How can QMS Software Improve Profitability 1

How can QMS Software Improve Profitability


How can QMS Software Improve Profitability

Adopting a QMS or Quality Management System unfolds myriad benefits to an organisation while rewarding it with an almost definite rise in its profitability. However, besides requiring an active change in the employee’s mindset, implementing a QMS in an organisation involves a wide array of new procedures and processes. Here is where a QMS software comes as an effective tool for accomplishing an easy and smooth execution of an otherwise daunting task.


Strikingly useful features of QMS software

While supporting ISO 9001 prescribed standards, a QMS software provides a structured format to fit in all quality-related business operations. Typically, with its given features, a software can help businesses in the following ways:

  • It schedules key business activities such as process checks, administration maintenance, and Quality Quality tasks.
  • It serves as a centralised register for keeping records and inputs, such as customer feedback, complaints, accidents, staff suggestions etc.
  • It tracks improvement while providing documented evidence of task completion.
  • As an audit manager, it adopts a systematic approach to ensure execution of documented policies, procedures and processes.


How QMS Software Increases Profitability


Provides Quantifiable Data on Quality

One of the chief advantages of working with a QMS software is that you get quantifiable data on various aspects of Quality, on a regular basis. The data generated by the digital machine can be utilised by managers to suggest and instruct the staff on changes, as when and where they are required. The reports generated by the QMS software also bring into focus the progress achieved in tasks enforcement and lacunae which need to be looked into. With time as organisations learn to base their work on reports from data analysis, a definite quality culture shapes up. The regular monitoring and feedback provided by the software while reducing defects contribute to quality based output, thus furthering the company’s profits.


Ensures Customer Satisfaction

ISO 9001 specifications demand organisations to conduct their business operations in a customer-centric manner. A QMS software is equipped to monitor different facets of business processes, tasks and operations to ensure quality output. It provides the staff with easy measurements, analyses performances and keeps a safe account of all documents. In this all-encompassing way, the software ensures the user company to offer quality services and products to customers, which in turn furthers its profitability.


Promotes Organic Business Growth

By delivering satisfactory products and services, a company retains its existing customer base and also, in course of time, expands it. The older customers give referrals and create new ones for a company. Without a quality consciousness in its work, no organisation can attain business growth. The QMS software through its regular metrics and updates ensures a continual improvement in QMS. Maintenance of quality culture is imperative for higher profits


Helps Curtail Wastage

A QMS software helps an organisation maintain a documented with error log so that the managers can keep an eye on staff performance and also on the efficiency of the processes. The software gives out prompt notifications to indicate product defects and inefficiency in processes. This data should promptly look into check loopholes in services and production. Timely and routine checks can contribute to curtailing wastage in an organisation in a big way. Cutting down on costs is never a bad business idea!


Helps Improve the Tender Process

Since QMS software support ISO standards, they can be extremely useful for organisations aspiring for ISO certification. The certification is declarative of the compliance of its holder to international quality standards. ISO 9001 is recognised in more than 88 countries, while many business houses and suppliers across the world prefer to work with ISO certified companies alone. Bearing certification awards respect and a greater reputation to companies and helps them in passing their business tenders with relative ease. The business of an organisation, in the process, expands, leading to a wider profit base.



A QMS software is a valuable asset for an organisation. Its multifarious operations provide quantifiable data to measure performances, thereby keeping the management and workers on alert for delivering quality output. In, this way a QMS becomes an indispensable tool for furthering business and profits.

Dont ignore your customer complaints

Don’t ignore your customer complaints


Don’t ignore your customer complaints ‘Customer is the king’.  This adage holds more significance today in the business world than ever before. Businesses in all sectors have gone global and as a result, becoming fiercer by day. Hence, in a bid to keep your customers happy, your company needs to work extra hard. The pursuit requires customer needs and complaints to be realised and addressed on a regular and consistent basis. ISO 9001:2015 on its part mandates – “organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled.”

