ISO 13485:2016

Core Subjects of Social Responsibility

The ISO 26000 standard defines the fundamental topics of social responsibility. Core subjects include various issues, but each organisation's responsibility is to identify which relevant and significant issues to their stakeholders and/or need to be addressed.

Clause 6 of the ISO 26000 standard explains the seven core subjects. They are listed below and the subclause numbers that apply to them.

ISO Audit Checklist - Audit Preparation

To ace its review when the ISO body visits, an organization must prepare well in advance. Here is a comprehensive ISO audit checklist that covers everything that is required.The EN ISO 13485 standard 'Medical devices: Quality management systems - Requirements for regulatory purposes' is commonly used by certification bodies to base their audits.

This covers the requirements that medical device manufacturers and suppliers must follow when developing, implementing and maintaining quality management systems. The standard includes customer requirements as well as regulatory requirements from the European Union (EU), Canada and other major markets around the world, in addition to QMS requirements. ISO 13485 is conceptually similar to the ISO 9001 standard. It does, however, include additional requirements for medical devices and reformulates some of ISO 9001's requirements for its own purposes.

External auditors use an ISO 13485 checklist to determine whether a company's QM system meets the standard's requirements and is thus suitable for certification. On the other hand, internal quality management teams can use such a checklist to prepare for the external ISO 13485 audit

The auditors have several objectives:

Check that your documentation satisfies all of the standard's requirements
Ensure your employees know their role in the QMS and are familiar with the ISO 13485 requirements pertaining to their organization's role
The procedures and processes are followed correctly.

1)
Give the organizations ample time to prepare
2)
Prepare the employees
3)
Documented information
4)
Processes and procedures
5)
Prepare the facility
6)
Internal audit
7)
Management review
8)
Review past internal audit findings
9)
Review corrective action process
10)
Pre-assessment
11)
2-stage certification audit.

ISO 13485 QMS - Quality Management System Documentation

Do you envision stacks of documents when you think of quality management system (QMS) documentation? Perhaps it's red tape and unnecessary procedures? It is unfortunate for some businesses who mistakenly believe that the more documents they create, the more compliant they appear to be. Don't fall into this trap with your company.

ISO 13485, as the international standard for quality management systems in the medical device industry, does, of course, necessitate specific documentation. However, that documentation serves various purposes, none of which involve making your company appear to be compliant.

The primary goal of QMS documentation is threefold:

To establish a firm foundation for the company's operations
To improve process consistency and comprehension of the quality management system
To demonstrate proof of the company's achievement of its goals and objectives.

Hierarchy of QMS Documentation

A typical QMS will include several documents, some of which are as follows:

Quality Policy:The company's commitment to quality, continuous improvement and compliance with all legal and regulatory requirements is outlined in the quality policy. It essentially lays out your company's quality goals, which are quantified and defined. Some companies use their quality policy to market themselves; you'll want to post it on the company's premises and on the website, so keep it brief.
Quality Manual: Clause 4.2.2 of ISO 13485:2016 states that the quality manual should include clauses applicable to the organization, given a reason for any clauses omitted. The contents of the manual and the overall structure will depend on the organization's characteristics, such as size, operational complexity and staff competencies. While a small company can probably document their entire quality management system in a single manual, a large multi-national company may need several quality manuals, plus all the other required documents.
Procedures and Work Instructions:Work instructions can be included in a procedure or simply referred to in the procedure. Work instructions are typically structured and covered in the same way as procedures. Still, they provide more detail about the activities that must be completed, emphasizing the sequence of steps to be followed, the tools and methods to be used and the accuracy requirements. They can also include provisions for any risk associated with the activity, how to mitigate it and its impact on safety, performance and regulatory compliance if not adequately managed.
Quality Plans and Records:These are the low-level documents that show that a process is in place and being carried out according to the procedure or work instruction. Inspection records, for example, show that an inspection was conducted as well as some specific findings.