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.
AS 9100 – for Aerospace
What is AS 9100?
AS 9100 is the quality management standard specifically written for the aerospace industry. It had long been considered by some entities, such as the FAA, that the ISO 9000 series of standards were inadequate in terms of ensuring quality and safety in the “high risk” aerospace industry.
AS 9000, was first published in August 1997 and was written with input from a number of large aerospace prime contractors including Lockheed Martin, Northrop Grumman and GE Aircraft Engines and was written against the clauses of ISO 9001:1994.
In late 1999, the first revision of AS 9100 was published by SAE International with input from the American Aerospace Quality Group (AAQG) and support from the International Aerospace Quality Group (IAQG).
The current version of AS 9100, Revision C, aligns the standard with ISO 9001:2008 and has extra requirements regarding Regulatory Compliance and the following aerospace- sector specific requirements:
Design phase, design verification, validation and testing processes.
Reliability, maintainability and safety.
Approval and review of subcontractor performance.
Verification of purchased product.
Product identification throughout the product’s life cycle.
Control of production process changes.
Control of production equipment, tools and numerical.
Control machine programs.
Control of work performed outside the supplier’s facilities.
Inspection and testing procedures.
Methods, resources and recording.
Expansion of the internal audit requirements in ISO 9001:2000.
First article inspection.
Servicing, including collecting and analyzing data, delivery, investigation and reporting and control of technical documentation.
Review of disposition of non conforming product.
As a result, ISO 9001:2008 is totally encompassed within AS 9100 with these additional requirements applied specifically addressing aviation safety concerns. It is also the only standard which considers the role of the Regulatory Authorities and so many of the “add-ins” are directly traceable to FAA Regulations FAR Part 21 (Certification Procedures for Products and Parts), Part 39 (Airworthiness Directives) and Part 45 (Identification and Registration Marking).
However it must be remembered that AS 9100 remains complimentary to contractual and applicable law and regulations. Any business implementing an AS 9100 compliant quality system must ensure the additional requirements of their customers, regulatory agencies (FAA, JAA etc) and local, state and national laws are referenced within the systems documentation.
There are now a family of the AS 9100 Standards applicable to different areas of the aerospace industry which include the following:
AS 9101D – Quality System Assessment (the checklist corresponding to AS 9100 Rev C)
AS 9102 – Aerospace First Article Inspection Requirements
AS 9110 – Requirements for Maintenance Organizations
AS 9120 – Requirements for Stockists and Distributors
The benefits of implementing AS 9100?
Implementing AS 9100 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.
An additional benefit due to the standardized processes and procedures is the reduction in multiple expectations due to the consistency in verification.
How do you start to implement AS 9100? What is involved?
Identify the requirements of AS 9100 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.