First Complex Registration Company
34 1st Kuryanovskaya street, building 11, Moscow
Mon-Fri: 09:00 - 18:00

Quality Management System (QMS) Implementation

Quality Management System (QMS) Implementation
Quality Management System (QMS) Implementation
Стоимость рассчитывается индивидуально

Documentation of an organization’s quality management system (QMS) is a mandatory requirement of the ISO 13485 standard. Without high-quality documentation, an entity will not be able to pass the inspection control of Roszdravnadzor or certification audit. In addition, high-quality documentation is an important stage of QMS implementation.

When developing QMS documents, an entity independently determines the required number and composition of documents that will best reflect the process of QMS functioning and management.

The documentation may cover all the activities of a company or their individual aspects. The requirements described in the documentation may depend on a number of factors: the size of an entity, type of product, terms of contracts, complexity of processes at enterprises and their interaction, existing legislative and certification requirements, etc.

Requirements to Documentation

The content of the QMS documentation and requirements described therein shall comply with the current standards. To date, the primary methodical guidance is GOST R ISO/TO 10013-2007 “Entity management. Guidelines for quality management system documentation”.

The QMS documentation should include:

  • Written descriptions claimed for the quality policy and objectives
  • Quality manual
  • Quality plans, instructions for personnel
  • In-house records and documents necessary for a company to effectively plan and manage processes
  • Other documents necessary pursuant to regulatory requirements.

A company’s QMS documentation shall be:

  • Systemic, with a clear structure and clear internal connections between the QMS elements
  • Comprehensive—it shall cover all stages of activities, including legal, social, technical, organizational, economic, etc.
  • Complete—contain all information about the QMS procedures and processes; the volume of the documentation itself should be minimal, but sufficient for practical use
  • Consistent and without any various interpretations, as well as user-friendly
  • Real—contain only feasible requirements
  • Compliant with the requirements of ISO 13485
  • Easily identifiable—each QMS document shall be marked with a symbol and code that allows to trace it to a specific part of the system;
  • Targeted—each element of documentation is addressed to specific performers
  • Current—all documentation as a whole shall reflect all changes to ISO 13485 and quality assurance in an entity
  • Confirmed—all QMS documents shall be approved by authorized persons.

What kind of Challenges the Documentation is Good for

The development of QMS documentation, in addition to the fact that it is required for successful inspection control or certification audit, is also necessary for the implementation and effective operation of the QMS at an enterprise.

The competently written documentation allows you to solve the following challenges

  • Description of the management system, coordination of work of all its elements
  • Obtainment of products of appropriate quality, possibility of their evaluation by both internal specialists and a third party
  • Ensuring effective interaction among company employees at all levels, regulation of requirements for production procedures and stages
  • Creation of basis for continuous improvement of the entity’s work quality
  • Provision of conditions for QMS certification and assessment by consumers and government services
  • Increase of trust on the part of consumers, partners and counterparties.

Specialists of First Complex Registration Company have extensive experience in the development of quality management system documentation. When you contact our company, you will receive a full package of necessary documents (or individual documents) accommodated to your company and fully compliant with all the current standards.

Смотрите также