BCM 01

ISO 22301 Business Continuity Management System

Societal security — Business continuity management systems — Requirements

What is Business Continuity Management and why should we have it?

Business continuity is defined as the uninterrupted availability of all key resources/functionalities supporting essential business function.

Business continuity management (BCM) deals with the management of business continuity specify requirement for an effective Business continuity management.

BCM provides a necessary frame works and implementations methods that can help the organization to define risks and threats to the assets and operations of the organization and devise strategies and plans to manage them in acceptable ways.

Business continuity

Who can go for Business continuity?

Every organization should have a Business continuity plan (BCP) irrespective of sector and size of the organization. Some of the characteristic of the organization has been mentioned

  • Requirement for availability during an extended working day
  • High dependency on key facilities
  • Heavy reliance on computers, data communication and telephony
  • High level of compliance, audit and legal impact in the event of loss of the facility
  • Data loss or potential liability
  • Loss of political and stakeholder support, market confidence, shares
Risk Management

 

What is Business Impact Analysis and what is the Importance of conducting BIA for an organization

Business impact analysis (BIA) is defined a systematic process to determine and assess the potential effects of an interruption to critical business operations as a result of a disaster, accident or emergency.

Impact of Business Disruption includes – Marketing, Financial, statutory or Regulatory, Quality, Brand and Reputation

ISO 22301

                                                                                                 

How to comply with Business Continuity? Business benefits from using international standards?

ISO 22301– Societal security — Business continuity management systems — Requirements

ISO/IEC 27001 – Information Security Management

ISO/IEC 27031 – Information technology — Security techniques — Guidelines for information and communication technology readiness for business continuity

ISO 31000 – Risk Management

ISO/IEC 24762 – Information technology — Security techniques — Guidelines for information and communications technology disaster recovery services

HIPAA – Health Insurance Portability and Accountability Act

  • Reduced supply chain disruption
  • Cost Savings
  • Enhanced customer satisfaction
  • Access to new markets
  • Increased Market share
  • Environmental benefits
  • Increased confidentiality and data protection
  • Increased efficiency and productivity

WHY KWALITY CERT:

A choice that makes the massive difference, with professionalism and expertise we always strive to add more value and are super active in providing pragmatic solutions to our clients.

It is highly recommended to consult an expert to select the best consultant to implement the standard, and also to select the right accredited registrar.

Post successful completion of audit, a certificate is issued by the accredited registrar.

Our experts are available on the following International standards for the mentioned countries:

1. ISO 9000 – Quality Management; 2. ISO  27000 – Information Security Management Systems; 3. ISO 14000 – Environmental Management; 4. ISO 31000 – Risk Management; 5. ISO 50001 – Energy Management; 6. ISO 26000 – Social Responsibility; 7. ISO 28000– Specifications for Security Management Systems for the Supply Chain; 8. ISO 37001 Anti-Bribery Management Systems; 9. ISO 45001 – Occupational Health and Safety; 10. ISO 22000 – Food Management Systems, HACCP, CE MARK, CMMI, HALAL, GDPR

Afghanistan, Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Austria, Austrian Empire, Azerbaijan, Baden*, Bahamas, The Bahrain, Bangladesh, Barbados, Bavaria*, Belarus, Belgium, Belize, Benin (Dahomey), Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Brunswick and Lüneburg, Bulgaria, Burkina Faso (Upper Volta), Burma, Burundi, Cabo Verde, Cambodia, Cameroon , Canada, Cayman Islands, The Central African Republic, Central American Federation*, Chad, Chile, China, Colombia, Comoros, Congo Free State, The Costa Rica, Cote d’Ivoire (Ivory Coast),  Croatia, Cuba, Cyprus,  Czechia, Czechoslovakia, Democratic Republic of the Congo,  Denmark, Djibouti, Dominica, Dominican Republic, Duchy of Parma, East Germany (German Democratic Republic),  Ecuador, Egypt, El Salvador,  Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia, Federal Government of Germany (1848-49)*,Fiji, Finland, France, Gabon, Gambia, The Georgia, Germany, Ghana, Grand Duchy of Tuscany, The*, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Hanover*, Hanseatic Republics*, Hawaii*, Hesse*, Holy See, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kingdom of Serbia/Yugoslavia*, Kiribati, Korea, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Lew Chew (Loochoo)*, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mecklenburg-Schwerin*, Mecklenburg-Strelitz*, Mexico, Micronesia, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Namibia, Nassau*, Nauru, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, North German Confederation*, North German Union*, North Macedonia, Norway, Oldenburg*, Oman, Orange Free State*, Pakistan, Palau, Panama, Papal States*, Papua New Guinea, Paraguay, Peru, Philippines, Piedmont-Sardinia*, Poland, Portugal, Qatar, Republic of Genoa*, Republic of Korea (South Korea), Republic of the Congo, Romania, Russia, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Schaumburg-Lippe*Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Syria, Tajikistan, Tanzania, Texas*, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Tuvalu, Two Sicklies*, Uganda, Ukraine, Union of Soviet Socialist Republics*, United Arab Emirates,  United Kingdom, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Württemberg*, Yemen, Zambia, Zimbabwe.

