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In this article we outline some advice for those people working in the Pharma sector who are facing the daunting task of starting a new QMS for the first time.

Starting a new QMS – the Macro overview

In the first instance, when starting a new QMS, a macro overview needs to be taken.  You will need to decide what is to be embraced within the system – the scope of the system.  Within an organisation this could either be a product or service scope (the system will only embrace particular products or services) or a process scope (the system will embrace these processes).  Ideally we will decide on the product/ service to be covered and then, what processes related to that product or service will be embraced (ISO 9001 – clause 4.1). 

In deciding the process coverage we should be mindful not just of the manufacturing or service provision process itself but also those processes that would impact upon it and/ or those processes upon which it depends, thus creating an embracing system rather than an insular one.   In completing this analysis we should also be aware of any required or impacting outsourced processes such as distribution or engineering or laboratory support.

The Product or Service Process overview

The next stage in starting a new QMS is to establish the necessary core processes related to the provision of that product or service – an iterative loop of interdependent processes could be established for each product or service offered.

All products or services provided require customers and all systems require an exacting and well defined customer focus (ISO 9001 – clause 7.2).  For the products or services chosen within the system we need to consider how we gain these customers, look after their orders, maintain communication with them and feed their orders into the system.  Customers could, of course, be internal customers.  In the first instance the system requires a strong external customer focus, without these customers there would be no demand for the product or service.  Consequently the often neglected Customer Service or Sales & Marketing process/ department are an integral part of our whole system.

We then need to establish how the product or service will be programmed or planned (ISO 9001 – 7.1) into the system and be aware of what may need to be purchased (ISO 9001 – 7.4) to achieve the product realisation.  And so we see the importance of both the Planning and Purchasing processes.

On receipt of purchased product we will need to ensure adequate processes for the inspection, handling and storage of incoming materials (ISO 9001 – 7.4.1 & 7.5.5) – an incoming inspection process.

We will then need to ensure that the product or service provided is realised under controlled conditions (ISO 9001 – 7.5.1).  This could be the manufacturing process itself, which should be monitored throughout (ISO 9001 – 8.2.4) the product realisation process.

Finally, in the case of a manufactured product, we will need to store and preserve the product (ISO 9001 – 7.5.5).  Perhaps in a distribution warehouse, prior to despatch to the customer, a despatch process and one that should liaise with the initial customer service process informing them of such despatch. Customer services would then monitor delivery progress and seek the customer’s perception (ISO 9001 – 8.2.1) of the product or service delivered.

An iterative process itself and one which, rather than linear, is a loop of activities, beginning and ending with Customer Services and which would be pertinent for all products and services provided by the system. 

Core ProcessesISO Clause
Customer Service / Sales & Marketing process7.2
Planning process 7.1
Purchasing process7.4
Incoming Inspection process.7.4.1 & 7.5.5
Product Realisation process7.5.1
Despatch process7.5.5
Customer Service process8.2.1

Essentially we have defined the Core Processes that relate to each of the products and services offered and we would do well to document these processes and linkages within a Quality Manual (ISO 9001 – 4.2.2) or the like. 

The product or service process internal workings

Having gained this process overview the next stage in starting a new QMS would now be to control and manage the internal workings of each process.  In doing this we need to be aware of the mechanics of process operation and the fact that each process comprises inputs, a transformation activity and outputs.

Each process within our system has inputs and the principle input requirements are outlined below.  These would be generic considerations for each of the processes identified at section 2 (above). 

InputsISO Clause
The process trigger and interaction with the internal supplier4.1b
How the process is controlled4.1c & 7.5.1
Process objectives5.4.1
Process planning7.1
Legal / legislative requirements related to the process7.2.1c
Preventive mechanisms / risk assessment for the process8.5.3

In similar vein we acknowledge that each process has outputs, these often directly forming the input into another process.  The principle output requirements may be identified.  Again, these would be generic elements related to each of the processes identified earlier in section 2. 

OutputsISO Clause
The process interaction with the internal customer4.1b
Achievement of objectives5.4.1
Internal customer focus8.2.1
Process monitoring and measurement8.2.3
Process data analysis8.4
Non-conforming product or service8.3
Corrective action8.5.2
Continual improvement8.5.1

These elements, related to inputs and outputs, are crucial if two of the premises of our QMS design are to promote efficient operation and continual improvement.

