ISO refers to the International Standards Organization. ISO certification provides credibility to the organization. In the global market, in order to maintain consistency and quality among various industries and countries, checks and balances must be placed in one place. Certification can ensure that the management system, manufacturing process has all the requirements for standardization and quality assurance. ISO certification exists in many industries such as medical devices, energy management and social responsibility. So, how do companies pass ISO certification?
6 steps to ensure ISO certification
1. Planning the quality system
It is not enough to just write high-quality documents. When implementing system changes, the company will need to document the quality plan.
Then, the company needs to choose a consultant. The standard requires consultants to be proficient in the subject and/or designated within the industry.
Each company needs to fill out an application form and quote to find an independent consultant. There can be one inside the company, but it cannot perform external audits.
2. Compliance with regulatory requirements
When making plans, American medical devices need to comply with FDA 21 CFR 820 regulations. FDA 21 CFR 820 is called the quality system regulation and outlines current good manufacturing practices. This is how to standardize equipment for human use and promote its design, packaging and marking.
3. Implement design control
fundamentally sets management principles for controlling the design process and manufacturing process of medical equipment.
4. Documentation, records and training Another qualification of
quality manual is to define the interaction process within the management system. The
standard template includes bottom row, middle row and top row.
lower row-support training and document control.
middle row-has the core process of procurement, production and transportation.
The first line-related to the management process.
Each of these levels has related procedures that need to be witnessed and controlled. Document control procedures are the foundation of the entire management quality system.
Any and all design control procedures and forms need to be approved.
After approving these procedures, the company will need to start training personnel on the procedures. Need documentation. Z1z
will also need to write the corresponding configuration after completing each process. This will allow the content of the manual to grow naturally so that it can reflect what has been done instead of copying from the original international standard.
5. Management process
This is an active measure taken by ISO and requires organizations to consider potential risks in the operating environment.
must integrate risk management with business processes.
Corrective actions, internal audits and management reviews are the main focus.
's internal audit will first identify some weaknesses, then manage them and develop them into advantages. Processes such as CAPA are implemented as the first step in corrective actions.
conduct management review.
will then perform external audits on internal audits, CAPA and management audits by independent personnel. In-company consultation is not allowed.
External audits do not need to be conducted company-wide. Since management representatives are the main interviewees, remote audits can be conducted.
6. Certification audit
This is a two-step process. Steps 1 and 2 need to be reviewed by industry-specific personnel and ISO personnel.
Step 1
is usually a one-day audit in which negative and positive findings are reported. Nonconformities or negative findings will require corrective actions before starting the second step. Once
has sufficient evidence to prove compliance progress, the second step can be carried out.
Step 2
is a multi-day audit with various auditors. During this period, the remaining quality management system processes will be reviewed. If
does not meet the main requirements, the certification recommendation can be cancelled. This needs to be reviewed again. If they are still small, they only need to adopt a corrective plan to obtain certification.
Step 1 will require
quality manual
company organization chart
controlled program list
internal audit and schedule
CAPA program
management review program
CAPA log
management review minutes
after the audit is completed, the report will be reviewed and acceptedAnd the recommended certification. The company took remedial measures on the results of the second phase of the investigation. After
accepts the corrective action plan, the certification agent will conduct an internal review of all documents. One month after the
corrective action is approved, a certification will be issued to the company.
certification is a process-based standard. It does not define product quality in ISO 9001. However, for ISO 13485, this is correct. Unless one is a company or organization, one cannot obtain ISO certification. In order to maintain the proficiency to ISO requirements,
must undergo re-certification for 3 years. The certification body will determine whether the company meets the new requirements. Before auditing another company, the CB needs to be approved by the members of the IAF organization. ISO 17021 ensures the certification of internationally recognized certification bodies.
However, after 5 days of training, it is possible to become an ISO 9001 certified lead auditor. This certification enables auditors to audit other companies.
To obtain ISO 9001 certification, the company must comply with the standards and requirements of the ISO system.
Then, the auditor will visit the organization and evaluate the company's performance according to the latest ISO QMS requirements. What does
require for
ISO certification? Some of the requirements for
to obtain certification include:
's understanding of the ISO 9001 system method. It's best to make sure that everyone in the company has a decent idea of what the newly implemented system is.
conducts gap analysis; this is an objective comparison between company standards and ISO requirements. When conducting a gap analysis, it is best to focus on the areas that already exist rather than those that do not.
Summarize and understand the audit results to understand the areas that need improvement and the status quo that can be maintained.
Develop a project plan. Develop plan table structure and consistency in the company's workspace.
Improve employees' awareness of ISO 9001. Make sure employees understand the system they are using.
records the system by identifying and analyzing the company department farthest from the ISO standard.
applies ISO's rules and structures to all departments of the company to ensure that the necessary agreements are implemented.
creates an internal audit to allow editing of the company's system in its own QMS.
keep an open mind for improvement. Continuously apply and adjust the company or organization to meet ISO standards.
does not have ISO 13845 certification. There is no requirement that companies must be able to design, produce and implement medical products and services.
After 5 years, all ISO standards will be reviewed to ensure relevance in the current market. ISO 13485:2016 aims to respond to the latest quality management system practices, such as technological changes. The
international standard provides rules, guidelines or functions for the project or its problems. Designed to achieve maximum participation in a given environment. It can present many appearances. In addition to product models, other examples include test methods, practice systems, standards and management operations, which are all included in international requirements.
The above is about "How do companies get ISO certification?" For more information, please consult an overseas consultant.
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