Develop an effective customer complaints management system

 Dealing with customer complaints is often pesky. However, if you deal with them in an organised manner, it would become an easier task to handle. The following set of strategies would be useful in devising a successful system:

  • Before putting your complaints handling system into effect, ask your team to do the required groundwork activities.
  • Devise a system that caters to the specific nature of customer complaints in your industry type. If you work with an automated system, make it user-friendly, encouraging customers to lodge their complaints elaborately.
  • Before the implementation of your complaint management system, prepare a document entailing a set of standard procedures to be followed. In due course of time, you should also record the complaints.
  • Your customer care executives should be trained adequately in handling the established procedures appropriately.
  • Weave in the process in your QMS ( quality management system) to enable the identification of opportunities for improving products and services.


Effective strategies to deal with customer complaints

For the complaints management system to work successfully, you would need to consider adopting the following measures:


Design a multi-channel communication system

The communication preferences of customers vary. So you need to develop a multi-channel communication system for them. Include in your system options such as writing in person, emails, telephone calls, online- chats and comments box. You should also outline the procedures your staff would follow to resolve the complaints and don’t forget to include the time-frame for resolution.  They should be mentioned in clear, concise and easy-to-follow language.


Set up an efficient internal complaint handling team

If your organisation is big enough, set up a separate team, assigning it the responsibilities of customer redressal. The staff should have clearly defined roles and be abreast with procedures for executing the remedial steps. While working on the complaints, you should collect all the relevant data, analyse them and wherever necessary seek the management’s help. Their resolution should also be put into the relevant records.

Make your system speedy

Given the fast-paced lives of people, your company should resolve customer complains as quickly as possible. The customer care team should be dynamic while dealing with the issues in hand. Depending on the nature of the case, take appropriate and prompt actions. Typically,  you would need to furnish an apology to the aggrieved customers or conduct face-to-face meetings. Make sure to make exchanges or refunds in the shortest span.

Subject your system to regular revision

The customer complaints handling system needs to work upon the QMS principle of continual improvement. A business operates upon dynamic factors and customer preferences also change rapidly with time.  Hence, it is necessary to revise your system periodically. Revisions also help in the evaluating its performance and making improvements wherever required.


Customer complaints give your company an opportunity for improvement. Hence, they are valuable tools for business growth. The success of an organisation rests critically on customer satisfaction. Their complaints, therefore require your complete attention.

Capturing your problem is the most important step in QMS


Capturing your problem is the most important step in QMS A new QMS or Quality management system in an organization overhauls to enhance its whole array of business activities. Its implementation, undoubtedly, is immensely challenging, while involving a radical shift in employees’ mindset and sprawling new investments. Every company possesses a unique set of quality-related problems which it seeks to address through QMS.  Therefore, it imperative that before implementing the new Quality solution, the top management captures its problems which require redressal. This act is advised to prevent a host of wastages over business time, efforts and resources.

Reasons why problem-capturing is essential

The discussion below attempts to make sense as to why the capturing problem is critical to QMS.

Helps set priorities, plans & goals

A QMS needs a well-defined structure, based on specific objectives, plans, and goals. The problem areas related to quality need to be highlighted so that QMS plans can integrate solutions for solving them. The overarching QMS then assumes a realistic base, while doing away things that are unnecessary. The employees can work with the QMS with more clarity and design result oriented action-plans, entailing processes and physical operations. When the entire workforce reckons the reasons for implementing QMS, their work gains more traction, ensuring quality output from its tasks.

Clarifies QMS operations

Once quality problems are defined, elaborate and effective quality plans and sub-plans can be mapped for a productive implementation of QMS. The vision for workers is thus clarified helping them produce better qualitative and quantitative results. A QMS plan offers solutions to problems by suggesting standard processes and practices. It also helps define processes, process owners, and the necessary tasks to capture data for quality metrics such as – Quality, Efficiency, Compliance, Maintenance, Reducing Production Costs etc.

