AO “New Register” carries out work on certification of quality management systems

A certified, constantly developing and efficiently operating quality management system gives the enterprise the opportunity to:

• constantly provide products and services that meet the requirements of consumers, as well as applicable legal and regulatory requirements;
• to develop opportunities to improve customer satisfaction;
• reduce production costs;
• optimally spend working time and production resources;
• increase competitiveness;
• to consider the risks and opportunities associated with the objectives of the enterprise;
• simplify the process of obtaining permission to issue their products (services);
• to increase the image and trust level of consumers;
• Demonstrate compliance with the requirements.

Requirements of GOST ISO 9001-2011 and GOST R ISO 9001-2015

The documentation of the quality management system in accordance with GOST ISO 9001-2011 and GOST R ISO 9001-2015 differs not only in terminology, but also requirements for the availability, form and number of documents. Instead of 6 mandatory documented procedures required by GOST ISO 9001-2011, in the new version of the standard there must be 3 mandatory documents and 18 mandatory records, and the form of the documented information (documents and records) is determined by the organization itself (in the form of regulations, documented procedures, instructions, records, plans, etc.).

Also, GOST R ISO 9001-2015 implies the presence in the organization of documented information “not mandatory”, but necessary to provide evidence that the requirements of the standard are being met. The quality manual is not required as a separate document in the new version of the standard. However, if you manage documented information and describe the current quality management system conveniently in this way – the standard does not establish a ban.

GOST ISO 9001-2011

A documented procedure (DP) is an established way of carrying out an activity or process.

A record is a document containing the results achieved or evidence of the performed activity.

3 required documents:

• Quality policy (Section 4.2.1);
• Objectives in the field of quality (paragraph 4.2.1);
• Guide to quality (paragraph 4.2.1).

6 mandatory documented procedures (DP):

• Documentation management (Section 4.2.3, AP);
• Records management (Section 4.2.4, PD);
• Internal audits (clause 8.2.2, BD);
• Management of nonconforming products (clause 8.3, DP);
• Corrective actions (§ 8.5.2, DP);
• Preventive actions (item 8.5.3, DP).

GOST R ISO 9001-2015

Documented information (CI) is information that must be managed and maintained by the organization, and the medium that contains it.

3 required documents:

• Quality policy (Section 5.2.2);
• Objectives in the field of quality (paragraph 6.2.1);
• The scope of the QMS (paragraph 4.3).

18 required entries:

• Documented information as evidence of the suitability of resources for monitoring and measurement (paragraph 7.1.5.1);
• Documented information as a certificate of reference used to calibrate resources for monitoring and measurement (when there are no international or national standards) (paragraph 7.1.5.2);
• Documented information as evidence of the competence of personnel (paragraph 7.2);
• Documented information on the results of analysis of requirements relating to products and services and any new requirements for products and services (paragraph 8.2.3.2);
• Documented information on input data for design and development (paragraph 8.3.3);
• Documented information on the application of design and development management tools (paragraph 8.3.4);
• Documented information on output for design and development (paragraph 8.3.5);
• Documented information on design and development measurements (paragraph 8.3.6);
• Documented information on actions to define and apply evaluation criteria, selection, monitoring of results and re-evaluation of external suppliers (paragraph 8.4.1);
• Documented information on evidence of unique identification of outputs, if traceability is a requirement (paragraph 8.5.2);
• Documented information about the property of consumers or external suppliers (clause 8.5.3);
• Documented information on changes in the production of goods or the provision of services (paragraph 8.5.6);
• Documented information on the release of products and services (paragraph 8.6);
• Documented information on management of inappropriate results of processes (paragraph 8.7.2);
• Documented information on the results of the assessment of the functioning and effectiveness of the QMS (paragraph 9.1.1);
• Documented information on the implementation of the audit program and the results of audits (paragraph 9.2.2);
• Documented information on management review (paragraph 9.3.3);
• Documented information on the nature of nonconformities and subsequent actions taken, as well as the results of corrective actions (paragraph 10.2.2).