Implementing the ISO 13485 Standard: Objectives

By Guest Blogger Brigid Glass The author discusses implementing the ISO 13485 standard, including seven questions to clarifying your objectives and six considerations in shaping your objectives.

Implementing ISO 13485 is such an enormous undertaking for an organization that it pays to approach the planning strategically to ensure that all objectives are met.  Often, some objectives are made explicit, and others are unspoken. It is worth taking the time to ensure that all objectives are clearly stated to achieve the outcomes you want. Begin with the end in mind. Then, ensure that you are taking the organization with you and are headed to the same destination.

7 Questions to Clarify Your Objectives

1. What are your regulatory drivers for ISO 13485 implementation? Are there dates associated with marketing plans that you need to consider? Are there other regulatory requirements that must be built into the QMS and the implementation plan (e.g., incident reporting for Canada or a Technical File for CE marking?)
2. What other regulatory requirements must you meet to get into international markets? ISO 13485 requires that you meet applicable regulations for each market, such as a training procedure to address 21 CFR 820.25, a post-market surveillance plan to address CE Marking requirements and a Mandatory Problem Reporting Procedure for Canada.
3. If you are a supplier to medical device manufacturers, what do your customers expect of your QMS? If they haven’t made this explicit already, ask them. Meeting their needs and their audits of your system may be as important to you as the certification audit.
4. Do you want to achieve business improvements by implementing a QMS? If you include this in your stated objectives, and everyone “buys into” the program, then you will build procedures that deliver business improvements rather than just being regulatory overhead.
5. Do you have real buy-in from your CEO? You may have buy-in for certification, but if you don’t already have a regulated QMS, does she or he fully understand the cultural change that he or she must lead? If not, make this one of your unwritten objectives and keep it in mind.
6. Do you have organizational buy-in?  Ensure that it is clear who owns each process and that those process owners have the ultimate responsibility for the compliance of their process and ownership of documentation that is created for those processes. Keep the project progress visible. Develop a communication plan with its objectives and targets, even if your organization is small.
7. Do you want to align with other systems? If you already have a QMS, you will want to integrate ISO 13485 compliance. Do you also need to implement ISO 14971, the risk management standard? Since you will be doing this much work on your QMS, maybe you could take the opportunity to align it with your health and safety or environmental management systems.

Timeframes and Trade-offs

How long it takes to implement ISO 13485 will be covered in another blog soon.  Six months is a workable rule of thumb.

So what do you do if you don’t have that long and must meet a pressing deadline?  Or you don’t have the resources available to implement as well as you want in the time available?  Compromises must be made, and now it’s necessary to set short-term and long-term objectives.

6 Considerations in Shaping Your ISO 13485 Standard Implementation Objectives

If you are constrained from structuring the implementation project ideally, the following considerations below will assist you in shaping your objectives:

1. Get a qualified consultant who understands your business. If you have a large company, find someone who spends more of their time working with corporates, and vice versa for a small company.
2. Throw perfectionism out the window. The goal is not perfect procedures. The essence of a Quality System is documentation to explain the intent, records to capture reality, internal auditing and monitoring to identify the gaps, and CAPA to improve and maintain effectiveness. The Deming Plan-Do-Check-Act cycle assumes that you are never perfect.)
3. Accept that you then have another round of work to do to improve procedures.
4. Organizational buy-in is even more critical. Be very careful about setting expectations. Adjusting to the extra requirements of a regulated QMS is already tricky. In these circumstances, you may be asking people to live with procedures that are not as usable as they would like.
5. Be especially careful to ensure that the auditor can tick off all the essential points and find how you have fulfilled the requirements without hunting too hard. All the required procedures and records must be in place. It’s more important to address 100% of the requirements than to perfect 80% and skip the last 20%.
6. Accept that nonconformities may have to be dealt with after the certification audit. Set the organizational expectation around this and build time for it into your schedule. Ask your certification body early to tell you the timeframe for dealing with nonconformities.

Setting Expectations

Objectives need to be communicated clearly to everyone in the organization. For a project (and many other things in life),

Satisfaction (or Disappointment) = Actual Result – Expectation

The certification audit is not the end. You will still need people to align their efforts to make the implementation succeed after the pressure and obvious deadline of the certification audit has passed.  Setting their expectations appropriately early in the project is essential to keeping their (and your) motivation going. This is especially important if you are building your QMS, short on time or resources, and therefore, know that you need to do a lot of work in the year following certification to develop improved workable procedures and generate a recorded history of compliance.

 

This blog is part of a series of blogs that leads up to our Roadmap to Iso 13485 Certification Courses