Helps in continual improvement

When a QMS in part works specifically towards improving the lacking areas, it needs to look out for metrics and reports based on quantifiable data. A QMS software could be of immense help to an organisation to track its progress on various processes at different levels of operations and manufacturing. This, in turn help the management to scale the levels to which their existing problems are being solved, based on which future plans for improvement can be devised. Periodic reviews become an inherent part of QMS contributing to the cause of continual improvement.

Reviews and audits become more focused

An audit is an essential QMS tool to take stock of a company’s progress of its quality related activities. The awareness of the problem, sensitisation of staff over it and solutions-oriented tasks streamline QMS functioning. Hence, audits can be conducted with more clarity, with a special focus on assessing the progress of an organisation in areas where it’s weak – the problem areas. Their analysis helps the staff to see deficiencies in performance, and thereupon take corrective measures.

Gears up QMS towards better customer satisfaction

Any organisation that serves customers quality products and services ought to rise. On the other hand, if it ignores or fails to work upon the problematic quality areas would be unable to win customer trust. Hence, it is essential for a workplace to understand its specific quality weaknesses before the adoption and implementation of QMS. A system streamlined to work towards eradicating inefficient quality-related processes would eventually deliver output for better customer satisfaction.


Ignoring quality related problems or their inefficient handling by the QMS would only result in an inferior-quality yield, thus leaving customers wanting. In contrast, their effective dealing through a QMS would ensure customer satisfaction.  Hence, capturing problems is the most critical step before QMS implementation.

Latest Inspection Methods in Automotive Manufacturing

Latest Inspection Methods in Automotive Manufacturing


In the manufacturing sector, the automotive industry has always captivated the minds of customers the most.  From its shop floors, this robust industry regularly rolls out attractive new and most sophisticatedly designed vehicles for us to drive. However, in fiercely competitive market manufacturers can ill-afford to ignore rigorous inspections. Manufacturers always need to be on their toes while ensuring their makes remain free of even a minute defect, with respect to quality and safety. Much to their benefit, in their inspection tasks, the current sea-change advancements in computer and robotics technologies, while virtually turning facilities into smart factories, are proving to be their valuable aid.

Latest Inspection Methods

The factory floors of all the leading automobile manufacturers are today equipped with extremely sophisticated technologies to undertake the vital inspection operations. The chief methods, most of which are used from the initial to concluding stages of manufacturing as mentioned below:

Machine Vision (MV)

The Machine Vision technology uses computerised sensors and robotics application for inspection tasks. The key inspections performed by MV include:

  • Cosmetic flaws like dents, dings and wrinkles on body panels and functional flaws such as bearing surface irregularities of automotive rocker arms etc.
  • Spacing issues determination and mounting holes size checking on disk brake pads.
  • MV also verifies whether all parts are present at various stages of production. In the assembly line, it detects errors related to closure panels that include doors, lift gates, hoods, and tailgates.
  • It also indicates incorrect shapes of parts such as gears, which go toothless or with malformed teeth.
  • MV with the use of dimensional gauging looks into the of precision machined components like fasteners, transmissions etc and rejects parts outside the correct tolerances. find their way to into vehicles departing the assembly line.

Innovating Laser-based Robotic Inspection

This inline method involves inspection through 6-axis robot arms mounted on either side of the production line. With the help of laser rays, they are able to automatically inspect areas otherwise hidden the from the line of sight because of the doorframe or other body panels.

The robot can move around the laser-radar, guaranteeing collection of measurements of vehicle coordinate with precise accuracy. This data is feed into a software which processes it and gives instant reports. The addition of new vehicles styles in the future only needs a re-programming of the inspection plan.

Automated dimensional metrology

Automotive manufacturing companies are increasingly shedding off manual inspections in favour of optical metrology systems on robots in their plants.

For inspections. the advanced technology integrates thermal sensors with Coordinate Measuring Machines or CMMs for detecting temperature variations and applying corrections to the CMM in real time. The factory floor CMMs can be used in the production line, even under thermally unstable environments. The inline CMMs consist of highly automated systems which enable high-speed inspection of vehicle parts during manufacturing.

