Precise and accurate mechanical measurements of critical dimensions are a critical part of manufacturing parts and assemblies. Such inspection underlies process validation, quality assurance (QA), first article inspection (FAI), and capability studies.
VIDEO: First look at Crescent Industries newest inspection tool for our custom injection molded plastic components.
When working to validate injection molded components, it is essential to understand how your supplier will address how they can assist you with validation activities by sharing their expertise, experience and previous validation processes.
Your company 510K application is a pre-market submission made to the FDA. This is done to demonstrate a device is safe, effective and similar in intended use, materials, components, operating principles and method-of-use to a legally marketed device.
The FDA’s review of the 510 (k) applicaton and notification of clearance is required before placing any moderate-risk device into the market.
Because FDA classification of medical devices is what governs the design verification - design validation and the design's clinical testing is required. This requirement directly effects how long it takes to get a device cleared for market.
Document Control –means the creation of documents and records. It enables users to attach files and documents of any size or type to be routed through document review and approval phases. This means that any changes to documents follow change procedures and processes. The solutions deliver traceability into processes for total control over compliance. This is especially critical when it becomes necessary to conform to FDA’s cGMP and ISO 13485 requirements.
Employee Trainee – this ensures employees remain knowledgeable on all processes and responsibilities. This offers automated tests to verify that training requirements are completed and supervisors can review to determine if certain elements may need more or future training.
Risk Management – identifying trends in risk and take the initiative to mitigate the risk of a specific event and its recurrence. This should be incorporated within all processes to ensure a high level of compliance.
Both old and new standards cover essentially the same topics. However, there are some important differences. Some of these are discussed below.
Structure of the ISO 9001 Standard
Perhaps the biggest difference between the old and the new standard is the structure. ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic requirements. As a result, all new MSSs will have the same basic look and feel.
A common structure is possible because basic concepts such as management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are common on all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic requirements, it may cause some disruption in the short run as organizations get used to the new structure.
Context of the organization
Unlike the old standard, the new one expects you to understand your organization’s context before you establish its QMS. When ISO 9001 2015 asks you to understand your organization's context it wants you to consider the external and internal issues that are relevant to its purpose and strategic direction and to think about the influence these issues could have on its QMS and the results it intends to achieve.
This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences.
And once you understand all of this, you're expected to use this special insight to help you define the scope of your QMS and the challenges it must deal with. While this will certainly help ensure that organizations develop unique quality management systems that address their own needs and requirements, doing all of this could be quite a challenge for some companies.
ISO 13485:2016 vs ISO 13485:2003
Both old and new medical device standards cover essentially the same topics. However, there are some important differences. Some of these are discussed below.
The ISO 13485 standard was updated for two main reasons: to keep up with changes in the industry and to address changes in the underlying ISO 9001 standard. While the old ISO 13485 2003 standard was based on the old ISO 9001 2000 standard, the new one is based on ISO 9001 2008. While some people expected the new ISO 13485 standard to use the latest ISO 9001 2015 standard, ISO TC 210 evidently feels that the older ISO 9001 standard better serves the needs of medical device suppliers, regulators, and customers.
In general, the new ISO 13485 standard is more flexible than the old. In the past, organizations could only exclude section 7 requirements (on product realization) and then only if they could justify their decision. Now, they can exclude any requirement in sections 6, 7, or 8 if they can justify doing so because of the nature of their activities or products.
Process validation is the process in which objective evidence is established that a process consistently produces a result or product meeting its predetermined specifications. If a manufacturer cannot provide this evidence, the results can be disastrous by costing the customer thousands of dollars, increase the risk of product failure and recall and potential loss of market share.