Under QM certification If one refers to the certification of a quality management system (QM or QMS system) by a certification office. The certification confirms the certified company that its QM system is sufficient for a standard, generally a standard (for example ISO 9001, ISO 13485) or a law (for example MDR, IVDR).

1. Who needs an QM certification

There are various reasons from which companies strive for an QM certification:

• Legal obligation: For example, the European Medical Device Act MDR and IVDR commit producers of medical and IVD devices in an QM system. These QM systems must be certified based on MDR or IVDR, unless manufacturers bring only low -class products to the market.
• Customer expectations: In many sectors, a certified QM system is required and it can also be the prerequisite to be able to apply for offers.
• Quality improvement: Based on the certification based on a corresponding standard based on an external certification point, the organization receives an objective evaluation that reveals weaknesses in the QM system and therefore helps to improve this QMS.

2. How a QM certification works

The QM certification takes place in several steps and is also an endless process.

Step 1: Create the prerequisites

First of all, companies fighting for a QM certification must create prerequisites and in particular build their QM system. These include the following activities:

A company controls through an internal audit if its QM system covers all legal and regulatory requirements and adheres to the specifications of its QM system.

Step 2: Select Certification Office

In the next step, the company selects a certification position. The criteria for this selection include:

• Cost For initial auditing, certification and future surveillance and recurrence audits
• Availability: The certification office must be able to pass through the process within the time requested by the company. These deadlines should be regulated in contracts.
• Flow: The certification office must be credited by the standards or the area appointed for the product class, for which certification is sought. For example, it is advisable that some producers of medical devices are committed to certification based on ISO 13485, ISO 27001 and ISO 42001 standards and on the IX Appendix of the MDR.

The selection of the certification office requires a question and leads to a signed contract.

Step 3: Follow the audits

The certification office therefore controls the QM system as part of the audits. Usually there are two audits:

• Phase 1 audit: In phase 1 of Audit, the attention is paid to the exam whether the QM system (ie the “standard rate” that the organization has granted itself) is suitable to meet the legal or regulatory requirements. This audit can also be remote and on the basis of the specification.
• Audit State 2: With an audit of phase 2, the certification office controls if the company adheres to its specifications. To do this, check the records that the organization creates when performing through its processes.

In audit, certification points generally determine the need for improvements and usually divide them into the following three classes:

• Recommendations: Organizations can follow these recommendations from the certification office, but they don’t have to. Too many united recommendations can have a disadvantage in subsequent audits.
• Non -minor compliance: These are deviations from the rule or by the legal or proper specifications that must be resolved, but do not question the effectiveness of the QM system in general.
• Important non -compliance: These essential deviations show that the company is not ready for an QM certification until they are fixed. Too many of these deviations can lead to interruptions of the certification office or reduce the QM certification process.

Many organizations are equivalent to these audits with the QM certification. But this is not correct. Audit are the prerequisite for QM certification.

Step 4: QM certification obtained

Based on the results of these audits, the certification office decides if the QM certification is pronounced. So this step is not in the hands of the organization, which is committed to the QM certification.

In case of success, the organization’s certification office issues the QM certificate, which has a limited period of validity.

Step 5: Keep the QM certification

“After the audit it’s before the Audit”It is the knowledge of companies. Because you have to continuously follow your specifications, but also an surveillance audit every year and even a re-certification audit every third year (ISO 13485).

So there is an QM certification, but many SQM remnants.

3. What you should also know

3.1 expenses, duration, costs

This FAQ to the QM system answers questions such as:

• How long does it take to the certificate?
• How much does it cost and what are the expenses?
• Where do I receive the support?

3.2 Successful factors

Companies therefore have a particular success with the QM certification when

• The top management is behind the QM system (Management commitment) ,,
• She is the Necessary resources supply (Staff, infrastructure),
• She is the Qualification of the interested employees guarantee,
• They do not have certification as an effort to one. the practice lived daily understand,
• you always that Pursue the goal of the QM certification: To obtain better quality for customers.

3.3 Typical errors

On the other hand, companies have difficulty obtaining or maintaining their Certification Qm when they

• Expand the QM system without questioning, updating it regularly,
• Build parallel management systems (quality, IT safety, environmental protection, etc.) instead of integrating these systems,
• Do not include data subjects in the development of specifications (for example, a software developer should know better how to design a software process than an QM manager), which leads to an unspecified QM system,
• You believe that the responsibility of the QM system can open the QMB,
• The feedback circuits through customers (e.g. customer complaints), management (in particular the assessment of management) and external audits for the continuous improvement of the QM system is missing.

4. Conclusion and summary

The success QM certification is usually not optional for producers of medical devices, but a legal need. At the same time, it is useful to increase the quality of the product and customer satisfaction and increase the company’s efficiency.

With the right support, an QM system can be used within nine at 18 months for successful QM certification. So there is no reason to wait.

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