Mechanisms, such as Departmental Purpose Analysis and/ or Process & Quality Improvement Teams may be employed to analyse process interaction (ISO 9001 – 4.1b) and the meeting of internal customer requirements.  Additionally, it is critical that we review the process performance (ISO 9001 – 8.2.4).  This can only be achieved through on-going monitoring and analysis of data (ISO 9001 – 8.4) and such review needs to be conducted in terms of both effective and efficient operation with associated objectives, metrics and Key Performance Indicators.

As a result of such monitoring we can identify non-conforming product or service (ISO 9001 – 8.3), put in place corrective actions (ISO 9001 – 8.5.2), that will prevent recurrence of the failing and thus, in a reactive manner, promote continual improvement (ISO 9001 – 8.5.1).  This reactive stance, when combined with the more proactive identification of preventive mechanism inputs, would enable a two-pronged approach to the promotion of continual improvement.

As well as inputs and outputs each process has related transformation activities.  These largely relate to effective operation within the actual process and, again, can be viewed generically and can be related to any process. 

Transformation ActivityISO Clause
Document control4.2.3
Record keeping4.2.4
Roles and responsibilities5.5.1
Internal communication5.5.3
Training6.2.1 & 6.2.2
Work environment and infrastructure6.3 & 6.4

Within any process and critical to effective operation will be our mechanisms related to document and record control (ISO 9001 – 4.2.3 & 4.2.4), the adequate delineation of roles and responsibilities (ISO 9001 – 5.5.1) as well as appropriate internal communication (ISO 9001 – 5.5..3) and training (ISO 9001 – 6.2.1 & 6.2.2).  Of course the maintenance of a suitable work environment and infrastructure (ISO 9001 –6.3 & 6.4) is crucial as is the identification (ISO 9001 – 7.5.3) of the product or service as it moves through this transformation phase.

And so, in the transformation activity stage of starting a new QMS we have begun to identify supporting systems – elements that support the transformation of inputs into outputs.

Allied to this identification of course may well be additional supporting processes such as Engineering, Documentation, Human Resources, Information Technology, Quality, Laboratory Services and Finance.  Each with their own inputs, outputs and transformation activity and the management of these supporting  core process interactions is critical if we are to operate efficiently.

Over-arching Systems

To date in starting a new QMS we have been concerned with the identification of the scope of our system, the clarification and documentation of the processes within that scope and the mechanics of each process operation – the latter being set down in terms of required inputs, outputs and transformation activity.

There are though certain over-arching systems that we should ensure are in place.  The first related to the role and remit of management within the system (ISO 9001 – 5.1), it is after all their system and they rely on it and are responsible for it. 

Over-arching Systems – ManagementISO Clause
Policy and direction5.3

Management review

Results of audits

Customer feedback

Process performance and product conformity

Status of preventive and corrective actions

Changes that could affect the system

Recommendations for improvement

5.6.1 & 5.6.2

The whole system will require a sense of direction, a sense of purpose, leadership (ISO 9001 – 5.1).  This provided by management and the establishment of policies and objectives (ISO 9001 – 5.4.1) which, in turn, can then be cascaded to the individual departments or processes.  Without this whole sense of system purpose the processes that it comprises will attempt to work in a vacuum. 

Similarly the system will not function effectively unless it is allocated appropriate resources (ISO 9001 – 6.1), this in terms of both human and physical resources and mechanisms need to be established which plan and prioritise the allocation of such.

Review mechanisms (ISO 9001 – 5.6.1 & 5.6.2) will also need to be established.  Whilst these may be established at different levels within the organisation they should be designed to ultimately feed into a top management review and embrace the results of audits (all audits – both external and internal), customer feedback (both external and internal), the results of process performance and product conformity monitoring and the status of preventive and corrective actions.  Importantly such review should also be forward-looking and consider changes that could affect the system in the future (such as supplier changes, operational changes, regulatory changes and so on) and, finally, the reviews should consider any recommendations for improvement.

Finally, when starting a new QMS, our system should include any necessary elements of Good Manufacturing Practice, Good Distribution Practice and so on where necessary.

Quite a challenge! Share your experences using the comments section below.

This article is based on an extract from Module 2 of our Pharma and QP QMS courses.

Our 5-day GMP Pharmaceutical GMP Auditor/Lead Auditor Training Course may also be of value in this area.

You can aslo visit our QMS collection of videos on the Vimeo platform.


Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

Our 2-day course is updated for Annex 1 changes

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