Barcode scanners

Barcode scanners are a part of the visual inspection itinerary which uses machine vision for reading 2D data matrix. This technology is employed for reading codes laser etched on automobile parts, They check if the right barcodes are passing in the supply chain from the cartons or as individual items. The scanners are typically linked to the database through software for checking and sorting purposes.


The automotive industry has drawn remarkable benefits from the advancements in the fields of computer software engineering and robotics. Companies are manufacturing near flawless automobiles to ensure comfort and safety of the customers. The role of inspection in this process remains critically indispensable. Further advancements in technology can only refine the existing methods of automotive inspection.

Why is a centralised system of documentation of utmost necessity

Why is a centralised system of documentation of utmost necessity?



Documentation is an integral as well as a vital part of all modern day business operations, irrespective of the industry type. Many internationally recognised initiatives – like ISO 9001 and ISO 14001 make it mandatory for companies to create, review and update on a regular basis. And business mavens advise that to gain control and best benefits out of the documents it is mandatory to place them under the mechanism of centralised documentation system. Organising documents under a single system of control allows for their easy access, assessment, and better security too. Large organisations which engage with big data are especially to benefit tremendously out of centralised documentation system.

Key benefits of a centralised system of documentation

The following discussion dwells upon the key benefits of working out a centralised system of documentation.

Provides better control over big data

A centralised documentation system is created with the primary aim of imparting meta-data with an overall mechanism of control. It involves customising high-level information of the documents. Categories are created based on information such as subject, priority levels or ISO elements. This system helps the management in keeping documents under one inter-connected digital network while allowing employees to search for information via filters and key-words.

Makes task execution easier and more effective

A centralized system of documents provides a superstructure from which the staff can pull out relevant data as and when needed. On a given task, for example, staff training – the trainers can source out the various documents related to training. The system also automatically defines a lot of trainees while updating the records. Employees thus can participate in activities such self-training through the streamlining of the process. The use of processed and rich data makes tasks more effective and productive.

Enables a more active and efficient collaboration

A centralised documentation system enhances awareness of employees on their tasks through updates notifications and reports on documents of various departments. This, in turn, facilitates greater levels of collaboration for tasks which are inter-departmental. This process makes collaborative faster and in real time while averting the long-winding routes of emails or phone calls. Collaboration is eased through integration using programmes such as Microsoft Office (Word, Excel, PowerPoint, etc.).

Increased visibility contributes to better decision-making

Providing visibility to data the centralised documentation system provides real-time insight into the dynamic process of documentation. The digitalised system offers regular and a variety of reports to highlight the progress of tasks under execution and the analysis of those completed. Armed with the knowledge of the current statuses of various projects decision-makers feel more confident about their business decisions.

Helps maintain continual quality improvement

A centralised system of documentation automatically streamlines all work-processes in the company. Managers have easy access to the latest data from one place, to which they can make suggestions for changes and modifications.The staff can then promptly look into and work upon areas that require new efforts. In this way, the workflow is streamlined while ensuring quality improvement in the organisation happens on a regular basis.

Provides better security to documents

An important feature of the centralised documentation of documents is security, which becomes all- important during collaborative tasks with external parties like suppliers.

A good document control system ensures security through data filtering and other security features. Based on the established rules the system filters or locks up data for the unnecessary parties, thereby keeping sensitive documents and data safe.


Documentation is a critical aspect of all modern day businesses. Its scope and need have been further emphasised upon by the latest changes in the ISO. For making its business prospects better, it is imperative an organisation gains complete control over its documents. For this purpose, it is best advised to opt for a centralised documentation control system at the earliest.

Which Production Metrics Must You Track To improve QMS 1

Which Production Metrics Must You Track To improve QMS


QMS or Quality Management System, with its array of metrics, is a valuable tool for organisations to determine and continually improve the quality of its goods and services. The ISO requires all organisations in all types of industries to comply with certain standards primarily with a view to catering adequately to customer’s satisfaction and adhering to environmental and safety standards. To check if your organisation is on the right side of QMS you need to check certain Production metrics.