CE Mark 1

How To Get CE Mark Certification?

WHAT IS CE CERTIFICATE?

CE (“European Conformity”) Marking is a certification mark indicates that a product fulfils the requirements of relevant European product directives, safety health & environmental protection standards. The CE mark certified products can be affixed with CE Mark on the product or on the packaging.

WHY CE CERTIFICATION?

CE Marking on a product is mandatory to prove it meets the regulatory & safety requirements of the relevant Directive before it is placed in the market.

BENEFITS OF CE CERTIFICATION

  • Barrier free to enter European Market & also considered as trade passport
  • It builds confidence in the customer for to buy the products
  • Products are said to be safe and reliable

 

WHAT PRODUCTS NEED CE MARKING?

  • Medical Devices & Invitro Diagnostics
  • Active implantable medical devices
  • Appliances burning gaseous fuels
  • Lifts
  • Construction products
  • Pressure Equipment
  • Hot water Boilers
  • Simple pressure vessels
  • Electrical Equipment
  • Electromagnetic compatibility
  • Personal protective equipment
  • Noise Emission in the environment
  • Household refrigerators & freezers
  • Low Voltage & machinery
  • Measuring & Non-automatic weighing instruments
  • Radio equipment & telecommunications terminal equipment
  • Apex – Reproof
  • Safety of Toys
  • Restriction of hazardous substances in electrical & electronic equipment

CE Marking does not apply to items such as:

Limited Chemicals, Pharmaceuticals, cosmetics & Foodstuffs

GAINING CE CONFORMITY:

A full description of the conformity Assessment procedures and their associated requirements for a documented Quality management system. Details of the manufacturers tasks under each conformity module and the basic requirements for manufacturers of industrial products.

LIST OF DIRECTIVES – EU CE MARKING

1.         Machinery Directive – 2006/42/EC

2.         Low Voltage Directive – 2014/35/EU

3.         EMC Directive – 2014/30/EU

4.         Medical Devices Directive – 93/42/EEC

5.         Personal Protective Equipment Directive – 89/686/EEC (as of 21 April 2018 replaced by the  Personal Protective Equipment Regulation (Regulation (EU) 2016/425)

6.         Construction Products Regulation –  Regulation (EU) No 305/2011

7.         Pressure Equipment Directive – 2014/68/EU

8.         REACH – Regulation (EC) No 1907/2006

9.         RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU

10.       Waste Electrical and Electronic

Equipment Directive – 2012/19/EU

11.       ATEX Directive – 2014/34/EU

12.       Toy Directive – 2009/48/EU

13.       Radio Equipment Directive – 2014/53/EU

14.       Recreational Craft Directive – 2013/53/EU

15.       Active Implantable Medical Devices Directive – 90/385/EEC

16.       Explosive for Civil Use Directive – 93/15/EEC

17.       Noise Emission in the Environment Directive – 2000/14/EC

18.       Gas Appliances Directive – 2009/142/EC

19.       Lifts Directive – 2014/33/EU

20.       Pyrotechnic Directive – 2007/23/EC

21.       Measuring Instruments Directive –

2004/22/EC

 

 

STEPS INVOLVED IN CE MARK CERTIFICATION PROCESS FOR MEDICAL DEVICES

Stages Activity Responsibility Duration
Step 01 Appoint Medical Device Regulatory Consultant Client 7 Days
Step 02 Identify product standards and International standards Consultant + Client
Step 03 Determination of Intended use& Classification of MD & IVD Client 20 Days
Step 04 Production, Process, Sterilization, Environment requirements Consultant
Step 05 Risk Analysis Consultant + Client
Step 06 Identification of HARMONIZD Standards and Testing Laboratories Consultant + Client
Step 07 Collection of data related to device functionality and Shelf life Client
Step 08 Biocompatibility and sterilization related documents Client
Step 09 Clinical Evaluation Consultant
Step 10 Vigilance and Post market documents Consultant
Step 11 Technical File preparation Consultant
Step 12 Submission of Technical file to Notified Body Consultant + Client 45 Days
Step 13 Review of Technical file Notified Body 15 Days
Step 14 Supplementary Document Submission if requested by Notified Body Consultant + Client 60 Days
Step 15 Onsite Audit (ISO 13485 + MDD) NB + Client 02 – 04 Days
Step 16 Closure of NC’s Consultant + Client 02 – 04 Days
Step 17 Affix CE Mark Client

 

Medical Devices

ISO 13485 For Medical Devices Manufacturing

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Continuous innovation is key to the advancement of medical device technology. To allow for innovation, whilst also assuring safety and effectiveness, global standards are required. This article provides information for companies manufacturing medical devices on the benefits of holding ISO 13485 certification and how to get certified.

