"Contract Manufacturing" - How to review the existing ISO14001 documents

S

Sundaramurthi

#1
:rolleyes:Dear Friends,

I need your help....

Our organisation is ISO 14001 registered. We got certification in 2008 and seen one surveillance audit.

We have EMS surveillance audit ahead..... I need your help to explain how to include the following cases in to our existing ISO 14001 documents.

Case 1:
During the year 2009 after the EMS surveillance audit, we offered permission to a party for "Contract Manufacturing".

The contract manufacturer's product is different from our's.

The contract manufacturer have completed their manufacturing facility installations, procured raw materials and imported finished products that they manufactured in their own country and stored at our site. But so far they have not started their manufacturing process.

Case 2:
Our company has started expanding its product spectrum to includue manufacturing of new product the company has partially completed its installations during the last EMS surveillance audit. The installation for the new product manufacturing came to complition 2 months before and a first trial batch was manufactured 2 months before.


Now pls. explain me how to review my existing ISO 14001 document inview of the above explained two cases.

Regards,

S.Sundaramurthi
 
Elsmar Forum Sponsor
S

samsung

#2
You need to respond favourably to the changes made or introduced into the existing system. You may need to :

1. Review your existing environmental policy to see if it's still relevant & appropriate to your business. If not, revise it accordingly.

2. Evaluate the significance of the environmental aspects associated with the new processes and products and state how the impacts will be mitigated or controlled.

3. Also review the significance level of existing aspects lest it should escalate with the introduction of new processes/ products.

4. Evaluate if the employees are competent enough to manage the environmental impacts of the 'changes' introduced into the system. If not, get them trained to enhance their competence.

5. Check the applicability of any additional legal / other requirements to and how they are linked to your significant aspects.

In short, you need to review the entire EMS and compare the outcome against the requirements. If gaps are observed, they must be fixed.
 
Thread starter Similar threads Forum Replies Date
C Contract Review Template for an Inspection, Repair and Manufacturing Facility wanted Document Control Systems, Procedures, Forms and Templates 2
S Contract Review Procedure for a Manufacturing Business Contract Review Process 2
N Contract Review Question - China manufacturing site to exclude 7.2.2? Contract Review Process 6
N Contract Review Consolidation - Two different manufacturing sites Contract Review Process 2
M Contract Review Process - Risk Analysis - 7.2.2.2 Manufacturing feasibility Contract Review Process 4
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
Ed Panek Moving from Contract Manufacturing to Production In-House ISO 13485:2016 - Medical Device Quality Management Systems 3
S 21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing Other US Medical Device Regulations 1
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Q Converting Manufacturing Drawings from a Contract Supplier ISO 13485:2016 - Medical Device Quality Management Systems 7
Ajit Basrur Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing? Other US Medical Device Regulations 1
R Contract Manufacturing - OTC (Over the Counter) vs Prescription Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
D TS16949 & Design Responsibilities of a Contract Manufacturing Factory IATF 16949 - Automotive Quality Systems Standard 1
F Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J How to structure a DHF when all manufacturing is done by Contract Maufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J How to change the Manufacturing Site to another Contract Manufacturer Japan Medical Device Regulations 1
P Generic Contract Manufacturing of Generic Prescription Medications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
N Special Contract Manufacturing or 510k Licensing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Role of Qualified Person (QP) in Contract Manufacturing Pharma Business Quality Manager and Management Related Issues 2
M Tainted wipes maker Triad sues contract manufacturing customer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Sub-Contract Manufacturing of a Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Sample Manufacturing Plan or Template for Medical Device Contract Manufacturer Document Control Systems, Procedures, Forms and Templates 5
R 7.2.1 Customer Requirements Checklist for a Small Contract Manufacturing Machine Shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
G Medical Device Contract Manufacturing Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
I Contract Manufacturing Company - What does contract manufacturing company mean? Other Medical Device and Orthopedic Related Topics 4
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Requirements of Contract Manufacturing in respect to GMP? ISO 13485:2016 - Medical Device Quality Management Systems 13
E Environmental Screening of PCBAs in High Volume Electronics Contract Manufacturing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
C Contract Manufacturing of Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 11
T Electronic Industry Contract Manufacturing - Customer notification needed? Supplier Quality Assurance and other Supplier Issues 1
Scott Catron Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
M Industry DPMO Standards - Contract Electronics Manufacturing processes Statistical Analysis Tools, Techniques and SPC 2
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 0
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Similar threads


















































Top Bottom