Production Metrics you need to track

QMS calls for a continual improvement of the production processes, requiring organisations to keep a constant eye on visible production metrics. For the best quality improvements in your organisation, you could consider the following Production metrics which provide quantifiable data.

Metrics to Improve Quality

  • Yield: This metric calculates the percentage of correctly manufactured products in accordance with the standard specifications without any rework.
  • Customer Rejects/Return Material Authorizations/Returns: This is a measurement of the number of times customers rejected products and requested replacement owing to their low quality.
  • Supplier’s Quality Incoming: This refers to the percentage of satisfactory material for manufacture sourced from the supplier.

Metrics for Improving Efficiency

  • Throughput : This is the measure of the product being produced on the factory floor or on a machine or a line in a given period of time.
  • Capacity Utilization: is the measurement of the total manufacturing output capacity is utilized at a given point in time.
  • Overall Equipment Effectiveness (OEE) : Provides various metrics on machine or an entire production line. It is the product of Availability x Performance x Quality.
  • Schedule or Production Attainment: the metric pertains to measuring the percentage of time consumed in production within a specified schedule.

Metrics for Reducing Inventory

  • WIP Inventory/Turns: this is a radio calculation for measuring the efficient use of inventory materials derived from the cost of sold goods by the average cost of inventory utilised for their production.

Compliance Metrics

The compliance metrics drive the firm towards better adherence to the mandatory rules and regulations of different authorities. These include the measurement or an account of :

  • Reportable Health and Safety Incidents : A measure which accounts the number of health and safety related incidents in the factory or plant in a given period of time.
  • Reportable Environmental Incidents : A measure of the number of adverse environment- related incidents that were recorded as occurring over a period of time.
  • Number of Non-Compliance Events / Year : this metric entails measuring and documentation of events during production that violated the existing regulatory compliance within a period of a year. The details of the reason. Time and their resolutions need to be mentioned also.

Reducing Maintenance Metrics

This includes :

  • Percentage Planned vs. Emergency Maintenance Work Orders
  • Downtime in Proportion to Operating Time

Increasing Flexibility & Innovation

The New Products Introduction (NPI ) metric reflects how well a company is at striking and exploiting markets with its new products. The automation and electronics sector is especially known for utilising this metric to gauge their standing in the competitive market environment. This can be assessed with the help of –

  • Rate of New Product Introduction
  • Engineering Change Order Cycle Time

Reducing Costs & Increasing Profitability

This metric includes the following:

  • This can be calculated with a host of metric that include
  • Total Manufacturing Cost per Unit Excluding Materials
  • Manufacturing Cost as a Percentage of Revenue
  • Net Operating Profit
  • Productivity in Revenue per Employee
  • Average Unit Contribution Margin.
  • Return on Assets/Return on Net Assets
  • Energy Cost per Unit
  • Cash-to-Cash Cycle Time
  • Customer Fill Rate/On-Time delivery/Perfect Order Percentage


QMS is a valuable tool in organisations for observing and furthering the culture of quality. It is imperative, then, that management tracks the right Production metrics for attaining quality that comply with safety standards and customer satisfaction.

Setting up a Pharma Unit What latest Quality Management systems should I follow 1

Setting up a Pharma Unit? What latest Quality Management systems should I follow?


If you are embarking on a venture of setting up a pharma unit, it is imperative that you beforehand understand the vital needs and functions of a pharmaceutical quality system. Today, quality consciousness for all products is rife among customers. When it comes to the pharmaceutical industry, expectedly the need to deliver quality assumes paramount importance.

Pharma products directly affect people’s body and health. Hence, in a bid to ensure quality and safety standards, regulatory bodies like the FDA exercise rigorous and continual surveillance over their manufacturing. Additionally, the International Conference on Harmonization provides internationally harmonized guidance to pharmaceutical companies. ICH Q10 demands a quality management system ( QMS) for the Registration of Pharmaceuticals for Human Use and USFDA. If you seek to establish a pharmaceutical manufacturing unit and achieve success, remember you cannot do it without a robust QMS.