While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.)  This is because it does not follow the high-level structure (Annex L) of the latest version of ISO 9001 (which is 9001:2015). In addition, the documentation and safety requirements are much greater under ISO 13485:2016, whereas ISO 9001:2015 puts focus on customer satisfaction and continuous improvement.

This global standard is mandatory in some countries, and in the U.S. the FDA has proposed a rule which would harmonize U.S. FDA 21 CFR 820 with ISO 13485:2016, making ISO 13485 the FDA’s mandatory QMS for Medical Devices (the rule is expected to be released in 2019).  In the meantime, the medical device industry can rely on AAMI TIR102:2019, which is a bi-directional mapping tool that was released on August 30, 2019.

Medical support

Organizations involved in one or more stages of the medical device Lifecyle

  • Design and Development
  • Production
  • Storage
  • Distribution
  • Installation
  • ServicingSuppliers or External Parties who provide products to such Organizations
  • Raw materials
  • Components
  • Sub-assemblies
  • Medical devices
  • Sterilization services
  • Calibration services
  • Distribution services
  • Maintenance services

Our experts are available on the following International standards for the mentioned countries:

1. ISO 9000 – Quality Management; 2. ISO / IEC 27000 – Information Security Management Systems; 3. ISO 14000 – Environmental Management; 4. ISO 31000 – Risk Management; 5. ISO 50001 – Energy Management; 6. ISO 26000 – Social Responsibility; 7. ISO 28000: 2007 – Specifications for Security Management Systems for the Supply Chain; 8. ISO 37001: 2016 Anti-Bribery Management Systems; 9. ISO 45001 – Occupational Health and Safety; 10. ISO 22000 – Food Management Systems, HACCP, CE MARK, CMMI, HALAL, GDPR

Afghanistan, Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Austria, Austrian Empire, Azerbaijan, Baden*, Bahamas, The Bahrain, Bangladesh, Barbados, Bavaria*, Belarus, Belgium, Belize, Benin (Dahomey), Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Brunswick and Luneburg, Bulgaria, Burkina Faso (Upper Volta), Burma, Burundi, Cabo Verde, Cambodia, Cameroon , Canada, Cayman Islands, The Central African Republic, Central American Federation*, Chad, Chile, China, Colombia, Comoros, Congo Free State, The Costa Rica, Cote d’Ivoire (Ivory Coast),  Croatia, Cuba, Cyprus,  Czechia, Czechoslovakia, Democratic Republic of the Congo,  Denmark, Djibouti, Dominica, Dominican Republic, Duchy of Parma, East Germany (German Democratic Republic),  Ecuador, Egypt, El Salvador,  Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia, Federal Government of Germany (1848-49)*,Fiji, Finland, France, Gabon, Gambia, The Georgia, Germany, Ghana, Grand Duchy of Tuscany, The*, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Hanover*, Hanseatic Republics*, Hawaii*, Hesse*, Holy See, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kingdom of Serbia/Yugoslavia*, Kiribati, Korea, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Lew Chew (Lochia)*, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mecklenburg-Schwerin*, Mecklenburg-Strelitz*, Mexico, Micronesia, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Namibia, Nassau*, Nauru, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, North German Confederation*, North German Union*, North Macedonia, Norway, Oldenburg*, Oman, Orange Free State*, Pakistan, Palau, Panama, Papal States*, Papua New Guinea, Paraguay, Peru, Philippines, Piedmont-Sardinia*, Poland, Portugal, Qatar, Republic of Genoa*, Republic of Korea (South Korea), Republic of the Congo, Romania, Russia, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Schaumburg-Lippe*Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Syria, Tajikistan, Tanzania, Texas*, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Tuvalu, Two Sicklies*, Uganda, Ukraine, Union of Soviet Socialist Republics*, United Arab Emirates,  United Kingdom, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Württemberg*, Yemen, Zambia, Zimbabwe

Medical Devices Support image (1)

ISO 13485 Certification In India

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in India requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485:2016; Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

Medical Devices Support image (1)

ISO 13485 Certification In Saudi Arabia

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Saudi Arabia requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485 Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

Medical Devices

ISO 13485 Certification In Oman

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Oman requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

Medical Devices Support image (1)

ISO 13485 Certification In Iraq

 

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Iraq requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

 

HACCP

ISO 13485 Certification In Nigeria

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Nigeria requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

ISO 9001 certification in Iraq

How To Get ISO 9001 Certification In Algeria

ISO 9001 certification in Algeria is the most prominent management system standard. It is the quality management system standard developed and published by International organization for standardization. It is the most prominent certification among all other international standards. We are the leading ISO Consultants in Algeria. Qualitcert Provides ISO Certification in Algeria, Algeria, Annaba, and Oran like ISO 9001, ISO 27001, CE, ISO 14001, ISO 22000, ISO 45001, and HACCP. ISO 9001 confirmation is appropriate for all sizes and sorts of associations and is settled the world over as an important Quality Management System standard in Algeria. It is reasonable for associations in all industry divisions and will assist your association with improving administration procedures to contend locally and additionally universally in Algeria.

