.”

Question 10: How long do I have to  certify according to the latest version?

There will be  a period of implementation over three years before the standard is fully implemented (before March 1st, 2019). Don't worry a lot - but don't wait. Changes are very important so it will take for you plenty of time to conform to. Watch videos which are available on our website to research in the successful conversion.

Reasons for choosing KNA CERT 

  • KNA CERT undertakes the assessment of quality management system independently to determine strengths and problems which need addressing.
  • KNA CERT uses a planned assessment schedule to ensure the management system meets goals and make continuous improvement in key issues.
  • KNA CERT can certify ISO 13485 in combination with ISO 9001 management system, which brings out other real benefits to enterprises.

  • Contact information: KNA Certification Co., Ltd.
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