Latest QMS you should follow

Your QMS should be based on the guidelines of the latest pharmaceutical quality system which is internationally recognised and accepted. The International Conference on Harmonization (ICH), a joint initiative of Regulators and Research-based bodies spanning Europe, Japan and the US has devised standards and procedures for the pharmaceutical industry for attaining quality excellence in their products and services. Its chief aim is to ensure production based on – Safety, Quality and Efficacy. ICH 10 expounds a QMS model guided by the International Organization for Standardization (ISO) standards. The model encompasses and addresses critical quality concerns like good manufacturing practice (GMP), and complements regulation while emphasising on innovation and continual improvement during the entire length of the production cycle.

At the basic level, your pharma unit’s QMS should accomplish:

a) A proper system of infrastructure outlining the organizational structure, procedures, processes and resources

b) A set of systematic actions for contributing to the eventual delivery of quality based, customer-satisfactory products and services. This system will aid your QMS staff in performing Quality Assurance functions smoothly and efficiently.

Key Functions of a Pharmaceutical QMS

A pharmaceutical company is engaged in the manufacturing and sale of biotechnology and biological products. Your manufacturing processes would require constant and several layered quality checks at each stage and at all levels of the product lifecycle.


a) APIs development and manufacture

b) For investigations manufacturing of medical kits and devices

c) An efficient medical delivery systems

d) Pilot plant activities

f) Development of the essential medical devices for measuring accurate dosing

Analytical – manufacturing-related

a) An effective system of checks for acquisition and control of materials

b) Adequate provision of facilities and equipment

c) Production-related to including packaging and labelling

d) Storage at the stage of product technology transfer

e) Testing and quality assurance mechanism

System for product discontinuation

a) Sample retention and maintenance of documents

b) Continual assessment of products and reporting

Quality Management System in Testing Laboratories

While abiding by the ISO mandates on risk and safety, your laboratory staff would need to align its testing activities in line with them. Keeping the end-user in mind the pharmaceutical companies should possess a well-equipped laboratory manned by qualified, trained and skilled medical professionals. The staff is obliged to offer rigorous testing for all the company products and services before they are packaged for market.


Given the nature of their needs, the products and services of the pharmaceutical sector need to manufactured and provided under stringent regulations. Commonly, legal actions are taken against non-compliant firms. Hence, if you are to set up a pharma unit, keep quality production as your top-most priority. And, it goes without saying the purpose cannot be achieved without the presence of an active, alert and robust quality management system.


What’s most difficult while implementing a QMS system

What’s most difficult while implementing a QMS system


QMS or Quality Management System entails and demands from organisations systematic and continual processes of improvement on the quality front. Keeping customers requirements in mind, it encourages organisations to prevent avoidable errors, adverse outcomes and reduction of waste during production.

Auditing – Most Difficult While Imposing QMS

QMS draws it guidelines on ‘quality’ from the standards entailed in ISO 9000: 2000, the latest ISO QMS version. This version is both expansive and exhaustive, thus, posing tenuous challenges to the companies for its fulfilment. The principles and standards of the version are adapted to the new and ever-changing international markets, businesses, and socio-cultural and political conditions of the day. Implementation of ISO in the newer context demands arduous efforts. Most organisations face maximum difficulties in the auditing process. Auditors need to evolve their own unique techniques since no definite method serves as the necessary recipe for their successful implementation of QMS.

What makes Auditing Daunting?

Auditors are placed in sensitive positions charged with maintaining or changing perceptions about their company. Their job while drawing up QMS audits need to be based on the following standards.

Auditing requires new mindset

The expansive scope of standards ISO 9000: 2000 demands newer approaches and style of work from the auditors, stemming from the rather drastically different mindset. In adherence to IAF (International Accreditation Forum) auditors need to constantly work in tandem with numerous certification bodies and registrars, which make new laws and regulations on safety, environment etc from time to time. Companies need to abide by them and provide evidence-based audits the the concerned authorities.