Get ISO 9001 Certified, Hire A Professional:

The first step towards acquiring ISO 9001 certification in Algeria starts with you giving Sterling International Consulting a call and engaging our ISO solution services. With our experienced, highly skilled and knowledgeable, as well as expertly trained ISO professionals; you can be sure that a thorough job will be done to put your company’s management and operations on the right track towards acquiring ISO 9001 certification in Algeria. We will do this by first subjecting your present management and operational procedures to complete scrutiny and then re-adjusting them to meet very high international standards for operational and management quality.

Our ISO certification services cover training, gap analysis, documentation, implementation assistance, internal audit, pre-assessment audit, assistance in selection of the ISO certification body and ensuring successful completion of the ISO certification audit.

Once your organization is ISO certified, we make sure that you continue getting benefits from our post certification services to continually improve effectiveness of the system and maintain compliance level required to ensure that the regular surveillance audits and recertification audit is completed without any problem.

We have provided our ISO certification related services to thousands of organizations across the world in the most cost effective manner in the most optimum time period resulting in an impressive 100% success rate for all the clients.

With us, you just don’t get an ISO certification but you get a management system that helps your organization its true potential by improving processes and performance.

Kindly contact us [email protected] to get your customized ISO certification programmer developed for your organization.

ISO 14001 certification in Iraq

How To Get ISO 14001 Certification In Algeria

 

Best ISO certification provider Qualitcert provides all the certifications of ISO ( ISO 9001, ISO 14001, OHSAS 18001, ISO 13485), HACCP Registration, CE Certification, VAPT testing. We help clients to maintain their system according to ISO standards so clients can improve their system and avail benefits. We are the leading ISO Consultants in Algeria. Qualitcert Provides ISO Certification in Algeria, Algeria, Annaba, and Oran like ISO 9001, ISO 27001, CE, ISO 14001, ISO 22000, ISO 45001, and HACCP. ISO 9001 confirmation is appropriate for all sizes and sorts of associations and is settled the world over as an important Quality Management System standard in Algeria.

Qualitcert services is a Professional ISO 14001 Consultant in Algeria, providing ISO 14001 Certification in Algeria, Erbil, Baghdad, Mosul, Bashar, Najaf, Karbala, Nasiriyah, Sulaymaniyah, Duhok, Kufa, Halabja the Assurance of Implementation, Documentation, Audit, Templates, Gap analysis, Services, training, Registration process at an affordable cost to all Industries of Environmental Management Certification in Algeria or EMS Certification in Algeria .

There are 10 Clauses in ISO 14001 certification in Algeria out of which the first three classes are non-auditable which are

  1. Scope this scope is nothing but the scope of the standard which specifies requirements of an environmental management system in a firm and says that needs to be demonstrated to show the ability of consistently providing services or product that meets the customers and statutory regulatory requirements and also improve the customer satisfaction level show the effective implementation of environmental management system into their firm which is nothing but by preventing ISO 14001 Certification Services in Algeria.
  2. Normative references the fundamentals and vocabulary of ISO 14001 normative references in whole or in a park samosas are like the date references cover edition references etc.
  3. Terms and definitions which states that terms and definitions of ISO 14001 needs to be defined for the purpose of this particular standard.

To know more about the Clauses and implementation of ISO 14001 in Algeria please contact www.kwalitycert.com expert Advisers and consultation providers will help you and implementing ISO 14001 in Algeria into your company and also will help you to get ISO 14001 certification inherit in a simpler easier and quicker way so what else are you waiting for go ahead and get yourself certified for ISO 14001 in Algeria.

Why to choose Qualitcert ?

  • Local ISO consultants in Major cities of Algeria to ensure you get all benefits of onsite and online consulting.
  • Experience in working with organizations of small-medium-large scale across various ISO standards. New industries have been benefited hugely due to the cost factor and quality delivered.
  • Industry specific knowledge of our ISO consultants in Algeria will optimize processes for your existing businesses.
  • Expertise in recommending the best cost-effective Certification Body to fit your needs. Thereby ensuring success to your ISO certification in Algeria.
  • Authenticated process and certificates are only issued, Our certificates are globally recognized and accepted.

Kindly contact us [email protected] to get your customized ISO certification programmer developed for your organization.