Requires regular and rigorous communication

Auditors need to work with a range of sections in the organisation, which also includes the two extreme ends of the spectrum – the top management and board of directors, and, the shop-floor workers. They have to undergo appropriate training to imbibe intellectual potential and socio-cultural sensitivity to accomplish successful communication. Collection of relevant data and feedback for audits entail vibrant interactions with the relevant departments.

Audits needs are expansive and complex

  • On Governance and Corporate Responsibility

Conformity assessment has significantly broadened for all organisations calling upon compliance with the latest ISO Quality standards. Auditors need to document with evidence the performance of the organisation on governance and corporate responsibility. Auditing principles mentioned in ISO 19011:2000 demand ethical conduct, independence, fair presentations and evidence-based approaches. Continual review of these principles assures quality and to attain it auditors have to have their toes on the track relentlessly.

  • On Practice of Environmental Standards

Environmental laws and regulations have become stringent for manufacturers worldwide, which find their expression in the latest quality management principles of the ISO version. Auditors through their reports establish how the overall results of the output align with the environmental friendly practices in the factories and plants. A positive report is critical for gaining conformities.


The socio-cultural, political and business context of commerce is always in a state of flux. However, in the flux what remains fixed in the heart of all the practices is Quality. ISO 90001 (quality) and ISO 14001 (environment) have brought forth new challenges to enterprises, especially to their auditing teams.

An active and dedicated auditing staff is required to implement the QMS principles so that their organisations attain the desired standards as spelt out by the ISO. Amongst other factors, organisations require impressive audits for their success.

Why is a quality management system is mandatory in the Pharma Industry

Why is a quality management system is mandatory in the Pharma Industry?


The operations of the pharmaceutical industry are subject to strict regulations as it serves people directly for their health reasons. More than the products of any other sector, the pharma produce needs to be reliable on various parameters. Quality experts emphasise on the adoption of the quality management system (QMS) by the pharma firms in compliance with the ISO 17025  to deliver standard medical products to customers. Implementation of a robust QMS is mandatory for a pharmaceutical company. The QMS must factor in all conformity standards set up by regulatory bodies like the FDA, ensuring the delivery of safe and healthy products to customers.

Essential features of QMS in the pharma sector

In order to be effective, the QMS of a pharmaceutical company should incorporte the following features:

Organizational structures

Before implementing a QMS, a pharma company should work towards getting legally recognized. To make the QMS effective, the organization should have a structure congenial and supportive of its implementation. For standard compliance, the laboratory needs to well-equipped and staffed with skilled technicians. For monitoring the lab’s activities, the company must appoint a Technical manager with a well-defined role and set of responsibilities. The executive should have direct access to the management to keep it informed about the critical activities.

Technical staffing

It is of critical importance for organisations to man their labs with well qualified and skilled technicians, whose activities are monitored by a medico-quality expert. The staff should be well-versed with the handling of different types of equipment, sample testing, issuing test reports based on rigorous analysis.

Effective system of Documentation

Documentation is critical for the successful functioning of a QMS. It is a mechanism to standardise procedures for the manufacturing and testing tasks. It also serves as a basis for monitoring the quality system in the company. Good documentation should comprise a hierarchy of essential quality-related documents, the most important of them being Quality manual, which details out the policy, structures of the laboratory, procedures, and the technical and administrative responsibilities of the staff for the execution of the QMS.

Document Control

It is essential for all pharma companies to exercise rigorous control over their documents, both internal and external. The set of measures encompasses tasks on documents creation, amendments, reviews, approvals, distribution and their archiving. For observing continual improvement latest versions of documents based on compliance standards should be furnished to the technicians and testers and hence, their data should be validated by electronic records and automated data-capture systems.

Regular Audits

An audit is a systematic, independent and documented process undertaken by an organisation to obtain evidence for performance evaluation. The main objective is to asses to what extent the staff has been successful in fulfilling its audit criteria. All companies conduct two types of audits, internal and external. For these audits the quality staff should make all its quality documents readily available.  The management should clearly define for its staff the criteria, scope and objectives of the audits.

Corrective and Preventive Action

The onus lies with the erring organisation to delve into an investigation to determine the root cause of non-compliance or failure. Once the reasons are unravelled, corrective action needs to be undertaken promptly. After the resolution of non-conformity issues, the staff needs to devise measures to ensure a similar problem doesn’t arise in the future.

Complaints and Feedback

Customer complaints and feedback help pharmaceuticals to assess their the laboratory performance and effectiveness of their products. Hence, the QMS should develop a system to document, evaluate and conduct prompt follow-up actions. The staff should follow the standardised procedures to resolve customer complaints promptly.


Pharmaceutical organisations can produce quality products if they are under the reign of an active and effective QMS. Organisations dealing in manufacturing, testing or storage of drugs and other health-related medicines need to keep a constant watch on the quality of their products. Conformity to regulations and standards of international authorities make it mandotory for pharma firms to invest in a good QMS.

Whats new with IAFT 16949

What’s new with IAFT 16949



IATF 16949 entails a set of quality system standard for the automotive industry based on ISO 9001 with an emphatic focus on customer specific requirements. It demands from the automotive sector compliance with a process-oriented quality management system that provides for continual improvement and defect prevention. A  development and replacement over SO/TS 16949, IATF 16949 came into effect by the initiative by the Automotive Industry Action Group members. Seeking to be interdisciplinary in its approach, the new certification brings in fresh elements related to risk management, customer satisfaction, leadership, and process. The chief driving force behind IATF 16949’s development has been risk-control to imbue more confidence in manufacturers on products they work with.

What’s changed?

The discussion below discusses the significant changes brought about by IATF 16949 in quality system standard for the automotive industry.

Increased documentation

Documentation is an integral part of quality management systems for all organisations, irrespective to the industry they operate in. In the automotive industry, more so, the quality system holds a paramount importance as it entails standards on safety too. Rightly, then, under IAFT guidelines organisations, a larger emphasis is laid on documentation.

Companies are required to maintain documented evidence and documentation work on the following:

  • From the quality management systems of the suppliers, a conformance to statutory and regulatory requirements is demanded
  • A continuous review of engineering standards used and changes across product lines should be documented.
  • Documentation of the supplier selection process for the purpose of assessing risks and maintaining product quality conforming to customer specifications.
  • Standardization of work at all levels of operations. This would include -instructions on product verification, in-process checks and shutdown verification.
  • Risk assessments should be documented, along with the analysis and their mitigation. This assessment needs to be carried out at all levels of the organization and at all levels of production.

Introduction of customer-specific requirements

ISO/TS 16949 had as its focal point organization’s requirements. But with IATF 16949 things have changed with its standards being customer-centric. To determine how well organisations are meeting the standards, they are now required to conduct audits around customer specifications and requirements. Customer needs and satisfaction, thus, acquires a centre-stage in the quality related actives of an automotive company.

Emphasis on Accountability and Safety

IATF 16949 standards have widened the scope of QMS or Quality Management System of an organisation, weaving in standards dealing with accountability and safety in a wider and a more rigorous manner. It makes it mandatory for organisations to implement policies on Corporate Responsibility, encompassing anti-bribery rules, mandatory codes, and ethics escalation policies.

Risk awareness and analysis

IAFT standards expound stringent policies on safety. As per them the automotive manufacturers and suppliers are mandated to incorporate risk management at levels of their quality system, including CAPA and FMEA. All employees should be adequately sensitised and trained to adhere to these standards in their daily tasks and operations. Non-conformity could call for adverse action from authorities and bad publicity too.


IAFT 16949 is a step in the right direction. It has rightly determined customer specifications, safety and ethical conduct to be an integral part of business operations. Its certification, therefore, holds much credibility. Organisations aspiring for it should work towards imbibing its standards in a sincere and methodical way. Although IAFT 16949 emphasises on customer specifications, eventually, those organisations adhering to its standards would find their way to business prosperity.